COPE for Children With Asthma: Intervention for Children With Asthma



Status:Completed
Conditions:Anxiety, Asthma, Depression
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:8 - 12
Updated:8/23/2018
Start Date:July 15, 2017
End Date:May 21, 2018

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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.

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.

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.
We found this trial at
1
site
Columbus, Ohio 43210
Principal Investigator: Bernadette Melnyk, PhD
Phone: 614-292-4844
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mi
from
Columbus, OH
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