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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • China
      • Hong Kong, China
        • HKSKH Lady MacLehose Center

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Baseline and 6-month post-intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
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
Baseline and 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
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
Change from baseline in intimate partner violence at 6-month post-intervention
Time Frame: Baseline and 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
Change from baseline in safety behaviors at 6-month post-intervention
Time Frame: Baseline and 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Hong Kong

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

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 30, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 2, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 3, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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