Family Approach to Managing Asthma in Early Teens
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|ClinicalTrials.gov Identifier: NCT00241852|
Recruitment Status : Completed
First Posted : October 19, 2005
Last Update Posted : January 10, 2014
|Condition or disease||Intervention/treatment||Phase|
|Asthma Lung Diseases||Behavioral: Asthma: It's a Family Affair! Behavioral: Asthma and Stress Comparator||Phase 3|
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.
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 (Clinical Trial)|
|Actual Enrollment :||392 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Family Approach to Managing Asthma in Early Teens|
|Study Start Date :||May 2005|
|Primary Completion Date :||June 2010|
|Study Completion Date :||June 2010|
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.
- Symptom severity [ Time Frame: baseline, immediate post-intervention and every 2 months thereafter up to and including 12-months post-intervention ]
- quality of life [ Time Frame: Baseline, and immediate, 6-months and 12-months post-intervention ]
- asthma management skills [ Time Frame: Baseline, and immediate, 6-months and 12-months post-intervention ]
- Urgent health care utilization [ Time Frame: baseline, immediate post-intervention and every 2 months thereafter up to and including 12-months post-intervention ]
- days with activity restriction [ Time Frame: baseline, immediate post-intervention and every 2 months thereafter up to and including 12-months post-intervention ]
- parent-child interactions [ Time Frame: Baseline, and immediate, 6-months and 12-months post-intervention ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00241852
|United States, New York|
|New York University School of Medicine|
|New York, New York, United States, 10016|
|Principal Investigator:||Jean-Marie Bruzzese, PhD||New York University School of Medicine|