Back to resultsTargeting Insomnia in School Aged Children With Autism Spectrum Disorder (RECHArge)
Primary Purpose
Insomnia Chronic, Autism Spectrum Disorder
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
In-Person CBT for insomnia in children with autism
Remote CBT for insomnia in children with autism
Remote sleep hygiene and related education (SHARE) for insomnia in children with autism
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia Chronic focused on measuring cognitive behavioral therapy, behavioral therapy, children
Eligibility Criteria
Inclusion Criteria:
- 1) 6-12a yrs
- 2) Verbal IQ >= 70
- 3) participation of child's parent or legal guardian living in the same home
- 4) parent/guardian ability to read and understand English at the 5th-grade level
- 5) child diagnosed with ASD and insomnia
ASD:
- 1) previous DSM diagnosis of ASD
- 2) evaluation using gold-standard diagnostic tools (i.e., Autism Diagnostic Observation Schedule (ADOS) and/or Autism Diagnostic Interview-Revised [ADI-R])
Insomnia:
- 1) complaints of difficulties falling asleep, staying asleep, or early morning awakening by child report or parent observation for 3+ mos
- 2) daytime dysfunction (mood, cognitive, social, academic) due to insomnia
- 3) baseline diaries and actigraphy indicate >30 mins. of sleep onset latency, wake after sleep onset, or early morning awakening (time between last awakening and out of bed time) on 6+ nights
Exclusion Criteria:
- 1) parent unable to provide informed consent or child unable to provide assent
- 2) unwilling to accept random assignment
- 3) participation in another randomized research project
- 4) parent unable to complete forms or implement treatment procedures due to cognitive impairment
- 5) untreated medical comorbidity, including other sleep disorders (e.g., apnea, epilepsy, psychotic disorders, suicidal ideation/intent, [frequent] parasomnias)
- 6) psychotropic or other medications that alter sleep with the exceptions of stimulants, sleep medications, and/or melatonin as described in #7 (see Notes below for details)
- 7) stimulants, sleep medications (prescribed or OTC), and/or melatonin within the last 1 month (unless stabilized on medication for 3+ months)
- 8) participation in non-pharmacological treatment (including CBT) for sleep outside current trial
- 9) parent report of inability to undergo Holter Monitoring or actigraphy (e.g., extreme sensitivity, behavioral outbursts)
- 10) other conditions adversely affecting trial participation
Sites / Locations
- Thompson Center for Autism and Neurodevelopmental DisordersRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
In-person CBT for insomnia in children with autism
Remote CBT for insomnia in children with autism
Remote behavioral SHARE for insomnia in children with autism
Arm Description
In-person cognitive-behavioral treatment (CBT) for insomnia in children with autism will be conducted at the Thompson Center. In-person treatment will consist of four 50-minute, individually administered sessions and four bi-monthly, 20-minute telephone boosters. Using a flexible, case conceptualization approach, the therapist will adapt the treatment to parent and child characteristics (i.e., verbal skills, development) and family situation/dynamics - promoting optimal efficacy and enhancing broad clinical applicability. Module administration order will be tailored to prioritize each child/family's most pressing sleep concerns based on the clinical interview.
Remote/videoconferenced cognitive-behavioral treatment (CBT) for insomnia in children with autism will be conducted from home (families)/Thompson Center (therapist). Remote treatment will consist of four 50-minute, individually administered sessions and four bi-monthly, 20-minute telephone boosters. Using a flexible, case conceptualization approach, the therapist will adapt the treatment to parent and child characteristics (i.e., verbal skills, development) and family situation/dynamics - promoting optimal efficacy and enhancing broad clinical applicability. Module administration order will be tailored to prioritize each child/family's most pressing sleep concerns based on the clinical interview.
Remote/videoconferenced behavioral sleep hygiene and related education (SHARE) for insomnia in children with autism will be conducted from home (families)/Thompson Center (therapist). Remote treatment will consist of four 50-minute, individually administered sessions and four bi-monthly, 20-minute telephone boosters. Using a flexible, case conceptualization approach, the therapist will adapt the treatment to parent and child characteristics (i.e., verbal skills, development) and family situation/dynamics - promoting optimal efficacy and enhancing broad clinical applicability. Module administration order will be tailored to prioritize each child/family's most pressing sleep and related health related concerns/interests.
Outcomes
Primary Outcome Measures
Baseline Average Objective Sleep Efficiency for the child
Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity
Change in Average Objective Sleep Efficiency for the child from baseline to immediately after the intervention
Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity
Change in Average Objective Sleep Efficiency for the child from baseline to 6 months
Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity
Change in Average Objective Sleep Efficiency for the child from baseline to 12 months
Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity
Baseline Average Bed/Waketime Variability for the child
Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity and daily diary report
Change in Average Bed/Waketime Variability for the child from baseline to immediately after the intervention
Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity and daily diary report
Change in Average Bed/Waketime Variability for the child from baseline to 6 months
Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity and daily diary report
Change in Average Bed/Waketime Variability for the child from baseline to 12 months
Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity and daily diary report
Baseline Average RMSDNN (root mean squared st. dev. of N-N intervals) for the child
Child arousal measured by Holter Monitors, 8 min ECG
Change in Average RMSDNN (root mean squared st. dev. of N-N intervals) for the child from baseline to immediately after the intervention
Child arousal measured by Holter Monitors, 8 min ECG
Change in Average RMSDNN (root mean squared st. dev. of N-N intervals) for the child from baseline to 6 months
Child arousal measured by Holter Monitors, 8 min ECG
Change in Average RMSDNN (root mean squared st. dev. of N-N intervals) for the child from baseline to 12 months
Child arousal measured by Holter Monitors, 8 min ECG
Baseline Average Objective Total Sleep Time for the parent
Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity
Change in Average Objective Total Sleep Time for the parent from baseline to immediately after the intervention
Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity
Change in Average Objective Total Sleep Time for the parent from baseline to 6 months
Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity
Change in Average Objective Total Sleep Time for the parent from baseline to 12 months
Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity
Secondary Outcome Measures
Baseline Aberrant Behavior Checklist (ABC) for the child
Aberrant Behavior Checklist (ABC) is a 58-item parent-report measure of daytime problem behaviors that is psychometrically strong and sensitive to treatment effects in children with ASD. It will be filled out by the parent in reference to the child.
Aberrant Behavior Checklist (ABC) for the child immediately after the intervention
Aberrant Behavior Checklist (ABC) is a 58-item parent-report measure of daytime problem behaviors that is psychometrically strong and sensitive to treatment effects in children with ASD. It will be filled out by the parent in reference to the child.
Aberrant Behavior Checklist (ABC) for the child at 6 months
Aberrant Behavior Checklist (ABC) is a 58-item parent-report measure of daytime problem behaviors that is psychometrically strong and sensitive to treatment effects in children with ASD. It will be filled out by the parent in reference to the child.
Aberrant Behavior Checklist (ABC) for the child at 12 months
Aberrant Behavior Checklist (ABC) is a 58-item parent-report measure of daytime problem behaviors that is psychometrically strong and sensitive to treatment effects in children with ASD. It will be filled out by the parent in reference to the child.
Baseline Conners' Continuous Performance Test - 3rd Edition (CCPT-3) for a child (ages 8+)
Conners' Continuous Performance Test - 3rd Edition (CCPT-3) is a computerized measure of inattentiveness, impulsivity, sustained attention, and vigilance for aged 8 and above. Conners' Kiddie Continuous Performance Test (K-CPT) will be used for children aged 6 and 7 which provides a comparable measure of the four domains of attention. To account for two different measures in analyses, standardized scores will be used.
Conners' Continuous Performance Test - 3rd Edition (CCPT-3) for a child (ages 8+) immediately after the intervention
Conners' Continuous Performance Test - 3rd Edition (CCPT-3) is a computerized measure of inattentiveness, impulsivity, sustained attention, and vigilance for aged 8 and above. Conners' Kiddie Continuous Performance Test (K-CPT) will be used for children aged 6 and 7 which provides a comparable measure of the four domains of attention. To account for two different measures in analyses, standardized scores will be used.
Conners' Continuous Performance Test - 3rd Edition (CCPT-3) for a child (ages 8+) at 6 months
Conners' Continuous Performance Test - 3rd Edition (CCPT-3) is a computerized measure of inattentiveness, impulsivity, sustained attention, and vigilance for aged 8 and above. Conners' Kiddie Continuous Performance Test (K-CPT) will be used for children aged 6 and 7 which provides a comparable measure of the four domains of attention. To account for two different measures in analyses, standardized scores will be used.
