COPE for Children With Asthma: Intervention for Children With Asthma

August 20, 2018 updated by: Ohio State University

COPE for Children With Asthma: A Cognitive Behavior Skills-Building

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The Interventionist was trained on the implementation of the COPE intervention and will deliver the COPE for Asthma intervention. The intervention, delivered by Colleen McGovern -the Interventionist, will take place in a room within the school separate from other students. The room will include a door for privacy. The intervention will be once/week, 30 minute sessions, for 7 weeks - during lunch and/or recess time. Groups during lunch and recess, or "lunch bunch" groups, are routinely held in the school system by the social workers, guidance counselors, and school nurses. Participants will be given weekly tickets allowing them to get in line first to pick up their lunch to maximize the allotted time. If the material for a session is not covered (i.e., school-wide fire drill, lock down, or other unforeseen event), the session will be moved to the following week.

In the event a participant has severely elevated t-scores, >=70, on the anxiety or depression screening tools or expresses feelings or intent to harm self or others (at any time point or otherwise), the principal, school nurse and/or guidance counselor/social worker will be notified for follow-up per the school district's protocol. A form letter will be sent to the child's CG that day. If child discloses accounts of abuse or neglect, Franklin County Children's Services will be notified and the principal, school nurse and/or guidance counselor/social worker.

Consent/assent of the CG and child and initial screening for anxiety/depression:SCARED and PROMIS measures; will be completed by the Interventionist and a research assistant, RA, from Dr. Melnyk's research team. Data collection and the intervention will start when >=5 child/CG dyads have been consented/assented in a school.

Week 1 at baseline. To avoid bias, the Interventionist will serve as the interventionist and the RA will complete the data gathering. The measures for the child participants will be explained, then self-administered, and checked for completeness by the RA. The RA will conduct phone interviews with the CGs to gather data on demographics, controller medication adherence, and the Asthma Control Test. If phone contact is not possible, the surveys will be sent home with the child with sealable envelopes for the return.

Weeks 2 - 8. COPE for Asthma will be delivered in small groups (Interventionist may need to implement the intervention at several schools on different days; this is expected). Lessons include 30 minutes of didactic teaching and activities.

Post-Intervention Assessment, after the 7-week intervention. After the last COPE for Asthma session has been implemented in a group, a member of Dr. Melnyk's research team will administer the post-intervention follow-up surveys. CGs will be contacted to complete the parent/CG survey.

6-Week Post-Intervention Assessment. The same procedure as for the post-intervention assessment will be conducted for this time period for the children and CGs.

