AWARE Intervention: Feasibility and Efficacy Trial at Three University Health Services Centers
Condition: Depression; Anxiety; PTSD; Suicidal Ideation; Substance Use Disorders; Unsafe Sex; Coping Behavior
MeSH terms: Substance-Related Disorders; Suicidal Ideation
Study type: Interventional

Summary: 
      The goal of this study is to test the efficacy and the feasibility of the Asian Women's
      Action for Resilience and Empowerment (AWARE) intervention, in the real world setting --
      student health service centers at Boston University, Wellesley College, and Harvard
      University.

      AWARE is an 8-week group intervention specifically designed to address mental health and
      sexual health issues among Asian-Pacific Islander (API) women. One AWARE group (final number
      of 8-10 API women who will be treated) will be held at BU Student Health Services, two groups
      at Wellesley College, and two groups at Harvard University Health Services for undergraduate
      and graduate students who meet the demographic and clinical criteria.

      During the intervention period, participants will attend the AWARE group counseling sessions,
      which are 90 minutes, once a week, for 8 weeks. Each week's session is focused on a specific
      theme related to the cultural and gender-specific issues typical among young Asian American
      women. The sessions are led by staff therapists at either institution. Participants will fill
      out forms that detail their therapeutic goals ("commitments") and any adverse
      emotional/behavioral events from the past week. Participants will also receive daily text
      messages that reinforce the group session themes.

      Participants will be assessed pre- and post-intervention on clinical outcomes, including
      depression, anxiety, PTSD, and suicidality, using standardized quantitative instruments. This
      serves to evaluate the efficacy of AWARE at improving mental health outcomes. Participants
      will also participate in a post-intervention focus group session to evaluate the program's
      implementation and suggest ways for future improvement.
    

Detailed description: 
      After institutional review application is approved, study recruitment will begin immediately.
      Electronic and hard-copy fliers will be disseminated around campus. Fliers will be emailed to
      Offices of Student Affairs, as well as Asian American student groups, at Boston University
      and Harvard University. Publicity at Wellesley College will be conducted through the Office
      of the Dean of Students, Intercultural Education Program. The research group social media
      (AWSHIP Facebook, Instagram, Twitter, monthly newsletter) will also be used to recruit
      potential participants. Those who are interested in participating in AWARE will be directed
      to the AWSHIP website, where the link for the <3 minute demographic survey will be available.
      The survey will have 6 initial screening question and participants must answer in the
      affirmative to be eligible for the next recruitment step:

      "1. How or where did you hear about our study? Why did our advertisement grab your
      attention/our outreach effort interest you? 2. Do you self-identify as an Asian American
      female? 3. What is your marital status? 4. What is your age as of this screening? 5. What
      languages are you fluent in reading, writing, and speaking? 6. Do you currently have a mobile
      phone (either a regular phone or a smart phone) with a text-messaging plan?"

      Individuals who provide answers that meet the preliminary criteria will receive more detailed
      information about the study (either by phone or email) within a week. They will be invited to
      meet with the site coordinator/research assistant to complete the consent form. After
      participants sign the consent form, they will be asked to complete the clinical assessment in
      the same room (BUSSW: Rooms 345 or 340, Wellesley: Stone Center Counseling Service offices,
      Harvard U: Counseling and Mental Health Services offices) using the study laptops. Since the
      clinical assessments contain questionnaires that ask for details on history of mental health
      and suicidality, the research team will debrief with the participants asking them about their
      feelings, ensuring their safety and referring them to care immediately (if needed).

      The following questions will be asked in the debrief:

      "1. How do you feel after completing the measures? 2. Do you feel safe going about your day?
      3. Do you need to talk to someone?"

      Once the participant completes the assessment and leaves the room, research coordinators will
      calculate the scores and inform the PI to help determine if participants meet the threshold
      criteria based on the results of the clinical screening. The PI will only use the screening
      questionnaire scored to determine study eligibility. This will be done within 24 hours after
      the clinical assessment. The research coordinators will contact the participant within 48
      hours after the clinical assessment to inform whether they are eligible for the intervention.
      Eligible participants will be invited to join the intervention group until all the spots have
      been filled.

      The screening questionnaire will contain the following measures:

        1. The Center for Epidemiologic Studies Depression Scale - Revised (CESD-R) is a survey
           that screens for depression by measuring the severity of symptoms linked with depressive
           episodes. Eligibility criteria is a score equal to or greater than 16.

        2. The Hospital Anxiety and Depression Scale (HADS) determines the levels of depression and
           anxiety that a participant may be experiencing. Eligibility criteria is a score equal to
           or greater than 11.

        3. The PTSD Checklist - Civilian Version (PCL-C) screens for the key symptoms of PTSD that
           applies to any traumatic event that has happened. Eligibility criteria is a score equal
           to or greater than 30.

        4. As well, exposure to physical or sexual violence during childhood is assessed using the
           Adverse Childhood Experience International Questionnaire (ACE-IQ). The (ACE-IQ) surveys
           the first 18 years of the participant's life, such as physical or sexual abuse from
           household or non-household members.

        5. The SF-12 Health Survey (SF-12) asks for personal views on health and keeps track of how
           the participant feels/how well the participant is able to do perform usual activities.

        6. The Columbia-Suicide Severity Rating Scale (C-SSRS) assesses the suicidality of the
           participant, such as suicidal ideation, intent of ideations, and suicidal behavior. Any
           participant who indicates that they attempted suicide for the last two years, will be
           immediately referred to the Student Health Service Center therapist for individual
           psychotherapy instead of being part of the group intervention.

      In addition, for the Harvard University site, the pre-/post-intervention questionnaires will
      also contain measures that aim to clarify the psychosocial mechanisms through which the AWARE
      intervention acts to improve mental health outcomes:

        1. Frost Multidimensional Perfectionism Scale (MPS) measures the individual's propensity
           towards perfectionistic thinking and behavior;

        2. Distress Tolerance Scale (DTS) measures the individual's capacity and coping behaviors
           to tolerate emotionally distressful events;

        3. Asian American Family Conflict Scale (AAFCS) assesses the conflicts in values and
           practices between U.S.-raised children and their immigrant parents, in terms of
           likelihood of occurrence and seriousness of conflict;

        4. Multigroup Ethnic Identity Measures (MEIM) assess the individual's commitment (i.e.
           affirmation and belonging) towards her ethnic identity group, as well as the extent of
           her exploration and resolution of identity issues;

        5. Attitudes Toward Seeking Professional Psychological Help Scale - Short Form (ATSPPHS)
           measures the participant's stigma toward mental health and seeking psychological help.

      Following the screening and consent process, depending on demand, eligible participants may
      be assigned to a waiting list. Since this is a small study, it is anticipated that some
      participants may not be able to join the intervention during the clinical trial period. The
      research team will encourage those who will be unable to join the intervention to participant
      in any other form of mental health treatment offered at the student health service center. If
      the participants still want to be part of the intervention, they will be informed that they
      may be able to participate the following semester.

      For Wellesley College, approximately 30 participants are expected to complete the initial
      demographic screening, and approximately 75% (n = 23) of those women are expected to meet all
      inclusion criteria on the subsequent clinical screening. Approximately 85% (n = 20) will be
      both eligible for the inclusion criteria and will commit to 8 weeks of approximately 90
      minutes of AWARE intervention.

      For Boston University, approximately 30 participants are expected to complete the initial
      demographic screening, and approximately 75% (n = 23) of those women are expected to meet all
      inclusion criteria on the subsequent clinical screening. Approximately 40% (n = 10) will be
      both eligible for the inclusion criteria and will commit to 8 weeks of approximately 90
      minutes of AWARE intervention.

      For Harvard University, approximately 60 participants are expected to complete the initial
      demographic screening, and approximately 75% (n= 45) of those women are expected to meet all
      inclusion criteria on the subsequent clinical screening. Approximately 33% (n= 18-20) will be
      both eligible for the inclusion criteria and will commit to 8 weeks of approximately 90
      minutes AWARE intervention.

