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

This study has been completed.
Sponsor:
Collaborator:
University of Wisconsin, Madison
Information provided by (Responsible Party):
Betsy Roth-Wojcicki, Children's Hospital and Health System Foundation, Wisconsin
ClinicalTrials.gov Identifier:
NCT00359775
First received: July 31, 2006
Last updated: February 16, 2012
Last verified: February 2012
  Purpose

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?

Condition Intervention Phase
Rheumatologic Conditions (JRA,Lupus)
Epilepsy
Spina Bifida
Asthma
Behavioral: Coping Skills Training
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Children's Hospital and Health System Foundation, Wisconsin:

Primary Outcome Measures:
  • 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 ]

Enrollment: 38
Study Start Date: July 2006
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Coping Skills Training
    6 session behavioral program
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.

  Eligibility

Ages Eligible for Study:   8 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00359775

Locations
United States, Wisconsin
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53201
Sponsors and Collaborators
Children's Hospital and Health System Foundation, Wisconsin
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
  More Information

No publications provided

Responsible Party: Betsy Roth-Wojcicki, Pediatric Nurse Practitioner, Children's Hospital and Health System Foundation, Wisconsin
ClinicalTrials.gov Identifier: NCT00359775     History of Changes
Other Study ID Numbers: CHW 06/32,GC 95, UWM # 06-02-208
Study First Received: July 31, 2006
Last Updated: February 16, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital and Health System Foundation, Wisconsin:
Coping
psychosocial
Quality of Life
problem solving

Additional relevant MeSH terms:
Spinal Dysraphism
Asthma
Epilepsy
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neural Tube Defects
Nervous System Malformations
Congenital Abnormalities

ClinicalTrials.gov processed this record on July 23, 2014