Post-Traumatic Stress DisorderNCT00737035
Effectiveness of a Web-based Intervention for Guardians of Children Whose One Parent Has Murdered the Other
A study testing Interactive Healthcare Communication Application in people with Post-Traumatic Stress Disorder, run by University of Virginia at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post-Traumatic Stress Disorder
- What is being tested?
- Interactive Healthcare Communication Application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Jun 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to speak and read English at a 7th grade level
- Guardian of a child survivor of parental homicide aged 0 to 16 years
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22908
About this study
Official title: Testing an IHCA for Guardians of Survivors of Intraparental Homicide
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.
Read the 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.
- Conditions
- Post-Traumatic Stress Disorder
- Being tested
- Interactive Healthcare Communication Application, Control Web sites
- Keywords
- Intimate Partner Homicide, Parental Homicide, Guardians of Child Survivors of Parental Homicide, Post-Traumatic Stress Disorder, Uxoricide Project
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive Healthcare Communication ApplicationBehavioural
Also called IHCA
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 sitesBehavioural
Only publicly available Web sites on parenting, child development, and trauma will be used.
| Study group | Role | What they receive |
|---|---|---|
| 1-Intervention | Experimental | For 16 weeks, participants will have access to an interactive healthcare communication application (IHCA). Receives: Behavioral: Interactive Healthcare Communication Application |
| 2- Control | Active comparator | For 16 weeks, participants will have access to generally available Internet-based information about parenting, trauma, and child development. Receives: Behavioral: Control Web sites |
What is being measured
The primary outcome is the main question the study is designed to answer.
Family Crisis Oriented Personal Evaluation Scales (F-COPES)
Measured: Measured at 16 weeks
Secondary outcomes (3)
Parenting Stress Index (PSI)
Measured: Measured at 16 weeks
Child Behavior Checklist (CBCL/6-18) Parent form
Measured: Measured at 16 weeks
Child PTSD Inventory-Parent (CPTSDI-P):
Measured: Measured at 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2008 (estimated)
- Study startJul 2008
- Primary completionMar 2009
- Study completionJun 2009
Why it stopped: Recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post-Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Investigators
- Kathryn S. Laughon, PhD RN, Principal investigator, University of Virginia School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00737035
- Sponsor's protocol ID
- 2008-0130-00
- Other IDs
- R21MH082197, 1R21MH082197-01A1, DDTR B3-PDS
- Status last verified
- Aug 2015
- First submitted
- 14 Aug 2008
- Last updated
- 7 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 18497591Steeves 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.
PubMed 17729173
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing an IHCA for Guardians of Survivors of Intraparental Homicide
- ClinicalTrials.gov ID
- NCT00737035
- Acronym / sponsor ID
- 2008-0130-00
- Conditions
- Post-Traumatic Stress Disorder
- Keywords
- Intimate Partner Homicide, Parental Homicide, Guardians of Child Survivors of Parental Homicide, Post-Traumatic Stress Disorder, Uxoricide Project
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Recruitment difficulties
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jul 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 18 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1-Intervention | Experimental | Behavioral: Interactive Healthcare Communication ApplicationFor 16 weeks, participants will have access to an interactive healthcare communication application (IHCA). |
| 2- Control | Active comparator | Behavioral: Control Web sitesFor 16 weeks, participants will have access to generally available Internet-based information about parenting, trauma, and child development. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Able to speak and read English at a 7th grade level
- Guardian of a child survivor of parental homicide aged 0 to 16 years
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interactive Healthcare Communication ApplicationAlso: IHCAThe 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. | Behavioural | 1-Intervention |
| Control Web sitesOnly publicly available Web sites on parenting, child development, and trauma will be used. | Behavioural | 2- Control |
Primary outcome
Family Crisis Oriented Personal Evaluation Scales (F-COPES)
Time frame: Measured at 16 weeks
3 secondary outcomes
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2015.
- Background: PubMed 18497591Laughon 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.
- Background: PubMed 17729173Steeves 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathryn S. Laughon, PhD RN principal investigator
University of Virginia School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive Healthcare Communication Application in people with Post-Traumatic Stress Disorder, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Family Crisis Oriented Personal Evaluation Scales (F-COPES) (time frame: Measured at 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00737035, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2015.