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NCT03481673 · ClinicalTrials.gov registry record · NA
COPE for Children With Asthma: Intervention for Children With Asthma
A NA study of Childhood Asthma and Childhood Depression, sponsored by Ohio State University.
- Completed
- Registry status
- NA
- Development phase
- 33
- Enrollment target
- 1
- Study location
NCT03481673 is a NA study of Childhood Asthma and Childhood Depression that has completed, run by Ohio State University. The registered enrollment target is 33 participants, below the 220-participant average among 4 other Childhood Asthma trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03481673, a NA study of Childhood Asthma and Childhood Depression, has completed, sponsored by Ohio State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 33 participants
- Enrollment target
- 1
- Study location
Study Summary
Children with a chronic condition are at a significantly higher risk for anxiety and depression than those without a chronic condition. Asthma is the most common childhood chronic condition. Children with asthma and co-morbid anxiety and/or depression are at risk of poor health outcomes. The purpose of this study is to evaluate the effects of a manualized cognitive behavior skills-building intervention on key physical and mental health outcomes in 8 to 12-year old children with persistent asthma and co-morbid anxiety and/or depression. The results of this study will inform a large scale randomized controlled trial to fully test this needed intervention. COPE (Creating Opportunities for Personal Empowerment), developed by Dr. Melnyk, is a manualized intervention that has been implemented with children, adolescents, and young adults. COPE is a cognitive behavior skills-building program based on cognitive behavior theory. Results from previous studies using COPE have shown consistent decreases in anxiety and depression as well as an increase in healthy lifestyle behaviors in youth with elevated anxiety and depressive symptoms in inner city and rural settings, youth with obesity, and teens experiencing chronic recurrent headaches. However, the COPE program has never been adapted and tested with children who have persistent asthma. This study proposes to test an adaptation of this evidence-based program, "COPE for Asthma," with 8 to 12-year-old children with persistent asthma and elevated anxiety and/or depressive symptoms. COPE for Asthma combines components of asthma education with cognitive behavioral skills. This novel adaptation could fill a gap in research by providing a scalable intervention for this highly vulnerable population.
Conditions Studied
Interventions
- BEHAVIORAL COPE for Asthma
Study Locations (1)
Ohio
- Columbus City Schools - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2017-07-15 |
| Est. Completion | 2018-05-21 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03481673
The ClinicalTrials.gov registry entry for NCT03481673 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 220-participant average among 4 other Childhood Asthma trials with a reported enrollment target (85% lower). The listed sponsor is Ohio State University, which has 552 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Childhood Asthma appearing as the primary indexed condition, and to 1 intervention - of which COPE for Asthma is the first listed.
NCT03481673 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT03481673 about?
NCT03481673 is a clinical study titled "COPE for Children With Asthma: Intervention for Children With Asthma". Children with a chronic condition are at a significantly higher risk for anxiety and depression than those without a chronic condition. Asthma is the most common childhood chronic condition. Children with asthma and co-morbid anxiety and/or depression are at risk of poor health outcomes. The purpose...
What is the current status of trial NCT03481673?
This trial is currently completed. It is a NA study. The enrollment target is 33 participants. The study started on 2017-07-15. Estimated completion is 2018-05-21.
What conditions does trial NCT03481673 study?
This clinical trial studies the following conditions: Childhood Asthma, Childhood Depression, Childhood Anxiety Disorder.
What interventions are being tested in trial NCT03481673?
The interventions under investigation include: COPE for Asthma (BEHAVIORAL).
Who is sponsoring clinical trial NCT03481673?
This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03481673 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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Read our methodology - how this data is sourced, computed, and verified.
Related
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