Multisystemic Therapy to Reduce Health Disparities in Adolescents With Asthma

NCT ID: NCT00916240

Last Updated: 2016-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2013-06-30

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.

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).

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

Participants will receive Multisystemic Therapy (MST).

Group Type: EXPERIMENTAL

Multisystemic Therapy

Intervention Type: BEHAVIORAL

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.

2

Participants will receive home-based, non-directive family support.

Group Type: ACTIVE_COMPARATOR

Home-based, Non-Directive Family Support

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

MST

Eligibility 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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: lead

Responsible Party

Wayne State University School of Medicine, Department of Pediatrics

Principal Investigators

Sylvie Naar-King, PhD

Role: PRINCIPAL_INVESTIGATOR

Wayne State University

Locations

Wayne State University School of Medicine

Detroit, Michigan, United States

Countries

United States

References

Naar S, Ellis D, Cunningham P, Pennar AL, Lam P, Brownstein NC, Bruzzese JM. Comprehensive Community-Based Intervention and Asthma Outcomes in African American Adolescents. Pediatrics. 2018 Oct;142(4):e20173737. doi: 10.1542/peds.2017-3737. Epub 2018 Sep 5.

Reference Type: DERIVED

PMID: 30185428 (View on PubMed)

Other Identifiers

1R01HL087272-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

648

Identifier Type: -

Identifier Source: org_study_id