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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: Completed NA study of Autism Spectrum Disorder and Sleep Disturbance, sponsored by The Cleveland Clinic.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Modified Simonds \& Parraga Sleep Questionnaire-Composite Sleep Index (MSPSQ - CSI). The modified version of the Simonds \& Parraga Sleep Questionnaire (MSPSQ6 was completed by the child's primary caregiver at baseline, and weeks 5 and 10 weeks for both groups. We used earlier described conventions for determining the MSPSQ - CSI score. The CSI was calculated by assigning a score to the frequency of sleep problems targeted: bedtime resistance (item 5), night waking (item 10), early waking (item
Conditions Studied
Interventions
- BEHAVIORAL Sleep Parent Training
- BEHAVIORAL Sleep Parent Education
Study Locations (1)
Ohio
- Cleveland Clinic Centerl for Autism - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 91 participants |
| Start Date | 2018-11-01 |
| Est. Completion | 2022-12-26 |
| Phase | NA |
What the finished NCT03668873 record still lists
NCT03668873 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 91 participants, a relatively small participant target, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (33% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03668873's enrollment target sits among peer trials
91 82nd of 224 higher than 142 of 224 other Autism Spectrum Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Autism Spectrum Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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