Sleep Intervention in Children With ASD
Effects of Digitally Delivered Parent-based Behavioural Sleep Intervention in Children With Autism Spectrum Disorder (ASD) - A Randomised Controlled Trial
1 other identifier
interventional
195
1 country
1
Brief Summary
The goal of this randomised controlled trial is to examine the following research questions: 1) whether digitally delivered parent-based behavioural sleep intervention with or without personalised support is effective in improving sleep, clinical and daytime symptoms, and 2) whether such interventions can also improve parental sleep, mental health, and parenting stress in children with ASD and insomnia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2025
CompletedFirst Submitted
Initial submission to the registry
February 2, 2026
CompletedFirst Posted
Study publicly available on registry
February 9, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
February 9, 2026
February 1, 2026
2.5 years
February 2, 2026
February 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Child: Change of child's sleep problems
The Children's Sleep Habits Questionnaire (CSHQ) - parent report is a commonly used measure to assess sleep symptoms in children aged 4-12 years. It consists of 33 items to evaluate a child's sleep behavior over the past week. Items are rated on a 3-point scale to indicate the frequency of each sleep behavior: "usually/five to seven times per week," "sometimes/two to four times per week," and "rarely/zero to once per week." The CSHQ total score is the sum of the 33 questions and ranges from 33 to 99. Higher scores indicate more severe sleep disturbances.
Baseline, Post-Treatment (1 week after intervention completion) for all participants, and additionally two follow-ups at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Secondary Outcomes (15)
Child: Change of child's ASD symptoms
Baseline, Post-Treatment (1 week after intervention completion) for all participants, and additionally two follow-ups at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Child: Change of child's emotional and behavioural problems
Baseline, Post-Treatment (1 week after intervention completion) for all participants, and additionally two follow-ups at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Child: Change of child's executive function
Baseline, Post-Treatment (1 week after intervention completion) for all participants, and additionally two follow-ups at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Child: Change of child's daytime sleepiness
Baseline, Post-Treatment (1 week after intervention completion) for all participants, and additionally two follow-ups at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Child: Change of child's quality of life
Baseline, Post-Treatment (1 week after intervention completion) for all participants, and additionally two follow-ups at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
- +10 more secondary outcomes
Study Arms (3)
App-based CBT-I with personalised telephone support
EXPERIMENTALApp-based cognitive behavioural therapy for insomnia with personalised telephone support
App-based CBT-I without personalised support
EXPERIMENTALApp-based cognitive behavioural therapy for insomnia without personalised telephone support
TAU group
NO INTERVENTIONParticipants will continue their usual clinical follow-up and receive standard treatment where needed. No app-based intervention and telephone support will be provided to this group.
Interventions
Participants in this group will be instructed to download a smartphone application. The smartphone app-based intervention, involving six sequential modules, is structured and based on the well-established behavioural sleep intervention elements for managing sleep problems in children, with the consideration of catering to the needs of children with ASD. The main treatment components include: (1) psychoeducation about sleep in the developmental context as well as in the context of ASD, (2) sleep hygiene education, (3) sleep-focused behavioural strategies (e.g., consistent bedtime routine, bedtime fading, extinction, sleep restriction, use of 'bedtime pass'), (4) relaxation strategies, (5) cognitive restructuring (targeting dysfunctional cognitions) and (6) relapse prevention. A weekly phone call support by a trained therapist, using a semi-structured script, will be provided during the intervention period (around 15 mins each time) to the parents.
Participants in this group will be instructed to download the same smartphone application used in the app-based CBT-I with personalised support. No telephone support will be provided to this group.
Eligibility Criteria
You may qualify if:
- (1) Parents/caregivers with a child aged 6 to 12 years old, and attending a local mainstream primary school at the time of recruitment;
- (2) The child is diagnosed to have ASD, which will be based on the assessment conducted by a psychiatrist or a clinical psychologist that incorporates the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) assessment criteria, with corroboration by the Autism Diagnostic Interview - Revised (ADI-R);
- (4) Parent owns and knows how to use smartphones and can comprehend Chinese language;
- (5) The child's parent or guardian gives written informed consent of participation into the study;
- (6) Being able to comply with the study protocol.
You may not qualify if:
- (1) Children with diagnosed intellectual disability;
- (2) Children with any diagnosed co-morbid neurological or medical conditions which could have affected their sleep, such as blindness, traumatic brain injury, epilepsy and poorly controlled eczema;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The University of Hong Konglead
- Chinese University of Hong Kongcollaborator
Study Sites (1)
Sleep Research Clinic & Laboratory, Department of Psychology, The University of Hong Kong
Hong Kong, Hong Kong
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
February 2, 2026
First Posted
February 9, 2026
Study Start
January 1, 2025
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
February 9, 2026
Record last verified: 2026-02