Parent-Youth Teamwork in Pediatric Asthma Management

This study has been completed.
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00166582
First received: September 9, 2005
Last updated: June 28, 2007
Last verified: November 2005

September 9, 2005
June 28, 2007
April 2002
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medication adherence, parental involvement , perceived parent-adolescent conflict, associated health outcome
Same as current
Complete list of historical versions of study NCT00166582 on ClinicalTrials.gov Archive Site
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Parent-Youth Teamwork in Pediatric Asthma Management
Parent-Youth Teamwork in Pediatric Asthma Management

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Asthma
  • Device: electronic medication monitoring system
  • Behavioral: parent-adolescent communication and problem-solving skills
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
September 2005
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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
Both
9 Years to 15 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00166582
R03HD39767
Not Provided
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Not Provided
Principal Investigator: Christina D Adams, PhD Children's Mercy Hospital Kansas City
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
November 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP