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

Tracking Information

First Received Date ^ICMJE

July 31, 2006

Last Updated Date

May 7, 2008

Start Date ^ICMJE

July 2006

Estimated Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Child Depression measured by Child Depression Inventory (CDI) [ Time Frame: ongoing ] [ Designated as safety issue: No ]
Parent Depression measured by Beck Depression inventory (BDI) [ Time Frame: ongoing ] [ Designated as safety issue: No ]
Quality of life measured by Child Health Questionnaire [ Time Frame: ongoing ] [ Designated as safety issue: No ]
Impact on Family measured by the Impact of Family Scale. [ Time Frame: ongoing ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00359775 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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:

What is the impact of CST on child depression, QOL, health motivation, attitude toward illness, and self-management efficacy?
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 Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Other, Randomized, Open Label, Placebo Control, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Rheumatologic Conditions
Epilepsy
Spina Bifida

Intervention ^ICMJE

Behavioral: Coping Skills Training

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2009

Estimated Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

8 Years to 12 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Betsy l. Roth-Wojcicki, MS, CPNP	414-266-6762	broth-wojcicki@chw.org
Contact: Kathleen J Sawin, DSN, CPNP	414-266-3615	ksawin@chw.org

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00359775

Responsible Party

Betsy roth-wojcicki RN,MS,CPNP, Children's hospital of WI

Study ID Numbers ^ICMJE

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

Study Sponsor ^ICMJE

Children's Hospital and Health System Foundation, Wisconsin

Collaborators ^ICMJE

University of Wisconsin, Madison

Investigators ^ICMJE

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

Information Provided By

Children's Hospital and Health System Foundation, Wisconsin

Verification Date

April 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP