Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00166582
Status:
COMPLETED
Last Update Posted:
2007-07-02
First Post:
2005-09-09
Brief Title:
Parent-Youth Teamwork in Pediatric Asthma Management
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
Parent-Youth Teamwork in Pediatric Asthma Management
Status:
COMPLETED
Status Verified Date:
2005-11
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 research study is to examine the effectiveness of a parent-youth teamwork treatment and an asthma education treatment in helping children use their asthma medicines correctly We also want to learn about how these treatments affect parental involvement in asthma care parent and youth relationships and childrens health care
Detailed Description:
Noncompliance with medication is a prevalent problem for pediatric asthma patients particularly for pre-adolescents and adolescents Families reportedly struggle with the transition of expecting adolescents to assume more independence and responsibility in asthma management Parent-child collaborative management of pediatric chronic illness regimens has been related to better adherence to medical regimens and improved health outcome This study has four aims The first aim is to investigate the effectiveness of a low-intensity behavioral intervention aimed at promoting parental involvement in childrens asthma management particularly in improving medication adherence The second aim is to examine how the role of parental involvement changes across time and participation in a 5-month study A third aim is to determine whether parent-adolescent conflict is changed by the intervention The fourth aim is to evaluate whether participation in the treatment program is associated with improved health status eg improved pulmonary function test results
Established asthma patients ages 9-15 will be randomly assigned to one of three groups Treatment Intervention TI Asthma Education AE and Standard Care SC The TI and AE groups will receive four 30-minute treatment sessions every two weeks The TI intervention will consist of strategies aimed at promoting parent-youth management in asthma management The AE group will receive structured reviews of asthma educational materials typically given to asthma patients SC participants will have no contact with researchers beyond that necessary to gather data Data will be collected from all participants every two weeks for the first 8-weeks of study involvement and also about 3-months after the final treatment session Outcome data will include objective measures of medication adherence parental involvement in asthma and health outcome
Established asthma patients ages 9-15 will be randomly assigned to one of three groups Treatment Intervention TI Asthma Education AE and Standard Care SC The TI and AE groups will receive four 30-minute treatment sessions every two weeks The TI intervention will consist of strategies aimed at promoting parent-youth management in asthma management The AE group will receive structured reviews of asthma educational materials typically given to asthma patients SC participants will have no contact with researchers beyond that necessary to gather data Data will be collected from all participants every two weeks for the first 8-weeks of study involvement and also about 3-months after the final treatment session Outcome data will include objective measures of medication adherence parental involvement in asthma and health outcome
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