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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.
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 that 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.
Age
3 - 7 years
Sex
ALL
Healthy Volunteers
No
Emory School Of Medicine
Atlanta, Georgia, United States
Case Western Reserve University
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Start Date
March 1, 2026
Primary Completion Date
January 1, 2031
Completion Date
January 1, 2031
Last Updated
February 27, 2026
180
ESTIMATED participants
Sleep Parent Training (SPT)
BEHAVIORAL
Sleep Parent Education (SPE)
BEHAVIORAL
Lead Sponsor
Emory University
Collaborators
NCT06032377
NCT06807086
NCT06181643
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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