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Telehealth Delivery of Treatment for Sleep Disturbances in Young Children With Autism Spectrum Disorder

NCT03668873 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2024-09-19

Study results available
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Summary

Study Design: Ninety children with Autism Spectrum Disorder (ASD), between the ages of 2 to less than 7 years, and their parents will be recruited for this 10 week randomized clinical trial. Participants will be randomized to five individually delivered sessions of Sleep Parent Training (SPT) or five individually delivered sessions of Sleep Parent Education (SPE). Delivery of the programs will be via telehealth platform which also includes parent-child coaching in real-time. In addition to baseline, outcome measures will be collected at week 5 (midpoint of trial) and week 10 (endpoint of trial) as well as follow-up at week 16 to determine durability of treatment.

Conditions

Interventions

BEHAVIORAL

Sleep Parent Training

SPT provides a comprehensive intervention that teaches parents the basic concepts and practical skills to address an array of sleep problems.

BEHAVIORAL

Sleep Parent Education

SPE is a structured program intended to mimic treatment as usual. Thus, SPE is an accepted treatment and serves as an active comparator that controls for time and attention.

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Cynthia R Johnson, PhD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-01
Primary Completion
2022-11-20
Completion
2022-12-26

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03668873 on ClinicalTrials.gov