MedPath

Family Approach to Managing Asthma in Early Teens

Phase 3
Completed
Conditions
Lung Diseases
Asthma
Interventions
Behavioral: Asthma and Stress Comparator
Registration Number
NCT00241852
Lead Sponsor
NYU Langone Health
Brief Summary

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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
392
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Behavioral Control GroupAsthma and Stress ComparatorStudents and parents participate in an education only control group
Primary Outcome Measures
NameTimeMethod
Symptom severitybaseline, immediate post-intervention and every 2 months thereafter up to and including 12-months post-intervention
quality of lifeBaseline, and immediate, 6-months and 12-months post-intervention
asthma management skillsBaseline, and immediate, 6-months and 12-months post-intervention
Secondary Outcome Measures
NameTimeMethod
parent-child interactionsBaseline, and immediate, 6-months and 12-months post-intervention
Urgent health care utilizationbaseline, immediate post-intervention and every 2 months thereafter up to and including 12-months post-intervention
days with activity restrictionbaseline, immediate post-intervention and every 2 months thereafter up to and including 12-months post-intervention

Trial Locations

Locations (1)

New York University School of Medicine

🇺🇸

New York, New York, United States

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