Feasibility Study for Abused Chinese Immigrant Women

Sponsor
University of Texas at Austin (Other)
Overall Status
Recruiting
CT.gov ID
NCT05011552
Collaborator
(none)
50
1
2
9
5.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Self-Compassion, Health, and Empowerment (SHE)
  • Behavioral: The Control Condition
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Self-Compassion, Health, and Empowerment: A Feasibility Intervention Study for Chinese Immigrant Women With Intimate Partner Violence in the U.S.
Actual Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Intimate Partner Violence [It will be assessed at baseline before the start of the 8-week intervention.]

    The Revised Conflict Tactics Scales (CTS2)

  2. Intimate Partner Violence [It will be assessed immediately after the 8-week intervention.]

    The Revised Conflict Tactics Scales (CTS2)

  3. Intimate Partner Violence [It will be assessed 2 months after the 8-week intervention.]

    The Revised Conflict Tactics Scales (CTS2)

  4. Depression [It will be assessed at baseline before the start of the 8-week intervention.]

    The Patient Health Questionnaire-9 (PHQ-9)

  5. Depression [It will be assessed immediately after the 8-week intervention.]

    The Patient Health Questionnaire-9 (PHQ-9)

  6. Depression [It will be assessed 2 months after the 8-week intervention.]

    The Patient Health Questionnaire-9 (PHQ-9)

  7. Anxiety [It will be assessed at baseline before the start of the 8-week intervention.]

    The Generalized Anxiety Disorder-7 (GAD-7)

  8. Anxiety [It will be assessed immediately after the 8-week intervention.]

    The Generalized Anxiety Disorder-7 (GAD-7)

  9. Anxiety [It will be assessed 2 months after the 8-week intervention.]

    The Generalized Anxiety Disorder-7 (GAD-7)

  10. Posttraumatic Stress Disorder (PTSD) [It will be assessed at baseline before the start of the 8-week intervention.]

    The PTSD Checklist for DSM-5 (PCL-5)

  11. Posttraumatic Stress Disorder (PTSD) [It will be assessed immediately after the 8-week intervention.]

    The PTSD Checklist for DSM-5 (PCL-5)

  12. Posttraumatic Stress Disorder (PTSD) [It will be assessed 2 months after the 8-week intervention.]

    The PTSD Checklist for DSM-5 (PCL-5)

Secondary Outcome Measures

  1. Number of Safety Behaviors Taken by Participants [It will be assessed at baseline before the start of the 8-week intervention.]

    The Intimate Partner Violence Strategies Index

  2. Number of Safety Behaviors Taken by Participants [It will be assessed immediately after the 8-week intervention.]

    The Intimate Partner Violence Strategies Index

  3. Number of Safety Behaviors Taken by Participants [It will be assessed 2 months after the 8-week intervention.]

    The Intimate Partner Violence Strategies Index

  4. Self-Compassion [It will be assessed at baseline before the start of the 8-week intervention.]

    The Self-Compassion Scale-Short Form (SCS-SF)

  5. Self-Compassion [It will be assessed immediately after the 8-week intervention.]

    The Self-Compassion Scale-Short Form (SCS-SF)

  6. Self-Compassion [It will be assessed 2 months after the 8-week intervention.]

    The Self-Compassion Scale-Short Form (SCS-SF)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The University of Texas At Austin Austin Texas United States 78712

Sponsors and Collaborators

  • University of Texas at Austin

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yang Li, Assistant Professor, University of Texas at Austin
ClinicalTrials.gov Identifier:
NCT05011552
Other Study ID Numbers:
  • STUDY00001645
First Posted:
Aug 18, 2021
Last Update Posted:
Jun 6, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 6, 2022