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

NCT ID: NCT00359775

Last Updated: 2012-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2012-01-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Interventions

Coping Skills Training

6 session behavioral program

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Wisconsin, Madison

OTHER

Sponsor Role: collaborator

Children's Hospital and Health System Foundation, Wisconsin

OTHER

Sponsor Role: lead

Responsible Party

Betsy Roth-Wojcicki

Pediatric Nurse Practitioner

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Betsy Roth-Wojcicki, MS, CPNP

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin/Children's Hospital of Wisconsin

Kathleen Sawin, DNS, CPNP,

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin Milwaukee/Children's Hopsital of Wisconsin

Locations

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

UWM # 06-02-208

Identifier Type: -

Identifier Source: secondary_id

CHW 06/32,GC 95

Identifier Type: -

Identifier Source: org_study_id