Parent-Mediated Telehealth Intervention for Insomnia in Young Autistic Children

NCT07435740 | Not Yet Recruiting DMC

• 2 other identifiers: 2025P013830R01HD114631
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 3

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.

Conditions

Insomnia

Keywords

autism

Outcome Measures

Primary Outcomes (1)

• Pediatric Autism Insomnia Scale (PAIRS) Score

  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.

  Baseline, Week 5, Week 10

Secondary Outcomes (1)

• Rate of Positive Response on the Clinical Global Impression - Improvement (CGI-I) Scale

  Week 10

Study Arms (2)

Sleep Parent Treatment (SPT)

EXPERIMENTAL

Autistic children with moderate or greater insomnia who are randomly assigned to receive 5 sessions of Sleep Parent Treatment (SPT) delivered over 10 weeks.

Behavioral: Sleep Parent Training (SPT)

Sleep Parent Education (SPE)

ACTIVE COMPARATOR

Autistic children with moderate or greater insomnia who are randomly assigned to receive 5 sessions of Sleep Parent Education (SPE) delivered over 10 weeks.

Behavioral: Sleep Parent Education (SPE)

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 Treatment (SPT)

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.

Sleep Parent Education (SPE)

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Emory University: lead
• The Cleveland Clinic: collaborator
• Ohio State University: collaborator

Study Sites (3)

Emory School Of Medicine

Atlanta, Georgia, 30322, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Autistic Disorder

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders

Study Officials

• Luc Lecavalier, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

• Cynthia R Johnson

  Cleveland Clinic Center for Autism

  PRINCIPAL INVESTIGATOR

• Lawrence Scahill, MSN, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cynthia Johnson, PhD

CONTACT

(216) 448-6440; johnsoc@ccf.org

Luc Lecavalier, PhD

CONTACT

(614) 685-8722; luc.lecavalier@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 20, 2026
• First Posted: February 27, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): January 1, 2031
• Study Completion (Estimated): January 1, 2031
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)