- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00737035
Effectiveness of a Web-based Intervention for Guardians of Children Whose One Parent Has Murdered the Other
Testing an IHCA for Guardians of Survivors of Intraparental Homicide
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Virginia
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Charlottesville, Virginia, United States, 22908
- University of Virginia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Able to speak and read English at a 7th grade level
- Guardian of a child survivor of parental homicide aged 0 to 16 years
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: 1-Intervention
For 16 weeks, participants will have access to an interactive healthcare communication application (IHCA).
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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.
Other Names:
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Active Comparator: 2- Control
For 16 weeks, participants will have access to generally available Internet-based information about parenting, trauma, and child development.
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Only publicly available Web sites on parenting, child development, and trauma will be used.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Family Crisis Oriented Personal Evaluation Scales (F-COPES)
Time Frame: Measured at 16 weeks
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Measured at 16 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Parenting Stress Index (PSI)
Time Frame: Measured at 16 weeks
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Measured at 16 weeks
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Child Behavior Checklist (CBCL/6-18) Parent form
Time Frame: Measured at 16 weeks
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Measured at 16 weeks
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Child PTSD Inventory-Parent (CPTSDI-P):
Time Frame: Measured at 16 weeks
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Measured at 16 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kathryn S. Laughon, PhD RN, University of Virginia School of Nursing
Publications and helpful links
General Publications
- Laughon K, Steeves RH, Parker B, Knopp A, Sawin EM. Forgiveness, and other themes, in women whose fathers killed their mothers. ANS Adv Nurs Sci. 2008 Apr-Jun;31(2):153-63. doi: 10.1097/01.ANS.0000319565.68760.4d.
- Steeves R, Laughon K, Parker B, Weierbach F. Talking about talk: the experiences of boys who survived intraparental homicide. Issues Ment Health Nurs. 2007 Aug;28(8):899-912. doi: 10.1080/01612840701493576.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2008-0130-00
- DDTR B3-PDS (Other Identifier: FDAAA)
- R21MH082197 (U.S. NIH Grant/Contract)
- 1R21MH082197-01A1 (U.S. NIH Grant/Contract)
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