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Completed

NCT Number: NCT00241852

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.

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Key information

Age range

11 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

New York University School of Medicine

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Asthma: It's a Family Affair!

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Symptom severity

    Time frame: baseline, immediate post-intervention and every 2 months thereafter up to and including 12-months post-intervention

  2. quality of life

    Time frame: Baseline, and immediate, 6-months and 12-months post-intervention

  3. asthma management skills

    Time frame: Baseline, and immediate, 6-months and 12-months post-intervention

Secondary outcomes

  1. Urgent health care utilization

    Time frame: baseline, immediate post-intervention and every 2 months thereafter up to and including 12-months post-intervention

  2. days with activity restriction

    Time frame: baseline, immediate post-intervention and every 2 months thereafter up to and including 12-months post-intervention

  3. parent-child interactions

    Time frame: Baseline, and immediate, 6-months and 12-months post-intervention

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2005
Primary completion
2010
Study completion
2010
First posted
Oct 19, 2005
Registry last updated
Jan 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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