Back to resultsA Brief Parent-based Sleep Intervention for Children With Autism Spectrum Disorder
Primary Purpose
ASD, Insomnia
Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Sleep hygiene practices and behavioural intervention
Sponsored by
About this trial
This is an interventional treatment trial for ASD focused on measuring Sleep, ASD, Insomnia, Behavioral Intervention
Eligibility Criteria
Inclusion Criteria:
- Parents/caregivers (aged 21 or above) of preschool children (aged 3 to 6 years old) with a clinical diagnosis of ASD attending paediatric developmental clinic or clinical psychology service at the Duchess of Kent Child Assessment Centre (DKCAC)
- Clinical diagnosis of ASD would be made by either a Pediatrician or a Clinical Psychologist, using at least one of the following diagnostic tools: Childhood Autism Rating Scale, Second Edition (CARS-2), Autism Diagnostic Observation Schedule, Second Edition (ADOS-2), Autism Diagnostic Interview-Revised (ADI-R) and clinical interview based on diagnostic criteria of ASD depicted in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
Exclusion Criteria:
- Parent/caregiver of children with diagnosed co-morbid neurological, psychiatric or medical conditions which could have affected their sleep, such as obstructive sleep apnea, epilepsy, childhood anxiety disorder
Sites / Locations
- Department of Clinical Psychology, The Duchess of Kent Children's Hospital at Sandy Bay, HKWC, Hospital Authority
- Sleep Research Clinic & Laboratory, Department of Psychology, The University of Hong Kong
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Waiting-list control
Arm Description
The intervention will involve three consultation sessions and four follow-up phone calls with parents to help them learn sleep hygiene practices and specific behavioural strategies to improve their child's sleep and follow up on the progress.
Children in the waiting-list control group will receive usual clinical care.
Outcomes
Primary Outcome Measures
Child: Change of child's sleep
Change of the child's sleep measured by the Children's Sleep Habits Questionnaire (CSHQ). The total score of CSHQ ranges from 33 to 99. A higher score reflects more sleep disturbance.
Child: change of insomnia symptoms (bedtime resistance)
Change of the child's bedtime resistance measured by the Children's Sleep Habits Questionnaire (CSHQ) bedtime resistance score (6 items; score range: 6-18)
Child: change of insomnia symptoms (sleep onset delay)
Change of the child's sleep onset delay measured by the Children's Sleep Habits Questionnaire (CSHQ) sleep onset delay score (1 item; score range: 1-3)
Child: change of insomnia symptoms (night waking)
Change of the child's night waking measured by the Children's Sleep Habits Questionnaire (CSHQ) night waking score (3 items; score range: 3-9)
Secondary Outcome Measures
Parent: Change of parental self-reported sleep quality
Pittsburgh Sleep Quality Index (PSQI), a validated 19-item measure used to assess sleep habits, quality, and quantity, producing a total score and seven sub-scores in sleep quality, sleep onset latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. The global score can range from 0 to 21. Higher scores suggest poorer sleep quality.
Parent: Change of parental insomnia symptoms
Insomnia Severity Index (ISI). Total score ranges from 0-28 and higher scores indicate greater insomnia severity.
Child: Change of child's behaviour & other clinical symptoms
Strengths and Difficulties Questionnaire - parent report, which is a 25-item screening measure for emotional and behavioral problems in children. It consists of five subscales. Each of the subscales consists of five items, and scale scores range from 0-10. A higher score is indicative of more problems for all subscales, except for the prosocial scale, where higher scores correspond to fewer difficulties in prosocial behaviour.
Child: Change of child's executive functions reported by parents
Behavioral Rating Inventory of Executive Function - Preschool Version (BRIEF-P). It consists of 63 items that measure various behavioral manifestations of EF based on parent or teacher ratings, within the context of the child's everyday environment.
Parent: Change of parental mood symptoms
Depression Anxiety Stress Scales - 21 item (DASS-21) consists of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Each of the three DASS-21 scales contains 7 items. Higher scores suggest more depression, anxiety and stress, respectively.
Parent: Change of parental stress
Chinese version of Parental Stress Scale (PSS). It contains 17 items representing pleasure or positive themes of parenthood (emotional benefits, self-enrichment, personal development) and negative components (demands on resources, opportunity costs and restrictions). Higher scores on the scale indicate greater stress.
