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NCT02996175 · ClinicalTrials.gov registry record · NA
Treatment of Sleep Disturbances in School-age Children With Down Syndrome
A NA study, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- NA
- Development phase
- 34
- Enrollment target
NCT02996175: Completed NA study, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT02996175 is a NA study that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 34 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02996175, a NA study, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- NA
- Development phase
- 34 participants
- Enrollment target
Study Summary
The investigators long-term goal is to improve outcomes for children with Down syndrome (DS) and their caregivers. Towards that goal, the investigators propose a randomized clinical trial of a behavioral sleep treatment designed specifically for children with DS, documenting the impact not only on sleep, but also on the child's daytime inhibitory control and behavior problems, and the caregiver's sleep and stress levels. The investigators will randomize 80 families of children with DS ages 6-17 to receive either a 5-session behavioral sleep treatment (BST; targeting sleep education, behavioral principles and visual supports) or a general-education control condition (CON). The BST will cater to the unique needs of children with DS, adapting an intervention that successfully treats behavioral sleep disturbances in children with autism1. Pre- and post-intervention, children will undergo comprehensive assessments of cognitive, behavioral, and adaptive functioning involving direct testing and input from parents and teachers. Child and parent sleep will be monitored via actigraphy and parent-completed sleep diaries, and parents will report on their stress levels and mood.
Primary Outcome
33-item Parent reported sleep quality for Child over past week. Each item is scored 1-3 (1 = Rarely, 0-1x/week; 2 = Sometimes, 2-4x/week; 3= Usually, 5-7x/week). There are 6 questions with reverse scoring. This will yield a total between 33 and 99. This will be acquired from parent three times throughout study, data scored and entered into SPSS by coordinator using total score data for comparatives to actigraph results for total sleep.
Interventions
- BEHAVIORAL Behavioral Sleep Treatment
- BEHAVIORAL Standard of care sleep treatment enhanced with psychoeducation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2015-07 |
| Est. Completion | 2018-05 |
| Phase | NA |
What the finished NCT02996175 record still lists
NCT02996175 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Behavioral Sleep Treatment is the first listed.
NCT02996175 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02996175 about?
NCT02996175 is a clinical study titled "Treatment of Sleep Disturbances in School-age Children With Down Syndrome". The investigators long-term goal is to improve outcomes for children with Down syndrome (DS) and their caregivers. Towards that goal, the investigators propose a randomized clinical trial of a behavioral sleep treatment designed specifically for children with DS, documenting the impact not only on s...
What is the current status of trial NCT02996175?
This trial is currently completed. It is a NA study. The enrollment target is 34 participants. The study started on 2015-07. Estimated completion is 2018-05.
What interventions are being tested in trial NCT02996175?
The interventions under investigation include: Behavioral Sleep Treatment (BEHAVIORAL), Standard of care sleep treatment enhanced with psychoeducation (BEHAVIORAL).
Who is sponsoring clinical trial NCT02996175?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02996175's enrollment target sits among peer trials
34 1570th of 2000 higher than 427 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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