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COPE Intervention for Parents of Children With Epilepsy - NCT00767026-02115(Clinical Trial 244873)



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City:  Boston
State:  
MA
Zip Code: 02115
Conditions: Epilepsy
Purpose: The purpose of this study is to determine if the program Creating Opportunities for Parent Empowerment (COPE) is feasible to administer to parents of children with neurological conditions. The goal of the study is to empower parents by providing them with educational materials designed to teach them how to foster healthy coping skills in their child.
Study summary: Chronic neurological conditions have a significant impact on the child and family system. Parents of children with neurological conditions want to foster the healthy development of their child, however, they struggle with constant feelings of uncertainty, which results in an increased level of stress that can interfere with this goal. Stress in parents also results in anxiety, depression, decreased confidence in care giving skills, ultimately leading to an increase in behavior problems in the child with epilepsy. Pediatric nurses are in a position to intervene with parents of children with epilepsy to facilitate coping with and adjustment to these issues. Although many researchers have identified the relationship between effective parental coping and the improved psychosocial outcomes of children with epilepsy, little has been done to test interventions that may be effective in improving the coping strategies of parents of children with epilepsy. COPE (Creating Opportunities for Parent Empowerment) is a nurse coached educational intervention, which shows promise for improving coping in parents of hospitalized children. This is particularly significant for parents of children with neurological conditions, as these conditions are associated with repeated hospitalizations, stigma, and numerous comorbidities. Collectively, these factors make epilepsy one of the most stress producing pediatric conditions for parents to manage. This study will help to advance Nursing science in several ways. First, this study will develop an intervention that can be used to teach parents how to help their children cope with living with a chronic condition. This intervention could further advance Nursing science because it could be adapted and trials performed with children who have a wide variety of medical conditions. This study has the potential to improve the way we prepare parents and children for hospitalization. This study will guide nursing in how to best help families cope with caring for a child with a chronic condition. The research consent form has been reviewed and approved by the IRB at both Children's Hospital Boston and Boston College. The consent form addresses the following topics: A. Why the research is being conducted and what is its purpose B. Who is conducting the study and where it is being conducted C. How individuals are selected to be in the study and how many will participate D. What the participant needs to do in the research study E. What are the risks of the study and what could go wrong F. What are the benefits of the study G. Costs and payments associated with the study H. What happens to the information obtained from the study and what about confidentiality I. What are the choices if the participant does not want to be involved with the study J. What are the rights of a research participant K. HIPAA
Criteria: Inclusion Criteria: - Parents of children ages 2-6 with epilepsy - Children must have been diagnosed with epilepsy for a minimum period of six months - Parents of children currently admitted to the Children's Hospital Boston inpatient neuroscience unit (CHB-INU) for long term EEG - High school graduate literate in English - Access to cellular or home telephone Exclusion Criteria: - Parents of children who have been diagnosed with co-morbid conditions including, but not limited to: cancer, mitochondrial or metabolic disorders
Study is available at: Children's Hospital Boston
Boston, MA 02115
United States

Primary Contact:
Lisa V Duffy, PhD(c), CPNP-PC
Email: lisa.duffy@childrens.harvard.edu
Phone: 781-461-2624
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 22, 2011
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