Parent-Mediated Telehealth Intervention for Insomnia in Young Autistic Children

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Insomnia
• Intervention / Treatment: Behavioral: Sleep Parent Training (SPT); Behavioral: Sleep Parent Education (SPE)

Detailed Description

In the general pediatric population, insomnia affects an estimated 20-25% of children, however, insomnia affects as many as 40-80% of children with autism spectrum disorder (ASD).

Insomnia is characterized by problems of initiating sleep and/or maintaining sleep occurring three or more nights per week for more than three months accompanied by distress, impairment or both. The diagnostic criteria stipulate that the sleep problem is not attributable to another cause (e.g., restless legs syndrome, caffeine intake). In autistic children, insomnia may interfere with concentration and learning, may contribute to daytime sleepiness, disruptive daytime behavior, emotion dysregulation and physical injury. The child's bedtime behavior and sleep disturbances may also interfere with sleep for caregivers or other family members and predict elevated parental stress. Chronic insomnia in children may have detrimental effects on cardiovascular, endocrine or immune systems. Parents of autistic children with insomnia consistently report that the child's bedtime resistance behaviors may be difficult to manage.

Accumulated data indicate that parent-mediated behavioral interventions for insomnia can be effective, however, only a few randomized controlled trials have rigorously tested parent-mediated behavioral interventions for insomnia in autistic children. A recently completed telehealth trial compared two behavioral interventions and found that Sleep Parent Treatment (SPT) was superior to Sleep Parent Education (SPE) for improving child sleep outcomes, parental self-efficacy and parental distress. Although encouraging, the sample size of this study provided limited exploration of treatment moderators. The researchers now propose a large-scale, definitive study of telehealth SPT versus individualized, menu-driven SPE.

In this study, autistic children with at least moderate insomnia will be randomly assigned to SPT or SPE for 10 weeks. The primary outcome is the parent-rated PAIRS, a newly validated, continuous measure assessing insomnia severity in children with ASD. It will be collected at baseline, midpoint (Week 5) and endpoint (Week 10) in the randomized phase.

Longitudinal differences in PAIRS between randomized groups will be tested for significance using a general linear mixed effects regression model (GLMM). The GLMM will use data from all study time points and report on the baseline-adjusted least-squares mean (LS-mean) difference in PAIRS at Week 10 for SPT compared to SPE, with 95% confidence interval (CI) and p-value. The researchers will follow intention-to-treat (ITT) principles throughout, analyzing participants according to originally assigned groups, regardless of what treatment they received (if any) or attrition.

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Luc Lecavalier, PhD; Phone Number: (614) 685-8722; Email: luc.lecavalier@osumc.edu
• Study Contact Backup: Name: Cynthia Johnson, PhD; Phone Number: (216) 448-6440; Email: johnsoc@ccf.org

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory School Of Medicine
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Case Western Reserve University
    • Columbus, Ohio, United States, 43210
      • Ohio State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sleep Parent Treatment (SPT); 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); 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.
Active Comparator: Sleep Parent Education (SPE); 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Positive Response on the Clinical Global Impression - Improvement (CGI-I) Scale	The Clinical Global Impression - Improvement (CGI-I) Scale is a clinician-rated, 7-point scale designed to measure overall change from baseline. Scores range from 1 (Very Much Improved) to 4 (Unchanged) to 7 (Very Much Worse). Sleep problems will be weighted in the assessment of the CGI-I, but blinded independent evaluators will consider all aspects of the child's status to assign the CGI-I score. In this study, a positive response is defined as a response of Much Improved or Very Much Improved.	Week 10

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); The Cleveland Clinic; Ohio State University
• Investigators: Principal Investigator: Lawrence Scahill, MSN, PhD, Emory University; Principal Investigator: Luc Lecavalier, PhD, Ohio State University; Principal Investigator: Cynthia R Johnson, Cleveland Clinic Center for Autism

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): January 1, 2031
• Study Completion (Estimated): January 1, 2031

Study Registration Dates

• First Submitted: February 20, 2026
• First Submitted That Met QC Criteria: February 20, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: autism
• Additional Relevant MeSH Terms: Autism Spectrum Disorder; Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Sleep Disorders, Intrinsic; Dyssomnias; Autistic Disorder; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 2025P013830; R01HD114631 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No