Family Approach to Managing Asthma in Early Teens

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jean-Marie Bruzzese, New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00241852
First received: October 17, 2005
Last updated: January 9, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to test two asthma management programs: (a) a school-based curriculum to empower middle school students to manage their asthma and (b) a parent training curriculum to teach childrearing skills that support the youths' growing autonomy and need to self-manage their disease.


Condition Intervention Phase
Asthma
Lung Diseases
Behavioral: Asthma: It's a Family Affair!
Behavioral: Asthma and Stress Comparator
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Family Approach to Managing Asthma in Early Teens

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Symptom severity [ Time Frame: baseline, immediate post-intervention and every 2 months thereafter up to and including 12-months post-intervention ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: Baseline, and immediate, 6-months and 12-months post-intervention ] [ Designated as safety issue: No ]
  • asthma management skills [ Time Frame: Baseline, and immediate, 6-months and 12-months post-intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Urgent health care utilization [ Time Frame: baseline, immediate post-intervention and every 2 months thereafter up to and including 12-months post-intervention ] [ Designated as safety issue: No ]
  • days with activity restriction [ Time Frame: baseline, immediate post-intervention and every 2 months thereafter up to and including 12-months post-intervention ] [ Designated as safety issue: No ]
  • parent-child interactions [ Time Frame: Baseline, and immediate, 6-months and 12-months post-intervention ] [ Designated as safety issue: No ]

Enrollment: 392
Study Start Date: May 2005
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Behavioral Intervention: Asthma: It's a Family Affair
Separate student and parent intervention groups.
Behavioral: Asthma: It's a Family Affair!
Intervention families will receive a comprehensive program with two complementary components: (1) a school-based intervention to empower middle school students to manage their asthma and (2) parent training to teach their caregivers childrearing skills that support the youth's growing autonomy and need to self-manage their disease. The student component is comprised of 6, 60 minute group workshops; the caregiver component consists of 5, 90-minute group workshops.
Active Comparator: Behavioral Control Group
Students and parents participate in an education only control group
Behavioral: Asthma and Stress Comparator
Caregivers assigned to the Asthma and Stress Comparator group will receive a single educational workshop focusing on the developmental changes adolescents experience, how these changes may cause stress, and ways to cope with stress. The children will also participate in a single school-based session on similar topics. Both caregivers and students will learn basic asthma facts.

Detailed Description:

BACKGROUND:

Asthma is a public health problem with its prevalence and morbidity being significant in 11- to 14-year olds, particularly among ethnic minorities. Despite this, little has been done to intervene with this age group. This is surprising considering the success of asthma education programs for younger children. In addition, there are no reports of parenting training to help families manage asthma despite the significant influence parenting strategies have on the management of chronic illnesses.

DESIGN NARRATIVE:

The overall goal of this study is to test the efficacy of a program with two complementary components: (a) a school-based curriculum to empower middle school students to manage their asthma and (b) a parent training curriculum to teach childrearing skills that support the youths' growing autonomy and need to self-manage their disease. The specific aims are: (1) to implement screening to identify 6th - 8th grade students with persistent asthma; and (2) to provide health education and parent training to help children and parents manage asthma more effectively. The student program is based on Coping with Asthma at Home and at School, a successful program developed in Holland. The parent program is an adaptation of Thriving Teens, an effective parent training program developed by the investigators. Participants in this randomized control trial will be 384 children with asthma and their caregivers from 16 New York City public schools serving low-income, ethnic minorities. It is hypothesized that students randomized to the intervention will have, relative to controls, improvements in three primary outcomes: (1) reduced symptom severity; (2) improved quality of life; and (3) better asthma management skills. Also, when compared to controls, intervention students will show improvement in the following secondary outcomes: (4) urgent health care utilization; (5) days with activity restriction; and (6) parent-child interactions. Caregivers and children will complete comprehensive surveys assessing these outcomes at baseline, and immediately and 6- and 12-months after the intervention.

  Eligibility

Ages Eligible for Study:   11 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria for Youth:

  • Prior diagnosis of asthma from a medical provider
  • Asthma symptoms an average of 3 times per month during the 12 months prior to study entry OR less frequent symptoms but having 1 or more urgent visits to a doctor/emergency room or hospitalization for asthma during the 12 months prior to study entry
  • Use of prescribed asthma medication in the 12 months prior to study entry

Inclusion Criteria for Families:

  • Child and participating parent must live together

Exclusion Criteria for Youth:

  • Co-morbidity that might affect lung function, such as cystic fibrosis or sickle cell anemia
  • Highly specialized developmental or learning needs (e.g., Down's syndrome, mental retardation, severe ADHD)
  • Major psychiatric illness

Exclusion Criteria for Families:

  • Foster parents and their children
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00241852

Locations
United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Jean-Marie Bruzzese, PhD New York University School of Medicine
  More Information

Publications:
Responsible Party: Jean-Marie Bruzzese, Associate Professor, New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00241852     History of Changes
Other Study ID Numbers: 333, R01HL079953, R01 HL79953
Study First Received: October 17, 2005
Last Updated: January 9, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Asthma
Lung Diseases
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 15, 2014