COPE for Children With Asthma: Intervention for Children With Asthma
Condition: Childhood Asthma; Childhood Anxiety Disorder; Childhood Depression
MeSH terms: Asthma; Depression; Anxiety Disorders
Study type: Interventional

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.
    

Intervention name(s): COPE for Asthma
Intervention type(s): Behavioral
Intervention description(s): 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 model: Single Group Assignment
Intervention model description: Single group, pre-experimental, intervention pilot study.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Childhood Asthma; Childhood Anxiety; Childhood Depression; Childhood Quality of Life