Viewing Study NCT00767026



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Last Modification Date: 2024-10-26 @ 9:56 AM
Study NCT ID: NCT00767026
Status: COMPLETED
Last Update Posted: 2011-06-22
First Post: 2008-10-03

Brief Title: COPE Intervention for Parents of Children With Epilepsy
Sponsor: Boston Childrens Hospital
Organization: Boston Childrens Hospital

Study Overview

Official Title: COPE Intervention for Parents of Children With Epilepsy
Status: COMPLETED
Status Verified Date: 2011-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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
Detailed Description: 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 Childrens 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
F31NR010645 NIH None httpsreporternihgovquickSearchF31NR010645