- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01503138
Intervention for Abused Chinese Immigrant Women
December 2, 2014 updated by: 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
250
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hong Kong, China
- HKSKH Lady MacLehose Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
|
No Intervention: 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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in depressive symptoms at 6-month post-intervention
Time Frame: Baseline and 6-month post-intervention
|
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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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in parenting stress at 6-month post-intervention
Time Frame: Baseline and 6-month post-intervention
|
The Parenting Stress Index is used to measure paretning stress at baseline and also at 6-month post-intervention
|
Baseline and 6-month post-intervention
|
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Change from baseline in perceptions of social support at 6-month post-intervention
Time Frame: Baseline and 6-month post-intervention
|
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
Time Frame: 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
Time Frame: 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
Time Frame: 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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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2011
Primary Completion (Actual)
March 1, 2014
Study Completion (Actual)
March 1, 2014
Study Registration Dates
First Submitted
December 30, 2011
First Submitted That Met QC Criteria
December 30, 2011
First Posted (Estimate)
January 2, 2012
Study Record Updates
Last Update Posted (Estimate)
December 3, 2014
Last Update Submitted That Met QC Criteria
December 2, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- UW 11-051
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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