Asian Women's Action in Resilience and Empowerment (AWARE)
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|ClinicalTrials.gov Identifier: NCT03370549|
Recruitment Status : Completed
First Posted : December 12, 2017
Last Update Posted : December 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Mental Health Disorder||Behavioral: AWARE intervention||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||96 participants|
|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)|
|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|
Experimental: AWARE intervention
Group psychotherapy intervention for Asian-American women
Behavioral: AWARE intervention
Group psychotherapy for Asian-American women
Delayed AWARE intervention for Asian-American women
Behavioral: AWARE intervention
Group psychotherapy for Asian-American women
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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).
- 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.
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
|Principal Investigator:||Hyeouk Hahm, Ph.D., LCSW||Boston University School of Social Work|