Conners' Continuous Performance Test - 3rd Edition (CCPT-3) for a child (ages 8+) at 12 months
Conners' Continuous Performance Test - 3rd Edition (CCPT-3) is a computerized measure of inattentiveness, impulsivity, sustained attention, and vigilance for aged 8 and above. Conners' Kiddie Continuous Performance Test (K-CPT) will be used for children aged 6 and 7 which provides a comparable measure of the four domains of attention. To account for two different measures in analyses, standardized scores will be used.
Baseline Conners' Kiddie Continuous Performance Test (K-CPT) for a child (ages 6-7)
Conners' Continuous Performance Test - 3rd Edition (CCPT-3) is a computerized measure of inattentiveness, impulsivity, sustained attention, and vigilance for aged 8 and above. Conners' Kiddie Continuous Performance Test (K-CPT) will be used for children aged 6 and 7 which provides a comparable measure of the four domains of attention. To account for two different measures in analyses, standardized scores will be used.
Conners' Kiddie Continuous Performance Test (K-CPT) for a child (ages 6-7) immediately after the intervention
Conners' Continuous Performance Test - 3rd Edition (CCPT-3) is a computerized measure of inattentiveness, impulsivity, sustained attention, and vigilance for aged 8 and above. Conners' Kiddie Continuous Performance Test (K-CPT) will be used for children aged 6 and 7 which provides a comparable measure of the four domains of attention. To account for two different measures in analyses, standardized scores will be used.
Conners' Kiddie Continuous Performance Test (K-CPT) for a child (ages 6-7) at 6 months
Conners' Continuous Performance Test - 3rd Edition (CCPT-3) is a computerized measure of inattentiveness, impulsivity, sustained attention, and vigilance for aged 8 and above. Conners' Kiddie Continuous Performance Test (K-CPT) will be used for children aged 6 and 7 which provides a comparable measure of the four domains of attention. To account for two different measures in analyses, standardized scores will be used.
Conners' Kiddie Continuous Performance Test (K-CPT) for a child (ages 6-7) at 12 months
Conners' Continuous Performance Test - 3rd Edition (CCPT-3) is a computerized measure of inattentiveness, impulsivity, sustained attention, and vigilance for aged 8 and above. Conners' Kiddie Continuous Performance Test (K-CPT) will be used for children aged 6 and 7 which provides a comparable measure of the four domains of attention. To account for two different measures in analyses, standardized scores will be used.
Baseline Behavior Rating Inventory of Executive Function - 2nd Edition (BRIEF-2) for the child
Behavior Rating Inventory of Executive Function - 2nd Edition (BRIEF-2) is a 86-item parent-report measure of day-to-day executive functioning and impairment. It will be filled out by the parent in reference to the child.
Behavior Rating Inventory of Executive Function - 2nd Edition (BRIEF-2) for the child immediately after the intervention
Behavior Rating Inventory of Executive Function - 2nd Edition (BRIEF-2) is a 86-item parent-report measure of day-to-day executive functioning and impairment. It will be filled out by the parent in reference to the child.
Behavior Rating Inventory of Executive Function - 2nd Edition (BRIEF-2) for the child at 6 months
Behavior Rating Inventory of Executive Function - 2nd Edition (BRIEF-2) is a 86-item parent-report measure of day-to-day executive functioning and impairment. It will be filled out by the parent in reference to the child.
Behavior Rating Inventory of Executive Function - 2nd Edition (BRIEF-2) for the child at 12 months
Behavior Rating Inventory of Executive Function - 2nd Edition (BRIEF-2) is a 86-item parent-report measure of day-to-day executive functioning and impairment. It will be filled out by the parent in reference to the child.
Baseline Child and Adolescent Symptom Inventory - 4th Edition Revised (CASI-4R) for the child
Child and Adolescent Symptom Inventory - 4th Edition Revised (CASI-4R) includes 20 parent-reported items and is an appropriate outcome tool for children with ASD. It will be filled out by the parent in reference to the child.
Child and Adolescent Symptom Inventory - 4th Edition Revised (CASI-4R) for the child immediately after the intervention
Child and Adolescent Symptom Inventory - 4th Edition Revised (CASI-4R) includes 20 parent-reported items and is an appropriate outcome tool for children with ASD. It will be filled out by the parent in reference to the child.
Child and Adolescent Symptom Inventory - 4th Edition Revised (CASI-4R) for the child at 6 months
Child and Adolescent Symptom Inventory - 4th Edition Revised (CASI-4R) includes 20 parent-reported items and is an appropriate outcome tool for children with ASD. It will be filled out by the parent in reference to the child.
Child and Adolescent Symptom Inventory - 4th Edition Revised (CASI-4R) for the child at 12 months
Child and Adolescent Symptom Inventory - 4th Edition Revised (CASI-4R) includes 20 parent-reported items and is an appropriate outcome tool for children with ASD. It will be filled out by the parent in reference to the child.
Baseline Child Quality of Life: PedsQL Child Form for the child
Child Quality of Life: PedsQL is a 23-item scale measuring children's QOL. It has excellent internal consistency, clinical validity, and factor-analytic support. It will be filled out by the child in reference to the child.
Child Quality of Life: PedsQL Child Form for the child immediately after the intervention
Child Quality of Life: PedsQL is a 23-item scale measuring children's QOL. It has excellent internal consistency, clinical validity, and factor-analytic support. It will be filled out by the child in reference to the child.
Child Quality of Life: PedsQL Child Form for the child at 6 months
Child Quality of Life: PedsQL is a 23-item scale measuring children's QOL. It has excellent internal consistency, clinical validity, and factor-analytic support. It will be filled out by the child in reference to the child.
Child Quality of Life: PedsQL Child Form for the child at 12 months
Child Quality of Life: PedsQL is a 23-item scale measuring children's QOL. It has excellent internal consistency, clinical validity, and factor-analytic support. It will be filled out by the child in reference to the child.
Baseline Child Quality of Life: PedsQL Parent Form for the child
Child Quality of Life: PedsQL is a 23-item scale measuring children's QOL. It has excellent internal consistency, clinical validity, and factor-analytic support. It will be filled out by the parent in reference to the child.
Child Quality of Life: PedsQL Parent Form for the child immediately after the intervention
Child Quality of Life: PedsQL is a 23-item scale measuring children's QOL. It has excellent internal consistency, clinical validity, and factor-analytic support. It will be filled out by the parent in reference to the child.
Child Quality of Life: PedsQL Parent Form for the child at 6 months
Child Quality of Life: PedsQL is a 23-item scale measuring children's QOL. It has excellent internal consistency, clinical validity, and factor-analytic support. It will be filled out by the parent in reference to the child.
Child Quality of Life: PedsQL Parent Form for the child at 12 months
Child Quality of Life: PedsQL is a 23-item scale measuring children's QOL. It has excellent internal consistency, clinical validity, and factor-analytic support. It will be filled out by the parent in reference to the child.
