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Family Approach to Managing Asthma in Early Teens

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NYU Langone Health

Status and phase

Completed
Phase 3

Conditions

Asthma
Lung Diseases

Treatments

Behavioral: Asthma and Stress Comparator
Behavioral: Asthma: It's a Family Affair!

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00241852
333
R01HL079953 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

392 patients

Sex

All

Ages

11 to 14 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

392 participants in 2 patient groups

Behavioral Intervention: Asthma: It's a Family Affair
Experimental group
Description:
Separate student and parent intervention groups.
Treatment:
Behavioral: Asthma: It's a Family Affair!
Behavioral Control Group
Active Comparator group
Description:
Students and parents participate in an education only control group
Treatment:
Behavioral: Asthma and Stress Comparator

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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