Multisystemic Therapy to Reduce Health Disparities in Adolescents With Asthma

August 18, 2016 updated by: National Heart, Lung, and Blood Institute (NHLBI)
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

170

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Measured at study entry and Months 7 (post treatment) and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

June 5, 2009

First Submitted That Met QC Criteria

June 5, 2009

First Posted (Estimate)

June 9, 2009

Study Record Updates

Last Update Posted (Estimate)

August 19, 2016

Last Update Submitted That Met QC Criteria

August 18, 2016

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 648
  • 1R01HL087272-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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