Baseline Average Subjective Sleep Onset Latency for the child
Diary-reported amount of time from lights out to beginning of sleep filled out by the child (with parent help) regarding the child's sleep
Change in Average Subjective Sleep Onset Latency for the child from baseline to immediately after the intervention
Diary-reported amount of time from lights out to beginning of sleep filled out by the child (with parent help) regarding the child's sleep
Change in Average Subjective Sleep Onset Latency for the child from baseline to 6 months
Diary-reported amount of time from lights out to beginning of sleep filled out by the child (with parent help) regarding the child's sleep
Change in Average Subjective Sleep Onset Latency for the child from baseline to 12 months
Diary-reported amount of time from lights out to beginning of sleep filled out by the child (with parent help) regarding the child's sleep
Baseline Average Subjective Total Wake Time for the child
Diary-reported time awake from lights out until out of bed filled out by the child (with a parent's help) regarding the child's sleep
Change in Average Subjective Total Wake Time for the child from baseline to immediately after the intervention
Diary-reported time awake from lights out until out of bed filled out by the child (with a parent's help) regarding the child's sleep
Change in Average Subjective Total Wake Time for the child from baseline to 6 months
Diary-reported time awake from lights out until out of bed filled out by the child (with a parent's help) regarding the child's sleep
Change in Average Subjective Total Wake Time for the child from baseline to 12 months
Diary-reported time awake from lights out until out of bed filled out by the child (with a parent's help) regarding the child's sleep
Baseline Average Subjective Total Sleep Time for the child
Diary-reported total sleep time filled out by the child (with help of a parent) regarding the child's sleep
Change in Average Subjective Total Sleep Time for the child from baseline to immediately after the intervention
Diary-reported total sleep time filled out by the child (with help of a parent) regarding the child's sleep
Change in Average Subjective Total Sleep Time for the child from baseline to 6 months
Diary-reported total sleep time filled out by the child (with help of a parent) regarding the child's sleep
Change in Average Subjective Total Sleep Time for the child from baseline to 12 months
Diary-reported total sleep time filled out by the child (with help of a parent) regarding the child's sleep
Baseline Average Subjective Sleep Efficiency for the child
Diary-reported total sleep time/time in bed x 100% filled out by the child (with help from a parent) regarding the child's sleep
Change in Average Subjective Sleep Efficiency for the child from baseline to immediately after the intervention
Diary-reported total sleep time/time in bed x 100% filled out by the child (with help from a parent) regarding the child's sleep
Change in Average Subjective Sleep Efficiency for the child from baseline to 6 months
Diary-reported total sleep time/time in bed x 100% filled out by the child (with help from a parent) regarding the child's sleep
Change in Average Subjective Sleep Efficiency for the child from baseline to 12 months
Diary-reported total sleep time/time in bed x 100% filled out by the child (with help from a parent) regarding the child's sleep
Baseline Average LF/HF ratio for the child
An index of the child's autonomic nervous system regulation measured by Holter Monitors, 8 min ECG
Change in Average LF/HF ratio for the child from baseline to immediately after the intervention
An index of the child's autonomic nervous system regulation measured by Holter Monitors, 8 min ECG
Change in Average LF/HF ratio for the child from baseline to 6 months
An index of the child's autonomic nervous system regulation measured by Holter Monitors, 8 min ECG
Change in Average LF/HF ratio for the child from baseline to 12 months
An index of the child's autonomic nervous system regulation measured by Holter Monitors, 8 min ECG
Baseline Average pNN50 (% of N-N intervals > 50 ms) for the child
Child arousal measured by Holter Monitors, 8 min ECG
Change in Average pNN50 (% of N-N intervals > 50 ms) for the child from baseline to immediately after the intervention
Child arousal measured by Holter Monitors, 8 min ECG
Change in Average pNN50 (% of N-N intervals > 50 ms) for the child from baseline to 6 months
Child arousal measured by Holter Monitors, 8 min ECG
Change in Average pNN50 (% of N-N intervals > 50 ms) for the child from baseline to 12 months
Child arousal measured by Holter Monitors, 8 min ECG
Baseline Average LF/HF ratio for the parent
An index of the parent's autonomic nervous system regulation measured by Holter Monitors, 8 min ECG
Change in Average LF/HF ratio for the parent from baseline to immediately after the intervention
An index of the parent's autonomic nervous system regulation measured by Holter Monitors, 8 min ECG
Change in Average LF/HF ratio for the parent from baseline to 6 months
An index of the parent's autonomic nervous system regulation measured by Holter Monitors, 8 min ECG
Change in Average LF/HF ratio for the parent from baseline to 12 months
An index of the parent's autonomic nervous system regulation measured by Holter Monitors, 8 min ECG
Baseline Average pNN50 (% of N-N intervals > 50 ms) for the parent
Parent arousal measured by Holter Monitors, 8 min ECG
Change in Average pNN50 (% of N-N intervals > 50 ms) for the parent from baseline to immediately after the intervention
Parent arousal measured by Holter Monitors, 8 min ECG
Change in Average pNN50 (% of N-N intervals > 50 ms) for the parent from baseline to 6 months
Parent arousal measured by Holter Monitors, 8 min ECG
Change in Average pNN50 (% of N-N intervals > 50 ms) for the parent from baseline to 12 months
Parent arousal measured by Holter Monitors, 8 min ECG
Baseline Average RMSDNN (root mean squared st. dev. of N-N intervals) for the parent
Parent arousal measured by Holter Monitors, 8 min ECG
Change in Average RMSDNN (root mean squared st. dev. of N-N intervals) for the parent from baseline to immediately after the intervention
Parent arousal measured by Holter Monitors, 8 min ECG
Change in Average RMSDNN (root mean squared st. dev. of N-N intervals) for the parent from baseline to 6 months
Parent arousal measured by Holter Monitors, 8 min ECG
Change in Average RMSDNN (root mean squared st. dev. of N-N intervals) for the parent from baseline to 12 months
Parent arousal measured by Holter Monitors, 8 min ECG
Baseline State-Trait Anxiety Inventory (STAI-Y1) for the parent
State-Trait Anxiety Inventory (STAI-Y1) includes 20 self-descriptive statements rated according to how the parent generally feels on a 4-point scale [1 (not at all) to 4 (very much so)]. This will be filled out by the parents regarding the parents.
State-Trait Anxiety Inventory (STAI-Y1) for the parent immediately after the intervention
State-Trait Anxiety Inventory (STAI-Y1) includes 20 self-descriptive statements rated according to how the parent generally feels on a 4-point scale [1 (not at all) to 4 (very much so)]. This will be filled out by the parents regarding the parents.
State-Trait Anxiety Inventory (STAI-Y1) for the parent at 6 months
State-Trait Anxiety Inventory (STAI-Y1) includes 20 self-descriptive statements rated according to how the parent generally feels on a 4-point scale [1 (not at all) to 4 (very much so)]. This will be filled out by the parents regarding the parents.
State-Trait Anxiety Inventory (STAI-Y1) for the parent at 12 months
State-Trait Anxiety Inventory (STAI-Y1) includes 20 self-descriptive statements rated according to how the parent generally feels on a 4-point scale [1 (not at all) to 4 (very much so)]. This will be filled out by the parents regarding the parents.
Baseline Beck Depression Inventory (BDI-II) for the parent
Beck Depression Inventory (BDI-II) includes 21 items that measures the severity of depressive symptomatology on a 4-point scale (0-absence of symptoms; 3-severe). This will be filled out by the parents regarding the parents.
Beck Depression Inventory (BDI-II) for the parent immediately after the intervention
Beck Depression Inventory (BDI-II) includes 21 items that measures the severity of depressive symptomatology on a 4-point scale (0-absence of symptoms; 3-severe). This will be filled out by the parents regarding the parents.
Beck Depression Inventory (BDI-II) for the parent at 6 months
Beck Depression Inventory (BDI-II) includes 21 items that measures the severity of depressive symptomatology on a 4-point scale (0-absence of symptoms; 3-severe). This will be filled out by the parents regarding the parents.
Beck Depression Inventory (BDI-II) for the parent at 12 months
Beck Depression Inventory (BDI-II) includes 21 items that measures the severity of depressive symptomatology on a 4-point scale (0-absence of symptoms; 3-severe). This will be filled out by the parents regarding the parents.
Baseline Fatigue Severity Scale for the parent
Fatigue Severity Scale includes 9 items on the severity of fatigue and how fatigue interferes with activities on a 7-point scale (1-strongly disagree; 7-strongly agree). This will be filled out by the parents regarding the parents.
Fatigue Severity Scale for the parent immediately after the intervention
Fatigue Severity Scale includes 9 items on the severity of fatigue and how fatigue interferes with activities on a 7-point scale (1-strongly disagree; 7-strongly agree). This will be filled out by the parents regarding the parents.
Fatigue Severity Scale for the parent at 6 months
Fatigue Severity Scale includes 9 items on the severity of fatigue and how fatigue interferes with activities on a 7-point scale (1-strongly disagree; 7-strongly agree). This will be filled out by the parents regarding the parents.
Fatigue Severity Scale for the parent at 12 months
Fatigue Severity Scale includes 9 items on the severity of fatigue and how fatigue interferes with activities on a 7-point scale (1-strongly disagree; 7-strongly agree). This will be filled out by the parents regarding the parents.
Baseline Daily Fatigue for the parent
Daily Fatigue rated on electronic diaries (0-none;100-most intense imaginable). This will be filled out by the parents regarding the parents.
Daily Fatigue for the parent immediately after the intervention
Daily Fatigue rated on electronic diaries (0-none;100-most intense imaginable). This will be filled out by the parents regarding the parents.
Daily Fatigue for the parent at 6 months
Daily Fatigue rated on electronic diaries (0-none;100-most intense imaginable). This will be filled out by the parents regarding the parents.
Daily Fatigue for the parent at 12 months
Daily Fatigue rated on electronic diaries (0-none;100-most intense imaginable). This will be filled out by the parents regarding the parents.
Baseline Caregiver Strain Index (CSI) for the parent
Caregiver Strain Index (CSI) includes 12 items on caregiving impact on well-being. This will be filled out by the parents regarding the parents.
Caregiver Strain Index (CSI) for the parent immediately after the intervention
Caregiver Strain Index (CSI) includes 12 items on caregiving impact on well-being. This will be filled out by the parents regarding the parents.
Caregiver Strain Index (CSI) for the parent at 6 months
Caregiver Strain Index (CSI) includes 12 items on caregiving impact on well-being. This will be filled out by the parents regarding the parents.
Caregiver Strain Index (CSI) for the parent at 12 months
Caregiver Strain Index (CSI) includes 12 items on caregiving impact on well-being. This will be filled out by the parents regarding the parents.
