COPE Intervention for Parents of Children With Epilepsy
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|ClinicalTrials.gov Identifier: NCT00767026|
Recruitment Status : Completed
First Posted : October 6, 2008
Last Update Posted : June 22, 2011
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy||Behavioral: COPE (Creating Opportunities for Parent Empowerment) Behavioral: Standard education||Phase 1|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||88 participants|
|Intervention Model:||Single Group Assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||COPE Intervention for Parents of Children With Epilepsy|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2010|
Behavioral: COPE (Creating Opportunities for Parent Empowerment)
Twenty-four hours after admission to the hospital, this group will receive Phase I of the study which includes information focusing on what parents can expect during their child's hospital stay, and how they can help their child cope with the experience. Prior to discharge parents will receive additional information pertaining to Phase II of the study. At 3 days post discharge, the participants will receive a follow up phone call to reiterate the information provided in Phase II and ask parents about questions or problems since discharge. One week following, participants will be asked to complete assessments. At 6 weeks after the hospitalization they will receive Phase III, which includes, additional information on behaviors parents can expect to see in their children following a hospitalization. Parents will be given a workbook that will teach them techniques to help their child cope. Then at 6 weeks after the last intervention phase, participants will again complete assessments.
|Active Comparator: 2||
Behavioral: Standard education
This group will receive standard education regarding medication management and seizure first aid. This group will also receive information, oral and written, that will discuss tests to be administered during the hospitalization. The usual care group also receives a call at home within one week after discharge from a nurse to ask if they had any problems with their stay, and if they have any further needs or questions.
- Parental depression [ Time Frame: 24 hours, 1-, 8 -, and 12- weeks after discharge ]
- Parental Anxiety [ Time Frame: 24 hours, 1-, 8 -, and 12- weeks after discharge ]
- Confidence in Parenting Skills [ Time Frame: 24 hours, 1-, 8 -, and 12- weeks after discharge ]
- Behavior problems in the child [ Time Frame: 24 hours, 1-, 8 -, and 12- weeks after discharge ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00767026
|United States, Massachusetts|
|Children's Hospital Boston|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Lisa V Duffy, PhD(c), CPNP-PC||Boston Children's Hospital|