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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: Completed NA study of Childhood Asthma and Childhood Depression, sponsored by Ohio State University.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Asthma Management Self-Efficacy: The Child ASE scale (14 items) measures children's perception of their own ability to manage asthma (e.g., "...can tell when a serious breathing problem can be controlled at home"); assesses asthma symptoms, health status, and impact of the child's illness on the family. Higher scores indicate greater self-efficacy; (α=.87). This measure has been validated in children ages 7 - 15 years.

Conditions Studied

Childhood Asthma Childhood Depression Childhood Anxiety Disorder

Interventions

  • BEHAVIORAL COPE for Asthma

Study Locations (1)

Ohio

  • Columbus City Schools - Columbus

Trial Details

FieldValue
Enrollment Target 33 participants
Start Date 2017-07-15
Est. Completion 2018-05-21
Phase NA
Ohio State University

552 total trials

What the finished NCT03481673 record still lists

NCT03481673 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 220-participant average among 4 other Childhood Asthma trials with a reported enrollment target (85% lower).

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 a single indexed study location in 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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Related registry views

Source: ClinicalTrials.gov NCT03481673, the US trial registry maintained by the National Library of Medicine. NCT03481673 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.