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Personalized Integrated Alcohol and Sexual Assault Prevention Among College Students (+Change)

Primary Purpose

Alcohol Drinking, Sexual Assault

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Positive Change (+Change)
A healthy lifestyles attention control
Positive Change (+Change) Plus Booster
Sponsored by
Georgia State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol Drinking

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18-25 years old
  • Current student at university of study
  • Valid email address at university of study
  • Endorse engaging in heavy episodic drinking at least once in the past month on the screening survey

Exclusion Criteria:

• There are no exclusion criteria other than not meeting inclusion criteria

Sites / Locations

  • Georgia State University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Control

Positive Change (+Change)

Positive Change (+Change) Plus Booster

Arm Description

A healthy lifestyles attention control will be used as the control condition. We will match the control and intervention conditions on content (text, pictures, number of pages); type (interactive vs. psychoeducation); and average completion time.

This is an integrated social norms-based personalized feedback intervention for college students targeting alcohol misuse and sexual assault. It targets alcohol, sexual assault victimization risk, sexual assault perpetration, and bystander intervention. It is tailored by gender and sexual orientation.

This is an integrated social norms-based personalized feedback intervention for college students targeting alcohol misuse and sexual assault. It targets alcohol, sexual assault victimization risk, sexual assault perpetration, and bystander intervention. It is tailored by gender and sexual orientation. It is provided at baseline and a booster at 6 months.

Outcomes

Primary Outcome Measures

Changes in Alcohol use
Number of drinks will be assessed using the daily drinking questionnaire. Higher scores indicate higher alcohol use.
Changes in Sexual Assault Victimization
Sexual assault victimization severity will be assessed using a modified version of the Sexual Experiences Survey. Responses are rated on number of times each experience occurred (0, 1, 2, 3+). Higher scores indicate higher sexual assault victimization.
Changes in Bystander Intervention
Bystander intervention behavior will be assessed using the 44-item Bystander Behavior Scale to assess engaging in bystander behavior with friends. Responses indicate if the participant engaged in each bystander behavior with a friend or not, or if they had no opportunity to engage in the behavior. Higher scores indicate higher bystander intervention behaviors.
Changes in Sexual Assault Perpetration
Sexual assault perpetration severity will be assessed using a modified version of the Sexual Strategies Survey. Participants check all items that apply. Higher scores indicate higher sexual assault perpetration.

Secondary Outcome Measures

Full Information

First Posted
November 5, 2021
Last Updated
May 17, 2023
Sponsor
Georgia State University
Collaborators
Arizona State University
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1. Study Identification

Unique Protocol Identification Number
NCT05281874
Brief Title
Personalized Integrated Alcohol and Sexual Assault Prevention Among College Students
Acronym
+Change
Official Title
Personalized Integrated Alcohol and Sexual Assault Prevention Among College Students
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 3, 2022 (Actual)
Primary Completion Date
May 31, 2026 (Anticipated)
Study Completion Date
May 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Georgia State University
Collaborators
Arizona State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Heavy episodic drinking and sexual assault are problematic on college campuses. This study includes a randomized controlled trial of Positive Change (+Change), an integrated alcohol and sexual assault prevention program, compared to an attention-matched control condition across two universities in reducing alcohol use, sexual assault victimization, sexual assault perpetration, and increasing sexual assault bystander intervention. This study will also test the efficacy of +Change plus Booster session, an identical version of +Change delivered 6 months after the baseline, compared to +Change alone in long-term reductions in alcohol use, sexual assault victimization, sexual assault perpetration, and increases in sexual assault bystander intervention. This research is the next step of a NIAAA-funded planning grant (R34AA025691).
Detailed Description
Aim 1: Test the efficacy of Positive Change (+Change) among college students in each risk group (cisgender heterosexual men; cisgender heterosexual women; LGBTQ). Students aged 18-25 who engage in heavy episodic drinking will be recruited from 2 large public universities (n = 3,300) and will be randomly assigned to +Change, +Change plus +Booster, or an attention control. Alcohol use, sexual assault (victimization and perpetration), and bystander intervention will be assessed at baseline, 3-, 6-, 9-, and 12-month follow-ups. H1a: +Change conditions (+Change and +Change plus Booster) will result in less alcohol use, less sexual assault (victimization and perpetration), and more bystander intervention compared to the control condition at 3-month follow-up and maintained at 6 months. H1b: +Change plus booster at 6-months will maintain less alcohol use, less sexual assault (victimization and perpetration), and more bystander intervention compared to +Change over 9- and 12-month follow-ups (i.e., less decay of change). Aim 2: Investigate theoretical mechanisms through which +Change conditions impact alcohol use (e.g., descriptive drinking norms, drinking to cope with minority stress for LGBTQ students), sexual assault victimization and perpetration (e.g., sexual assault-related norms, sexual assault resistance self-efficacy, hypergender ideology), and bystander intervention (e.g., bystander intervention self-efficacy). Exploratory Aim: Examine +Change efficacy among LGBTQ subgroups (lesbian, gay, bisexual, trans, non-binary gender, gender queer, queer/questioning, intersex, asexual).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking, Sexual Assault

