NCT07435740 Parent-Mediated Telehealth Intervention for Insomnia in Young Autistic Children
| NCT ID | NCT07435740 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Emory University |
| Condition | Insomnia |
| Study Type | INTERVENTIONAL |
| Enrollment | 130 participants |
| Start Date | 2026-06-05 |
| Primary Completion | 2031-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 130 participants in total. It began in 2026-06-05 with a primary completion date of 2031-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Luc Lecavalier, PhD
PRINCIPAL INVESTIGATOR
Ohio State University
Frequently Asked Questions
Who can join the NCT07435740 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 7 Years, studying Insomnia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07435740 currently recruiting?
Yes, NCT07435740 is actively recruiting participants. Contact the research team at johnsoc@ccf.org for enrollment information.
Where is the NCT07435740 trial being conducted?
This trial is being conducted at Atlanta, United States, Cleveland, United States, Columbus, United States.
Who is sponsoring the NCT07435740 clinical trial?
NCT07435740 is sponsored by Emory University. The principal investigator is Luc Lecavalier, PhD at Ohio State University. The trial plans to enroll 130 participants.
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