Integrated Alcohol and Sexual Assault Intervention for College Men

March 15, 2023 updated by: Lindsay Orchowski Ph.D., Lifespan
This research will evaluate a new intervention that integrates evidence-based alcohol intervention strategies and promising sexual assault prevention strategies with the goal of decreasing sexual aggression among men who report heavy drinking; a particularly high risk group. Specifically, this study will conduct a randomized controlled pilot trial with college men who report heavy drinking to demonstrate the feasibility and acceptability of the proposed intervention. The main questions the study will answer are: 1) what is the feasibility of the recruitment plans, research design, intervention training methods, and delivery of the program?; and 2) does the intervention, relative to a mindfulness-based control condition, produce reductions in the quantity and frequency of alcohol use, perpetration of sexual aggression, and attitudes associated with sexual aggression over the 2- and 6-month follow-up. Follow-up assessments are completed at 2- and 6-months following the program. The intervention is compared to the mindfulness-based control group.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
115

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02904
        • Rhode Island Hospital

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 22 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Engaging in binge drinking, defined as 5 or more drinks per day for men on the same occasion by the Substance Abuse and Mental Health Services Administration on two or more occasions in the past month.
  • Engaging in oral, vaginal, or anal sexual intercourse with a female partner one or more times in the past four months

Exclusion Criteria:

  • Displaying symptoms consistent with alcohol use withdrawal
  • Reporting current suicidal or homicidal ideation
  • Meeting criteria consistent with a diagnosis of Antisocial Personality Disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Sexual Assault and Alcohol Feedback and Education (SAFE)
SAFE includes a motivational interviewing session addressing alcohol use and risk for sexual aggression, a workshop addressing alcohol use and sexual aggression, and a booster session review.
Behavioral: SAFE
SAFE includes a motivational interviewing session addressing alcohol use and risk for sexual aggression, a workshop addressing alcohol use and sexual aggression, and a booster session review.
Active Comparator: Mindfulness-Based Control Condition
The program includes the same amount of contacts as SAFE, including an individual session focused on mindfulness and stress, a group session, and a booster session review.
Behavioral: Mindfulness-Based Control Condition
The program includes the same amount of contacts as SAFE, including an individual session focused on mindfulness and stress, a group session, and a booster session review.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Alcohol use, heavy drinking quantity
Time Frame: Change from baseline alcohol use at 6 months.
Number of heavy drinking days in the past month (Minimum = 0, Maximum = 31), assessed via the timeline follow-back. Greater scores mean worse outcomes.
Change from baseline alcohol use at 6 months.
Alcohol use, drinks per week
Time Frame: Change from baseline alcohol use at 6 months.
The average number of drinks per week (Minimum = 0, Maximum = unspecified), assessed via the timeline follow-back. Greater scores mean worse outcomes.
Change from baseline alcohol use at 6 months.
Sexual aggression perpetration
Time Frame: Change in severity and frequency in comparison to control at 6-months.
Assessed via the sexual experiences survey. Scored based on frequency and severity (Minimum = 0, Maximum = 63). Higher scores mean worse outcomes.
Change in severity and frequency in comparison to control at 6-months.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Protective behavioral strategies
Time Frame: Change in protective behavioral strategy use in comparison to control at 6-months.
Assessed via the Self Control Questionnaire (Minimum = 37, Maximum = 185). Higher scores mean more positive outcomes.
Change in protective behavioral strategy use in comparison to control at 6-months.
Perceived peer drinking norms
Time Frame: Change in perceived peer norms relative to control at 6-months.
Assessed via the drinking norms rating form (Minimum = 0, Maximum = unspecified). Higher scores mean worse outcomes.
Change in perceived peer norms relative to control at 6-months.
Perceived peer norms regarding sexual aggression: Perceived peer bystander intervention
Time Frame: Change in perceived peer bystander intervention in comparison to control at 6-months.
Assessed via the sexual social norms inventory, perceived peer bystander intervention (Minimum = 8, Maximum = 40, higher scores better outcomes).
Change in perceived peer bystander intervention in comparison to control at 6-months.
Perceived peer norms regarding sexual aggression: Perceived peer engagement in sexual coercion
Time Frame: Change in perceived peer engagement in comparison to control at 6-months.
Assessed via the sexual social norms inventory, regarding perceived peer engagement in sexual coercion (Minimum = 7, Maximum = 35, lower are better outcomes).
Change in perceived peer engagement in comparison to control at 6-months.
Perceived peer norms regarding sexual aggression: Peer comfort with sexual aggression
Time Frame: Change in peer comfort with sexual aggression relative to control at 6-months.
Assessed via the sexual social norms inventory, perception of peer comfort with sexual aggression (Minimum = 7 , Maximum = 35, lower are better outcomes).
Change in peer comfort with sexual aggression relative to control at 6-months.
Attitudes relating to sexual aggression: Rape myth acceptance
Time Frame: Change in rape myth acceptance relative to control at 6-months.
Assessed via the rape myth acceptance scale (Minimum = 7, Maximum = 140, higher are worse outcomes).
Change in rape myth acceptance relative to control at 6-months.
Attitudes relating to sexual aggression: Hyper gender ideology
Time Frame: Change in hyper gender ideology and increases relative to control at 6-months.
Assessed via the hyper gender ideology scale (Minimum = 19, Maximum = 114, higher scores are worse outcomes).
Change in hyper gender ideology and increases relative to control at 6-months.
Attitudes relating to sexual aggression: Labeling of consent
Time Frame: Change in labeling of consent relative to control at 6-months.
Assessed via the labeling of consent scenarios (Minimum = 1, Maximum= 10, higher scores are better outcomes).
Change in labeling of consent relative to control at 6-months.
Bystander intervention intention to help strangers
Time Frame: Change in intention to help strangers relative to control at 6-months.
Assessed via the intentions to help strangers scale (Minimum = 0, Maximum = 800, higher scores are better outcomes).
Change in intention to help strangers relative to control at 6-months.
Bystander intervention intention to help friends
Time Frame: Change in intent to help friends relative to control at 6-months.
Assessed via the bystander intentions to help friends scale (Minimum = 0, Maximum = 1000, higher scores are better outcomes).
Change in intent to help friends relative to control at 6-months.
Bystander intervention attitudes
Time Frame: Change in bystander attitudes relative to control at 6-months.
Assessed via the bystander attitudes scale (Minimum = 51, Maximum = 255, higher scores are better outcomes).
Change in bystander attitudes relative to control at 6-months.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Motivation to change
Time Frame: Change in motivation relative to control from baseline to immediately after the session.
Assessed via the Contemplation latter (Minimum = 0, Maximum = 10, higher scores are better outcomes).
Change in motivation relative to control from baseline to immediately after the session.
Self-Efficacy
Time Frame: Change in self-efficacy relative to control at from baseline to immediately after the session.
Assessed via the brief situational confidence questionnaire (Minimum = 0, Maximum = 100, higher scores are better outcomes).
Change in self-efficacy relative to control at from baseline to immediately after the session.
Drinking intentions
Time Frame: Change in drinking intentions relative to control from baseline to immediately after the session.
Assessed via the drinking intention weekly report (Minimum = 0, Maximum = Unspecified, higher scores are worse outcomes).
Change in drinking intentions relative to control from baseline to immediately after the session.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 17, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 13, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 13, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 17, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 17, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R34AA020852 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data sharing requests can be made by contacting the study PI.

IPD Sharing Time Frame

Data can be requested from the PI .

IPD Sharing Access Criteria

A data sharing agreement can be requested by contacting the PI.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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