Clinical trial NCT03370549: Asian Women's Action in Resilience and Empowerment
Official title: Developing an Intervention to Promote API Women's Sexual and Mental Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Disorder
Keywords: Mental health
Suicide
Sexual risk behaviors
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
Collaborators: name: Rutgers University
First posted: 2017-12-12
Enrollment: 96
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: TREATMENT

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).

Detailed description: Recent epidemiological studies document two emerging public health problems among Asian-Pacific Islander (API) women in the US:

1. A growing incidence of HIV/AIDS. Although the prevalence of HIV/AIDS among APIs is low compared to those among Blacks, Whites, and Hispanics, HIV infection among APIs significantly increased (44%) between 2004 and 2007. Additionally, 75% of HIV transmission among API women is through heterosexual intercourse, which is substantially higher than percentages among other racial/ethnic groups of women.
2. Poor mental health functioning exhibited by completed suicide rates. Young API women (ages 15 to 34) have not only the highest rates of completed suicide compared to other women of the same age in the US, but also experienced the largest growth in rates of suicide over the past decade.

Our preliminary studies using both quantitative and qualitative methods found strong links between past trauma and poor sexual and mental health outcomes. For API women, reporting a history of forced sex was associated with higher odds of severe depression, substance use, getting pregnant, and HIV risk behaviors compared to API women who did not report a history of forced sex. API women continue to be vulnerable given their lower rates of HIV testing, lower mental health utilization, and premature dropout rates in mental health treatment compared to other racial groups. So far, no existing intervention targets both sexual health and mental health problems among API women. Specifically, this study builds upon data on API women from prior NIMH-funded work as the foundation for our intervention.

Eligibility criteria: Inclusion Criteria:

* 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;

Exclusion Criteria:

* 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;

Primary outcomes:
measure: Change in Sexual Risk Behaviors
timeFrame: Outcomes will be measured at: baseline, up to 12 weeks after the baseline, 3 months post intervention
Secondary outcomes:
measure: Change in Depressive Symptoms
timeFrame: Outcomes will be measured at: baseline, up to 12 weeks after the baseline, 3 months post intervention
measure: Change in Substance Use
timeFrame: Outcomes will be measured at: baseline, up to 12 weeks after the baseline, 3 months post intervention
measure: Change in Mental Distress
timeFrame: Outcomes will be measured at: baseline, up to 12 weeks after the baseline, 3 months post intervention
Other outcomes:
measure: Change in PTSD Symptoms
timeFrame: Outcomes will be measured at: baseline, up to 12 weeks after the baseline, 3 months post intervention
measure: Change in Safety Outcome
timeFrame: Outcomes will be measured at: baseline, up to 12 weeks after the baseline, 3 months post intervention
measure: Change in HIV Knowledge
timeFrame: Outcomes will be measured at: baseline, up to 12 weeks after the baseline, 3 months post intervention
measure: Change in Self-Efficacy Scale
timeFrame: Outcomes will be measured at: baseline, up to 12 weeks after the baseline, 3 months post intervention
measure: Feasibility Outcome
timeFrame: 8 weeks of treatment
Locations:
Study officials:
affiliation: Boston University
name: Hyeouk Hahm, Ph.D., LCSW
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.