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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00737035
Other study ID # 2008-0130-00
Secondary ID R21MH0821971R21M
Status Withdrawn
Phase N/A
First received August 14, 2008
Last updated August 5, 2015
Start date July 2008
Est. completion date June 2009

Study information

Verified date August 2015
Source University of Virginia
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date June 2009
Est. primary completion date March 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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:

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Intervention

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; and (6) personal stories of others dealing with IPH.
Control Web sites
Only publicly available Web sites on parenting, child development, and trauma will be used.

Locations

Country Name City State
United States University of Virginia Charlottesville Virginia

Sponsors (2)

Lead Sponsor Collaborator
University of Virginia National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Family Crisis Oriented Personal Evaluation Scales (F-COPES) Measured at 16 weeks No
Secondary Parenting Stress Index (PSI) Measured at 16 weeks No
Secondary Child Behavior Checklist (CBCL/6-18) Parent form Measured at 16 weeks No
Secondary Child PTSD Inventory-Parent (CPTSDI-P): Measured at 16 weeks No
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