Parent-Mediated Telehealth Intervention for Insomnia in Young Autistic Children

This study is testing two different parent-led approaches delivered through telehealth to help young autistic children (ages 3 to 7 years 11 months) with insomnia (trouble falling or staying asleep). One approach is called Sleep Parent Training (SPT), which teaches parents skills to help their child sleep. The other is Sleep Parent Education (SPE), which provides information about autism and sleep. The study aims to see which intervention is more effective at improving sleep, measured by a score on the Pediatric Autism Insomnia Scale (PAIRS). You can join if your child has an autism diagnosis and significant insomnia. The study plans to enroll 130 children, but the current recruitment status is unclear.

Study design: This is an interventional study where 130 participants will be randomly assigned to receive either Sleep Parent Training (SPT) or Sleep Parent Education (SPE) for 10 weeks.
What's involved: You would participate in five 60-90 minute telehealth sessions over 10 weeks. Your child's sleep will be assessed at the start, at week 5, and at week 10.
Compensation: Not stated in the trial record.
Follow-up: Participants are followed for 10 weeks, with assessments at baseline, week 5, and week 10.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Parent-Mediated Telehealth Intervention for Insomnia in Young Autistic Children

Recruiting

NAAges 3–7InterventionalTreatment

Emory University

~130 participants

Updated 2026-06-18 on ClinicalTrials.gov

What's tested:Sleep Parent Training (SPT)Sleep Parent Education (SPE)

At a glance

Recruiting sites

3 of 3 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Pediatric Autism Insomnia Scale (PAIRS) Score

Measured over Baseline, Week 5, Week 10

Conditions

Insomnia

Where it's being run

3 sites across 2 states

Ohio2

Georgia1

Study leadership

Luc Lecavalier, PhD · PRINCIPAL_INVESTIGATOR · Ohio State University
Cynthia R Johnson · PRINCIPAL_INVESTIGATOR · Cleveland Clinic Center for Autism
Lawrence Scahill, MSN, PhD · PRINCIPAL_INVESTIGATOR · Emory University

Who to contact

Cynthia Johnson, PhD

[email protected]

(216) 448-6440

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

Pediatric Autism Insomnia Scale (PAIRS) ScoreBaseline, Week 5, Week 10
Insomnia severity is assessed with the Pediatric Autism Insomnia Scale (PAIRS) instrument. The PAIRS is a 21- item measure designed to capture the frequency and impact of insomnia (e.g., trouble initiating or maintaining sleep) in autistic children. Responses to items are scored on a 4-point scale, ranging from 0 to 3. Example of items are "My child has a bedtime routine; small changes throw it off" and "My child has a hard time settling down to fall asleep at night." Total scores range from 0 to 63, with higher score reflecting greater severity of insomnia symptoms. A score of \>30 is required for study entry.

Trialytics