Baseline Average Subjective Sleep Onset Latency for the parent
Diary-reported amount of time from lights out to beginning of sleep filled out by the parent regarding parent sleep
Change in Average Subjective Sleep Onset Latency for the parent from baseline to immediately after the intervention
Diary-reported amount of time from lights out to beginning of sleep filled out by the parent regarding parent sleep
Change in Average Subjective Sleep Onset Latency for the parent from baseline to 6 months
Diary-reported amount of time from lights out to beginning of sleep filled out by the parent regarding parent sleep
Change in Average Subjective Sleep Onset Latency for the parent from baseline to 12 months
Diary-reported amount of time from lights out to beginning of sleep filled out by the parent regarding parent sleep
Baseline Average Subjective Total Wake Time for the parent
Diary-reported time awake from lights out until out of bed filled out by the parent regarding the parent's sleep
Change in Average Subjective Total Wake Time for the parent from baseline to immediately after the intervention
Diary-reported time awake from lights out until out of bed filled out by the parent regarding the parent's sleep
Change in Average Subjective Total Wake Time for the parent from baseline to 6 months
Diary-reported time awake from lights out until out of bed filled out by the parent regarding the parent's sleep
Change in Average Subjective Total Wake Time for the parent from baseline to 12 months
Diary-reported time awake from lights out until out of bed filled out by the parent regarding the parent's sleep
Baseline Average Subjective Total Sleep Time for the parent
Diary-reported total sleep time filled out by the parent regarding the parent's sleep
Change in Average Subjective Total Sleep Time for the parent from baseline to immediately after the intervention
Diary-reported total sleep time filled out by the parent regarding the parent's sleep
Change in Average Subjective Total Sleep Time for the parent from baseline to 6 months
Diary-reported total sleep time filled out by the parent regarding the parent's sleep
Change in Average Subjective Total Sleep Time for the parent from baseline to 12 months
Diary-reported total sleep time filled out by the parent regarding the parent's sleep
Baseline Average Subjective Sleep Efficiency for the parent
Diary-reported total sleep time/time in bed x 100% filled out by the parent regarding the parent's sleep
Change in Average Subjective Sleep Efficiency for the parent from baseline to immediately after the intervention
Diary-reported total sleep time/time in bed x 100% filled out by the parent regarding the parent's sleep
Change in Average Subjective Sleep Efficiency for the parent from baseline to 6 months
Diary-reported total sleep time/time in bed x 100% filled out by the parent regarding the parent's sleep
Change in Average Subjective Sleep Efficiency for the parent from baseline to 12 months
Diary-reported total sleep time/time in bed x 100% filled out by the parent regarding the parent's sleep
Full Information
NCT ID
NCT04545606
First Posted
August 26, 2020
Last Updated
March 16, 2022
Sponsor
University of Missouri-Columbia
Collaborators
United States Department of Defense
1. Study Identification
Unique Protocol Identification Number
NCT04545606
Brief Title
Targeting Insomnia in School Aged Children With Autism Spectrum Disorder
Acronym
RECHArge
Official Title
Targeting Insomnia in School Aged Children With Autism Spectrum Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2020 (Actual)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
August 2030 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia
Collaborators
United States Department of Defense
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Children with Autism Spectrum Disorder (ASD) and insomnia, and their parent(s) will undergo 4 sessions of behavioral therapy for sleep problems followed by 4 bimonthly booster sessions. Children and their families will be randomly assigned to one of three conditions: cognitive behavioral therapy (in-person), cognitive behavioral therapy (remote), or behavioral therapy (remote). Arousal will be measured through heart-rate variability. Sleep and secondary outcomes (child daytime behavior, parent sleep) will be collected at baseline (weeks 1-2 before starting the treatment), post-treatment (weeks 6-8 from baseline), 6-month follow-up, and 12-month follow-up.
Detailed Description
Children with autism often have difficulties falling and staying asleep at night. Those sleep difficulties can contribute to daytime problems with irritability, learning, and behavior. Parents are often stressed about their child's sleep difficulties and as a result, their sleep can suffer as well. Treatment that focuses on establishing behaviors and routines that help reduce arousal and support good sleep are helpful for improving the sleep of children without autism, but have not yet been tested in children with autism.
Previous studies have indicated that distance can make it difficult for families to participate in treatment. As such, we will conduct treatment remotely for two of treatment arms. Having remote versions of the treatment can expand the number of children and families that are able to receive these promising treatments. This may be particularly important for children with ASD living in rural and underserved areas as well as those in military families that may not have access to a healthcare provider with training in behavioral sleep treatments.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia Chronic, Autism Spectrum Disorder
Keywords
cognitive behavioral therapy, behavioral therapy, children
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
In-person CBT for insomnia in children with autism
Arm Type
Experimental
Arm Description
In-person cognitive-behavioral treatment (CBT) for insomnia in children with autism will be conducted at the Thompson Center. In-person treatment will consist of four 50-minute, individually administered sessions and four bi-monthly, 20-minute telephone boosters. Using a flexible, case conceptualization approach, the therapist will adapt the treatment to parent and child characteristics (i.e., verbal skills, development) and family situation/dynamics - promoting optimal efficacy and enhancing broad clinical applicability. Module administration order will be tailored to prioritize each child/family's most pressing sleep concerns based on the clinical interview.
Arm Title
Remote CBT for insomnia in children with autism
Arm Type
Experimental
Arm Description
Remote/videoconferenced cognitive-behavioral treatment (CBT) for insomnia in children with autism will be conducted from home (families)/Thompson Center (therapist). Remote treatment will consist of four 50-minute, individually administered sessions and four bi-monthly, 20-minute telephone boosters. Using a flexible, case conceptualization approach, the therapist will adapt the treatment to parent and child characteristics (i.e., verbal skills, development) and family situation/dynamics - promoting optimal efficacy and enhancing broad clinical applicability. Module administration order will be tailored to prioritize each child/family's most pressing sleep concerns based on the clinical interview.
Arm Title
Remote behavioral SHARE for insomnia in children with autism
Arm Type
Experimental
Arm Description
Remote/videoconferenced behavioral sleep hygiene and related education (SHARE) for insomnia in children with autism will be conducted from home (families)/Thompson Center (therapist). Remote treatment will consist of four 50-minute, individually administered sessions and four bi-monthly, 20-minute telephone boosters. Using a flexible, case conceptualization approach, the therapist will adapt the treatment to parent and child characteristics (i.e., verbal skills, development) and family situation/dynamics - promoting optimal efficacy and enhancing broad clinical applicability. Module administration order will be tailored to prioritize each child/family's most pressing sleep and related health related concerns/interests.