Parent: Change of parental sense of competence and satisfactory in parenting
Parental Sense of Competence Scale (PSOC), which is a scale designed to measures parental competence on two dimensions: Satisfaction and Efficacy. It is a 16-item Likert-scale questionnaire (on a 6-point scale ranging from strongly agree [1] to strongly disagree [6]), with nine questions under Satisfaction and seven under Efficacy.
Parent: Parent's satisfaction to the treatment
Treatment satisfaction rating scale, a parent-report measure specifically designed for the study. Lower scores suggest higher parental satisfaction.
Parent: Parent's overall health status
Short Form 12-item Health Survey (SF-12v2), a validated measure of health-related quality of life (HRQOL). It consists of 12 items that cover 8 subscales, namely physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE) and mental health (MH). The eight subscale scores can be aggregated into a physical component summary (PCS) score and a mental component summary (MCS) score. Each of the eight SF-12v2 subscale has a scoring range from 0 to 100; a higher score indicates better HRQOL.
Full Information
NCT ID
NCT05010824
First Posted
August 5, 2021
Last Updated
September 19, 2023
Sponsor
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT05010824
Brief Title
A Brief Parent-based Sleep Intervention for Children With Autism Spectrum Disorder
Official Title
Effects of Parent-based Educational Programme for Sleep Problems in Children With Autism Spectrum Disorder (ASD): A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
August 5, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Sleep problems are very common in children with ASD, with a prevalence rate as high as 78%, and often pose significant challenges and stress to the families. Sleep problems in children with ASD are strongly associated with the exacerbation of daytime symptoms, and poor parental sleep quality and mental health. The present study is a randomised controlled trial to compare the effects of a parent-based sleep intervention for children with ASD (aged 3-6). Eligible participants will be randomised to either intervention (three consultation sessions and four follow-up phone calls) or waiting-list control condition. Assessments will be conducted at pre-treatment (baseline), and one-week after the intervention (post-treatment).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ASD, Insomnia
Keywords
Sleep, ASD, Insomnia, Behavioral Intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
The intervention will involve three consultation sessions and four follow-up phone calls with parents to help them learn sleep hygiene practices and specific behavioural strategies to improve their child's sleep and follow up on the progress.
Arm Title
Waiting-list control
Arm Type
No Intervention
Arm Description
Children in the waiting-list control group will receive usual clinical care.
Intervention Type
Behavioral
Intervention Name(s)
Sleep hygiene practices and behavioural intervention
Intervention Description
The first session will involve the provision of sleep-related psycho-education (e.g. sleep hygiene practices) and specific strategies to tackle problematic sleep-related behaviours, as well as collaborative goal setting and development of management plan tailored to the child's sleep problem. The second and third session will involve a review of the sleep diary and a reinforcement of learned strategies, and focus on problem-solving to tackle any issues that have emerged from implementing the behavioural strategies at home. Follow-up phone calls provide parents with an opportunity to ask any further questions and to consolidate learned strategies and further troubleshoot.
Primary Outcome Measure Information:
Title
Child: Change of child's sleep
Description
Change of the child's sleep measured by the Children's Sleep Habits Questionnaire (CSHQ). The total score of CSHQ ranges from 33 to 99. A higher score reflects more sleep disturbance.
Time Frame
Baseline, immediately after the treatment
Title
Child: change of insomnia symptoms (bedtime resistance)
Description
Change of the child's bedtime resistance measured by the Children's Sleep Habits Questionnaire (CSHQ) bedtime resistance score (6 items; score range: 6-18)
Time Frame
Baseline, immediately after the treatment
Title
Child: change of insomnia symptoms (sleep onset delay)
Description
Change of the child's sleep onset delay measured by the Children's Sleep Habits Questionnaire (CSHQ) sleep onset delay score (1 item; score range: 1-3)
Time Frame
Baseline, immediately after the treatment
Title
Child: change of insomnia symptoms (night waking)
Description
Change of the child's night waking measured by the Children's Sleep Habits Questionnaire (CSHQ) night waking score (3 items; score range: 3-9)
Time Frame
Baseline, immediately after the treatment
Secondary Outcome Measure Information:
Title
Parent: Change of parental self-reported sleep quality
Description
Pittsburgh Sleep Quality Index (PSQI), a validated 19-item measure used to assess sleep habits, quality, and quantity, producing a total score and seven sub-scores in sleep quality, sleep onset latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. The global score can range from 0 to 21. Higher scores suggest poorer sleep quality.
