Clinical trial NCT03481673: COPE for Children With Asthma: Intervention for Children With Asthma
Official title: COPE for Children With Asthma: A Cognitive Behavior Skills-Building
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Asthma
Childhood Anxiety Disorder
Childhood Depression
Keywords: Childhood Asthma
Childhood Anxiety
Childhood Depression
Childhood Quality of Life
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: American Nurses Foundation
name: Sigma Theta Tau International Honor Society of Nursing
name: National Association of Pediatric Nurse Practitioners
name: Sigma Theta Tau Epsilon Branch
First posted: 2018-03-29
Enrollment: 33
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group, pre-experimental, intervention pilot study.
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Measure change in perception of asthma self-management over three time points
timeFrame: 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:
measure: Measure change in anxiety symptoms over three time points
timeFrame: Baseline (before the intervention starts), post-intervention (after the 7-week intervention), and 6-weeks post-intervention.
measure: Measure change in depressive symptoms over three time points
timeFrame: Baseline (before the intervention starts), post-intervention (after the 7-week intervention), and 6-weeks post-intervention.
measure: Measure change in confidence in managing stress over three time points
timeFrame: Baseline (before the intervention starts), post-intervention (after the 7-week intervention), and 6-weeks post-intervention.
measure: Measure change in symptom interpretation over three time points
timeFrame: Baseline (before the intervention starts), post-intervention (after the 7-week intervention), and 6-weeks post-intervention.
measure: Measure change in barriers to controller medications over three time points
timeFrame: Baseline (before the intervention starts), post-intervention (after the 7-week intervention), and 6-weeks post-intervention.
measure: Measure change in quality of life over three time points
timeFrame: Baseline (before the intervention starts), post-intervention (after the 7-week intervention), and 6-weeks post-intervention.
measure: Measure change in asthma control over three time points
timeFrame: Baseline (before the intervention starts), post-intervention (after the 7-week intervention), and 6-weeks post-intervention.
measure: Measure comprehension over each lesson
timeFrame: Baseline (before the intervention starts), post-intervention (after the 7-week intervention), and 6-weeks post-intervention.
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Columbus City Schools
state: Ohio
Study officials:
affiliation: Ohio State University
name: Colleen McGovern, PhD(c)
role: PRINCIPAL_INVESTIGATOR
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