Targeting Sleep in Kids With Autism Spectrum Disorder
Primary Purpose
Autism Spectrum Disorder, Chronic Insomnia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder
Eligibility Criteria
Inclusion Criteria:
- previous Diagnostic and Statistical Manual of Mental Disorders diagnosis of Autism Spectrum Disorder, and previous evaluation using gold standard diagnostic tools, including the Autism Diagnostic Observation Schedule (ADOS)27 and/or Autism Diagnostic Interview - Revised (ADI-R).
- Who have IQ>75.
- Child will report or parent will observe sleep latency (time to fall asleep) or wake during the night >30 minutes that is confirmed by baseline sleep diaries.
- Participation of the child's parent or legal guardian living in the same home, and parental ability to read and understand English at the 5th grade level.
Exclusion Criteria:
- unable to provide informed consent
- unable to implement treatment due to sleep disorder other than insomnia (i.e., sleep apnea [apnea/hypopnea index, AHI >15], Periodic Limb Movement Disorder (PLMD [myoclonus arousals per hour >15])
- bipolar or seizure disorder (due to risk of sleep restriction treatment)
- other major psychopathology except depression or anxiety (e.g., suicidal ideation/intent, psychotic disorders)
Sites / Locations
- Department of Health Psychology, University of Missouri-Columbia
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CBT-CI-A Therapy
Arm Description
Participants in this group receive Cognitive Behavioral Therapy for children with Chronic Insomnia and Autism Spectrum Disorder (CBT-CI-A)
Outcomes
Primary Outcome Measures
Change from Baseline Subjective Sleep at 12 weeks
With parental assistance, all child participants will complete daily sleep diaries each morning
Change from Baseline Objective Sleep at 12 weeks
Child participants will wear an actigraph all day for those weeks
Change from Baseline Subjective Sleep at 18 weeks
With parental assistance, all child participants will complete daily sleep diaries each morning
Change from Baseline Objective Sleep at 18 weeks
Child participants will wear an actigraph during those weeks
Secondary Outcome Measures
Child Behavior at Baseline
The Aberrant Behavior Checklist is a 58-item parent-report measure of daytime problem behaviors
Child Behavior at Post-treatment
The Aberrant Behavior Checklist is a 58-item parent-report measure of daytime problem behaviors
Child Behavior at Follow-up
The Aberrant Behavior Checklist is a 58-item parent-report measure of daytime problem behaviors
Change in subjective Parent Sleep from Baseline at 12 weeks
Parents will complete daily sleep diaries each morning
Change in subjective Parent Sleep from Baseline at 18 weeks
Parents will complete daily sleep diaries each morning
Change in objective Parent Sleep from Baseline at 12 weeks
Parents will wear an actigraph during those weeks
Change in objective Parent Sleep from Baseline at 18 weeks
Parents will wear an actigraph during those weeks
Full Information
NCT ID
NCT02755051
First Posted
March 11, 2016
Last Updated
July 18, 2018
Sponsor
University of Missouri-Columbia
1. Study Identification
Unique Protocol Identification Number
NCT02755051
Brief Title
Targeting Sleep in Kids With Autism Spectrum Disorder
Official Title
Targeting Sleep in Kids With Autism Spectrum Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Children with Autism Spectrum Disorder (ASD) and insomnia, and their parent(s) will undergo 8 sessions of Cognitive Behavioral Therapy designed for Children with Chronic Insomnia and ASD (CBT-CI-A). Treatment delivery will be assessed for each session. Treatment receipt will be assessed at the end of session 3. Treatment enactment will be assessed throughout treatment, post-treatment, and follow-up. Sleep and secondary outcomes (child daytime behavior, parent sleep) will be collected at baseline, post-treatment, and 1-month follow-up.
Study Flow:
Baseline (wk1-2) ---> CBT-CI-A (wk3-10) ---> Post-Treatment (wk11-12) --->Wks 13-16 --->Follow-up (wk 17-18)
Session:
Sleep education
Sleep scheduling, limit setting, and stimulus control
Teaching relaxation strategies and other adaptive coping skills
Parenting strategies (differential attention, rewards, consequences)
Identification of maladaptive & adaptive cognitions
Problem solving & communication skills
Sleep restriction; bright light to change circadian rhythms
Review gains and plan for long-term maintenance
Detailed Description
Children with ASD and insomnia, and their parent(s) will undergo 8 sessions of CBT-CI-A. Treatment delivery will be assessed for each session. Treatment receipt will be assessed at the end of session 3. Treatment enactment will be assessed throughout treatment, post-treatment, and follow-up. Sleep and secondary outcomes (child daytime behavior, parent sleep) will be collected at baseline, post-treatment, and 1-month follow-up.
Children (6-12 yrs; n = 30) who meet full DSM (Diagnostic and Statistical Manual) criteria18 for ASD and insomnia will be recruited from an existing clinical registry database. Eligibility criteria for initial recruitment will include IQ (intelligence quotient) of 75 or above (to ensure ability to participate in cognitive components of treatment), previous DSM diagnosis of ASD, and previous evaluation using gold standard diagnostic tools, including the Autism Diagnostic Observation Schedule (ADOS)27 and/or Autism Diagnostic Interview - Revised (ADI-R).28 The Thompson Center database currently includes 337 children with ASD ages 6-12 who have completed the ADOS and/or ADIR and have IQ>75. Following initial recruitment, eligibility for participation will include DSM diagnosis of insomnia. Insomnia will be diagnosed by study staff using gold standard diagnostic tools, a brief (10 min.) structured interview, Child Sleep Habits Questionnaire29, and sleep diaries.30 Child will report or parent will observe sleep latency (time to fall asleep) or wake during the night >30 minutes that is confirmed by baseline sleep diaries. Dr. Sahota will provide referrals for children with suspected sleep apnea. Additional criteria will include participation of the child's parent or legal guardian living in the same home, and parental ability to read and understand English at the 5th grade level. Given previous experience, size of the database and insomnia prevalence in ASD, the investigators expect no difficulty recruiting our target sample size.
