Insomnia Clinical Trials

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Parent-Mediated Telehealth Intervention for Insomnia in Young Autistic Children

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 7
Healthy Volunteers: f
View:

• 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

Locations
United States
Georgia
Emory School Of Medicine
RECRUITING
Atlanta
Ohio
Case Western Reserve University
RECRUITING
Cleveland
Ohio State University
RECRUITING
Columbus
Contact Information
Primary
Cynthia Johnson, PhD
johnsoc@ccf.org
(216) 448-6440
Backup
Luc Lecavalier, PhD
luc.lecavalier@osumc.edu
(614) 685-8722
Time Frame
Start Date: 2026-06-05
Estimated Completion Date: 2031-01
Participants
Target number of participants: 130
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Collaborators: The Cleveland Clinic, Ohio State University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Leads: Emory University

This content was sourced from clinicaltrials.gov