Parent-Youth Teamwork in Pediatric Asthma Management

United States Department of Health and Human Services (HHS) logo

United States Department of Health and Human Services (HHS)

Status and phase

Completed
Phase 2

Conditions

Asthma

Treatments

Device: electronic medication monitoring system
Behavioral: parent-adolescent communication and problem-solving skills

Study type

Interventional

Funder types

NIH

Identifiers

NCT00166582
R03HD039767

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

9 to 15 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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