Translating an Efficacious Illness Management Intervention for Youth With Asthma

Study Overview
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Brief Summary
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The propose of the study is to test the effectiveness of Reach for Control (RFC) as compared to Michigan MATCH to improve asthma symptoms, asthma management and lung functioning and to decrease ED visits and admissions for youth with poorly controlled asthma when integrated into hospital emergency departments and delivered by community health workers. The study is a hybrid implementation-effectiveness design and will test RFC for use in real world, public healthcare settings.

Detailed Description
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The study will be conducted in the emergency department at Children's Hospital of Michigan; CHM). 170 adolescents with poorly controlled asthma and their primary caregivers will be enrolled. Families will be randomly assigned to six months of home-based family treatment consisting of either RFC or Michigan MATCH , a model program endorsed by the State of Michigan for treatment of poorly controlled asthma. Treatment content of RFC consists of weekly sessions focusing on asthma education, asthma management skills, improving home-school community for asthma, access to care and case management. MATCH includes asthma education but is less intensive and does not focus on family management skills. Treatment will be provided by community health workers (CHWs) employed by a community agency providing MATCH as their standard of care. Consent and data collection will be completed in the home at baseline with additional data collection visits at 6, 12 and 18 months after baseline. Data collection is completed by project research assistants and consists of questionnaires and interviews with the adolescent and parent to assess asthma management, asthma symptoms and hospital utilization. The adolescent also completes a pulmonary function test on a portable spirometer and is observed using medication devices to assess asthma care skills objectively.The data analyses will be intent-to-treat, meaning that all randomized participants are included regardless of the intervention dose received. Trial data will analyzed using the linear mixed effect models.

Official Title
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Translating an Efficacious Illness Management Intervention for Youth With Poorly Controlled Asthma to Real World Settings

Conditions
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Asthma in Children

Intervention / Treatment
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* Behavioral: Reach for Control
* Behavioral: MATCH


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adolescent/Parent: Child aged 12 years, 0 months to 16 years, 11 months Moderate to severe persistent asthma Child seen in the CHM emergency department for treatment of asthma exacerbation Child has experienced 2 or more ED visits and/ or inpatient admissions in prior 12 months (i.e. poorly controlled asthma) Parent/ legal guardian willing to participate in home-based family treatment Child and family resides within 20 miles of CHM (allows for home-based data collection and intervention) Exclusion Criteria: Adolescent/Parent: Child is currently in an out-of-home placement Schizophrenia or other psychosis on the part of the youth or parent Current suicidality or homicidality on the part of the youth or parent Cognitive impairment or learning disability that prevents comprehension of research measures on the part of parent or youth

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 16 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reach for Control<br>Reach For Control is a multi-component, home-based family therapy that targets the multiple causes of poor adolescent asthma management across individual, family and community systems. | Behavioral: Reach for Control<br>* In Phase 1 (weeks 1-4), the CHW conducts an initial intake and then completes a comprehensive functional analysis (FA) of behavior to determine the causes of poor asthma management for each youth regarding asthma management. In Phase 2 (weeks 5-20) is a treatment phase and consists of a combination of mandatory cognitive-behavioral skills training (CBST) modules (received by all families) and flexible CBST modules chosen and individualized based on the results of the Phase 1 FA. This includes but not limited to In-vivo Asthma Skills Training, Improving Family Communication and Behavioral Contracting. Phase 3 (weeks 21-24) involves termination planning and relapse prevention<br>* Other names: RFC;|
| Active Comparator: Michigan MATCH<br>Program endorsed by the State of Michigan for treatment of poorly controlled asthma. | Behavioral: MATCH<br>* Managing Asthma Through Case Management in Home (MATCH) is the current intervention provided by WCHAP to youth with poorly controlled asthma and their families.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary Functioning (FEV1) | Spirometry will be obtained using a portable calibrated recording spirometer. | Change from Baseline at 6 months, change from Baseline at 12 months and change from Baseline at 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Family Asthma Management System Scale | Identifies family strengths and weaknesses in the management of pediatric asthma across a variety of domains. This is a semi-structured interview that is rated on seven to nine 9-point subscales with higher scores indicating better management. The rating manual provides elaboration and brief examples at key anchor points for each rating scale. A FAMSS summary score is computed for each family by taking a mean across all subscales. | Change from Baseline at 6 months, change from Baseline at 12 months and change from Baseline at 18 months | 
| Asthma Device Use Skills | Observational measure where device use competency is rated during adolescent demonstration of use of their own quick relief and controller medication devices. | Change from Baseline at 6 months, change from Baseline at 12 months and change from Baseline at 18 months | 
| Asthma Symptom Frequency | Self report assessing wheezing, nighttime symptoms, speech limitations and activity limitations. | Change from Baseline at 6 months, change from Baseline at 12 months and change from Baseline at 18 months | 
| Number of emergency department visits, hospitalizations, and total hospital days | Hospitalizations will be obtained from electronic medical records and service utilization forms | Change from Baseline at 3 months, Change from Baseline at 6 months, change from Baseline at 9 months, change from Baseline at 12 months, change from Baseline at 15 months and change from Baseline at 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma management, adolescents