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Parent-Mediated Telehealth Intervention for Insomnia in Young Autistic Children

Sponsor: The Cleveland Clinic • ClinicalTrials.gov ID: NCT07435740

Registry updated: 2026-10-08

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Description

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.

Interventions

Sleep Parent Training (SPT) (Behavioral)
Five SPT sessions, each 60-90 minutes in duration, are individually delivered over 10 weeks. Each session employs direct instruction, modeling, and role-playing to promote parental skill acquisition. The SPT manual includes a therapist script and parent activity sheets for each session. Video vignettes for each session model specific techniques, including correct application of a technique and ineffective strategies. To supplement the 5 sessions, three virtual parent-child coaching sessions occur to ensure implementation fidelity. A sleep plan for the child is developed with the parent and is revised, as needed, at each session.
Sleep Parent Education (SPE) (Behavioral)
SPE includes five 60-90 minute sessions, delivered individually over 10 weeks. SPE provides useful information to families of young children with ASD and insomnia. The sessions cover a review of autism, sleep hygiene, interpretation of clinical evaluations, child advocacy and evaluation of available treatments, and information on evidence-based treatments.

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

Conditions

Insomnia

Locations

Cleveland Clinic Children's Center for Autism — Cleveland, Ohio, United States
Case Western Reserve University — Cleveland, Ohio, United States
Ohio State University — Columbus, Ohio, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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