Intervention Type
Behavioral
Intervention Name(s)
In-Person CBT for insomnia in children with autism
Intervention Description
7 modules administered in-person
Sleep Hygiene & Sleep Prescription
Bedtime Routine & Parent Management
Cue Control & Parent Management
Co-Sleeping & Parents Fading out of Room
Circadian Education, Morning Routine, & Relaxation
Cognitive Therapy Basics
Nighttime Fears, Anxiety, & Nightmares
Intervention Type
Behavioral
Intervention Name(s)
Remote CBT for insomnia in children with autism
Intervention Description
7 modules administered over telehealth/videoconferencing
Sleep Hygiene & Sleep Prescription
Bedtime Routine & Parent Management
Cue Control & Parent Management
Co-Sleeping & Parents Fading out of Room
Circadian Education, Morning Routine, & Relaxation
Cognitive Therapy Basics
Nighttime Fears, Anxiety, & Nightmares
Intervention Type
Behavioral
Intervention Name(s)
Remote sleep hygiene and related education (SHARE) for insomnia in children with autism
Intervention Description
7 modules administered over telehealth/videoconferencing
Sleep Education
Sleep Architecture & Parasomnias
Physical Activity & Sleep
Nutrition, My Plate, & Breathing during Sleep
Stress, Sleep, Dreams, & Nightmares Connections
Mood, Self-Esteem, & Sleep
Light & Dark Cycle
Primary Outcome Measure Information:
Title
Baseline Average Objective Sleep Efficiency for the child
Description
Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity
Time Frame
24/7 during each 2 week assessment at Baseline
Title
Change in Average Objective Sleep Efficiency for the child from baseline to immediately after the intervention
Description
Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity
Time Frame
24/7 during each 2 week assessment immediately after the intervention
Title
Change in Average Objective Sleep Efficiency for the child from baseline to 6 months
Description
Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity
Time Frame
24/7 during each 2 week assessment at 6 month follow up
Title
Change in Average Objective Sleep Efficiency for the child from baseline to 12 months
Description
Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity
Time Frame
24/7 during each 2 week assessment at 12 month follow up
Title
Baseline Average Bed/Waketime Variability for the child
Description
Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity and daily diary report
Time Frame
24/7 during each 2 week assessment at Baseline
Title
Change in Average Bed/Waketime Variability for the child from baseline to immediately after the intervention
Description
Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity and daily diary report
Time Frame
24/7 during each 2 week assessment immediately after the intervention
Title
Change in Average Bed/Waketime Variability for the child from baseline to 6 months
Description
Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity and daily diary report
Time Frame
24/7 during each 2 week assessment at 6 month follow up
Title
Change in Average Bed/Waketime Variability for the child from baseline to 12 months
Description
Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity and daily diary report
Time Frame
24/7 during each 2 week assessment at 12 month follow up
Title
Baseline Average RMSDNN (root mean squared st. dev. of N-N intervals) for the child
Description
Child arousal measured by Holter Monitors, 8 min ECG
Time Frame
8 minute protocol during rest at Baseline (in clinic)
Title
Change in Average RMSDNN (root mean squared st. dev. of N-N intervals) for the child from baseline to immediately after the intervention
Description
Child arousal measured by Holter Monitors, 8 min ECG
Time Frame
8 minute protocol during rest immediately after the intervention (in clinic)
Title
Change in Average RMSDNN (root mean squared st. dev. of N-N intervals) for the child from baseline to 6 months
Description
Child arousal measured by Holter Monitors, 8 min ECG
Time Frame
8 minute protocol during rest at 6 month follow up (in clinic)
Title
Change in Average RMSDNN (root mean squared st. dev. of N-N intervals) for the child from baseline to 12 months
Description
Child arousal measured by Holter Monitors, 8 min ECG
Time Frame
8 minute protocol during rest at 12 month follow up (in clinic)
Title
Baseline Average Objective Total Sleep Time for the parent
Description
Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity
Time Frame
24/7 during each 2 week assessment at Baseline
Title
Change in Average Objective Total Sleep Time for the parent from baseline to immediately after the intervention
Description
Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity
Time Frame
24/7 during each 2 week assessment immediately after the intervention
Title
Change in Average Objective Total Sleep Time for the parent from baseline to 6 months
Description
Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity
Time Frame
24/7 during each 2 week assessment at 6 month follow up
Title
Change in Average Objective Total Sleep Time for the parent from baseline to 12 months
Description
Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity
Time Frame
24/7 during each 2 week assessment at 12 month follow up
Secondary Outcome Measure Information:
Title
Baseline Aberrant Behavior Checklist (ABC) for the child
Description
Aberrant Behavior Checklist (ABC) is a 58-item parent-report measure of daytime problem behaviors that is psychometrically strong and sensitive to treatment effects in children with ASD. It will be filled out by the parent in reference to the child.
Time Frame
Baseline
Title
Aberrant Behavior Checklist (ABC) for the child immediately after the intervention
Description
Aberrant Behavior Checklist (ABC) is a 58-item parent-report measure of daytime problem behaviors that is psychometrically strong and sensitive to treatment effects in children with ASD. It will be filled out by the parent in reference to the child.
Time Frame
Immediately after the intervention
Title
Aberrant Behavior Checklist (ABC) for the child at 6 months
Description
Aberrant Behavior Checklist (ABC) is a 58-item parent-report measure of daytime problem behaviors that is psychometrically strong and sensitive to treatment effects in children with ASD. It will be filled out by the parent in reference to the child.
Time Frame
At 6 month follow up
Title
Aberrant Behavior Checklist (ABC) for the child at 12 months
Description
Aberrant Behavior Checklist (ABC) is a 58-item parent-report measure of daytime problem behaviors that is psychometrically strong and sensitive to treatment effects in children with ASD. It will be filled out by the parent in reference to the child.
Time Frame
At 12 month follow up
Title
Baseline Conners' Continuous Performance Test - 3rd Edition (CCPT-3) for a child (ages 8+)
Description
Conners' Continuous Performance Test - 3rd Edition (CCPT-3) is a computerized measure of inattentiveness, impulsivity, sustained attention, and vigilance for aged 8 and above. Conners' Kiddie Continuous Performance Test (K-CPT) will be used for children aged 6 and 7 which provides a comparable measure of the four domains of attention. To account for two different measures in analyses, standardized scores will be used.
Time Frame
Baseline
Title
Conners' Continuous Performance Test - 3rd Edition (CCPT-3) for a child (ages 8+) immediately after the intervention
Description
Conners' Continuous Performance Test - 3rd Edition (CCPT-3) is a computerized measure of inattentiveness, impulsivity, sustained attention, and vigilance for aged 8 and above. Conners' Kiddie Continuous Performance Test (K-CPT) will be used for children aged 6 and 7 which provides a comparable measure of the four domains of attention. To account for two different measures in analyses, standardized scores will be used.
Time Frame
Immediately after the intervention
Title
Conners' Continuous Performance Test - 3rd Edition (CCPT-3) for a child (ages 8+) at 6 months
Description
Conners' Continuous Performance Test - 3rd Edition (CCPT-3) is a computerized measure of inattentiveness, impulsivity, sustained attention, and vigilance for aged 8 and above. Conners' Kiddie Continuous Performance Test (K-CPT) will be used for children aged 6 and 7 which provides a comparable measure of the four domains of attention. To account for two different measures in analyses, standardized scores will be used.
Time Frame
At 6 month follow up
Title
Conners' Continuous Performance Test - 3rd Edition (CCPT-3) for a child (ages 8+) at 12 months
Description
Conners' Continuous Performance Test - 3rd Edition (CCPT-3) is a computerized measure of inattentiveness, impulsivity, sustained attention, and vigilance for aged 8 and above. Conners' Kiddie Continuous Performance Test (K-CPT) will be used for children aged 6 and 7 which provides a comparable measure of the four domains of attention. To account for two different measures in analyses, standardized scores will be used.
Time Frame
At 12 month follow up
Title
Baseline Conners' Kiddie Continuous Performance Test (K-CPT) for a child (ages 6-7)
Description
Conners' Continuous Performance Test - 3rd Edition (CCPT-3) is a computerized measure of inattentiveness, impulsivity, sustained attention, and vigilance for aged 8 and above. Conners' Kiddie Continuous Performance Test (K-CPT) will be used for children aged 6 and 7 which provides a comparable measure of the four domains of attention. To account for two different measures in analyses, standardized scores will be used.
Time Frame
Baseline
Title
Conners' Kiddie Continuous Performance Test (K-CPT) for a child (ages 6-7) immediately after the intervention
Description
Conners' Continuous Performance Test - 3rd Edition (CCPT-3) is a computerized measure of inattentiveness, impulsivity, sustained attention, and vigilance for aged 8 and above. Conners' Kiddie Continuous Performance Test (K-CPT) will be used for children aged 6 and 7 which provides a comparable measure of the four domains of attention. To account for two different measures in analyses, standardized scores will be used.
Time Frame
Immediately after the intervention
Title
Conners' Kiddie Continuous Performance Test (K-CPT) for a child (ages 6-7) at 6 months
Description
Conners' Continuous Performance Test - 3rd Edition (CCPT-3) is a computerized measure of inattentiveness, impulsivity, sustained attention, and vigilance for aged 8 and above. Conners' Kiddie Continuous Performance Test (K-CPT) will be used for children aged 6 and 7 which provides a comparable measure of the four domains of attention. To account for two different measures in analyses, standardized scores will be used.
Time Frame
At 6 month follow up
Title
Conners' Kiddie Continuous Performance Test (K-CPT) for a child (ages 6-7) at 12 months
Description
Conners' Continuous Performance Test - 3rd Edition (CCPT-3) is a computerized measure of inattentiveness, impulsivity, sustained attention, and vigilance for aged 8 and above. Conners' Kiddie Continuous Performance Test (K-CPT) will be used for children aged 6 and 7 which provides a comparable measure of the four domains of attention. To account for two different measures in analyses, standardized scores will be used.
Time Frame
At 12 month follow up
Title
Baseline Behavior Rating Inventory of Executive Function - 2nd Edition (BRIEF-2) for the child
Description
Behavior Rating Inventory of Executive Function - 2nd Edition (BRIEF-2) is a 86-item parent-report measure of day-to-day executive functioning and impairment. It will be filled out by the parent in reference to the child.
Time Frame
Baseline
Title
Behavior Rating Inventory of Executive Function - 2nd Edition (BRIEF-2) for the child immediately after the intervention
Description
Behavior Rating Inventory of Executive Function - 2nd Edition (BRIEF-2) is a 86-item parent-report measure of day-to-day executive functioning and impairment. It will be filled out by the parent in reference to the child.
Time Frame
Immediately after the intervention
Title
Behavior Rating Inventory of Executive Function - 2nd Edition (BRIEF-2) for the child at 6 months
Description
Behavior Rating Inventory of Executive Function - 2nd Edition (BRIEF-2) is a 86-item parent-report measure of day-to-day executive functioning and impairment. It will be filled out by the parent in reference to the child.
