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Recruiting NCT07435740

Parent-Mediated Telehealth Intervention for Insomnia in Young Autistic Children

Conditions: Insomnia

Sex: All
Ages: 3 Years – 7 Years
Healthy volunteers: No
Phase: NA
Enrollment: 130
Sponsor: The Cleveland Clinic

Location: Cleveland Clinic Children's Center for Autism Cleveland Ohio

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07435740). StuddyBuddy aggregates publicly available trial information.