Time Frame
Baseline, immediately after the treatment
Title
Parent: Change of parental insomnia symptoms
Description
Insomnia Severity Index (ISI). Total score ranges from 0-28 and higher scores indicate greater insomnia severity.
Time Frame
Baseline, immediately after the treatment
Title
Child: Change of child's behaviour & other clinical symptoms
Description
Strengths and Difficulties Questionnaire - parent report, which is a 25-item screening measure for emotional and behavioral problems in children. It consists of five subscales. Each of the subscales consists of five items, and scale scores range from 0-10. A higher score is indicative of more problems for all subscales, except for the prosocial scale, where higher scores correspond to fewer difficulties in prosocial behaviour.
Time Frame
Baseline, immediately after the treatment
Title
Child: Change of child's executive functions reported by parents
Description
Behavioral Rating Inventory of Executive Function - Preschool Version (BRIEF-P). It consists of 63 items that measure various behavioral manifestations of EF based on parent or teacher ratings, within the context of the child's everyday environment.
Time Frame
Baseline, immediately after the treatment
Title
Parent: Change of parental mood symptoms
Description
Depression Anxiety Stress Scales - 21 item (DASS-21) consists of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Each of the three DASS-21 scales contains 7 items. Higher scores suggest more depression, anxiety and stress, respectively.
Time Frame
Baseline, immediately after the treatment
Title
Parent: Change of parental stress
Description
Chinese version of Parental Stress Scale (PSS). It contains 17 items representing pleasure or positive themes of parenthood (emotional benefits, self-enrichment, personal development) and negative components (demands on resources, opportunity costs and restrictions). Higher scores on the scale indicate greater stress.
Time Frame
Baseline, immediately after the treatment
Title
Parent: Change of parental sense of competence and satisfactory in parenting
Description
Parental Sense of Competence Scale (PSOC), which is a scale designed to measures parental competence on two dimensions: Satisfaction and Efficacy. It is a 16-item Likert-scale questionnaire (on a 6-point scale ranging from strongly agree [1] to strongly disagree [6]), with nine questions under Satisfaction and seven under Efficacy.
Time Frame
Baseline, immediately after the treatment
Title
Parent: Parent's satisfaction to the treatment
Description
Treatment satisfaction rating scale, a parent-report measure specifically designed for the study. Lower scores suggest higher parental satisfaction.
Time Frame
Baseline, immediately after the treatment
Title
Parent: Parent's overall health status
Description
Short Form 12-item Health Survey (SF-12v2), a validated measure of health-related quality of life (HRQOL). It consists of 12 items that cover 8 subscales, namely physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE) and mental health (MH). The eight subscale scores can be aggregated into a physical component summary (PCS) score and a mental component summary (MCS) score. Each of the eight SF-12v2 subscale has a scoring range from 0 to 100; a higher score indicates better HRQOL.
Time Frame
Baseline, immediately after the treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Parents/caregivers (aged 21 or above) of preschool children (aged 3 to 6 years old) with a clinical diagnosis of ASD attending paediatric developmental clinic or clinical psychology service at the Duchess of Kent Child Assessment Centre (DKCAC)
Clinical diagnosis of ASD would be made by either a Pediatrician or a Clinical Psychologist, using at least one of the following diagnostic tools: Childhood Autism Rating Scale, Second Edition (CARS-2), Autism Diagnostic Observation Schedule, Second Edition (ADOS-2), Autism Diagnostic Interview-Revised (ADI-R) and clinical interview based on diagnostic criteria of ASD depicted in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
Exclusion Criteria:
- Parent/caregiver of children with diagnosed co-morbid neurological, psychiatric or medical conditions which could have affected their sleep, such as obstructive sleep apnea, epilepsy, childhood anxiety disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shirley Xin Li, PhD,DClinPsy
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Clinical Psychology, The Duchess of Kent Children's Hospital at Sandy Bay, HKWC, Hospital Authority
City
Hong Kong
Country
Hong Kong
Facility Name
Sleep Research Clinic & Laboratory, Department of Psychology, The University of Hong Kong
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Brief Parent-based Sleep Intervention for Children With Autism Spectrum Disorder
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