Time Frame
At 6 month follow up
Title
Behavior Rating Inventory of Executive Function - 2nd Edition (BRIEF-2) for the child at 12 months
Description
Behavior Rating Inventory of Executive Function - 2nd Edition (BRIEF-2) is a 86-item parent-report measure of day-to-day executive functioning and impairment. It will be filled out by the parent in reference to the child.
Time Frame
At 12 month follow up
Title
Baseline Child and Adolescent Symptom Inventory - 4th Edition Revised (CASI-4R) for the child
Description
Child and Adolescent Symptom Inventory - 4th Edition Revised (CASI-4R) includes 20 parent-reported items and is an appropriate outcome tool for children with ASD. It will be filled out by the parent in reference to the child.
Time Frame
Baseline
Title
Child and Adolescent Symptom Inventory - 4th Edition Revised (CASI-4R) for the child immediately after the intervention
Description
Child and Adolescent Symptom Inventory - 4th Edition Revised (CASI-4R) includes 20 parent-reported items and is an appropriate outcome tool for children with ASD. It will be filled out by the parent in reference to the child.
Time Frame
Immediately after the intervention
Title
Child and Adolescent Symptom Inventory - 4th Edition Revised (CASI-4R) for the child at 6 months
Description
Child and Adolescent Symptom Inventory - 4th Edition Revised (CASI-4R) includes 20 parent-reported items and is an appropriate outcome tool for children with ASD. It will be filled out by the parent in reference to the child.
Time Frame
At 6 month follow up
Title
Child and Adolescent Symptom Inventory - 4th Edition Revised (CASI-4R) for the child at 12 months
Description
Child and Adolescent Symptom Inventory - 4th Edition Revised (CASI-4R) includes 20 parent-reported items and is an appropriate outcome tool for children with ASD. It will be filled out by the parent in reference to the child.
Time Frame
At 12 month follow up
Title
Baseline Child Quality of Life: PedsQL Child Form for the child
Description
Child Quality of Life: PedsQL is a 23-item scale measuring children's QOL. It has excellent internal consistency, clinical validity, and factor-analytic support. It will be filled out by the child in reference to the child.
Time Frame
Baseline
Title
Child Quality of Life: PedsQL Child Form for the child immediately after the intervention
Description
Child Quality of Life: PedsQL is a 23-item scale measuring children's QOL. It has excellent internal consistency, clinical validity, and factor-analytic support. It will be filled out by the child in reference to the child.
Time Frame
Immediately after the intervention
Title
Child Quality of Life: PedsQL Child Form for the child at 6 months
Description
Child Quality of Life: PedsQL is a 23-item scale measuring children's QOL. It has excellent internal consistency, clinical validity, and factor-analytic support. It will be filled out by the child in reference to the child.
Time Frame
At 6 month follow up
Title
Child Quality of Life: PedsQL Child Form for the child at 12 months
Description
Child Quality of Life: PedsQL is a 23-item scale measuring children's QOL. It has excellent internal consistency, clinical validity, and factor-analytic support. It will be filled out by the child in reference to the child.
Time Frame
At 12 month follow up
Title
Baseline Child Quality of Life: PedsQL Parent Form for the child
Description
Child Quality of Life: PedsQL is a 23-item scale measuring children's QOL. It has excellent internal consistency, clinical validity, and factor-analytic support. It will be filled out by the parent in reference to the child.
Time Frame
Baseline
Title
Child Quality of Life: PedsQL Parent Form for the child immediately after the intervention
Description
Child Quality of Life: PedsQL is a 23-item scale measuring children's QOL. It has excellent internal consistency, clinical validity, and factor-analytic support. It will be filled out by the parent in reference to the child.
Time Frame
Immediately after the intervention
Title
Child Quality of Life: PedsQL Parent Form for the child at 6 months
Description
Child Quality of Life: PedsQL is a 23-item scale measuring children's QOL. It has excellent internal consistency, clinical validity, and factor-analytic support. It will be filled out by the parent in reference to the child.
Time Frame
At 6 month follow up
Title
Child Quality of Life: PedsQL Parent Form for the child at 12 months
Description
Child Quality of Life: PedsQL is a 23-item scale measuring children's QOL. It has excellent internal consistency, clinical validity, and factor-analytic support. It will be filled out by the parent in reference to the child.
Time Frame
At 12 month follow up
Title
Baseline Average Subjective Sleep Onset Latency for the child
Description
Diary-reported amount of time from lights out to beginning of sleep filled out by the child (with parent help) regarding the child's sleep
Time Frame
Each morning for 2 weeks at Baseline
Title
Change in Average Subjective Sleep Onset Latency for the child from baseline to immediately after the intervention
Description
Diary-reported amount of time from lights out to beginning of sleep filled out by the child (with parent help) regarding the child's sleep
Time Frame
Each morning for 2 weeks immediately after the intervention
Title
Change in Average Subjective Sleep Onset Latency for the child from baseline to 6 months
Description
Diary-reported amount of time from lights out to beginning of sleep filled out by the child (with parent help) regarding the child's sleep
Time Frame
Each morning for 2 weeks at 6 month follow up
Title
Change in Average Subjective Sleep Onset Latency for the child from baseline to 12 months
Description
Diary-reported amount of time from lights out to beginning of sleep filled out by the child (with parent help) regarding the child's sleep
Time Frame
Each morning for 2 weeks at 12 month follow up
Title
Baseline Average Subjective Total Wake Time for the child
Description
Diary-reported time awake from lights out until out of bed filled out by the child (with a parent's help) regarding the child's sleep
Time Frame
Each morning for 2 weeks at Baseline
Title
Change in Average Subjective Total Wake Time for the child from baseline to immediately after the intervention
Description
Diary-reported time awake from lights out until out of bed filled out by the child (with a parent's help) regarding the child's sleep
Time Frame
Each morning for 2 weeks immediately after the intervention
Title
Change in Average Subjective Total Wake Time for the child from baseline to 6 months
Description
Diary-reported time awake from lights out until out of bed filled out by the child (with a parent's help) regarding the child's sleep
Time Frame
Each morning for 2 weeks at 6 month follow up
Title
Change in Average Subjective Total Wake Time for the child from baseline to 12 months
Description
Diary-reported time awake from lights out until out of bed filled out by the child (with a parent's help) regarding the child's sleep
Time Frame
Each morning for 2 weeks at 12 month follow up
Title
Baseline Average Subjective Total Sleep Time for the child
Description
Diary-reported total sleep time filled out by the child (with help of a parent) regarding the child's sleep
Time Frame
Each morning for 2 weeks at Baseline
Title
Change in Average Subjective Total Sleep Time for the child from baseline to immediately after the intervention
Description
Diary-reported total sleep time filled out by the child (with help of a parent) regarding the child's sleep
Time Frame
Each morning for 2 weeks immediately after the intervention
Title
Change in Average Subjective Total Sleep Time for the child from baseline to 6 months
Description
Diary-reported total sleep time filled out by the child (with help of a parent) regarding the child's sleep
Time Frame
Each morning for 2 weeks at 6 month follow up
Title
Change in Average Subjective Total Sleep Time for the child from baseline to 12 months
Description
Diary-reported total sleep time filled out by the child (with help of a parent) regarding the child's sleep
Time Frame
Each morning for 2 weeks at 12 month follow up
Title
Baseline Average Subjective Sleep Efficiency for the child
Description
Diary-reported total sleep time/time in bed x 100% filled out by the child (with help from a parent) regarding the child's sleep
Time Frame
Each morning for 2 weeks at Baseline
Title
Change in Average Subjective Sleep Efficiency for the child from baseline to immediately after the intervention
Description
Diary-reported total sleep time/time in bed x 100% filled out by the child (with help from a parent) regarding the child's sleep
Time Frame
Each morning for 2 weeks immediately after the intervention
Title
Change in Average Subjective Sleep Efficiency for the child from baseline to 6 months
Description
Diary-reported total sleep time/time in bed x 100% filled out by the child (with help from a parent) regarding the child's sleep
Time Frame
Each morning for 2 weeks at 6 month follow up
Title
Change in Average Subjective Sleep Efficiency for the child from baseline to 12 months
Description
Diary-reported total sleep time/time in bed x 100% filled out by the child (with help from a parent) regarding the child's sleep
Time Frame
Each morning for 2 weeks at 12 month follow up
Title
Baseline Average LF/HF ratio for the child
Description
