Coping Skills Training (CST) for Children With Chronic Health Conditions

February 16, 2012 updated by: Betsy Roth-Wojcicki, Children's Hospital and Health System Foundation, Wisconsin

Coping Skills Training (CST) for Children With Chronic Health Conditions: An Extension From Children With Diabetes to Children With Rheumatologic Conditions, Epilepsy, Spina Bifida, and Asthma

Purpose of the study The purpose of this study is to pilot an adapted Coping Skills Training (CST) intervention for feasibility and preliminary efficacy with a sample of children 8 to 12 years of age and their parents. The participants in this study at Children's Hospital of Wisconsin are dealing with one of three chronic health conditions (Rheumatologic Conditions, Epilepsy,Spina Bifida, and Asthma).

Research Questions/Study Aims

The research questions addressed in the full study are:

  1. What is the impact of CST on child depression, QOL, health motivation, attitude toward illness, and self-management efficacy?
  2. What is the impact of CST on parent depression, perception of child's quality of life, perception of impact of CHC on family, and family conflict?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Many children with chronic health conditions (CHC) are at increased risk for poor adaptation such as psychosocial problems, behavioral disturbances, and decreased quality of life (QOL). Their parents face economic, social and emotional challenges. In addition, management of the CHC and the involvement of the child in that management can severely challenge both child and parent. Effective coping has been shown to moderate the negative impact of CHC. This study is a pilot study to evaluate the feasibility and preliminary efficacy of adapting a Coping Skills Training (CST) intervention developed for children with diabetes. The CST intervention will be adapted for an integrated sample of school-aged children 8 to 12 years of age with four health conditions (Rheumatologic Conditions, Epilepsy,Spina Bifida, and Asthma). The study will be a randomized clinical trial with a wait-list control group. Each arm will consist of 25 families. CST is a 6-session group intervention based on cognitive behavioral and learning theory. The impact of CST on both outcomes (child: depression, QOL; parent: depression, Child QOL, CHC impact on family) and protective factors (child: health motivation, attitude, self-management efficacy; parent: family conflict) will be measured.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 2

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
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53201
        • Children's Hospital of Wisconsin

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

8 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female children ages 8 to 12 with no known severe cognitive delays,
  • Who are English speaking,
  • With one of the three target conditions; and
  • Have at least one parent willing to participate.

Exclusion Criteria:

  • Children with cognitive delay

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

  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Child Depression measured by Child Depression Inventory (CDI)
Time Frame: ongoing
ongoing
Parent Depression measured by Beck Depression inventory (BDI)
Time Frame: ongoing
ongoing
Quality of life measured by Child Health Questionnaire
Time Frame: ongoing
ongoing
Impact on Family measured by the Impact of Family Scale.
Time Frame: ongoing
ongoing

Collaborators and Investigators

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

Sponsor

Children's Hospital and Health System Foundation, Wisconsin

Collaborators

University of Wisconsin, Madison

Investigators

  • Principal Investigator: Betsy Roth-Wojcicki, MS, CPNP, Medical College of Wisconsin/Children's Hospital of Wisconsin
  • Principal Investigator: Kathleen Sawin, DNS, CPNP,, University of Wisconsin Milwaukee/Children's Hopsital of Wisconsin

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

July 1, 2006

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

July 31, 2006

First Submitted That Met QC Criteria

July 31, 2006

First Posted (Estimate)

August 2, 2006

Study Record Updates

Last Update Posted (Estimate)

February 20, 2012

Last Update Submitted That Met QC Criteria

February 16, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHW 06/32,GC 95
  • UWM # 06-02-208

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.

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