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AWARE Program for Survivors of Sexual Trauma (AWARE Trial)

N/A

Recruiting

Research Sponsored by Lifespan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up reductions in severity and frequency of victimization in comparison to control at 6 months.

Awards & highlights

AWARE Trial Summary

This trial aims to develop a program to reduce alcohol use, sexual distress & sexual assault risk among college women who have been victimized. The intervention will be compared to a general health promotion control. Follow-up assessments will be conducted 2 & 6 months after program completion.

Who is the study for?

This trial is for college women aged 18-24 who speak English and have experienced sexual victimization since age 14. They must also report heavy drinking twice or more in the past month, be sexually active, and show signs of sexual distress. Women at suicide risk or with alcohol withdrawal symptoms cannot participate.Check my eligibility

What is being tested?

The study tests an intervention called AWARE aimed at reducing alcohol use, alleviating sexual distress, and lowering the risk of further sexual assault compared to a general health promotion program. Participants will receive individual and group sessions with follow-ups at 2 and 6 months after completion.See study design

What are the potential side effects?

Since this trial involves behavioral interventions rather than medications, there are no direct side effects like those seen with drugs. However, discussing sensitive topics may cause emotional discomfort.

AWARE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change in sexual related drinking motives at 6 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change in sexual related drinking motives at 6 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and change in sexual related drinking motives at 6 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Alcohol Use Disorder

Sexual Distress

Sexual Victimization

Secondary outcome measures

Sex-Related Drinking Motives

AWARE Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: AWARE ProgramExperimental Treatment1 Intervention

The AWARE program addresses alcohol use, sexual distress and sexual revictimization risk.

Group II: General Health PromotionPlacebo Group1 Intervention

The General Health Promotion program is a attention and dose-matched comparison condition.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

AWARE

2018

N/A

~280

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

LifespanLead Sponsor

40 Previous Clinical Trials

40,998 Total Patients Enrolled

Media Library

AWARE Clinical Trial Eligibility Overview. Trial Name: NCT05599620 — N/A

Alcohol Use Disorder Research Study Groups: AWARE Program, General Health Promotion

Alcohol Use Disorder Clinical Trial 2023: AWARE Highlights & Side Effects. Trial Name: NCT05599620 — N/A

AWARE 2023 Treatment Timeline for Medical Study. Trial Name: NCT05599620 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals aged 80+ being enrolled in this trial?

"The minimum age for inclusion in this trial is 18, with a maximum of 24. Those younger than 18 have access to 24 trials and those over 65 are able to partake in 187 studies."

Answered by AI

What criteria must potential participants meet in order to enroll in this trial?

"This study seeks to admit 90 individuals aged 18-24 who have suffered sexual assault. Additionally, they must be able to converse in English and report recent penetrative acts of victimization (oral, anal or vaginal) since the age of 14 either through force or incapacitation. Furthermore, participants should exhibit above average alcohol consumption two times a month as well as past month sexual activity and exceed clinical cut points on the Female Sexual Functioning Index."

Answered by AI

Is this investigation open to additional participants?

"According to the information provided on clinicaltrials.gov, this trial is not welcoming any more patients at this time as it was last updated on October 28th 2022. Nonetheless, there are 275 other medical studies open for enrollment right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Reducing Alcohol Use and Sexual Dysfunction in Survivors of Sexual Trauma

Lindsay Orchowski Ph.D. 2023. "Reducing Alcohol Use and Sexual Dysfunction in Survivors of Sexual Trauma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05599620.