- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01503138
Intervention for Abused Chinese Immigrant Women
2. december 2014 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
250
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Hong Kong, Kina
- HKSKH Lady MacLehose Center
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Kvinde
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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 indgriben: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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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 |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. december 2011
Primær færdiggørelse (Faktiske)
1. marts 2014
Studieafslutning (Faktiske)
1. marts 2014
Datoer for studieregistrering
Først indsendt
30. december 2011
Først indsendt, der opfyldte QC-kriterier
30. december 2011
Først opslået (Skøn)
2. januar 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
3. december 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. december 2014
Sidst verificeret
1. december 2014
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- UW 11-051
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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