- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01503138
Intervention for Abused Chinese Immigrant Women
2. desember 2014 oppdatert av: TIWARI, Agnes, The University of Hong Kong
The Effect of a Purpose-built Intervention on Mental Health in Mainland Chinese Immigrant Women Survivors of Intimate Partner Violence: A Randomized Controlled Trial
The purpose of this study is to evaluate the efficacy of a purpose-built intervention in improving the mental health of abused Mainland Chinese immigrant women in a community in Hong Kong.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Depression is one of the most common mental health sequelae of Intimate partner violence.
Not only does depression have an adverse effect on abused women's health and well-being, it also reduces their capacity to cope with the abuse by limiting their ability to perform self-care, meet work requirement, maintain independence, establish relationships, and access social support.
Previously, the ability of abused women to take care of themselves was found to be a protective factor for depression.
In order to enhance abused women's self-care, advocacy interventions have been developed to help them make sense of the abusive situation, identify potential solutions, and achieve their goals.
Also, immigration status was shown to be significantly associated with a higher level of depressive symptoms among the abused women.
The findings are important as they point to the need for further research to develop and evaluate culturally congruent interventions to meet the needs of abused Mainland Chinese immigrant women in Hong Kong.
Therefore, the purpose of this study is to develop a purpose-built intervention to address the unmet needs of Mainland Chinese immigrant women survivors of Intimate partner violence and to assess its effect on the mental health of the women.
Studietype
Intervensjonell
Registrering (Faktiske)
250
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Hong Kong, Kina
- HKSKH Lady MacLehose Center
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Hunn
Beskrivelse
Inclusion Criteria:
- Mainland Chinese immigrant women,
- 18 years of age or older,
- holding a one-way or two-way permit,
- have settled in Hong Kong with their intimate partners for less than seven years,
- have at least one child under 18 years of age,
- residing in the Kwai Chung, Tsuen Wan or Tsing Yi districts, and
- assessed to be abused by an intimate partner, based on the Abuse Assessment Screen.
Exclusion Criteria:
- participated in our positive parenting program or advocacy intervention previously, or
- will not be in Hong Kong during the intervention/standard health education program or the follow-up telephone interview, or
- is abused by someone who is not her intimate partner, or
- is unable to communicate in Cantonese or Putonghua.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Purpose-built intervention
A purpose-built intervention consists of: (i) Empowerment; (ii) Parenting workshops; and (iii) Telephone social support and Peer support.
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A purpose-built intervention consists of: (i) Empowerment; (ii) Parenting workshops; and (iii) Telephone social support and Peer support.
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Ingen inngripen: Standard community health education program
The community health education programme consists of two group sessions with one on the topic of osteoporosis and one on dietary therapy based on the concepts of Chinese medicine.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Change from baseline in depressive symptoms at 6-month post-intervention
Tidsramme: Baseline and 6-month post-intervention
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The Beck Depression Inventory version II is used to assess depressive symptoms at baseline and also at 6-month post-intervention
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Baseline and 6-month post-intervention
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Change from baseline in parenting stress at 6-month post-intervention
Tidsramme: Baseline and 6-month post-intervention
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The Parenting Stress Index is used to measure paretning stress at baseline and also at 6-month post-intervention
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Baseline and 6-month post-intervention
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Change from baseline in perceptions of social support at 6-month post-intervention
Tidsramme: Baseline and 6-month post-intervention
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The 12-item Interpersonal Support Evaluation List is used to assess perceptions of social supportat baseline and also at 6-month post-intervention
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Baseline and 6-month post-intervention
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Change from baseline in health-related quality of life at 6-month post-intervention
Tidsramme: Baseline and 6-month post-intervention
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The SF-12 Health Survey is used to assess health-related quality of life at baseline and also at 6-month post-intervention
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Baseline and 6-month post-intervention
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Change from baseline in intimate partner violence at 6-month post-intervention
Tidsramme: Baseline and 6-month post-intervention
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The Revised Conflict Tactics Scales is used to measure the type and frequency of behaviors used by the perpetrator during partner conflict at baseline and also at 6-month post-intervention.
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Baseline and 6-month post-intervention
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Change from baseline in safety behaviors at 6-month post-intervention
Tidsramme: Baseline and 6-month post-intervention.
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The Safety Assessment Checklist is used to to measure the safety behaviours used by abused women to avert intimate partner violence at baseline and also at 6-month post-intervention.
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Baseline and 6-month post-intervention.
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Golding JM. Intimate partner violence as a risk factor for mental disorders: a meta-analysis. J Fam Viol 1999; 14: 99-132.
- Kendall-Tackett KA. Inflammation, cardiovascular disease, and metabolic syndrome as sequelae of violence against women: the role of depression, hostility, and sleep disturbance. Trauma Violence Abuse. 2007 Apr;8(2):117-26. doi: 10.1177/1524838007301161. Erratum In: Trauma Violence Abuse. 2007 Jul;8(3):table of contents.
- Constantino RE, Sekula LK, Rabin B, Stone C. Negative life experiences, depression, and immune function in abused and nonabused women. Biol Res Nurs. 2000 Jan;1(3):190-8. doi: 10.1177/109980040000100304.
- Brush LD. Battering, traumatic stress, and welfare-to-work transition. Violence Against Women 2000; 6:1039-1065.
- O'Brien SM. Staying alive: a client with chronic mental illness in an environment of domestic violence. Holist Nurs Pract. 2002 Apr;16(3):16-23. doi: 10.1097/00004650-200204000-00006.
- Carlson BE, McNutt L, Choi DY, Rose IM. Intimate partner abuse and mental health: The role of social support and other protective factors. Violence Against Women 2002; 8: 720-745.
- Campbell JC, Kub J, Belknap RA, Templin TN. Predictors of depression in battered women. Violence Against Women 1997; 3: 271-93. PMID: 12349116
- Ford-Gilboe M, Varcoe C, Wuest J, Merritt-Gray M. Intimate partner violence and nursing practice. In Humphreys J, Campbell JC, eds. Family violence and nursing practice (2nd ed). New York: Springer 2010; 115-154.
- Wong JY, Tiwari A, Fong DY, Humphreys J, Bullock L. Depression among women experiencing intimate partner violence in a Chinese community. Nurs Res. 2011 Jan-Feb;60(1):58-65. doi: 10.1097/NNR.0b013e3182002a7c.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. desember 2011
Primær fullføring (Faktiske)
1. mars 2014
Studiet fullført (Faktiske)
1. mars 2014
Datoer for studieregistrering
Først innsendt
30. desember 2011
Først innsendt som oppfylte QC-kriteriene
30. desember 2011
Først lagt ut (Anslag)
2. januar 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
3. desember 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. desember 2014
Sist bekreftet
1. desember 2014
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- UW 11-051
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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