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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00737035 |
This study will determine whether a specialized Web site geared for the guardians of children whose one parent has murdered the other can increase guardian capabilities, reduce guardian stress, and improve child behavior and mental health.
Condition | Intervention |
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Post-Traumatic Stress Disorder |
Behavioral: Interactive Healthcare Communication Application Behavioral: Control websites |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Testing an IHCA for Guardians of Survivors of Intraparental Homicide |
Estimated Enrollment: | 126 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1-Intervention: Experimental
For 16 weeks, participants will have access to an interactive healthcare communication application (IHCA).
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Behavioral: Interactive Healthcare Communication Application
The IHCA is an Internet-based tool that integrates multiple resources for guardians of survivors of interparental homicide. The IHCA will have six components: 1) an Instant Library of articles on topics of interest; 2) a resource directory of both national and local support and service organizations; 3) access to a peer communication system; 4) a Frequently Asked Questions section, updated with responses to user generated questions; 5) an 'Ask an Expert' system staffed by researchers; 6) personal stories of others dealing with IPH.
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2- Control: Active Comparator
For 16 weeks, participants will have access to generally available internet-based information about parenting, trauma, and child development.
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Behavioral: Control websites
Only publicly available websites on parenting, child development, and trauma will be used.
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Intraparental homicide, when one parent kills the other, leaves approximately 4,000 children bereaved each year, adding to a total of 70,000 currently in the United States. Although few studies have focused on this phenomenon, available data indicates children of IPH suffer short- and long-term mental health consequences, including post-traumatic stress disorder (PTSD). Prior research also indicates that guardians, often family members under stress themselves, do not know how to help the children. No interventions directed at guardians of child survivors of IPH are found in scientific and clinical literature. Use of a specialized Web site called an Interactive Healthcare Communication Application (IHCA) has been found effective in treating multiple health conditions, including breast cancer in women and asthma in children. This study aims to refine an IHCA Web site for use by guardians of child survivors of IPH, to determine the safety and effectiveness of this Web site, and to determine how it is used by targeted guardians.
In the first phase of this study researchers will develop the IHCA based on feedback from a small focus group of guardians of child survivors of IPH. Then guardians of survivors of IPH up to 16 years old will be randomly assigned either to receive access to the IHCA created for them or to have access only to generally available internet information. The IHCA will have six components: 1) an Instant Library of articles on topics of interest; 2) a resource directory of both national and local support and service organizations; 3) access to a peer communication system; 4) a Frequently Asked Questions section, updated with responses to user generated questions; 5) an 'Ask an Expert' system staffed by researchers; 6) personal stories of others dealing with IPH. Participants with access to the IHCA will receive print and phone instructions explaining the Web site and have their usage monitored by tracking software. Those in the control group will be directed to a Web site linking to publically available, pre-existing support Web sites. After 16 weeks of unlimited access to the IHCA or control group Web sites from their home computers, all participants will complete four evaluation reviews: the Family Crisis Oriented Personal Evaluation Scales, the Parenting Stress Index, the Child Behavior Checklist, and the Child PTSD Inventory - Parent.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Kathryn S. Laughon, PhD, RN | 434-962-3335 | klaughon@virginia.edu |
United States, Virginia | |
University of Virginia | Recruiting |
Charlottesville, Virginia, United States, 22908 | |
Contact: Kathryn S. Laughon, PhD, RN 434-962-3335 klaughon@virginia.edu | |
Principal Investigator: Kathryn S. Laughon, PhD RN |
Principal Investigator: | Kathryn S. Laughon, PhD RN | University of Virginia School of Nursing |
Responsible Party: | University of Virginia School of Nursing ( Kathryn Laughon, PhD RN ) |
Study ID Numbers: | R21 MH082197, 1R21MH082197 - 01A1, DDTR B3-PDS |
Study First Received: | August 14, 2008 |
Last Updated: | August 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00737035 |
Health Authority: | United States: Federal Government |
Intimate Partner Homicide Parental Homicide Guardians of Child Survivors of Parental Homicide Post-Traumatic Stress Disorder Uxoricide Project |
Anxiety Disorders Mental Disorders Stress Disorders, Post-Traumatic Stress Stress Disorders, Traumatic |