NCT00916240

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P50-P75 for not_applicable asthma

Timeline
Completed

Started Sep 2008

Longer than P75 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 9, 2009

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

August 19, 2016

Status Verified

July 1, 2009

Enrollment Period

4.8 years

First QC Date

June 5, 2009

Last Update Submit

August 18, 2016

Conditions

Keywords

AdolescentsAfrican American

Outcome Measures

Primary Outcomes (2)

  • Pulmonary functioning (FEV-1, FVC)

    Measured at study entry and Months 7 (post treatment) and 12

  • Hospital and emergency department utilization (for asthma exacerbation)

    Measured at study entry and Months 7 (post treatment) and 12

Secondary Outcomes (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.

    Measured at study entry and Months 7 (post treatment) and 12

Study Arms (2)

1

EXPERIMENTAL

Participants will receive Multisystemic Therapy (MST).

Behavioral: Multisystemic Therapy

2

ACTIVE COMPARATOR

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

Behavioral: Home-based, Non-Directive Family Support

Interventions

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.

Also known as: MST
1

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.

2

Eligibility Criteria

Age12 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wayne State University School of Medicine

Detroit, Michigan, 48201, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Sylvie Naar-King, PhD

    Wayne State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

June 5, 2009

First Posted

June 9, 2009

Study Start

September 1, 2008

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

August 19, 2016

Record last verified: 2009-07

Locations