NCT07435740

Parent-Mediated Telehealth Intervention for Insomnia in Young Autistic Children

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 3 Years – 7 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Insomnia

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2026-03-01
• Primary completion: 2031-01-01
• Completion: 2031-01-01
• First posted: 2026-02-27
• Last updated: 2026-02-27

Locations

3 sites across 1 country: United States