Parent-Mediated Telehealth Intervention for Insomnia in Young Autistic Children
Recruiting
Who can join
Ages 3 to 7 · All sexes
Full 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
About the study
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.
What is being tested
- Sleep Parent Training (SPT) (behavioral)
- Sleep Parent Education (SPE) (behavioral)
Sponsor: Emory University · Participants: 130 · Started: Jun 5, 2026
Contact the study team
- Cynthia Johnson, PhD · Phone: (216) 448-6440
- Luc Lecavalier, PhD · Phone: (614) 685-8722
Official record on ClinicalTrials.gov — NCT07435740
Locations in the U.S.
| Georgia | Emory School Of Medicine, Atlanta |
| Ohio | Case Western Reserve University, Cleveland Ohio State University, Columbus |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.