Trial record 8 of 139 for:    Open Studies | "Mental Health"

Intervention for Abused Chinese Immigrant Women

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by The University of Hong Kong
Sponsor:
Information provided by (Responsible Party):
TIWARI, Agnes, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01503138
First received: December 30, 2011
Last updated: December 12, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Mental Health Wellness 1
Domestic Violence
Behavioral: Purpose-built intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Effect of a Purpose-built Intervention on Mental Health in Mainland Chinese Immigrant Women Survivors of Intimate Partner Violence: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • Change from baseline in depressive symptoms at 6-month post-intervention [ Time Frame: Baseline and 6-month post-intervention ] [ Designated as safety issue: No ]
    The Beck Depression Inventory version II is used to assess depressive symptoms at baseline and also at 6-month post-intervention


Secondary Outcome Measures:
  • Change from baseline in parenting stress at 6-month post-intervention [ Time Frame: Baseline and 6-month post-intervention ] [ Designated as safety issue: No ]
    The Parenting Stress Index is used to measure paretning stress at baseline and also at 6-month post-intervention

  • Change from baseline in perceptions of social support at 6-month post-intervention [ Time Frame: Baseline and 6-month post-intervention ] [ Designated as safety issue: No ]
    The 12-item Interpersonal Support Evaluation List is used to assess perceptions of social supportat baseline and also at 6-month post-intervention

  • Change from baseline in health-related quality of life at 6-month post-intervention [ Time Frame: Baseline and 6-month post-intervention ] [ Designated as safety issue: No ]
    The SF-12 Health Survey is used to assess health-related quality of life at baseline and also at 6-month post-intervention

  • Change from baseline in intimate partner violence at 6-month post-intervention [ Time Frame: Baseline and 6-month post-intervention ] [ Designated as safety issue: No ]
    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.

  • Change from baseline in safety behaviors at 6-month post-intervention [ Time Frame: Baseline and 6-month post-intervention. ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 250
Study Start Date: December 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Purpose-built intervention
A purpose-built intervention consists of: (i) Empowerment; (ii) Parenting workshops; and (iii) Telephone social support and Peer support.
Behavioral: Purpose-built intervention
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01503138

Contacts
Contact: Agnes Tiwari, PhD 852-28192622 afytiwar@hku.hk

Locations
China
HKSKH Lady MacLehose Center Recruiting
Hong Kong, China
Contact: Helina Yuk    852-24235045    director@skhmaclehose.org.hk   
Sponsors and Collaborators
The University of Hong Kong
Investigators
Principal Investigator: Agnes Tiwari, PhD The University of Hong Kong
  More Information

Publications:
Golding JM. Intimate partner violence as a risk factor for mental disorders: a meta-analysis. J Fam Viol 1999; 14: 99-132.
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

Responsible Party: TIWARI, Agnes, Professor and Head, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01503138     History of Changes
Other Study ID Numbers: UW 11-051
Study First Received: December 30, 2011
Last Updated: December 12, 2013
Health Authority: Hong Kong: Ethics Committee

Keywords provided by The University of Hong Kong:
Intimate Partner Violence
Depressive Symptoms
Intervention
Randomized Controlled Trial
Mainland Chinese
Immigrants
Women

ClinicalTrials.gov processed this record on September 22, 2014