NCT07398183 Sleep Intervention in Children With ASD
| NCT ID | NCT07398183 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The University of Hong Kong |
| Condition | Insomnia |
| Study Type | INTERVENTIONAL |
| Enrollment | 195 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2027-06-30 |
Trial Parameters
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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.
Eligibility Criteria
Inclusion Criteria: * (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
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