Parent-Youth Teamwork in Pediatric Asthma Management

Asthma Clinical Trial

Official title:

Parent-Youth Teamwork in Pediatric Asthma Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00166582
• Other study ID #: R03HD039767
• Status: Completed
• Phase: Phase 2
• First received: September 9, 2005
• Last updated: June 28, 2007
• Start date: April 2002
• Est. completion date: September 2005

Study information

• Verified date: November 2005
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 9 Years to 15 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Device:
• electronic medication monitoring system

Behavioral:
• parent-adolescent communication and problem-solving skills

Locations

Country	Name	City	State
United States	Children's Mercy Hospitals and Clinics	Kansas City	Missouri
United States	West Virginia Univeristy	Morgantown	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	medication adherence, parental involvement , perceived parent-adolescent conflict, associated health outcome