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Asian Women's Action in Resilience and Empowerment (AWARE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03370549
Recruitment Status : Completed
First Posted : December 12, 2017
Last Update Posted : December 12, 2017
Sponsor:
Collaborator:
Rutgers University
Information provided by (Responsible Party):
Hyeouk Hahm, Boston University Charles River Campus

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).

Condition or disease Intervention/treatment Phase
Mental Health Disorder Behavioral: AWARE intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Developing an Intervention to Promote API Women's Sexual and Mental Health
Actual Study Start Date : August 1, 2013
Actual Primary Completion Date : June 23, 2016
Actual Study Completion Date : July 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

Arm Intervention/treatment
Experimental: AWARE intervention
Group psychotherapy intervention for Asian-American women
Behavioral: AWARE intervention
Group psychotherapy for Asian-American women

Waitlist control
Delayed AWARE intervention for Asian-American women
Behavioral: AWARE intervention
Group psychotherapy for Asian-American women




Primary Outcome Measures :
  1. Change in Sexual Risk Behaviors [ Time Frame: Outcomes will be measured at: baseline, up to 12 weeks after the baseline, 3 months post intervention ]
    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.


Secondary Outcome Measures :
  1. Change in Depressive Symptoms [ Time Frame: Outcomes will be measured at: baseline, up to 12 weeks after the baseline, 3 months post intervention ]
    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.

  2. Change in Substance Use [ Time Frame: Outcomes will be measured at: baseline, up to 12 weeks after the baseline, 3 months post intervention ]
    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.

  3. Change in Mental Distress [ Time Frame: Outcomes will be measured at: baseline, up to 12 weeks after the baseline, 3 months post intervention ]
    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.


Other Outcome Measures:
  1. Change in PTSD Symptoms [ Time Frame: Outcomes will be measured at: baseline, up to 12 weeks after the baseline, 3 months post intervention ]
    The PTSD Checklist, Civilian version (PCL-C) is a 17-item self-report measure of PTSD symptom severity. Each item corresponds to a PTSD symptom outlined in the fourth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV). Participants reported both the frequency and intensity of their experiences of PTSD symptoms over the past three months on a 5-point scale ranging from low to high. Symptom severity was computed by summing the frequency and intensity scores. Total scores ranged from 17 to 85, with a score of 50 used as the cutoff to assess a diagnosis of PTSD.

  2. Change in Safety Outcome [ Time Frame: Outcomes will be measured at: baseline, up to 12 weeks after the baseline, 3 months post intervention ]
    The Columbia-Suicide Severity Rating Scale (C-SSRS) was used to assess history of suicidal ideation and suicidal intent. Participants who reported yes to either one of the following questions were classified as having suicidal ideation--wished to be dead, thought of killing yourself, and thought about how to do this. Suicidal intent was measured with answering yes to either one of having intention of acting on thoughts of killing yourself as well as having worked out the details of how to do it. At baseline (T0), lifetime suicidal outcomes were measured and. For the post intervention evaluations (T1, T2), suicidal outcomes of the past 30 days were measured.

  3. Change in HIV Knowledge [ Time Frame: Outcomes will be measured at: baseline, up to 12 weeks after the baseline, 3 months post intervention ]
    The HIV-Knowledge Questionnaire (HIV-KQ) is a 45-item assessment on knowledge pertaining to HIV. Statements are responded to in a true/false/don't know format, addressing topics of prevention (i.e. safe sex practices), transmission (i.e. sexual transmission and other modes) and consequences (i.e. testing and treatment). The HIV-KQ exhibits a high internal consistency, with Cronbach's alpha = 0.91.

  4. Change in Self-Efficacy Scale [ Time Frame: Outcomes will be measured at: baseline, up to 12 weeks after the baseline, 3 months post intervention ]
    The Self-efficacy Scale for Limiting HIV Risk Behaviors (LHRB) contains 9 statements on self-efficacy pertaining to HIV risk behaviors. Participants are asked to rate how sure they are that they could perform each statement (0= not sure at all to 4=very sure).

  5. Feasibility Outcome [ Time Frame: 8 weeks of treatment ]
    Participant retention was evaluated using the number of sessions attended. The "completers" of the intervention were defined as those who attended at least 80% of the sessions. Similar definitions have been used in other studies.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03370549


Sponsors and Collaborators
Boston University Charles River Campus
Rutgers University
Investigators
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Principal Investigator: Hyeouk Hahm, Ph.D., LCSW Boston University School of Social Work
  Study Documents (Full-Text)

Documents provided by Hyeouk Hahm, Boston University Charles River Campus:
Study Protocol  [PDF] July 24, 2015
Informed Consent Form  [PDF] August 11, 2015

Publications:

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Responsible Party: Hyeouk Hahm, Associate Professor, Boston University Charles River Campus
ClinicalTrials.gov Identifier: NCT03370549    
Other Study ID Numbers: BostonUCRC
First Posted: December 12, 2017    Key Record Dates
Last Update Posted: December 12, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hyeouk Hahm, Boston University Charles River Campus:
Mental health
Suicide
Sexual risk behaviors
Additional relevant MeSH terms:
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Mental Disorders