COPE for Children With Asthma: Intervention for Children With Asthma

NCT03481673 | Completed

• 1 other identifier: 2017B0094
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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

Childhood Asthma; Childhood Anxiety Disorder; Childhood Depression

Keywords

Childhood Asthma; Childhood Anxiety; Childhood Depression; Childhood Quality of Life

Outcome Measures

Primary Outcomes (1)

• Measure change in perception of asthma self-management over three time points

  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.

  Baseline (week 1, before the intervention starts), post-intervention (week 8-9, after the 7-week intervention), and 6-weeks post-intervention (week 16-17).

Secondary Outcomes (8)

• Measure change in anxiety symptoms over three time points

  Baseline (before the intervention starts), post-intervention (after the 7-week intervention), and 6-weeks post-intervention.

• Measure change in depressive symptoms over three time points

  Baseline (before the intervention starts), post-intervention (after the 7-week intervention), and 6-weeks post-intervention.

• Measure change in confidence in managing stress over three time points

  Baseline (before the intervention starts), post-intervention (after the 7-week intervention), and 6-weeks post-intervention.

• Measure change in symptom interpretation over three time points

  Baseline (before the intervention starts), post-intervention (after the 7-week intervention), and 6-weeks post-intervention.

• Measure change in barriers to controller medications over three time points

  Baseline (before the intervention starts), post-intervention (after the 7-week intervention), and 6-weeks post-intervention.

Study Arms (1)

Intervention

EXPERIMENTAL

This pre-experimental pilot project is a single group, pretest-posttest design with a 6-week post-intervention follow-up. A single group design was chosen for this feasibility pilot study because the COPE for Asthma intervention is newly adapted for 8 to 12-year-old children with asthma in an urban setting. The intervention will consist of 7 weekly sessions (30 minutes each). COPE for Asthma is a manualized, cognitive behavior skills-building intervention to improve the physical and mental health outcomes of children with asthma and elevated symptoms of anxiety or depression. Surveys with children and their parents/caregivers (CGs) will occur at baseline, immediately post-intervention and 6 weeks' post-intervention.

Behavioral: COPE for Asthma

Interventions

COPE for Asthma BEHAVIORAL

The intervention will consist of 7 weekly sessions (30 minutes each). COPE for Asthma is a manualized, cognitive behavior skills-building intervention to improve the physical and mental health outcomes of children with asthma and elevated symptoms of anxiety or depression.

Intervention

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children age 8-12 years enrolled in Columbus City Schools
• Diagnosis of persistent asthma requiring daily inhaled controller medication use at some point (medical condition form on file with the school/CG report)
• Have symptoms depression or anxiety per the PROMIS/SCARED measures
• Have written consent to participate provided by care giver and child assent
• The participating care giver has primary or at least equal responsibility for the day-to-day management of the child's asthma
• care givers provide written consent for their own participation
• Be able to speak, read, and write in English (care giver and child).

You may not qualify if:

• has other significant pulmonary conditions (e.g., pulmonary fibrosis, cystic fibrosis)
• currently receiving treatment from a mental health professional
• child or CG has cognitive learning disability that could interfere with the ability to comprehend the interview questions.

Sponsors & Collaborators

• Ohio State University: lead
• American Nurses Foundation: collaborator
• Sigma Theta Tau International Honor Society of Nursing: collaborator
• National Association of Pediatric Nurse Practitioners: collaborator
• Sigma Theta Tau Epsilon Branch: collaborator

Study Sites (1)

Columbus City Schools

Columbus, Ohio, 43210, United States

Location

Related Publications (42)

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Study Officials

• Colleen McGovern, PhD(c)

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single group, pre-experimental, intervention pilot study.

Study Record Dates

• First Submitted: November 20, 2017
• First Posted: March 29, 2018
• Study Start: July 15, 2017
• Primary Completion: May 21, 2018
• Study Completion: May 21, 2018
• Last Updated: August 21, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)