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Columbus City Schools

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 12 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure change in perception of asthma self-management over three time points
Time Frame: 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).
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure change in anxiety symptoms over three time points
Time Frame: Baseline (before the intervention starts), post-intervention (after the 7-week intervention), and 6-weeks post-intervention.
Anxiety Symptoms: SCARED (Screen for Child Anxiety Related Emotional Disorders) assesses five factors including panic/somatic, general anxiety disorder, separation anxiety, social phobia, and school phobia; it has been validated with children and adolescents ages 8 - 19 years. Items are scored from 0 (not true or hardly ever true) to 2 (very true or often true). Higher scores indicate greater anxiety with a total score of 25 as having a potential anxiety disorder and 30 as more specific (α=.70 - .90).
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
Time Frame: Baseline (before the intervention starts), post-intervention (after the 7-week intervention), and 6-weeks post-intervention.
Depressive Symptoms: PROMIS Pediatric Short Form: Assesses negative mood (e.g., sadness), decrease in positive affect (e.g., loss of interest), negative views of self (e.g., worthlessness), and negative social cognition (e.g., loneliness, interpersonal alienation). Items are scored from 0 (never) to 4 (almost always). Higher scores indicate greater anxiety(α=.85). The PROMIS Pediatric Instruments are intended for children between the ages of 8 - 17 years.
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
Time Frame: Baseline (before the intervention starts), post-intervention (after the 7-week intervention), and 6-weeks post-intervention.
Personal Beliefs Scale: Child Version: 10-item Likert-type scale with items scored from 1 (strongly disagree) to 5 (strongly agree); assesses personal beliefs and confidence about managing stress. Higher scores indicate greater beliefs (α=.85). This scale has been used in prior studies for children and youth between the ages of 9 - 18 years.
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
Time Frame: Baseline (before the intervention starts), post-intervention (after the 7-week intervention), and 6-weeks post-intervention.
Symptom Interpretation: Childhood Asthma Symptom Checklist (CASCL): Interpretation of symptoms; 20-item measure of the frequency that children experience physical symptoms, irritability, and panic-fear during asthma attacks.191 Items are scored on a 4-point scale from 1 (never) to 4 (always). In addition to the three subscales the instrument yields a total symptom score (α=.81). This measure has been validated for children between the ages of 6 - 18 years.
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
Time Frame: Baseline (before the intervention starts), post-intervention (after the 7-week intervention), and 6-weeks post-intervention.
Asthma Illness Representation Scale (AIRS-C): Child Version: The 17-item AIRS Child (AIRS-C) was designed to identify barriers and risk factors for under-utilization of controller medications. Higher scores indicate closer alignment with the professional model for asthma management. This scale has been adapted from the validated parent version and was tested in a small pilot study with acceptable reliability(α=.84). It has been validated for children between the ages of 6 - 17 years.
Baseline (before the intervention starts), post-intervention (after the 7-week intervention), and 6-weeks post-intervention.
Measure change in quality of life over three time points
Time Frame: Baseline (before the intervention starts), post-intervention (after the 7-week intervention), and 6-weeks post-intervention.
Pediatric Asthma Quality of Life Questionnaire (PAQLQ): 14-item Likert-type scale validated for children between ages 7 - 17 years; measures the functional problems (symptoms, activity limitations, emotional function) that are troublesome to children with asthma.31 Items are scored from 1 (extremely bothered) to 7 (not bothered at all) and the total score is the mean of items. Higher scores denote better QoL.
Baseline (before the intervention starts), post-intervention (after the 7-week intervention), and 6-weeks post-intervention.
Measure change in asthma control over three time points
Time Frame: Baseline (before the intervention starts), post-intervention (after the 7-week intervention), and 6-weeks post-intervention.
Asthma control: The Childhood Asthma Control Test (C-ACT) consists of questions for children (ages 4-11 years; 4 items) and parents (3 items) and the ACT (for individuals 12 years and older) has similar questions which are self-administered. This instruments assesses interference with activities, asthma symptoms, and nighttime awakenings. The C-ACT (α=.79) exhibits good reliability and validity, and classifies children as very poorly controlled, not well-controlled, or well controlled.
Baseline (before the intervention starts), post-intervention (after the 7-week intervention), and 6-weeks post-intervention.
Measure comprehension over each lesson
Time Frame: Baseline (before the intervention starts), post-intervention (after the 7-week intervention), and 6-weeks post-intervention.
Education Manipulation Checks: 4 (ordinal) questions will be asked after each session to evaluate children's comprehension of session content. Answering 3 out of 4 questions correctly indicates understanding. The Interventionist will review the incorrect questions and provide re-education for that item. These questions are age appropriate questions in line with the manual.
Baseline (before the intervention starts), post-intervention (after the 7-week intervention), and 6-weeks post-intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University

Collaborators

American Nurses Foundation
Sigma Theta Tau International Honor Society of Nursing
National Association of Pediatric Nurse Practitioners
Sigma Theta Tau Epsilon Branch

Investigators

  • Principal Investigator: Colleen McGovern, PhD(c), Ohio State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 15, 2017

Primary Completion (ACTUAL)

May 21, 2018

Study Completion (ACTUAL)

May 21, 2018

Study Registration Dates

First Submitted

November 20, 2017

First Submitted That Met QC Criteria

March 27, 2018

First Posted (ACTUAL)

March 29, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 21, 2018

Last Update Submitted That Met QC Criteria

August 20, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017B0094

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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