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Family Approach to Managing Asthma in Early Teens

Primary Purpose

Asthma, Lung Diseases

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Asthma: It's a Family Affair!
Asthma and Stress Comparator
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Asthma

Eligibility Criteria

11 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New York University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Behavioral Intervention: Asthma: It's a Family Affair

Behavioral Control Group

Arm Description

Separate student and parent intervention groups.

Students and parents participate in an education only control group

Outcomes

Primary Outcome Measures

Symptom severity
quality of life
asthma management skills

Secondary Outcome Measures

Urgent health care utilization
days with activity restriction
parent-child interactions

Full Information

First Posted
October 17, 2005
Last Updated
January 9, 2014
Sponsor
NYU Langone Health
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT00241852
Brief Title
Family Approach to Managing Asthma in Early Teens
Official Title
Family Approach to Managing Asthma in Early Teens
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
NYU Langone Health
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Lung Diseases

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
392 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Behavioral Intervention: Asthma: It's a Family Affair
Arm Type
Experimental
Arm Description
Separate student and parent intervention groups.
Arm Title
Behavioral Control Group
Arm Type
Active Comparator
Arm Description
Students and parents participate in an education only control group
Intervention Type
Behavioral
Intervention Name(s)
Asthma: It's a Family Affair!
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Asthma and Stress Comparator
Intervention Description
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 Outcome Measure Information:
Title
Symptom severity
Time Frame
baseline, immediate post-intervention and every 2 months thereafter up to and including 12-months post-intervention
Title
quality of life
Time Frame
Baseline, and immediate, 6-months and 12-months post-intervention
Title
asthma management skills
Time Frame
Baseline, and immediate, 6-months and 12-months post-intervention
Secondary Outcome Measure Information:
Title
Urgent health care utilization
Time Frame
baseline, immediate post-intervention and every 2 months thereafter up to and including 12-months post-intervention
Title
days with activity restriction
Time Frame
baseline, immediate post-intervention and every 2 months thereafter up to and including 12-months post-intervention
Title
parent-child interactions
Time Frame
Baseline, and immediate, 6-months and 12-months post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Marie Bruzzese, PhD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18411832
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.
Results Reference
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Family Approach to Managing Asthma in Early Teens

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