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
  Purpose

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.


Condition Intervention Phase
Asthma
Device: electronic medication monitoring system
Behavioral: parent-adolescent communication and problem-solving skills
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Parent-Youth Teamwork in Pediatric Asthma Management

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • medication adherence, parental involvement , perceived parent-adolescent conflict, associated health outcome

Estimated Enrollment: 60
Study Start Date: April 2002
Estimated Study Completion Date: September 2005
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.

  Eligibility

Ages Eligible for Study:   9 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00166582

Locations
United States, Missouri
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States, 64108
United States, West Virginia
West Virginia Univeristy
Morgantown, West Virginia, United States, 26506
Sponsors and Collaborators
Investigators
Principal Investigator: Christina D Adams, PhD Children's Mercy Hospital Kansas City
  More Information

No publications provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00166582     History of Changes
Other Study ID Numbers: R03HD39767
Study First Received: September 9, 2005
Last Updated: June 28, 2007
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
pediatric asthma, medication adherence, adolescents

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014