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Completed

NCT Number: NCT00359775

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

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?

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Key information

Conditions

Rheumatologic Conditions (JRA,Lupus) Asthma Brain Diseases Bronchial Diseases Central Nervous System Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Epilepsy Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Nervous System Diseases Nervous System Malformations Neural Tube Defects Respiratory Hypersensitivity Respiratory Tract Diseases Spina Bifida Spinal Dysraphism

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coping Skills Training

Behavioral

6 session behavioral program

Primary outcomes

  1. Child Depression measured by Child Depression Inventory (CDI)

    Time frame: ongoing

  2. Parent Depression measured by Beck Depression inventory (BDI)

    Time frame: ongoing

  3. Quality of life measured by Child Health Questionnaire

    Time frame: ongoing

  4. Impact on Family measured by the Impact of Family Scale.

    Time frame: ongoing

Sponsors and collaborators

Lead sponsor

Children's Hospital and Health System Foundation, Wisconsin

Other

Collaborators

  • University of Wisconsin, Madison

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2012
Study completion
2012
First posted
Aug 2, 2006
Registry last updated
Feb 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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