ACTIVE_NOT_RECRUITING

Reducing Alcohol Use and Sexual Dysfunction in Survivors of Sexual Trauma

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to develop and evaluate the preliminary efficacy of an intervention to address alcohol use, sexual distress, and sexual assault risk among college women with a history of sexual victimization. The main questions it aims to answer are: 1) what is the feasibility of the recruitment method, research design, interventionist training methods, and delivery of the intervention; 2) does the intervention, relatively to control, the 2- and 4-month follow-up produces reductions in the quantity/frequency of alcohol use and heavy drinking, sexual distress, and sex-related drinking motives, and sexual revictimization. Participants will engage in both individual and group based intervention for alcohol use, sexual distress, and sexual assault risk. Follow-up assessments are completed at 2- and 4-months following program completion. The intervention is compared to a wait list control group who will have the opportunity to complete the program after completing the 4-month follow up.

Official Title

Reducing Alcohol Use and Sexual Dysfunction in Survivors of Sexual Trauma

Quick Facts

Study Start:2023-02-14
Study Completion:2026-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05599620

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 24 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. be between the ages of 18 and 24;
  2. 2. speak and comprehend English;
  3. 3. report a history of attempted or completed penetrative or non-penetrative acts of sexual victimization (i.e., oral, vaginal, anal) since age 14 via incapacitation, coercion, or force;
  4. 4. report exceeding the national recommended limits for daily drinking (4 or more for women) on one or more occasions in the past 6 months;
  5. 5. report past year sexual activity;
  6. 6. exceed the clinical cut point on the Female Sexual Functioning Index (score of 28.1 or lower) or exceed the cut point for the 13-item Female Sexual Distress Scale-Revised (score of 11 or higher)
  1. 1. suicide risk on items from the Beck Depression Inventory;
  2. 2. screen positive on the Alcohol Use Withdrawal Checklist.

Contacts and Locations

Study Locations (Sites)

Rhode Island Hospital
Providence, Rhode Island, 02904
United States

Collaborators and Investigators

Sponsor: Lifespan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-14
Study Completion Date2026-04-30

Study Record Updates

Study Start Date2023-02-14
Study Completion Date2026-04-30

Terms related to this study

Additional Relevant MeSH Terms

  • Alcohol Use, Unspecified
  • Sexual Dysfunction
  • Sexual Assault