An interventional study of Interactive Healthcare Communication Application and Control Web sites in Post-Traumatic Stress Disorder, sponsored by University of Virginia. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-08-07.
Sponsored by University of Virginia · Not applicable, Interventional, and Supportive care
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.
Intraparental homicide (IPH), 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 indicate 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; and (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.
1,147 studies on the registry are indexed under Stress Disorders, Traumatic; 108 are open to participants now.
Browse Stress Disorders, Traumatic studies →University of Virginia is the lead sponsor of 653 studies on the registry; 134 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 41 (68%) have results posted.
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Exclusion Criteria:
For 16 weeks, participants will have access to an interactive healthcare communication application (IHCA).
Behavioral: Interactive Healthcare Communication Application
For 16 weeks, participants will have access to generally available Internet-based information about parenting, trauma, and child development.
Behavioral: Control Web sites
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; and (6) personal stories of others dealing with IPH.
Also known as: IHCA
Only publicly available Web sites on parenting, child development, and trauma will be used.
Family Crisis Oriented Personal Evaluation Scales (F-COPES)
Time frame: Measured at 16 weeks
Parenting Stress Index (PSI)
Time frame: Measured at 16 weeks
Child Behavior Checklist (CBCL/6-18) Parent form
Time frame: Measured at 16 weeks
Child PTSD Inventory-Parent (CPTSDI-P):
Time frame: Measured at 16 weeks
This study is withdrawn, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
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