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Effectiveness of a Web-Based Intervention for Guardians of Children Whose One Parent Has Murdered the Other

This study is currently recruiting participants.
Verified by National Institute of Mental Health (NIMH), August 2008

Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00737035
  Purpose

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
Post-Traumatic Stress Disorder
Behavioral: Interactive Healthcare Communication Application
Behavioral: Control websites

MedlinePlus related topics:   Mental Health    Post-Traumatic Stress Disorder    Stress   

U.S. FDA Resources

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

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Family Crisis Oriented Personal Evaluation Scales (F-COPES) [ Time Frame: Measured at 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Parenting Stress Index (PSI) [ Time Frame: Measured at 16 weeks ] [ Designated as safety issue: No ]
  • Child Behavior Checklist (CBCL/6-18) Parent form [ Time Frame: Measured at 16 weeks ] [ Designated as safety issue: No ]
  • Child PTSD Inventory-Parent (CPTSDI-P): [ Time Frame: Measured at 16 weeks ] [ Designated as safety issue: No ]

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
1-Intervention: Experimental
For 16 weeks, participants will have access to an interactive healthcare communication application (IHCA).
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.
2- Control: Active Comparator
For 16 weeks, participants will have access to generally available internet-based information about parenting, trauma, and child development.
Behavioral: Control websites
Only publicly available websites on parenting, child development, and trauma will be used.

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00737035

Contacts
Contact: Kathryn S. Laughon, PhD, RN     434-962-3335     klaughon@virginia.edu    

Locations
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            

Sponsors and Collaborators

Investigators
Principal Investigator:     Kathryn S. Laughon, PhD RN     University of Virginia School of Nursing    
  More Information


Click here for more information about intraparental murder at the University of Virginia's Uxoricide Project Web site.  This link exits the ClinicalTrials.gov site
 

Publications:

Responsible Party:   University of Virginia School of Nursing ( Kathryn Laughon, PhD RN )
Study ID Numbers:   R21 MH082197, 1R21MH082197 - 01A1, DDTR B3-PDS
First Received:   August 14, 2008
Last Updated:   August 14, 2008
ClinicalTrials.gov Identifier:   NCT00737035
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Intimate Partner Homicide  
Parental Homicide  
Guardians of Child Survivors of Parental Homicide  
Post-Traumatic Stress Disorder  
Uxoricide Project  

Study placed in the following topic categories:
Anxiety Disorders
Mental Disorders
Stress Disorders, Post-Traumatic
Stress
Stress Disorders, Traumatic

ClinicalTrials.gov processed this record on November 19, 2008




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