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

Primary Purpose

Mental Health Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
AWARE intervention
Sponsored by
Boston University Charles River Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mental Health Disorder focused on measuring Mental health, Suicide, Sexual risk behaviors

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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;

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    AWARE intervention

    Waitlist control

    Arm Description

    Group psychotherapy intervention for Asian-American women

    Delayed AWARE intervention for Asian-American women

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.
    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.

    Full Information

    First Posted
    November 29, 2017
    Last Updated
    December 11, 2017
    Sponsor
    Boston University Charles River Campus
    Collaborators
    Rutgers University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03370549
    Brief Title
    Asian Women's Action in Resilience and Empowerment
    Acronym
    AWARE
    Official Title
    Developing an Intervention to Promote API Women's Sexual and Mental Health
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    August 1, 2013 (Actual)
    Primary Completion Date
    June 23, 2016 (Actual)
    Study Completion Date
    July 31, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Boston University Charles River Campus
    Collaborators
    Rutgers University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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: 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mental Health Disorder
    Keywords
    Mental health, Suicide, Sexual risk behaviors

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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)
    Allocation
    Randomized
    Enrollment
    96 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    AWARE intervention
    Arm Type
    Experimental
    Arm Description
    Group psychotherapy intervention for Asian-American women
    Arm Title
    Waitlist control
    Arm Type
    Other
    Arm Description
    Delayed AWARE intervention for Asian-American women
    Intervention Type
    Behavioral
    Intervention Name(s)
    AWARE intervention
    Intervention Description
    Group psychotherapy for Asian-American women
    Primary Outcome Measure Information:
    Title
    Change in Sexual Risk Behaviors
    Description
    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.
    Time Frame
    Outcomes will be measured at: baseline, up to 12 weeks after the baseline, 3 months post intervention
    Secondary Outcome Measure Information:
    Title
    Change in Depressive Symptoms
    Description
    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.
    Time Frame
    Outcomes will be measured at: baseline, up to 12 weeks after the baseline, 3 months post intervention
    Title
    Change in Substance Use
    Description
    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.
    Time Frame
    Outcomes will be measured at: baseline, up to 12 weeks after the baseline, 3 months post intervention
    Title
    Change in Mental Distress
    Description
    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.
    Time Frame
    Outcomes will be measured at: baseline, up to 12 weeks after the baseline, 3 months post intervention
    Other Pre-specified Outcome Measures:
    Title
    Change in PTSD Symptoms
    Description
    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.
    Time Frame
    Outcomes will be measured at: baseline, up to 12 weeks after the baseline, 3 months post intervention
    Title
    Change in Safety Outcome
    Description
    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.
    Time Frame
    Outcomes will be measured at: baseline, up to 12 weeks after the baseline, 3 months post intervention
    Title
    Change in HIV Knowledge
    Description
    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.
    Time Frame
    Outcomes will be measured at: baseline, up to 12 weeks after the baseline, 3 months post intervention
    Title
    Change in Self-Efficacy Scale
    Description
    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).
    Time Frame
    Outcomes will be measured at: baseline, up to 12 weeks after the baseline, 3 months post intervention
    Title
    Feasibility Outcome
    Description
    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.
    Time Frame
    8 weeks of treatment

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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;
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hyeouk Hahm, Ph.D., LCSW
    Organizational Affiliation
    Boston University School of Social Work
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    21259042
    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.
    Results Reference
    background
    PubMed Identifier
    21872488
    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.
    Results Reference
    background
    PubMed Identifier
    22866240
    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.
    Results Reference
    background
    PubMed Identifier
    23206203
    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.
    Results Reference
    background
    PubMed Identifier
    23848381
    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.
    Results Reference
    background
    PubMed Identifier
    24563680
    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.
    Results Reference
    background
    PubMed Identifier
    25031627
    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.
    Results Reference
    background
    PubMed Identifier
    26645481
    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.
    Results Reference
    background
    PubMed Identifier
    27364813
    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.
    Results Reference
    background

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