Family Approach to Managing Asthma in Early Teens

Asthma Clinical Trial

Official title:

Family Approach to Managing Asthma in Early Teens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00241852
• Other study ID #: 333
• Secondary ID: R01HL079953
• Status: Completed
• Phase: Phase 3
• First received: October 17, 2005
• Last updated: January 9, 2014
• Start date: May 2005
• Est. completion date: June 2010

Study information

• Verified date: January 2014
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 392
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 11 Years to 14 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Asthma
• Lung Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York University School of Medicine	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom severity		baseline, immediate post-intervention and every 2 months thereafter up to and including 12-months post-intervention	No
Primary	quality of life		Baseline, and immediate, 6-months and 12-months post-intervention	No
Primary	asthma management skills		Baseline, and immediate, 6-months and 12-months post-intervention	No
Secondary	Urgent health care utilization		baseline, immediate post-intervention and every 2 months thereafter up to and including 12-months post-intervention	No
Secondary	days with activity restriction		baseline, immediate post-intervention and every 2 months thereafter up to and including 12-months post-intervention	No
Secondary	parent-child interactions		Baseline, and immediate, 6-months and 12-months post-intervention	No