- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00737035
Effectiveness of a Web-based Intervention for Guardians of Children Whose One Parent Has Murdered the Other
Testing an IHCA for Guardians of Survivors of Intraparental Homicide
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Virginia
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Charlottesville, Virginia, Stati Uniti, 22908
- University of Virginia
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 1-Intervention
For 16 weeks, participants will have access to an interactive healthcare communication application (IHCA).
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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.
Altri nomi:
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Comparatore attivo: 2- Control
For 16 weeks, participants will have access to generally available Internet-based information about parenting, trauma, and child development.
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Only publicly available Web sites on parenting, child development, and trauma will be used.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Family Crisis Oriented Personal Evaluation Scales (F-COPES)
Lasso di tempo: Measured at 16 weeks
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Measured at 16 weeks
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Parenting Stress Index (PSI)
Lasso di tempo: Measured at 16 weeks
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Measured at 16 weeks
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Child Behavior Checklist (CBCL/6-18) Parent form
Lasso di tempo: Measured at 16 weeks
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Measured at 16 weeks
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Child PTSD Inventory-Parent (CPTSDI-P):
Lasso di tempo: Measured at 16 weeks
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Measured at 16 weeks
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Kathryn S. Laughon, PhD RN, University of Virginia School of Nursing
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2008-0130-00
- DDTR B3-PDS (Altro identificatore: FDAAA)
- R21MH082197 (Sovvenzione/contratto NIH degli Stati Uniti)
- 1R21MH082197-01A1 (Sovvenzione/contratto NIH degli Stati Uniti)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .