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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
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Jean-Marie Bruzzese, New York University School of Medicine

October 17, 2005
October 19, 2005
January 10, 2014
May 2005
June 2010   (Final data collection date for primary outcome measure)
  • 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 ]
Not Provided
Complete list of historical versions of study NCT00241852 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Family Approach to Managing Asthma in Early Teens
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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
  • Asthma
  • Lung Diseases
  • 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.
  • 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.
  • Experimental: Behavioral Intervention: Asthma: It's a Family Affair
    Separate student and parent intervention groups.
    Intervention: Behavioral: Asthma: It's a Family Affair!
  • Active Comparator: Behavioral Control Group
    Students and parents participate in an education only control group
    Intervention: Behavioral: Asthma and Stress Comparator
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
392
Not Provided
June 2010
June 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
11 Years to 14 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00241852
333
R01HL079953 ( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
Jean-Marie Bruzzese, New York University School of Medicine
New York University School of Medicine
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Jean-Marie Bruzzese, PhD New York University School of Medicine
New York University School of Medicine
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP