Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

COPE Intervention for Parents of Children With Epilepsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00767026
Recruitment Status : Completed
First Posted : October 6, 2008
Last Update Posted : June 22, 2011
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by:
Boston Children's Hospital

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.

Condition or disease Intervention/treatment Phase
Epilepsy Behavioral: COPE (Creating Opportunities for Parent Empowerment) Behavioral: Standard education Phase 1

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 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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arm Intervention/treatment
Experimental: 1 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.




Primary Outcome Measures :
  1. Parental depression [ Time Frame: 24 hours, 1-, 8 -, and 12- weeks after discharge ]
  2. Parental Anxiety [ Time Frame: 24 hours, 1-, 8 -, and 12- weeks after discharge ]
  3. Confidence in Parenting Skills [ Time Frame: 24 hours, 1-, 8 -, and 12- weeks after discharge ]

Secondary Outcome Measures :
  1. Behavior problems in the child [ Time Frame: 24 hours, 1-, 8 -, and 12- weeks after discharge ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
Layout table for location information
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children's Hospital
National Institute of Nursing Research (NINR)
Investigators
Layout table for investigator information
Principal Investigator: Lisa V Duffy, PhD(c), CPNP-PC Boston Children's Hospital
Publications:
Amdam, A., Langslet, B., & Holmseth, T. (2001). The penguin: A teaching Ppan for children with epilepsy. In: Pfafflin, M., Fraser, Thorbecke et al. (Eds). Comprehensive care for people with epilepsy. London: John Libbey.
Austin, J.K., McNelis, A.M., Shore, C.P., Dunn, D.W., & Musick, B. (2002). A feasibility study of a family seizure management program: "Be Seizure Smart." Journal of Neuroscience Nursing, 34(1), 30-37.
Hufford, B.S., Glueckauf, R.L., & Webb, P.M. (1999). Home-based, interactive videoconferencing for adolescents with epilepsy and their families. Rehabilitation Psychology, 44(2), 176-193.

Layout table for additonal information
Responsible Party: Lisa V. Duffy PhD(c), CPNP-PC, CNRN, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT00767026    
Other Study ID Numbers: 1F31NR010645-01 ( U.S. NIH Grant/Contract )
F31NR010645 ( U.S. NIH Grant/Contract )
First Posted: October 6, 2008    Key Record Dates
Last Update Posted: June 22, 2011
Last Verified: June 2011
Keywords provided by Boston Children's Hospital:
Epilepsy
Caregiver Burden
Parenting a Child with a Chronic Illness
Additional relevant MeSH terms:
Layout table for MeSH terms
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases