Multisystemic Therapy to Reduce Health Disparities in Adolescents With Asthma

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

Asthma is a chronic lung disease that inflames and narrows the airways. Symptoms can include recurring periods of wheezing, chest tightness, shortness of breath, and coughing. Minority, inner city teens are at increased risk for complications from the disease, possibly because of poor illness management. The purpose of this study is to test the effectiveness of Multisystemic Therapy (MST)—an intensive, home- and community-based psychotherapy—for improving asthma management and overall health and for reducing healthcare costs for inner city African American teens with asthma.

Condition or disease	Intervention/treatment	Phase
Asthma	Behavioral: Multisystemic Therapy; Behavioral: Home-based, Non-Directive Family Support	Not Applicable

Detailed Description:

Although rates of childhood asthma are increasing worldwide, more alarming is the disproportionate rise in rates of asthma among urban, disadvantaged, minority children. Inner city children, particularly adolescents, also appear to be most at risk for morbidity, mortality, and emergency department visits as a result of asthma. This may be caused by poor illness management.

Because of the multiple factors that affect whether or not a family is able to adequately manage a youth's asthma, educational interventions alone are typically insufficient to reduce morbidity and healthcare utilization, particularly in high-risk urban populations. As a result, more intensive, multi-component interventions are necessary to improve asthma management and outcomes for those youth at highest risk. MST is an innovative, flexible, home- and community-based family therapy that has been shown to improve health outcomes in urban children and adolescents with other chronic medical conditions such as type 1 diabetes and HIV infection. The purpose of this study is to determine the effectiveness of MST in improving health outcomes and reducing healthcare costs in high-risk urban adolescents with moderate to severe persistent asthma.

Participants will include high-risk African-American adolescents with moderate to severe asthma. High-risk youth are defined as those with one or more hospitalizations for asthma treatment in the previous 12 months. At a baseline hospital visit, participants will complete questionnaires and an interview, both of which will focus on the participant's family and asthma history. Participants will also have the option of having the study personnel visit their home instead. Participants will then be randomly assigned to receive either MST plus standard multidisciplinary specialty care or standard multidisciplinary care alone.

Participants assigned to MST will attend psychological treatment sessions in their homes for about 6 months. Treatment sessions will be attended by both children and parents, occur at a time designated by the participants, and last about 1 hour. Participants will also complete questionnaires about their interactions with the therapist and their satisfaction with treatment.

Participants assigned to standard multidisciplinary specialty care alone will receive weekly home-based, supportive family counseling for about 6 months. The treatment will provide emotional support to the family regarding asthma, help the family spot problems in asthma care, and address specific support that may help them with asthma management. Counseling sessions will last about 45 minutes.

Participants in both groups will receive treatment for 6 months and follow-up for 12 months. Participants will be evaluated at baseline and after 7 and 12 months. Families will also be contacted during Months 3 and 9 for medical information. During the study, the medical charts of participants with asthma will be reviewed for medical history and clinic visits. Other medical providers who directly care for the participant's asthma (e.g., primary care provider) may also be contacted. At the Month 6 evaluation, height and weight measurements will be taken.

The study completion date listed in this record was obtained from the "Completed Date" entered in the Query View Report System (QVR).

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	170 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Multisystemic Therapy to Reduce Health Disparities in Adolescents With Asthma
Study Start Date :	September 2008
Actual Primary Completion Date :	June 2013
Actual Study Completion Date :	June 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: 1; Participants will receive Multisystemic Therapy (MST).	Behavioral: Multisystemic Therapy; Treatment will consist of a home- and community-based intensive intervention. Psychological treatment sessions will be provided in participants' homes, at a time designated by the participant and will last about 1 hour.; Other Name: MST
Active Comparator: 2; Participants will receive home-based, non-directive family support.	Behavioral: Home-based, Non-Directive Family Support; Treatment will consist of Rogerian, client-centered, non-directive counseling. Participants will receive weekly home-based, supportive family counseling, with sessions lasting about 45 minutes.

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Pulmonary functioning (FEV-1, FVC) [ Time Frame: Measured at study entry and Months 7 (post treatment) and 12 ]
2. Hospital and emergency department utilization (for asthma exacerbation) [ Time Frame: Measured at study entry and Months 7 (post treatment) and 12 ]

Secondary Outcome Measures :

1. Identification of mediators and moderators of MST treatment effects, e.g., individual adolescent factors (asthma knowledge/skill, mental health); family factors (family routines and relationships), etc. [ Time Frame: Measured at study entry and Months 7 (post treatment) and 12 ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	12 Years to 16 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Moderate to severe persistent asthma
• African American
• One or more hospitalizations for asthma in the last 12 months

Exclusion Criteria:

• No exclusions will be made due to co-morbid mental health problems (i.e., attention deficit hyperactivity disorder [ADHD], conduct disorder, depression, anxiety disorder), with the exception of thought disorder (i.e. schizophrenia, autism), suicidality, or mental retardation

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Michigan
Wayne State University School of Medicine
Detroit, Michigan, United States, 48201

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Principal Investigator:	Sylvie Naar-King, PhD	Wayne State University

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Sylvie Naar-King, PhD, Principal Investigator, Wayne State University School of Medicine, Department of Pediatrics
ClinicalTrials.gov Identifier:	NCT00916240 History of Changes
Other Study ID Numbers:	648; 1R01HL087272-01A1 ( U.S. NIH Grant/Contract )
First Posted:	June 9, 2009
Last Update Posted:	August 19, 2016
Last Verified:	July 2009

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):

Adolescents; African American

Additional relevant MeSH terms:

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases	Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases