Asian Women's Action for Resilience and Empowerment (AWARE) Intervention: Feasibility and Efficacy Trial at Three University Health Services Centers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Change in depression symptoms
研究概览
简要总结
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.
详细描述
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?"
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •- participants must meet all of the following:
- •18 - 35 years old;
- •Identify as Asian American females;
- •Single (unmarried);
- •Have a mobile phone with a text messaging plan;
- •Having depressive symptoms (CESD-R score equal to or greater than 16), or clinical anxiety (HADS-A score equal to or greater than 11), or PTSD symptoms (PCL-C score equal to or greater than 30), or exposure to physical or sexual violence during childhood (assessed using the ACE-IQ).
排除标准
- •- participants who meet any of the following:
- •Actively suicidal and homicidal (assessed using C-SSRS);
- •Participants who show psychotic symptoms such as visual or auditory hallucinations;
- •Students at the trial facilities who are currently members of the research team.
研究组 & 干预措施
AWARE intervention
This arm is the "treatment group", which receives the intervention, and is the only arm in the study. See the "intervention" column for more descriptions.
干预措施: AWARE intervention (Behavioral)
结局指标
主要结局
Change in depression symptoms
时间窗: Pre/post-intervention (within 4 weeks prior / within 1 week following intervention)
Change in depression symptoms measured by the Center for Epidemiologic Studies Depression Scale - Revised (CESD-R). The CESD-R scoring scale ranges from 0 (no depression) to 80 (severe depression), and 16 or higher is the threshold for clinical depression diagnosis.
Change in anxiety symptoms
时间窗: Pre/post-intervention (within 4 weeks prior / within 1 week following intervention)
Change in depression symptoms measured by the Hospital Anxiety and Depression Scale (HADS). The HADS scoring scale ranges from 0 (no anxiety) to 21 (severe anxiety), and 11 or higher is the threshold for clinical anxiety disorder diagnosis.
Change in PTSD symptoms
时间窗: Pre/post-intervention (within 4 weeks prior / within 1 week following intervention)
Change in PTSD symptoms measured by the PTSD Checklist - Civilian Version (PCL-C). The PCL-C scoring scale ranges from 1 (no PTSD symptoms) to 85 (severe PTSD symptoms), and 30 or higher is the threshold for clinical PTSD diagnosis.
次要结局
未报告次要终点
研究者
Hyeouk Hahm
Associate Professor, Chair of Social Research
Boston University Charles River Campus