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Participants and principal investigator will be masked to intervention conditions.
Allocation
Randomized
Enrollment
3300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
A healthy lifestyles attention control will be used as the control condition. We will match the control and intervention conditions on content (text, pictures, number of pages); type (interactive vs. psychoeducation); and average completion time.
Arm Title
Positive Change (+Change)
Arm Type
Experimental
Arm Description
This is an integrated social norms-based personalized feedback intervention for college students targeting alcohol misuse and sexual assault. It targets alcohol, sexual assault victimization risk, sexual assault perpetration, and bystander intervention. It is tailored by gender and sexual orientation.
Arm Title
Positive Change (+Change) Plus Booster
Arm Type
Experimental
Arm Description
This is an integrated social norms-based personalized feedback intervention for college students targeting alcohol misuse and sexual assault. It targets alcohol, sexual assault victimization risk, sexual assault perpetration, and bystander intervention. It is tailored by gender and sexual orientation. It is provided at baseline and a booster at 6 months.
Intervention Type
Behavioral
Intervention Name(s)
Positive Change (+Change)
Intervention Description
This is an integrated social norms-based personalized feedback intervention for college students targeting alcohol misuse and sexual assault. It targets alcohol, sexual assault victimization risk, sexual assault perpetration, and bystander intervention. It is tailored by gender and sexual orientation.
Intervention Type
Behavioral
Intervention Name(s)
A healthy lifestyles attention control
Intervention Description
A healthy lifestyles attention control will be used as the control condition. We will match the control and intervention conditions on content (text, pictures, number of pages); type (interactive vs. psychoeducation); and average completion time.
Intervention Type
Behavioral
Intervention Name(s)
Positive Change (+Change) Plus Booster
Intervention Description
Positive Change (+Change) Plus Booster
Primary Outcome Measure Information:
Title
Changes in Alcohol use
Description
Number of drinks will be assessed using the daily drinking questionnaire. Higher scores indicate higher alcohol use.
Time Frame
3-, 6-, 9-, and 12-months
Title
Changes in Sexual Assault Victimization
Description
Sexual assault victimization severity will be assessed using a modified version of the Sexual Experiences Survey. Responses are rated on number of times each experience occurred (0, 1, 2, 3+). Higher scores indicate higher sexual assault victimization.
Time Frame
3-, 6-, 9-, and 12-months
Title
Changes in Bystander Intervention
Description
Bystander intervention behavior will be assessed using the 44-item Bystander Behavior Scale to assess engaging in bystander behavior with friends. Responses indicate if the participant engaged in each bystander behavior with a friend or not, or if they had no opportunity to engage in the behavior. Higher scores indicate higher bystander intervention behaviors.
Time Frame
3-, 6-, 9-, and 12-months
Title
Changes in Sexual Assault Perpetration
Description
Sexual assault perpetration severity will be assessed using a modified version of the Sexual Strategies Survey. Participants check all items that apply. Higher scores indicate higher sexual assault perpetration.
Time Frame
3-, 6-, 9-, and 12-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-25 years old Current student at university of study Valid email address at university of study Endorse engaging in heavy episodic drinking at least once in the past month on the screening survey Exclusion Criteria: • There are no exclusion criteria other than not meeting inclusion criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amanda Gilmore, PhD
Organizational Affiliation
Georgia State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Georgia State University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Personalized Integrated Alcohol and Sexual Assault Prevention Among College Students

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