App-Based Sleep Program for Parents of Children With Autism and Insomnia
Tests an app-based sleep program, with or without phone support, for autistic children.
Key facts
- Who runs it
- The University of Hong Kong
- Where
- Hong Kong, Hong KongSee the site
- Trial code
- Registry title
- Sleep Intervention in Children With ASD
- Status
- Recruiting
- People taking part
- 195 people, planned
- Started
- 1 Jan 2025
- Expected to end
- 31 Dec 2027
- Type of study
- Interventional, 3 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- App-based CBT-I with personalised telephone support
- App-based CBT-I without personalised telephone support
- Record updated
- 9 February 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for parents of children aged 6 to 12 with autism and sleep problems. It tests a phone-based sleep programme for parents.
- Age
- Child aged 6 to 12 years.
- Sex
- Boys and girls can join.
- Disease stage
- Child has autism spectrum disorder (ASD), diagnosed by a psychiatrist or clinical psychologist. Child has trouble falling asleep: sleep onset latency over 25 minutes, 3 or more times a week, for at least 3 months, affecting daily life.
- Earlier treatment
- Children on regular melatonin or SSRIs can still join if they meet the other criteria.
Main reasons for not taking part
- Child with diagnosed intellectual disability
- Child with a neurological or medical condition that could affect sleep, such as blindness, traumatic brain injury, epilepsy or poorly controlled eczema
- Child with a diagnosed sleep disorder other than insomnia
- Child with suspected sleep apnoea (score of 4 or above on the sleep-disordered breathing subscale of the CSHQ)
- Parent without a smartphone or who cannot understand Chinese
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- (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)
- (3) The child is reported by the parent/caregiver to have insomnia symptoms, typically a difficulty in falling asleep with or without bedtime resistance, which is operationally defined as sleep onset latency exceeding 25 minutes and occurring three or more times per week. The child's sleep problems have lasted for a minimum of three months and have led to an impairment in the daily functioning of the child and/or parents. Such inclusion criteria are based on the DSM-V criteria for insomnia, with the choice of a 25-minute sleep onset latency criteria based on the normative values reported by Scholle et al
- (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
Who cannot take part
- (3) Children with diagnosed sleep disorders other than insomnia or with suspected sleep apnoea (as assessed by the Children's Sleep Habits Questionnaire (CSHQ): obtaining a score of 4 or above on the sleep-disordered breathing subscale on the CSHQ) that may potentially contribute to a disruption in sleep continuity and quality. Children who are currently receiving regular melatonin treatment, as well as other medications such as Selective Serotonin Reuptake Inhibitors (SSRIs), will be considered for inclusion in the trial if they continue to meet the eligibility criteria
- (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
- (1) Children with diagnosed intellectual disability
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 6 and 12 years old?
Where in Hong Kong
- Sleep Research Clinic & Laboratory, Department of Psychology, The University of Hong KongHong Kong, Hong KongContact: Shirley X LiTaking people
About the trial
What the trial wants to find out
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.
The 3 groups in the trial
- App-based CBT-I with personalised telephone supportTreatment being tested
App-based cognitive behavioural therapy for insomnia with personalised telephone support
- App-based CBT-I without personalised supportTreatment being tested
App-based cognitive behavioural therapy for insomnia without personalised telephone support
Treatment: App-based CBT-I without personalised telephone support
- TAU groupNo study treatment, for comparison
Participants 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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Effects of Digitally Delivered Parent-based Behavioural Sleep Intervention in Children With Autism Spectrum Disorder (ASD) - A Randomised Controlled Trial
- Plain-language title
- App-Based Sleep Program for Parents of Children With Autism and InsomniaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Fit questions
- Built from NCT07398183, who can take part
- Record updated
- 9 February 2026