Problem-Solving Skills Training to Improve Care for Children With Asthma

April 25, 2013 updated by: RAND

Reducing Barriers to Care for Vulnerable Children With Asthma

The purpose of this study is to determine whether Problem-Solving Skills Training is effective in reducing barriers to health care and improving health-related quality of life for children with persistent asthma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Brief description: This 4-year research project will develop and test culturally and linguistically appropriate brief interventions to reduce barriers to health care for vulnerable children with persistent asthma.

Background: The U.S. health system presents formidable challenges to the timely receipt of high quality care, especially for vulnerable children (e.g., those in families of color, lower SES, limited English ability). This population is at greatest risk for poor health outcomes. Children with asthma are an important vulnerable subgroup. Asthma, with an estimated prevalence of 6.9%, is the most common chronic condition in children. It is the most frequent reason for pediatric hospitalization and is a condition with documented disparities in care outcomes.

A promising strategy for overcoming the barriers to quality care that these children encounter is the use of care coordinators who educate parents and children, connect the family with needed resources, and coordinate care from different settings. Care coordination has been shown effective in improving receipt of appropriate asthma services and health outcomes for children with asthma. Despite this evidence, there is concern that the effects of care coordination may not be maintained once these services end. This is particularly important given financial pressures to reduce the length and intensity of such services. In order to maintain the gains achieved during care coordination, families need to be able to identify and overcome barriers to care for and by themselves. This can be achieved through the use of Problem Solving Therapy, a documented behavioral method for teaching families the skills they need to resolve daily problems and improve adherence to medical regimens for children with chronic health conditions.

Study Goals: The overall goal of this project is to improve the quality of care and health outcomes for vulnerable children with asthma. The specific aims of this two-phase project are:

  • (Phase I) to adapt, in collaboration with community health workers and parents, existing materials to create two culturally and linguistically appropriate treatment manuals: a Care Coordination Treatment Manual that will standardize the delivery of culturally and linguistically appropriate home-based care coordination and asthma-specific education, and a Problem Solving Therapy Treatment Manual tailored to asthma that will include a detailed, step-by-step guide for implementing this approach to reduce barriers to care.
  • (Phase II) to use the manuals developed in Phase I to perform a randomized controlled clinical trial to evaluate the effectiveness of two brief interventions involving Care Coordination and tailored Problem Solving Therapy (tPST) in improving and maintaining improvement in health care quality and health-related quality of life for children with asthma.

Evidence for the efficacy of tPST and the availability of culturally and linguistically appropriate treatment manuals should spur diffusion of this innovation to other practitioners and programs seeking evidence-based, optimal clinical management strategies.

Methodology:

Phase I. Existing materials for the Care Coordination and tPST manuals will be edited and/or rewritten to make them specific to asthma. Then both the manuals and the proposed interventions will be assessed for cultural acceptability though two series of parallel focus groups: one for parents of children with asthma, and the other for home visitors already providing care coordination for families of children with asthma. The revised educational materials will then be translated into Spanish.

Phase II. Children ages 2-12 years with persistent asthma and their families (n = 366) will be randomized into two brief interventions:

  1. tPST (six sessions) plus Care Coordination (six home visits over 3 months) versus a Wait List control group (usual care) to evaluate the intervention's effectiveness in improving outcomes 3 months after baseline.
  2. tPST versus Care Coordination and Wait List to evaluate the intervention's effectiveness in maintaining outcomes 9 months after baseline.

Study Type

Interventional

Enrollment (Actual)

252

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92123
        • Children's Hospital, San Diego

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 12 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Child age 2 to 12 years old, inclusive
  • Diagnosis of persistent asthma (mild, moderate, or severe) according to NHLBI criteria
  • Family speaks English or Spanish

Exclusion Criteria:

  • Family does not speak English or Spanish
  • Child has other comorbid conditions that would affect care or outcomes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Problem solving + care coordination
Problem solving skills training and asthma care coordination
Behavioral: Problem solving skills training
See description in Results
Behavioral: Asthma care coordination
See description in Results
Other: Usual Care
Usual clinical care
EXPERIMENTAL: Asthma care coordination
Behavioral: Asthma care coordination
See description in Results
Other: Usual Care
Usual clinical care
ACTIVE_COMPARATOR: Wait-list control
Usual care
Other: Usual Care
Usual clinical care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parent Proxy-Reported Health-related Quality of Life (Pediatric Quality of Life Inventory)
Time Frame: Baseline (T1), Post Intervention (3mo, T2), 6-month follow up (9mo post baseline, T3)
The PedsQL™ 4.0 Generic Core Scales Total Scale Score (PedsQL™), which has been shown to be internally consistent, valid, and responsive to indicators of clinical change for children with asthma (Chan, Mangione-Smith, Burwinkle, Rosen, & Varni, 2005; Seid et al., in press; Varni et al., 2004). The 23-item PedsQL™ asks respondents how often various issues have been a 'problem' in the past month, yields a score of 0 to 100 (higher scores are better), and includes parallel child self-report (ages 5-18 years) and parent proxy-report (ages 2-18 years) forms. We measured both self- and proxy-report, although our a priori primary outcome was parent proxy-report.
Baseline (T1), Post Intervention (3mo, T2), 6-month follow up (9mo post baseline, T3)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Counts of Patients With One or More Asthma-related Emergency Department Visits.
Time Frame: Baseline (T1), Post Intervention (3mo, T2), 6-month follow up (9mo post baseline, T3)
Utilization was measured by parent recall of emergency room visits for asthma over the last 6 months (at T1), 3 months (at T2), and 6 months (at T3).
Baseline (T1), Post Intervention (3mo, T2), 6-month follow up (9mo post baseline, T3)
Asthma Symptoms
Time Frame: Baseline (T1), Post Intervention (3mo, T2), 6-month follow up (9mo post baseline, T3)
Asthma symptom frequency was measured via the number of days and nights with asthma symptoms over the past two weeks. Night time asthma symptoms were converted to number of subjects experiencing night time asthma symptoms more than 1 time per week.
Baseline (T1), Post Intervention (3mo, T2), 6-month follow up (9mo post baseline, T3)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RAND

Investigators

  • Principal Investigator: Michael Seid, PhD, Children's Hospital Medical Center, Cincinnati

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Primary Completion (ACTUAL)

October 1, 2007

Study Completion (ACTUAL)

October 1, 2007

Study Registration Dates

First Submitted

November 4, 2005

First Submitted That Met QC Criteria

November 4, 2005

First Posted (ESTIMATE)

November 8, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

June 3, 2013

Last Update Submitted That Met QC Criteria

April 25, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R40 MC 00331

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Asthma

Clinical Trials on Problem solving skills training

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saudi Arabia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe