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NCT03668873 · ClinicalTrials.gov registry record · NA

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

A NA study of Autism Spectrum Disorder and Sleep Disturbance, sponsored by The Cleveland Clinic.

Completed
Registry status
NA
Development phase
91
Enrollment target
1
Study location

NCT03668873 is a NA study of Autism Spectrum Disorder and Sleep Disturbance that has completed, run by The Cleveland Clinic. The registered enrollment target is 91 participants, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (33% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03668873, a NA study of Autism Spectrum Disorder and Sleep Disturbance, has completed, sponsored by The Cleveland Clinic.

COMPLETED
Registry status
NA
Development phase
91 participants
Enrollment target
1
Study location

Study 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 Studied

Autism Spectrum Disorder Sleep Disturbance

Interventions

  • BEHAVIORAL Sleep Parent Training
  • BEHAVIORAL Sleep Parent Education

Study Locations (1)

Ohio

  • Cleveland Clinic Centerl for Autism - Cleveland

Trial Details

FieldValue
Enrollment Target 91 participants
Start Date 2018-11-01
Est. Completion 2022-12-26
Phase NA

Sponsor

The Cleveland Clinic

688 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03668873

The ClinicalTrials.gov registry entry for NCT03668873 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 91 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (33% lower). The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Autism Spectrum Disorder appearing as the primary indexed condition, and to 2 interventions - of which Sleep Parent Training is the first listed.

NCT03668873 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.

Frequently Asked Questions

What is clinical trial NCT03668873 about?

NCT03668873 is a clinical study titled "Telehealth Delivery of Treatment for Sleep Disturbances in Young Children With Autism Spectrum Disorder". 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 fiv...

What is the current status of trial NCT03668873?

This trial is currently completed. It is a NA study. The enrollment target is 91 participants. The study started on 2018-11-01. Estimated completion is 2022-12-26.

What conditions does trial NCT03668873 study?

This clinical trial studies the following conditions: Autism Spectrum Disorder, Sleep Disturbance.

What interventions are being tested in trial NCT03668873?

The interventions under investigation include: Sleep Parent Training (BEHAVIORAL), Sleep Parent Education (BEHAVIORAL).

Who is sponsoring clinical trial NCT03668873?

This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03668873 being conducted?

This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.