Viewing Study NCT00241852



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Last Modification Date: 2024-10-26 @ 9:20 AM
Study NCT ID: NCT00241852
Status: COMPLETED
Last Update Posted: 2014-01-10
First Post: 2005-10-17

Brief Title: Family Approach to Managing Asthma in Early Teens
Sponsor: NYU Langone Health
Organization: NYU Langone Health

Study Overview

Official Title: Family Approach to Managing Asthma in Early Teens
Status: COMPLETED
Status Verified Date: 2014-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
R01HL079953 NIH None httpsreporternihgovquickSearchR01HL079953