Enhancing Treatment Adherence in Pediatric Asthma With a Problem Solving Intervention

Study Overview
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Brief Summary
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The purpose of this study is to determine the effectiveness of a tailored problem solving intervention in increasing adherence to asthma management behaviors in African American adolescents with asthma.

Detailed Description
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BACKGROUND: Children and adolescents who are unable to adhere to their medical regimen for the management of chronic illness present considerable challenges to health care providers and researchers. Pediatric asthma is a chronic illness where the consequences of non-adherence are particularly detrimental and widespread, especially among economically disadvantaged minority children and their families. Studies of intervention of asthma management are needed for this population. DESIGN NARRATIVE: The aim of the proposed study is to test the efficacy of a problem solving intervention that is tailored to the observed adherence behaviors and identified barriers to increasing adherence in African American children and adolescents with asthma, and their families. Patients are randomized to either a Tailored Problem Solving Intervention, or a control group who will receive Family Education Intervention. Duration of the intervention is four months.

Official Title
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Randomized Controlled Trial of Problem Solving Intervention to Enhance Treatment Adherence in Pediatric Asthma

Conditions
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Asthma

Intervention / Treatment
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* Behavioral: Tailored Problem Solving Intervention
* Behavioral: Family Education Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: African American Family income to be below the poverty line Physician-based diagnosis of asthma of at least 12 months Moderate to severe asthma (moderate asthma includes daily symptoms, daily use of inhaled short acting beta-agonist, exacerbations greater than 2 times per week that affect activity, and nighttime symptoms greater than once a week, FEV1 or Peak Flow PEF between 60 and 80 percent predicted and PEF variability greater than 30 percent; severe asthma includes continual symptoms, limited physical activity, frequent exacerbations together with frequent nighttime symptoms, FEV1 or PEF less than 60 percent predicted, and PEF variability greater than 30 percent) Likely to be on a stable and daily medication (inhaled steroid) that can be modified electronically for the time period required to participate in the study Exclusion Criteria: Presence of a serious comorbid chronic condition

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Examination of the efficacy of a tailored problem-solving intervention compared with family-based education in improving adherence to treatment regimens for children diagnosed as having asthma and their caregivers
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Tailored Problem Solving Intervention<br>Participants will be randomized to follow a tailored problem solving intervention for the child. | Behavioral: Tailored Problem Solving Intervention<br> <br> Behavioral: Family Education Intervention<br> <br> |
| Active Comparator: Control: Family Education Intervention<br>Participants will be randomized to follow a family education intervention. | Behavioral: Tailored Problem Solving Intervention<br> <br> Behavioral: Family Education Intervention<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to medical treatment, based on electronic monitors | describe the trajectories of adherence to daily inhaled corticosteroid (ICS) medication for a year in economically disadvantaged, African-American youth with asthma based on growth curve modeling | 3, 6, 9 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma-related morbidity, including symptoms, pulmonary functioning, and health-related quality of life | test the relationship of treatment adherence to symptom control, quick-relief medication, and healthcare utilization. | 3, 6, 9 and 12 months |