Treatment will be manualized and individually administered by graduate students trained by Drs. McCrae and Mazurek. Parent and child will be actively involved in treatment.
CBT-CI-A will use established behavioral sleep strategies.5-7 Treatment will be adapted from a manualized protocol developed and tested by Dr. McCrae in TD children. Adaptations for children with ASD will be based on Dr. Mazurek's experience and expertise, practice pathway recommendations of the ATN, and previously published CBT adaptations for treatment of anxiety in children with ASD. Adaptations will include increased use of visual supports, greater opportunities for repetition/practice, incorporation of special interests, and video modeling.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Chronic Insomnia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CBT-CI-A Therapy
Arm Type
Experimental
Arm Description
Participants in this group receive Cognitive Behavioral Therapy for children with Chronic Insomnia and Autism Spectrum Disorder (CBT-CI-A)
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Other Intervention Name(s)
CBT-CI-A
Intervention Description
Cognitive Behavioral Therapy for children with Chronic Insomnia and Autism Spectrum Disorder involves 8, one-hour sessions of a non-drug cognitive behavioral intervention. Session content listed below:
Sleep education
Sleep scheduling, limit setting, and stimulus control
Teaching relaxation strategies and other adaptive coping skills
Parenting strategies (differential attention, rewards, consequences)
Identification of maladaptive & adaptive cognitions
Problem solving & communication skills
Sleep restriction; bright light to change circadian rhythms
Review gains and plan for long-term maintenance
Primary Outcome Measure Information:
Title
Change from Baseline Subjective Sleep at 12 weeks
Description
With parental assistance, all child participants will complete daily sleep diaries each morning
Time Frame
Daily for 12 weeks from Baseline thru Post-treatment
Title
Change from Baseline Objective Sleep at 12 weeks
Description
Child participants will wear an actigraph all day for those weeks
Time Frame
Continuously for 2 weeks at Baseline and 2 weeks at Post-treatment
Title
Change from Baseline Subjective Sleep at 18 weeks
Description
With parental assistance, all child participants will complete daily sleep diaries each morning
Time Frame
Daily 18 weeks from Baseline thru Follow-up
Title
Change from Baseline Objective Sleep at 18 weeks
Description
Child participants will wear an actigraph during those weeks
Time Frame
Continuously for 2 weeks at Baseline, 2 weeks at Post-treatment and 2 weeks at Follow-up
Secondary Outcome Measure Information:
Title
Child Behavior at Baseline
Description
The Aberrant Behavior Checklist is a 58-item parent-report measure of daytime problem behaviors
Time Frame
To be completed at 2 weeks
Title
Child Behavior at Post-treatment
Description
The Aberrant Behavior Checklist is a 58-item parent-report measure of daytime problem behaviors
Time Frame
To be completed at 12 weeks
Title
Child Behavior at Follow-up
Description
The Aberrant Behavior Checklist is a 58-item parent-report measure of daytime problem behaviors
Time Frame
To be completed at 18 weeks
Title
Change in subjective Parent Sleep from Baseline at 12 weeks
Description
Parents will complete daily sleep diaries each morning
Time Frame
Daily for 12 weeks from Baseline thru Post-treatment
Title
Change in subjective Parent Sleep from Baseline at 18 weeks
Description
Parents will complete daily sleep diaries each morning
Time Frame
Daily for 18 weeks from Baseline thru Follow-up
Title
Change in objective Parent Sleep from Baseline at 12 weeks
Description
Parents will wear an actigraph during those weeks
Time Frame
Continuously for 2 weeks at Baseline and 2 weeks at Post-treatment
Title
Change in objective Parent Sleep from Baseline at 18 weeks
Description
Parents will wear an actigraph during those weeks
Time Frame
Continuously for 2 weeks at Baseline, 2 weeks at Post-treatment, and 2 weeks at Follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
previous Diagnostic and Statistical Manual of Mental Disorders diagnosis of Autism Spectrum Disorder, and previous evaluation using gold standard diagnostic tools, including the Autism Diagnostic Observation Schedule (ADOS)27 and/or Autism Diagnostic Interview - Revised (ADI-R).
Who have IQ>75.
Child will report or parent will observe sleep latency (time to fall asleep) or wake during the night >30 minutes that is confirmed by baseline sleep diaries.
Participation of the child's parent or legal guardian living in the same home, and parental ability to read and understand English at the 5th grade level.
Exclusion Criteria:
unable to provide informed consent
unable to implement treatment due to sleep disorder other than insomnia (i.e., sleep apnea [apnea/hypopnea index, AHI >15], Periodic Limb Movement Disorder (PLMD [myoclonus arousals per hour >15])
bipolar or seizure disorder (due to risk of sleep restriction treatment)
other major psychopathology except depression or anxiety (e.g., suicidal ideation/intent, psychotic disorders)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina S McCrae, Ph. D
Organizational Affiliation
University of Missouri-Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Health Psychology, University of Missouri-Columbia
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65203
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Targeting Sleep in Kids With Autism Spectrum Disorder
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