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NCT03961633 · ClinicalTrials.gov registry record · NA
AWARE Intervention: Feasibility and Efficacy Trial at Three University Health Services Centers
A NA study, sponsored by Boston University Charles River Campus.
- Completed
- Registry status
- NA
- Development phase
- 50
- Enrollment target
NCT03961633 is a NA study that has completed, run by Boston University Charles River Campus. The registered enrollment target is 50 participants.
The verdict
NCT03961633, a NA study, has completed, sponsored by Boston University Charles River Campus.
- COMPLETED
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
Study 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.
Interventions
- BEHAVIORAL AWARE intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2016-08-01 |
| Est. Completion | 2019-02-15 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03961633
The ClinicalTrials.gov registry entry for NCT03961633 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston University Charles River Campus, which has 104 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which AWARE intervention is the first listed.
NCT03961633 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03961633 about?
NCT03961633 is a clinical study titled "AWARE Intervention: Feasibility and Efficacy Trial at Three University Health Services Centers". 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 i...
What is the current status of trial NCT03961633?
This trial is currently completed. It is a NA study. The enrollment target is 50 participants. The study started on 2016-08-01. Estimated completion is 2019-02-15.
What interventions are being tested in trial NCT03961633?
The interventions under investigation include: AWARE intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT03961633?
This trial is sponsored by Boston University Charles River Campus, which has 104 total clinical trials registered on ClinicalTrials.gov.
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