Mental Health DisorderAWARENCT03370549
Asian Women's Action in Resilience and Empowerment
A study testing AWARE intervention in people with Mental Health Disorder, run by Boston University Charles River Campus.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mental Health Disorder
- What is being tested?
- AWARE intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2013to 31 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
Show all 9Show fewer
- 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;
Who cannot join
- 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;
About this study
Official title: Developing an Intervention to Promote API Women's Sexual and Mental Health
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).
Read the 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.
- Conditions
- Mental Health Disorder
- Being tested
- AWARE intervention
- Keywords
- Mental health, Suicide, Sexual risk behaviors
- Medical subject headings
- Mental Disorders, Psychological Well-Being, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AWARE interventionBehavioural
Group psychotherapy for Asian-American women
| Study group | Role | What they receive |
|---|---|---|
| AWARE intervention | Experimental | Group psychotherapy intervention for Asian-American women Receives: Behavioral: AWARE intervention |
| Waitlist control | Other | Delayed AWARE intervention for Asian-American women Receives: Behavioral: AWARE intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Outcomes will be measured at: baseline, up to 12 weeks after the baseline, 3 months post intervention
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Outcomes will be measured at: baseline, up to 12 weeks after the baseline, 3 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2017
- Study start1 Aug 2013
- Primary completion23 Jun 2016
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Mental Health DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Collaborators
- Rutgers University
- Responsible party
- Principal investigator, Hyeouk Hahm, Boston University Charles River Campus
- Investigators
- Hyeouk Hahm, Ph.D., LCSW, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03370549
- Sponsor's protocol ID
- BostonUCRC
- Acronym
- AWARE
- Status last verified
- Dec 2017
- First submitted
- 29 Nov 2017
- Last updated
- 12 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21259042Hahm 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.
PubMed 21872488Hahm 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.
PubMed 22866240Lee 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.
PubMed 23206203Hahm 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.
PubMed 23848381Hahm 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.
PubMed 24563680Hahm 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.
PubMed 25031627Augsberger 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.
PubMed 26645481Hahm 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.
PubMed 27364813
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing an Intervention to Promote API Women's Sexual and Mental Health
- ClinicalTrials.gov ID
- NCT03370549
- Acronym / sponsor ID
- AWARE / BostonUCRC
- Conditions
- Mental Health Disorder
- Keywords
- Mental health, Suicide, Sexual risk behaviors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Collaborators
- Rutgers University
- Study start
- 1 Aug 2013 (actual)
- Primary completion
- 23 Jun 2016 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 12 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| AWARE intervention | Experimental | Behavioral: AWARE interventionGroup psychotherapy intervention for Asian-American women |
| Waitlist control | Other | Behavioral: AWARE interventionDelayed AWARE intervention for Asian-American women |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (4 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AWARE interventionGroup psychotherapy for Asian-American women | Behavioural | AWARE intervention, Waitlist control |
Primary outcome
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.
3 secondary outcomes
Change in Depressive Symptoms
Time frame: Outcomes will be measured at: baseline, up to 12 weeks after the baseline, 3 months post intervention
Change in Substance Use
Time frame: Outcomes will be measured at: baseline, up to 12 weeks after the baseline, 3 months post intervention
Change in Mental Distress
Time frame: Outcomes will be measured at: baseline, up to 12 weeks after the baseline, 3 months post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2017.
- Background: PubMed 21259042Hahm 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.
- Background: PubMed 21872488Hahm 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.
- Background: PubMed 22866240Hahm 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.
- Background: PubMed 23206203Lee 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.
- Background: PubMed 23848381Hahm 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.
- Background: PubMed 24563680Hahm 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.
- Background: PubMed 25031627Hahm 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.
- Background: PubMed 26645481Augsberger 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.
- Background: PubMed 27364813Hahm 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyeouk Hahm, Ph.D., LCSW principal investigator
Boston University
Questions about this trial
What is this clinical trial studying?
A study testing AWARE intervention in people with Mental Health Disorder, run by Boston University Charles River Campus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Sexual Risk Behaviors (time frame: Outcomes will be measured at: baseline, up to 12 weeks after the baseline, 3 months post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03370549, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2017.