Family Approach to Managing Asthma in Early Teens

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.

Study Overview

• Status: Completed
• Conditions: Lung Diseases; Asthma
• Intervention / Treatment: Behavioral: Asthma: It's a Family Affair!; Behavioral: Asthma and Stress Comparator

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.

• Study Type: Interventional
• Enrollment (Actual): 392
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Symptom severity	baseline, immediate post-intervention and every 2 months thereafter up to and including 12-months post-intervention
quality of life	Baseline, and immediate, 6-months and 12-months post-intervention
asthma management skills	Baseline, and immediate, 6-months and 12-months post-intervention

Secondary Outcome Measures

Outcome Measure	Time Frame
Urgent health care utilization	baseline, immediate post-intervention and every 2 months thereafter up to and including 12-months post-intervention
days with activity restriction	baseline, immediate post-intervention and every 2 months thereafter up to and including 12-months post-intervention
parent-child interactions	Baseline, and immediate, 6-months and 12-months post-intervention

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Jean-Marie Bruzzese, PhD, NYU Langone Health

Publications and helpful links

General Publications

• Bruzzese JM, Unikel L, Gallagher R, Evans D, Colland V. Feasibility and impact of a school-based intervention for families of urban adolescents with asthma: results from a randomized pilot trial. Fam Process. 2008 Mar;47(1):95-113. doi: 10.1111/j.1545-5300.2008.00241.x.

Study record dates

Study Major Dates

• Study Start: May 1, 2005
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: October 17, 2005
• First Submitted That Met QC Criteria: October 17, 2005
• First Posted (Estimate): October 19, 2005

Study Record Updates

• Last Update Posted (Estimate): January 10, 2014
• Last Update Submitted That Met QC Criteria: January 9, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Lung Diseases; Asthma
• Other Study ID Numbers: 333 (Other Grant/Funding Number: Florida Department of Health); R01HL079953 (U.S. NIH Grant/Contract)