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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01503138
Other study ID # UW 11-051
Secondary ID
Status Completed
Phase N/A
First received December 30, 2011
Last updated December 2, 2014
Start date December 2011
Est. completion date March 2014

Study information

Verified date December 2014
Source The University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority Hong Kong: Ethics Committee
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 250
Est. completion date March 2014
Est. primary completion date March 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Behavioral:
Purpose-built intervention
A purpose-built intervention consists of: (i) Empowerment; (ii) Parenting workshops; and (iii) Telephone social support and Peer support.

Locations

Country Name City State
China HKSKH Lady MacLehose Center Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
The University of Hong Kong

Country where clinical trial is conducted

China, 

References & Publications (9)

Brush LD. Battering, traumatic stress, and welfare-to-work transition. Violence Against Women 2000; 6:1039-1065.

Campbell JC, Kub J, Belknap RA, Templin TN. Predictors of depression in battered women. Violence Against Women 1997; 3: 271-93. PMID: 12349116

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.

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. — View Citation

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.

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. Review. Erratum in: Trauma Violence Abuse. 2007 Jul;8(3):table of contents. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in depressive symptoms at 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 Baseline and 6-month post-intervention No
Secondary Change from baseline in parenting stress at 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 No
Secondary Change from baseline in perceptions of social support at 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 Baseline and 6-month post-intervention No
Secondary Change from baseline in health-related quality of life at 6-month post-intervention The SF-12 Health Survey is used to assess health-related quality of life at baseline and also at 6-month post-intervention Baseline and 6-month post-intervention No
Secondary Change from baseline in intimate partner violence at 6-month post-intervention 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. Baseline and 6-month post-intervention No
Secondary Change from baseline in safety behaviors at 6-month post-intervention 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. Baseline and 6-month post-intervention. No
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