Ignite Creation Date:
2025-12-24 @ 10:29 PM
Ignite Modification Date:
2025-12-25 @ 8:03 PM
Study NCT ID:
NCT00737035
Status:
WITHDRAWN
Last Update Posted:
2015-08-07
First Post:
2008-08-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of a Web-based Intervention for Guardians of Children Whose One Parent Has Murdered the Other
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Recruitment difficulties', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-05', 'studyFirstSubmitDate': '2008-08-14', 'studyFirstSubmitQcDate': '2008-08-14', 'lastUpdatePostDateStruct': {'date': '2015-08-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Family Crisis Oriented Personal Evaluation Scales (F-COPES)', 'timeFrame': 'Measured at 16 weeks'}], 'secondaryOutcomes': [{'measure': 'Parenting Stress Index (PSI)', 'timeFrame': 'Measured at 16 weeks'}, {'measure': 'Child Behavior Checklist (CBCL/6-18) Parent form', 'timeFrame': 'Measured at 16 weeks'}, {'measure': 'Child PTSD Inventory-Parent (CPTSDI-P):', 'timeFrame': 'Measured at 16 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Intimate Partner Homicide', 'Parental Homicide', 'Guardians of Child Survivors of Parental Homicide', 'Post-Traumatic Stress Disorder', 'Uxoricide Project'], 'conditions': ['Post-Traumatic Stress Disorder']}, 'referencesModule': {'references': [{'pmid': '18497591', 'type': 'BACKGROUND', '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.'}, {'pmid': '17729173', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nIn 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to speak and read English at a 7th grade level\n* Guardian of a child survivor of parental homicide aged 0 to 16 years\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT00737035', 'briefTitle': 'Effectiveness of a Web-based Intervention for Guardians of Children Whose One Parent Has Murdered the Other', 'organization': {'class': 'OTHER', 'fullName': 'University of Virginia'}, 'officialTitle': 'Testing an IHCA for Guardians of Survivors of Intraparental Homicide', 'orgStudyIdInfo': {'id': '2008-0130-00'}, 'secondaryIdInfos': [{'id': 'R21MH082197', 'link': 'https://reporter.nih.gov/quickSearch/R21MH082197', 'type': 'NIH'}, {'id': '1R21MH082197-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R21MH082197-01A1', 'type': 'NIH'}, {'id': 'DDTR B3-PDS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1-Intervention', 'description': 'For 16 weeks, participants will have access to an interactive healthcare communication application (IHCA).', 'interventionNames': ['Behavioral: Interactive Healthcare Communication Application']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2- Control', 'description': 'For 16 weeks, participants will have access to generally available Internet-based information about parenting, trauma, and child development.', 'interventionNames': ['Behavioral: Control Web sites']}], 'interventions': [{'name': 'Interactive Healthcare Communication Application', 'type': 'BEHAVIORAL', 'otherNames': ['IHCA'], '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.', 'armGroupLabels': ['1-Intervention']}, {'name': 'Control Web sites', 'type': 'BEHAVIORAL', 'description': 'Only publicly available Web sites on parenting, child development, and trauma will be used.', 'armGroupLabels': ['2- Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'overallOfficials': [{'name': 'Kathryn S. Laughon, PhD RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Virginia School of Nursing'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Virginia', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'oldNameTitle': 'Kathryn Laughon, PhD RN', 'oldOrganization': 'University of Virginia School of Nursing'}}}}