Asian Women's Action in Resilience and Empowerment

Study Overview
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Brief Summary
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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
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Recent epidemiological studies document two emerging public health problems among Asian-Pacific Islander (API) women in the US: 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. 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.

Official Title
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Developing an Intervention to Promote API Women's Sexual and Mental Health

Conditions
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Mental Health Disorder

Intervention / Treatment
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* Behavioral: AWARE intervention


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AWARE intervention<br>Group psychotherapy intervention for Asian-American women | Behavioral: AWARE intervention<br>* Group psychotherapy for Asian-American women<br>|
| Other: Waitlist control<br>Delayed AWARE intervention for Asian-American women | Behavioral: AWARE intervention<br>* Group psychotherapy for Asian-American women<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Depressive Symptoms | The Center for Epidemiological Studies Depression Scale (CES-D) is a 20-item self-report questionnaire designed to assess depressive symptomatology. For each item, participants reported their status over the past two weeks using a Likert-type scale ranging from rarely or never (0) to most days or always (3). Responses were summed to create a total symptom score ranging from 0 to 60. The CES-D has demonstrated very high internal consistency, reliability and validity. The internal consistency of our sample ranged from .86 to .92. | Outcomes will be measured at: baseline, up to 12 weeks after the baseline, 3 months post intervention | 
| Change in Substance Use | Addiction Severity Index (ASI) is a self-report questionnaire for patients who present for substance abuse treatment. The instrument gathers information about seven areas of a patients life: medical, employment/support, drug and alcohol use, legal, family history, family/social relationships. The scale has Cronbach's alpha of alcohol section of 0.75 and for Drug section is 0.70. This measure was used in testing SS for women who suffered from substance use and PTSD. | Outcomes will be measured at: baseline, up to 12 weeks after the baseline, 3 months post intervention | 
| Change in Mental Distress | The General Mental Distress Index (GMDI) is a 21-item scale screening for symptoms of depression, anxiety, suicidal ideation, and other aspects of mental and emotional distress. Each item is scored 1 for yes and 0 for no. A score of 4-6 indicates clinically-significant symptoms, and a score of 7+ indicates acute distress with the possibility of reoccurring mental health problems. | Outcomes will be measured at: baseline, up to 12 weeks after the baseline, 3 months post intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mental health, Suicide, Sexual risk behaviors