Clinical trial NCT00241852: Family Approach to Managing Asthma in Early Teens
Official title: Family Approach to Managing Asthma in Early Teens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Lung Diseases
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2005-10-19
Enrollment: 392
Sex: ALL
Minimum age (years): 11
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Symptom severity
timeFrame: baseline, immediate post-intervention and every 2 months thereafter up to and including 12-months post-intervention
measure: quality of life
timeFrame: Baseline, and immediate, 6-months and 12-months post-intervention
measure: asthma management skills
timeFrame: Baseline, and immediate, 6-months and 12-months post-intervention
Secondary outcomes:
measure: Urgent health care utilization
timeFrame: baseline, immediate post-intervention and every 2 months thereafter up to and including 12-months post-intervention
measure: days with activity restriction
timeFrame: baseline, immediate post-intervention and every 2 months thereafter up to and including 12-months post-intervention
measure: parent-child interactions
timeFrame: Baseline, and immediate, 6-months and 12-months post-intervention
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Jean-Marie Bruzzese, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1111/j.1545-5300.2008.00241.x.