An index of the child's autonomic nervous system regulation measured by Holter Monitors, 8 min ECG
Time Frame
8 minute protocol during rest at Baseline (in clinic)
Title
Change in Average LF/HF ratio for the child from baseline to immediately after the intervention
Description
An index of the child's autonomic nervous system regulation measured by Holter Monitors, 8 min ECG
Time Frame
8 minute protocol during rest immediately after the intervention (in clinic)
Title
Change in Average LF/HF ratio for the child from baseline to 6 months
Description
An index of the child's autonomic nervous system regulation measured by Holter Monitors, 8 min ECG
Time Frame
8 minute protocol during rest at 6 month follow up (in clinic)
Title
Change in Average LF/HF ratio for the child from baseline to 12 months
Description
An index of the child's autonomic nervous system regulation measured by Holter Monitors, 8 min ECG
Time Frame
8 minute protocol during rest at 12 month follow up (in clinic)
Title
Baseline Average pNN50 (% of N-N intervals > 50 ms) for the child
Description
Child arousal measured by Holter Monitors, 8 min ECG
Time Frame
8 minute protocol during rest at Baseline (in clinic)
Title
Change in Average pNN50 (% of N-N intervals > 50 ms) for the child from baseline to immediately after the intervention
Description
Child arousal measured by Holter Monitors, 8 min ECG
Time Frame
8 minute protocol during rest immediately after the intervention (in clinic)
Title
Change in Average pNN50 (% of N-N intervals > 50 ms) for the child from baseline to 6 months
Description
Child arousal measured by Holter Monitors, 8 min ECG
Time Frame
8 minute protocol during rest at 6 month follow up (in clinic)
Title
Change in Average pNN50 (% of N-N intervals > 50 ms) for the child from baseline to 12 months
Description
Child arousal measured by Holter Monitors, 8 min ECG
Time Frame
8 minute protocol during rest at 12 month follow up (in clinic)
Title
Baseline Average LF/HF ratio for the parent
Description
An index of the parent's autonomic nervous system regulation measured by Holter Monitors, 8 min ECG
Time Frame
8 minute protocol during rest at Baseline (in clinic)
Title
Change in Average LF/HF ratio for the parent from baseline to immediately after the intervention
Description
An index of the parent's autonomic nervous system regulation measured by Holter Monitors, 8 min ECG
Time Frame
8 minute protocol during rest immediately after the intervention (in clinic)
Title
Change in Average LF/HF ratio for the parent from baseline to 6 months
Description
An index of the parent's autonomic nervous system regulation measured by Holter Monitors, 8 min ECG
Time Frame
8 minute protocol during rest at 6 month follow up (in clinic)
Title
Change in Average LF/HF ratio for the parent from baseline to 12 months
Description
An index of the parent's autonomic nervous system regulation measured by Holter Monitors, 8 min ECG
Time Frame
8 minute protocol during rest at 12 month follow up (in clinic)
Title
Baseline Average pNN50 (% of N-N intervals > 50 ms) for the parent
Description
Parent arousal measured by Holter Monitors, 8 min ECG
Time Frame
8 minute protocol during rest at Baseline (in clinic)
Title
Change in Average pNN50 (% of N-N intervals > 50 ms) for the parent from baseline to immediately after the intervention
Description
Parent arousal measured by Holter Monitors, 8 min ECG
Time Frame
8 minute protocol during rest immediately after the intervention (in clinic)
Title
Change in Average pNN50 (% of N-N intervals > 50 ms) for the parent from baseline to 6 months
Description
Parent arousal measured by Holter Monitors, 8 min ECG
Time Frame
8 minute protocol during rest at 6 month follow up (in clinic)
Title
Change in Average pNN50 (% of N-N intervals > 50 ms) for the parent from baseline to 12 months
Description
Parent arousal measured by Holter Monitors, 8 min ECG
Time Frame
8 minute protocol during rest at 12 month follow up (in clinic)
Title
Baseline Average RMSDNN (root mean squared st. dev. of N-N intervals) for the parent
Description
Parent arousal measured by Holter Monitors, 8 min ECG
Time Frame
8 minute protocol during rest at Baseline (in clinic)
Title
Change in Average RMSDNN (root mean squared st. dev. of N-N intervals) for the parent from baseline to immediately after the intervention
Description
Parent arousal measured by Holter Monitors, 8 min ECG
Time Frame
8 minute protocol during rest immediately after the intervention (in clinic)
Title
Change in Average RMSDNN (root mean squared st. dev. of N-N intervals) for the parent from baseline to 6 months
Description
Parent arousal measured by Holter Monitors, 8 min ECG
Time Frame
8 minute protocol during rest at 6 month follow up (in clinic)
Title
Change in Average RMSDNN (root mean squared st. dev. of N-N intervals) for the parent from baseline to 12 months
Description
Parent arousal measured by Holter Monitors, 8 min ECG
Time Frame
8 minute protocol during rest at 12 month follow up (in clinic)
Title
Baseline State-Trait Anxiety Inventory (STAI-Y1) for the parent
Description
State-Trait Anxiety Inventory (STAI-Y1) includes 20 self-descriptive statements rated according to how the parent generally feels on a 4-point scale [1 (not at all) to 4 (very much so)]. This will be filled out by the parents regarding the parents.
Time Frame
Baseline
Title
State-Trait Anxiety Inventory (STAI-Y1) for the parent immediately after the intervention
Description
State-Trait Anxiety Inventory (STAI-Y1) includes 20 self-descriptive statements rated according to how the parent generally feels on a 4-point scale [1 (not at all) to 4 (very much so)]. This will be filled out by the parents regarding the parents.
Time Frame
Immediately after the intervention
Title
State-Trait Anxiety Inventory (STAI-Y1) for the parent at 6 months
Description
State-Trait Anxiety Inventory (STAI-Y1) includes 20 self-descriptive statements rated according to how the parent generally feels on a 4-point scale [1 (not at all) to 4 (very much so)]. This will be filled out by the parents regarding the parents.
Time Frame
At 6 month follow up
Title
State-Trait Anxiety Inventory (STAI-Y1) for the parent at 12 months
Description
State-Trait Anxiety Inventory (STAI-Y1) includes 20 self-descriptive statements rated according to how the parent generally feels on a 4-point scale [1 (not at all) to 4 (very much so)]. This will be filled out by the parents regarding the parents.
Time Frame
At 12 month follow up
Title
Baseline Beck Depression Inventory (BDI-II) for the parent
Description
Beck Depression Inventory (BDI-II) includes 21 items that measures the severity of depressive symptomatology on a 4-point scale (0-absence of symptoms; 3-severe). This will be filled out by the parents regarding the parents.
Time Frame
Baseline
Title
Beck Depression Inventory (BDI-II) for the parent immediately after the intervention
Description
Beck Depression Inventory (BDI-II) includes 21 items that measures the severity of depressive symptomatology on a 4-point scale (0-absence of symptoms; 3-severe). This will be filled out by the parents regarding the parents.
Time Frame
Immediately after the intervention
Title
Beck Depression Inventory (BDI-II) for the parent at 6 months
Description
Beck Depression Inventory (BDI-II) includes 21 items that measures the severity of depressive symptomatology on a 4-point scale (0-absence of symptoms; 3-severe). This will be filled out by the parents regarding the parents.
Time Frame
At 6 month follow up
Title
Beck Depression Inventory (BDI-II) for the parent at 12 months
Description
Beck Depression Inventory (BDI-II) includes 21 items that measures the severity of depressive symptomatology on a 4-point scale (0-absence of symptoms; 3-severe). This will be filled out by the parents regarding the parents.
Time Frame
At 12 month follow up
Title
Baseline Fatigue Severity Scale for the parent
Description
Fatigue Severity Scale includes 9 items on the severity of fatigue and how fatigue interferes with activities on a 7-point scale (1-strongly disagree; 7-strongly agree). This will be filled out by the parents regarding the parents.
Time Frame
Baseline
Title
Fatigue Severity Scale for the parent immediately after the intervention
Description
Fatigue Severity Scale includes 9 items on the severity of fatigue and how fatigue interferes with activities on a 7-point scale (1-strongly disagree; 7-strongly agree). This will be filled out by the parents regarding the parents.
Time Frame
Immediately after the intervention
Title
Fatigue Severity Scale for the parent at 6 months
Description
Fatigue Severity Scale includes 9 items on the severity of fatigue and how fatigue interferes with activities on a 7-point scale (1-strongly disagree; 7-strongly agree). This will be filled out by the parents regarding the parents.
Time Frame
At 6 month follow up
Title
Fatigue Severity Scale for the parent at 12 months
Description
Fatigue Severity Scale includes 9 items on the severity of fatigue and how fatigue interferes with activities on a 7-point scale (1-strongly disagree; 7-strongly agree). This will be filled out by the parents regarding the parents.
Time Frame
At 12 month follow up
Title
Baseline Daily Fatigue for the parent
Description
Daily Fatigue rated on electronic diaries (0-none;100-most intense imaginable). This will be filled out by the parents regarding the parents.
