CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 91 enrolled
Drug / intervention
Sleep Parent Training +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03668873
NCT03668873N/ACompleted
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Telehealth Delivery of Treatment for Sleep Disturbances in Young Children With Autism Spectrum Disorder

The Cleveland Clinic·interventional·Posted Sep 13, 2018·Updated Sep 19, 2024

In Brief

A clinical study evaluating Sleep Parent Training and Sleep Parent Education for Autism Spectrum Disorder and Sleep Disturbance. Completed, enrolled 91 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAutism Spectrum Disorder, Sleep Disturbance
CountriesUnited States
CollaboratorsUnited States Department of Defense

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedSep 13, 2018
Enrollment StartNov 1, 2018
Primary CompletionNov 20, 2022
Study CompletionDec 26, 2022
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 7.8 years ago

Interventions

Sleep Parent Trainingbehavioral

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

Sleep Parent Educationbehavioral

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.