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

Phase 2

Completed

• Conditions: Rheumatologic Conditions (JRA,Lupus); Epilepsy; Spina Bifida; Asthma

• Registration Number: NCT00359775
• Lead Sponsor: Children's Hospital and Health System Foundation, Wisconsin

Brief Summary

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?

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 Timeline

• Study Start: 2006-07
• Study First Submitted: 2006-07-31
• Study First Submitted QC: 2006-07-31
• Study First Posted: 2006-08-02
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-16
• Last Update Posted: 2012-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Trial Locations

Locations (1)

Children's Hospital of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States