Parent-Mediated Telehealth Intervention for Insomnia in Young Autistic Children (NCT07435740) | Clinical Trial Compass
RecruitingNot Applicable
Parent-Mediated Telehealth Intervention for Insomnia in Young Autistic Children
United States130 participantsStarted 2026-06-05
Plain-language summary
This study will evaluate the efficacy of a structured parent-mediated behavioral intervention called Sleep Parent Treatment (SPT) for insomnia in autistic children ages 3 to 7 years 11 months, compared to another behavioral intervention called Sleep Parent Education (SPE). Eligible children will be randomly assigned to either the SPT or SPE intervention for 10 weeks.
Who can participate
Age range
3 Years – 7 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age \>3 to 7 years 11 months
* Clinical diagnosis of ASD supported by the Autism Diagnostic Interview Revised (ADI-R)
* Score of 30 or more on the Parent-Rated Insomnia Scale - ASD (PAIRS) and the Clinical Global Impression Severity (CGI-S) score of Moderate or greater (a score of 4 or more)
* Medication and supplement free or on stable medication or supplements (no changes in the past 6 weeks and no planned changes for 10 weeks of the randomized trial)
* Parental proficiency in spoken and written English language. Study materials and many of the study measures are only available in English
Exclusion Criteria:
* Children with a history of serious medical condition or known medical cause insomnia (e.g., nocturnal seizures, unresolved gastrointestinal problems such as reflux or constipation)
* Children with a psychiatric disorder or serious behavioral problem requiring a different treatment
* Children with known sleep apnea, restless leg syndrome, or periodic limb movements during sleep, or a circadian-based sleep disorder (e.g., delayed or advanced sleep phase syndrome)
* Children of non-English language speaking caregivers will be excluded because study intervention materials and many of the study measures are only available in English
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is specifically for young autistic children with insomnia — would my child's age, autism diagnosis, and sleep difficulties make them worth considering for this study, or are there eligibility criteria that might rule them out?
2Since this is a telehealth-based, parent-mediated intervention, what would actually be required of me as a caregiver in terms of time, sessions, and technology access, and is that realistic given our family's current situation?
3The trial measures sleep improvement using something called the Pediatric Autism Insomnia Scale — can you help me understand what that tool measures and whether it captures the specific sleep problems my child is experiencing?
4Because this study is listed as Phase NA, meaning it may be testing a behavioral approach rather than a medication, what is currently known about the safety and effectiveness of parent-led sleep interventions for autistic children, and how does this compare to other options we might try first?
5Are there standard sleep treatments or therapies already available for autistic children with insomnia that we should consider before or alongside looking into this trial?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.