Effectiveness of a Web-based Intervention for Guardians of Children Whose One Parent Has Murdered the Other
Primary Purpose
Post-Traumatic Stress Disorder
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Interactive Healthcare Communication Application
Control Web sites
Sponsored by
About this trial
This is an interventional supportive care trial for Post-Traumatic Stress Disorder focused on measuring Intimate Partner Homicide, Parental Homicide, Guardians of Child Survivors of Parental Homicide, Post-Traumatic Stress Disorder, Uxoricide Project
Eligibility Criteria
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
Sites / Locations
- University of Virginia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1-Intervention
2- Control
Arm Description
For 16 weeks, participants will have access to an interactive healthcare communication application (IHCA).
For 16 weeks, participants will have access to generally available Internet-based information about parenting, trauma, and child development.
Outcomes
Primary Outcome Measures
Family Crisis Oriented Personal Evaluation Scales (F-COPES)
Secondary Outcome Measures
Parenting Stress Index (PSI)
Child Behavior Checklist (CBCL/6-18) Parent form
Child PTSD Inventory-Parent (CPTSDI-P):
Full Information
NCT ID
NCT00737035
First Posted
August 14, 2008
Last Updated
August 5, 2015
Sponsor
University of Virginia
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00737035
Brief Title
Effectiveness of a Web-based Intervention for Guardians of Children Whose One Parent Has Murdered the Other
Official Title
Testing an IHCA for Guardians of Survivors of Intraparental Homicide
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Recruitment difficulties
Study Start Date
July 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Virginia
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Stress Disorder
Keywords
Intimate Partner Homicide, Parental Homicide, Guardians of Child Survivors of Parental Homicide, Post-Traumatic Stress Disorder, Uxoricide Project
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1-Intervention
Arm Type
Experimental
Arm Description
For 16 weeks, participants will have access to an interactive healthcare communication application (IHCA).
Arm Title
2- Control
Arm Type
Active Comparator
Arm Description
For 16 weeks, participants will have access to generally available Internet-based information about parenting, trauma, and child development.
Intervention Type
Behavioral
Intervention Name(s)
Interactive Healthcare Communication Application
Other Intervention Name(s)
IHCA
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control Web sites
Intervention Description
Only publicly available Web sites on parenting, child development, and trauma will be used.
Primary Outcome Measure Information:
Title
Family Crisis Oriented Personal Evaluation Scales (F-COPES)
Time Frame
Measured at 16 weeks
Secondary Outcome Measure Information:
Title
Parenting Stress Index (PSI)
Time Frame
Measured at 16 weeks
Title
Child Behavior Checklist (CBCL/6-18) Parent form
Time Frame
Measured at 16 weeks
Title
Child PTSD Inventory-Parent (CPTSDI-P):
Time Frame
Measured at 16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathryn S. Laughon, PhD RN
Organizational Affiliation
University of Virginia School of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18497591
Citation
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.
Results Reference
background
PubMed Identifier
17729173
Citation
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.
Results Reference
background
Learn more about this trial
Effectiveness of a Web-based Intervention for Guardians of Children Whose One Parent Has Murdered the Other
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