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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00359775
• Other study ID #: CHW 06/32,GC 95
• Secondary ID: UWM # 06-02-208
• Status: Completed
• Phase: Phase 2
• First received: July 31, 2006
• Last updated: February 16, 2012
• Start date: July 2006
• Est. completion date: January 2012

Study information

• Verified date: February 2012
• Source: Children's Hospital and Health System Foundation, Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 12 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Asthma
• Disease
• Epilepsy
• Rheumatologic Conditions (JRA,Lupus)
• Spina Bifida
• Spinal Dysraphism

Intervention

Behavioral:
• Coping Skills Training
6 session behavioral program

Locations

Country	Name	City	State
United States	Children's Hospital of Wisconsin	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital and Health System Foundation, Wisconsin	University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Child Depression measured by Child Depression Inventory (CDI)		ongoing	No
Primary	Parent Depression measured by Beck Depression inventory (BDI)		ongoing	No
Primary	Quality of life measured by Child Health Questionnaire		ongoing	No
Primary	Impact on Family measured by the Impact of Family Scale.		ongoing	No