Feasibility Study for Abused Chinese Immigrant Women

April 14, 2023 updated by: Yang Li, University of Texas at Austin

Self-Compassion, Health, and Empowerment: A Feasibility Intervention Study for Chinese Immigrant Women With Intimate Partner Violence in the U.S.

Intimate partner violence (IPV) is a serious social and public health issue. In the U.S., more than 1 in 3 women experience physical or sexual violence, and/or stalking by an intimate partner during their lifetime. IPV has significant physical and mental health consequences such as injury, chronic pain, and depression. Chinese immigrants have been overlooked and underserved and represent an especially vulnerable group of IPV victims, as they are less likely to seek help through IPV service agencies, women's shelters, hospitals, or law enforcement. Effective IPV intervention programs that are culturally appropriate, accessible, and acceptable are essential to this underserved population. However, no studies have been conducted with abused Chinese immigrant women to help them deal with IPV and reduce mental health consequences.

Therefore, the study adapted a structured IPV intervention from the Domestic Violence Enhanced Home Visitation Program (DOVE) as well as incorporate self-compassion and relaxation techniques for Chinese immigrant women experiencing IPV. The intervention is called Self-Compassion, Health, and Empowerment (SHE). The study will test the feasibility and acceptability of the SHE to reduce IPV and improve mental health well-being for abused Chinese immigrant women residing in the US.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

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 Contact

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78712
        • The University of Texas at Austin

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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 18 years or older and female, self-identify as Chinese, reside in the U.S., have been in an intimate relationship at time of participation, and have experienced IPV within the current relationship.

Exclusion Criteria:

  • Women are excluded if they report substance use or suicidality or having been in mental health care for severe mental illness.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The intervention group
Behavioral: Self-Compassion, Health, and Empowerment (SHE)
The SHE intervention includes 8 weekly sessions and 24-hour access to the intervener for any additional support needed. The first and last sessions will be delivered over the phone with the woman based on a brochure. The brochure describes the four major components: a) IPV information, b) Danger Assessment, c) Safety Planning, and d) Resources. It will be discussed with the woman in an interactive manner so that the woman is encouraged to describe her experiences and choose her options as they proceed. Session 2-7 focus on providing mental health self-care resources, which are deep breathing, progressive muscle relaxation, visualization, general introduction and overview of self-compassion, mindfulness, and loving-kindness.
Placebo Comparator: The control group
Behavioral: The Control Condition
Women randomized to the control group will be provided with the same brochure and mental health care resources.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intimate Partner Violence
Time Frame: It will be assessed at baseline before the start of the 8-week intervention.
The Revised Conflict Tactics Scales (CTS2)
It will be assessed at baseline before the start of the 8-week intervention.
Intimate Partner Violence
Time Frame: It will be assessed immediately after the 8-week intervention.
The Revised Conflict Tactics Scales (CTS2)
It will be assessed immediately after the 8-week intervention.
Intimate Partner Violence
Time Frame: It will be assessed 2 months after the 8-week intervention.
The Revised Conflict Tactics Scales (CTS2)
It will be assessed 2 months after the 8-week intervention.
Depression
Time Frame: It will be assessed at baseline before the start of the 8-week intervention.
The Patient Health Questionnaire-9 (PHQ-9)
It will be assessed at baseline before the start of the 8-week intervention.
Depression
Time Frame: It will be assessed immediately after the 8-week intervention.
The Patient Health Questionnaire-9 (PHQ-9)
It will be assessed immediately after the 8-week intervention.
Depression
Time Frame: It will be assessed 2 months after the 8-week intervention.
The Patient Health Questionnaire-9 (PHQ-9)
It will be assessed 2 months after the 8-week intervention.
Anxiety
Time Frame: It will be assessed at baseline before the start of the 8-week intervention.
The Generalized Anxiety Disorder-7 (GAD-7)
It will be assessed at baseline before the start of the 8-week intervention.
Anxiety
Time Frame: It will be assessed immediately after the 8-week intervention.
The Generalized Anxiety Disorder-7 (GAD-7)
It will be assessed immediately after the 8-week intervention.
Anxiety
Time Frame: It will be assessed 2 months after the 8-week intervention.
The Generalized Anxiety Disorder-7 (GAD-7)
It will be assessed 2 months after the 8-week intervention.
Posttraumatic Stress Disorder (PTSD)
Time Frame: It will be assessed at baseline before the start of the 8-week intervention.
The PTSD Checklist for DSM-5 (PCL-5)
It will be assessed at baseline before the start of the 8-week intervention.
Posttraumatic Stress Disorder (PTSD)
Time Frame: It will be assessed immediately after the 8-week intervention.
The PTSD Checklist for DSM-5 (PCL-5)
It will be assessed immediately after the 8-week intervention.
Posttraumatic Stress Disorder (PTSD)
Time Frame: It will be assessed 2 months after the 8-week intervention.
The PTSD Checklist for DSM-5 (PCL-5)
It will be assessed 2 months after the 8-week intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Safety Behaviors Taken by Participants
Time Frame: It will be assessed at baseline before the start of the 8-week intervention.
The Intimate Partner Violence Strategies Index
It will be assessed at baseline before the start of the 8-week intervention.
Number of Safety Behaviors Taken by Participants
Time Frame: It will be assessed immediately after the 8-week intervention.
The Intimate Partner Violence Strategies Index
It will be assessed immediately after the 8-week intervention.
Number of Safety Behaviors Taken by Participants
Time Frame: It will be assessed 2 months after the 8-week intervention.
The Intimate Partner Violence Strategies Index
It will be assessed 2 months after the 8-week intervention.
Self-Compassion
Time Frame: It will be assessed at baseline before the start of the 8-week intervention.
The Self-Compassion Scale-Short Form (SCS-SF)
It will be assessed at baseline before the start of the 8-week intervention.
Self-Compassion
Time Frame: It will be assessed immediately after the 8-week intervention.
The Self-Compassion Scale-Short Form (SCS-SF)
It will be assessed immediately after the 8-week intervention.
Self-Compassion
Time Frame: It will be assessed 2 months after the 8-week intervention.
The Self-Compassion Scale-Short Form (SCS-SF)
It will be assessed 2 months after the 8-week intervention.

Collaborators and Investigators

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

Sponsor

University of Texas at Austin

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 (Actual)

March 1, 2022

Primary Completion (Actual)

March 3, 2023

Study Completion (Actual)

March 3, 2023

Study Registration Dates

First Submitted

August 10, 2021

First Submitted That Met QC Criteria

August 13, 2021

First Posted (Actual)

August 18, 2021

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 14, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00001645

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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