Time Frame
Baseline
Title
Daily Fatigue for the parent immediately after the intervention
Description
Daily Fatigue rated on electronic diaries (0-none;100-most intense imaginable). This will be filled out by the parents regarding the parents.
Time Frame
Immediately after the intervention
Title
Daily Fatigue for the parent at 6 months
Description
Daily Fatigue rated on electronic diaries (0-none;100-most intense imaginable). This will be filled out by the parents regarding the parents.
Time Frame
At 6 month follow up
Title
Daily Fatigue for the parent at 12 months
Description
Daily Fatigue rated on electronic diaries (0-none;100-most intense imaginable). This will be filled out by the parents regarding the parents.
Time Frame
At 12 month follow up
Title
Baseline Caregiver Strain Index (CSI) for the parent
Description
Caregiver Strain Index (CSI) includes 12 items on caregiving impact on well-being. This will be filled out by the parents regarding the parents.
Time Frame
Baseline
Title
Caregiver Strain Index (CSI) for the parent immediately after the intervention
Description
Caregiver Strain Index (CSI) includes 12 items on caregiving impact on well-being. This will be filled out by the parents regarding the parents.
Time Frame
Immediately after the intervention
Title
Caregiver Strain Index (CSI) for the parent at 6 months
Description
Caregiver Strain Index (CSI) includes 12 items on caregiving impact on well-being. This will be filled out by the parents regarding the parents.
Time Frame
At 6 month follow up
Title
Caregiver Strain Index (CSI) for the parent at 12 months
Description
Caregiver Strain Index (CSI) includes 12 items on caregiving impact on well-being. This will be filled out by the parents regarding the parents.
Time Frame
At 12 month follow up
Title
Baseline Average Subjective Sleep Onset Latency for the parent
Description
Diary-reported amount of time from lights out to beginning of sleep filled out by the parent regarding parent sleep
Time Frame
Each morning for 2 weeks at Baseline
Title
Change in Average Subjective Sleep Onset Latency for the parent from baseline to immediately after the intervention
Description
Diary-reported amount of time from lights out to beginning of sleep filled out by the parent regarding parent sleep
Time Frame
Each morning for 2 weeks immediately after the intervention
Title
Change in Average Subjective Sleep Onset Latency for the parent from baseline to 6 months
Description
Diary-reported amount of time from lights out to beginning of sleep filled out by the parent regarding parent sleep
Time Frame
Each morning for 2 weeks at 6 month follow up
Title
Change in Average Subjective Sleep Onset Latency for the parent from baseline to 12 months
Description
Diary-reported amount of time from lights out to beginning of sleep filled out by the parent regarding parent sleep
Time Frame
Each morning for 2 weeks at 12 month follow up
Title
Baseline Average Subjective Total Wake Time for the parent
Description
Diary-reported time awake from lights out until out of bed filled out by the parent regarding the parent's sleep
Time Frame
Each morning for 2 weeks at Baseline
Title
Change in Average Subjective Total Wake Time for the parent from baseline to immediately after the intervention
Description
Diary-reported time awake from lights out until out of bed filled out by the parent regarding the parent's sleep
Time Frame
Each morning for 2 weeks immediately after the intervention
Title
Change in Average Subjective Total Wake Time for the parent from baseline to 6 months
Description
Diary-reported time awake from lights out until out of bed filled out by the parent regarding the parent's sleep
Time Frame
Each morning for 2 weeks at 6 month follow up
Title
Change in Average Subjective Total Wake Time for the parent from baseline to 12 months
Description
Diary-reported time awake from lights out until out of bed filled out by the parent regarding the parent's sleep
Time Frame
Each morning for 2 weeks at 12 month follow up
Title
Baseline Average Subjective Total Sleep Time for the parent
Description
Diary-reported total sleep time filled out by the parent regarding the parent's sleep
Time Frame
Each morning for 2 weeks at Baseline
Title
Change in Average Subjective Total Sleep Time for the parent from baseline to immediately after the intervention
Description
Diary-reported total sleep time filled out by the parent regarding the parent's sleep
Time Frame
Each morning for 2 weeks immediately after the intervention
Title
Change in Average Subjective Total Sleep Time for the parent from baseline to 6 months
Description
Diary-reported total sleep time filled out by the parent regarding the parent's sleep
Time Frame
Each morning for 2 weeks at 6 month follow up
Title
Change in Average Subjective Total Sleep Time for the parent from baseline to 12 months
Description
Diary-reported total sleep time filled out by the parent regarding the parent's sleep
Time Frame
Each morning for 2 weeks at 12 month follow up
Title
Baseline Average Subjective Sleep Efficiency for the parent
Description
Diary-reported total sleep time/time in bed x 100% filled out by the parent regarding the parent's sleep
Time Frame
Each morning for 2 weeks at Baseline
Title
Change in Average Subjective Sleep Efficiency for the parent from baseline to immediately after the intervention
Description
Diary-reported total sleep time/time in bed x 100% filled out by the parent regarding the parent's sleep
Time Frame
Each morning for 2 weeks immediately after the intervention
Title
Change in Average Subjective Sleep Efficiency for the parent from baseline to 6 months
Description
Diary-reported total sleep time/time in bed x 100% filled out by the parent regarding the parent's sleep
Time Frame
Each morning for 2 weeks at 6 month follow up
Title
Change in Average Subjective Sleep Efficiency for the parent from baseline to 12 months
Description
Diary-reported total sleep time/time in bed x 100% filled out by the parent regarding the parent's sleep
Time Frame
Each morning for 2 weeks at 12 month follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1) 6-12a yrs
2) Verbal IQ >= 70
3) participation of child's parent or legal guardian living in the same home
4) parent/guardian ability to read and understand English at the 5th-grade level
5) child diagnosed with ASD and insomnia
ASD:
1) previous DSM diagnosis of ASD
2) evaluation using gold-standard diagnostic tools (i.e., Autism Diagnostic Observation Schedule (ADOS) and/or Autism Diagnostic Interview-Revised [ADI-R])
Insomnia:
1) complaints of difficulties falling asleep, staying asleep, or early morning awakening by child report or parent observation for 3+ mos
2) daytime dysfunction (mood, cognitive, social, academic) due to insomnia
3) baseline diaries and actigraphy indicate >30 mins. of sleep onset latency, wake after sleep onset, or early morning awakening (time between last awakening and out of bed time) on 6+ nights
Exclusion Criteria:
1) parent unable to provide informed consent or child unable to provide assent
2) unwilling to accept random assignment
3) participation in another randomized research project
4) parent unable to complete forms or implement treatment procedures due to cognitive impairment
5) untreated medical comorbidity, including other sleep disorders (e.g., apnea, epilepsy, psychotic disorders, suicidal ideation/intent, [frequent] parasomnias)
6) psychotropic or other medications that alter sleep with the exceptions of stimulants, sleep medications, and/or melatonin as described in #7 (see Notes below for details)
7) stimulants, sleep medications (prescribed or OTC), and/or melatonin within the last 1 month (unless stabilized on medication for 3+ months)
8) participation in non-pharmacological treatment (including CBT) for sleep outside current trial
9) parent report of inability to undergo Holter Monitoring or actigraphy (e.g., extreme sensitivity, behavioral outbursts)
10) other conditions adversely affecting trial participation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Melanie Stearns, PhD
Phone
859-327-7762
Email
mastearns@health.missouri.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sydney Shoemaker, MS
Phone
573-882-5113
Email
sds3mk@health.missouri.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina S McCrae, PhD
Organizational Affiliation
University of Missouri-Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thompson Center for Autism and Neurodevelopmental Disorders
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole Takahashi
Phone
573-884-1893
Email
TakahashiN@health.missouri.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
After all data have been collected and the results of the study have been published, de-identified data will be made available to other qualified investigators upon request. The request will be evaluated by the research team to ensure that it meets reasonable demands of scientific integrity.
IPD Sharing Time Frame
Data will be shared after data collection is complete and results have been published.
IPD Sharing Access Criteria
De-identified data will be made available to other qualified investigators who aim to verify data, conduct meta-analyses, or collaborate with the research team on analyses that are not already planned.
Citations:
PubMed Identifier
34433593
Citation
McCrae CS, Mazurek MO, Curtis AF, Beversdorf DQ, Deroche CB, Golzy M, Sohl KA, Ner ZH, Davis BE, Stearns MA, Nair N. Protocol for targeting insomnia in school-aged children with autism spectrum disorder without intellectual disability: a randomised control trial. BMJ Open. 2021 Aug 25;11(8):e045944. doi: 10.1136/bmjopen-2020-045944.
Results Reference
derived
Learn more about this trial
Targeting Insomnia in School Aged Children With Autism Spectrum Disorder
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