NCT01503138

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

December 30, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 2, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

December 3, 2014

Status Verified

December 1, 2014

Enrollment Period

2.2 years

First QC Date

December 30, 2011

Last Update Submit

December 2, 2014

Conditions

Keywords

Intimate Partner ViolenceDepressive SymptomsInterventionRandomized Controlled TrialMainland ChineseImmigrantsWomen

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • Change from baseline in parenting stress at 6-month post-intervention

    Baseline and 6-month post-intervention

  • Change from baseline in perceptions of social support at 6-month post-intervention

    Baseline and 6-month post-intervention

  • Change from baseline in health-related quality of life at 6-month post-intervention

    Baseline and 6-month post-intervention

  • Change from baseline in intimate partner violence at 6-month post-intervention

    Baseline and 6-month post-intervention

  • Change from baseline in safety behaviors at 6-month post-intervention

    Baseline and 6-month post-intervention.

Study Arms (2)

Purpose-built intervention

EXPERIMENTAL

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

Behavioral: Purpose-built intervention

Standard community health education program

NO INTERVENTION

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.

Interventions

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

Purpose-built intervention

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mainland Chinese immigrant women,
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HKSKH Lady MacLehose Center

Hong Kong, China

Location

Related Publications (9)

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

    BACKGROUND
  • 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.

    PMID: 17545569BACKGROUND
  • 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.

    PMID: 11232214BACKGROUND
  • Brush LD. Battering, traumatic stress, and welfare-to-work transition. Violence Against Women 2000; 6:1039-1065.

    BACKGROUND
  • 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.

    PMID: 11913224BACKGROUND
  • 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.

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

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 21127447BACKGROUND

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Agnes Tiwari, PhD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Head

Study Record Dates

First Submitted

December 30, 2011

First Posted

January 2, 2012

Study Start

December 1, 2011

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

December 3, 2014

Record last verified: 2014-12

Locations