Parent-Youth Teamwork in Pediatric Asthma Management
Primary Purpose
Asthma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
electronic medication monitoring system
parent-adolescent communication and problem-solving skills
Sponsored by

About this trial
This is an interventional treatment trial for Asthma focused on measuring pediatric asthma, medication adherence, adolescents
Eligibility Criteria
Inclusion Criteria: patient has been diagnosed with asthma for at least 6 months patient can be managed appropriately on study medications as determined by the attending physician Exclusion Criteria: patient shows evidence of neurological or significant cognitive impairment
Sites / Locations
- Children's Mercy Hospitals and Clinics
- West Virginia Univeristy
Outcomes
Primary Outcome Measures
medication adherence, parental involvement , perceived parent-adolescent conflict, associated health outcome
Secondary Outcome Measures
Full Information
NCT ID
NCT00166582
First Posted
September 9, 2005
Last Updated
June 28, 2007
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT00166582
Brief Title
Parent-Youth Teamwork in Pediatric Asthma Management
Official Title
Parent-Youth Teamwork in Pediatric Asthma Management
Study Type
Interventional
2. Study Status
Record Verification Date
November 2005
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
5. Study Description
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 children's 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 children's 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 (e.g., 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
pediatric asthma, medication adherence, adolescents
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
electronic medication monitoring system
Intervention Type
Behavioral
Intervention Name(s)
parent-adolescent communication and problem-solving skills
Primary Outcome Measure Information:
Title
medication adherence, parental involvement , perceived parent-adolescent conflict, associated health outcome
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patient has been diagnosed with asthma for at least 6 months
patient can be managed appropriately on study medications as determined by the attending physician
Exclusion Criteria:
patient shows evidence of neurological or significant cognitive impairment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina D Adams, PhD
Organizational Affiliation
Children's Mercy Hospital Kansas City
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Mercy Hospitals and Clinics
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
West Virginia Univeristy
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23248342
Citation
Duncan CL, Hogan MB, Tien KJ, Graves MM, Chorney JM, Zettler MD, Koven L, Wilson NW, Dinakar C, Portnoy J. Efficacy of a parent-youth teamwork intervention to promote adherence in pediatric asthma. J Pediatr Psychol. 2013 Jul;38(6):617-28. doi: 10.1093/jpepsy/jss123. Epub 2012 Dec 17.
Results Reference
derived
Learn more about this trial
Parent-Youth Teamwork in Pediatric Asthma Management
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