      The AWARE intervention was developed as a culturally informed treatment that addresses issues
      of family dynamics, trauma, mental health, and sexual health in Asian American women. The 8
      sessions in the AWARE intervention was developed to be sensitive to the gender power dynamics
      that is consistent throughout many Asian cultures. The sessions provide a safe space for
      Asian American women to explore the impact of family issues including conflict with parents
      and family violence as well as understanding coping styles and identity development. The
      AWARE intervention also addresses mental and physical symptoms that are relevant for trauma
      survivors. The AWARE intervention was also developed for Asian American women who have
      experienced Intimate Partner Violence. The sessions focus on how to achieve safety and
      stability by teaching participants various skills such as how to identify unhealthy
      relationship patterns and increase safety in their relationships and sexual practices.

      Each participant will complete the Adverse Events Log for each week. They will bring the log
      to each intervention session. The log will take 5-7 minutes to complete. The Adverse Events
      Log is a form that the subjects will complete to let the therapist know if there were any
      safety concerns in the previous week.

      The topics for the intervention follow the AWARE manual. The topics include:

      Session 1: Introduction to AWARE Session 2: "ABCDG" Parenting & Coping with Disempowerment
      Session 3: Catch-22: The Double Bind Session 4: Who Do I See in the Mirror? Body Image,
      Stereotypes, & the Media Session 5: Romance, Violence, & Everything in Between Session 6: Sex
      and Substance Use Session 7: Giving Yourself Grace Session 8: New Beginnings

      During the intervention, participants will receive text messages once a day that will provide
      helpful tips and strategies that promote wellness, encourage self-care, and provide new
      information and resources. The text messages will not indicate that the subjects are part of
      a research study.

      Examples of text message stories include:

      "Being empowered is easier said than done. When you are faced with an emotionally challenging
      obstacle, you can often act in ways that you feel you are not in control of recognizing your
      emotions and how you react to them is a key step in discovering how you can empower
      yourself."

        -  "STOP is a coping skill that we can use to cope. When we recognize that we are in an
           emotionally heightened state, take a moment to stop whatever you're doing or thinking,
           take a deep mindful breath, observe (with your senses and internally), and proceed with
           caution (respond not react)."

        -  "More often than not, you are who you are and your perceptions of yourself is connected
           to your experiences and/or relationship with your parents. Asian-American women often
           have complicated relationships with their parents; and their actions may confuse you. It
           is helpful to understand these experiences and this relationship as part of your healing
           process."

      Once the intervention has been completed, the participants will complete the post-test
      clinical evaluations. These evaluations will be the same as the measures completed during the
      clinical screening prior to the start of the intervention. The clinical evaluations will be
      send to the participants after the completion of the final session. The participants will
      receive an email link with their unique study identification number that they will input when
      they complete the clinical eligibility screening. The research team will encourage them to
      complete the clinical screening within 48 hours. This will take about 35-45 minutes.

      Participants will be asked to participate in a focus group after the completion of the
      post-test. The participants are not mandated to take part in the focus group. The focus group
      will allow the participants to give the principal investigator feedback on the AWARE
      intervention contents. The focus group discussion will use a semi-structured interview and
      last approximately 90 minutes.
    

Intervention name(s): AWARE intervention
Intervention type(s): Behavioral
Intervention description(s): will attend the AWARE group counseling sessions, which are 90 minutes, once a week, for 8 weeks. Each week's session is focused on a specific theme related to the cultural and gender-specific issues typical among young Asian American women. The sessions are led by staff therapists at either institution. For more info on each session's content, please see the "Study Description - Detailed Description" section.
Participants will fill out forms that detail their therapeutic goals ("commitments") and any adverse emotional / behavioral events from the past week. Participants will also receive daily text messages that reinforce the group session themes.
Intervention model: Single Group Assignment
Intervention model description: Participants are assigned to a single intervention ("treatment") group. Intervention at the two sites are not concurrent; the Boston University site intervention takes place in March - May 2018, and the Harvard University site intervention takes place in October - December 2018.
Masking: None (Open Label)
Primary purpose: Treatment