NCT03370549

Brief Summary

Our objective for this R34 is to develop gender/culture specific and trauma informed group psychotherapy intervention designed to treat Chinese-, Korean-, and Vietnamese-American young women with histories of interpersonal violence trauma. The intervention is called Asian Women's Action for Resilience and Empowerment (AWARE).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2013

Longer than P75 for not_applicable

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

August 1, 2013

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2016

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 12, 2017

Completed
Last Updated

December 12, 2017

Status Verified

December 1, 2017

Enrollment Period

2.9 years

First QC Date

November 29, 2017

Last Update Submit

December 11, 2017

Conditions

Keywords

Mental healthSuicideSexual risk behaviors

Outcome Measures

Primary Outcomes (1)

  • Change in Sexual Risk Behaviors

    AIDS Risk Behavior Assessment (ARBA) was used. Sexual risk behaviors were defined as engaging in unprotected sex, having multiple sex partners, and engaging in anal sex. Engagement in unprotected sex was assessed by asking participants, "Of those times that you had vaginal sex in the past three months, how often did you or your partner use condoms/latex protection?'' Responses were scored 0 for "never used a condom," "some of the time," "half of the time," "more than half of the time" and 1 for "every time." Having multiple sex partners was assessed by the question: "How many female/male sex partners have you had in the past three months?" Responses were coded dichotomously as 0 for none or one sexual partner and 1 for more than one sexual partner. Engagement in anal sex was assessed by the question, "How many times in the past three months did you have anal sex?" Responses were dichotomized as 0 for none, and 1 for one or more times.

    Outcomes will be measured at: baseline, up to 12 weeks after the baseline, 3 months post intervention

Secondary Outcomes (3)

  • Change in Depressive Symptoms

    Outcomes will be measured at: baseline, up to 12 weeks after the baseline, 3 months post intervention

  • Change in Substance Use

    Outcomes will be measured at: baseline, up to 12 weeks after the baseline, 3 months post intervention

  • Change in Mental Distress

    Outcomes will be measured at: baseline, up to 12 weeks after the baseline, 3 months post intervention

Other Outcomes (5)

  • Change in PTSD Symptoms

    Outcomes will be measured at: baseline, up to 12 weeks after the baseline, 3 months post intervention

  • Change in Safety Outcome

    Outcomes will be measured at: baseline, up to 12 weeks after the baseline, 3 months post intervention

  • Change in HIV Knowledge

    Outcomes will be measured at: baseline, up to 12 weeks after the baseline, 3 months post intervention

  • +2 more other outcomes

Study Arms (2)

AWARE intervention

EXPERIMENTAL

Group psychotherapy intervention for Asian-American women

Behavioral: AWARE intervention

Waitlist control

OTHER

Delayed AWARE intervention for Asian-American women

Behavioral: AWARE intervention

Interventions

Group psychotherapy for Asian-American women

AWARE interventionWaitlist control

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • self-identify as female;
  • are unmarried;
  • are between the ages 18 and 35;
  • are of Chinese, Korean, and/or Vietnamese descent;
  • are 1.5 (immigrated to the US before the age of 18) or 2nd (US-born children of 1st generation immigrants) generation;
  • are fluent in English;
  • have a mobile phone with text messaging;
  • have had penile-vaginal intercourse in their lifetime;
  • have a history of exposure to at least one of five selected criteria in the Traumatic Life Events Questionnaire (TLEQ). These criteria include: beaten by stranger, death threat, childhood physical abuse, family violence, and partner physical assault;

You may not qualify if:

  • at current significant risk of homicidal or suicidal behavior
  • having symptoms of psychosis;
  • have previously experienced natural disasters or other non-violent trauma;
  • are of mixed race other than Korean-, Chinese-, or Vietnamese-Americans;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • Hahm HC, Lee J, Rough K, Strathdee SA. Gender power control, sexual experiences, safer sex practices, and potential HIV risk behaviors among young Asian-American women. AIDS Behav. 2012 Jan;16(1):179-88. doi: 10.1007/s10461-011-9885-2.

    PMID: 21259042BACKGROUND
  • Hahm HC, Kolaczyk E, Lee Y, Jang J, Ng L. Do Asian-American women who were maltreated as children have a higher likelihood for HIV risk behaviors and adverse mental health outcomes? Womens Health Issues. 2012 Jan-Feb;22(1):e35-43. doi: 10.1016/j.whi.2011.07.003. Epub 2011 Aug 26.

    PMID: 21872488BACKGROUND
  • Hahm HC, Lee CH, Choe JY, Ward A, Lundgren L. Sexual Attitudes, Reasons for Forgoing Condom Use, and the Influence of Gender Power among Asian-American Women: A Qualitative Study. J AIDS Clin Res. 2011 Dec 30;(S1):004. doi: 10.4172/2155-6113.S1-004.

    PMID: 22866240BACKGROUND
  • Lee J, Hahm HC. HIV risk, substance use, and suicidal behaviors among Asian American lesbian and bisexual women. AIDS Educ Prev. 2012 Dec;24(6):549-63. doi: 10.1521/aeap.2012.24.6.549.

    PMID: 23206203BACKGROUND
  • Hahm HC, Jang J, Vu C, Alexander LM, Driscoll KE, Lundgren L. Drug use and suicidality among Asian American women who are children of immigrants. Subst Use Misuse. 2013 Dec;48(14):1563-76. doi: 10.3109/10826084.2013.808219. Epub 2013 Jul 12.

    PMID: 23848381BACKGROUND
  • Hahm HC, Gonyea JG, Chiao C, Koritsanszky LA. Fractured Identity: A Framework for Understanding Young Asian American Women's Self-harm and Suicidal Behaviors. Race Soc Probl. 2014;6(1):56-68. doi: 10.1007/s12552-014-9115-4.

    PMID: 24563680BACKGROUND
  • Hahm HC, Chang ST, Tong HQ, Meneses MA, Yuzbasioglu RF, Hien D. Intersection of suicidality and substance abuse among young Asian-American women: implications for developing interventions in young adulthood. Adv Dual Diagn. 2014;7(2):90-104. doi: 10.1108/ADD-03-2014-0012.

    PMID: 25031627BACKGROUND
  • Augsberger A, Yeung A, Dougher M, Hahm HC. Factors influencing the underutilization of mental health services among Asian American women with a history of depression and suicide. BMC Health Serv Res. 2015 Dec 8;15:542. doi: 10.1186/s12913-015-1191-7.

    PMID: 26645481BACKGROUND
  • Hahm HC, Lee J, Chiao C, Valentine A, Le Cook B. Use of Mental Health Care and Unmet Needs for Health Care Among Lesbian and Bisexual Chinese-, Korean-, and Vietnamese-American Women. Psychiatr Serv. 2016 Dec 1;67(12):1380-1383. doi: 10.1176/appi.ps.201500356. Epub 2016 Jul 1.

    PMID: 27364813BACKGROUND

MeSH Terms

Conditions

Mental DisordersPsychological Well-BeingSuicide

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorSelf-Injurious BehaviorBehavioral Symptoms

Study Officials

  • Hyeouk Hahm, Ph.D., LCSW

    Boston University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: We employed a two-arm randomized clinical trial to test the preliminary feasibility, safety, and efficacy for AWARE intervention comparing the AWARE intervention group (n=48) with the wait-list group (n =48).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 29, 2017

First Posted

December 12, 2017

Study Start

August 1, 2013

Primary Completion

June 23, 2016

Study Completion

July 31, 2017

Last Updated

December 12, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share