- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05281874
Personalized Integrated Alcohol and Sexual Assault Prevention Among College Students (+Change)
Study Overview
Status
Conditions
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).
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Georgia
-
Atlanta, Georgia, United States, 30303
- Georgia State University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Control
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.
|
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.
|
Experimental: Positive Change (+Change)
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.
|
Experimental: Positive Change (+Change) Plus Booster
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.
|
Positive Change (+Change) Plus Booster
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Alcohol use
Time Frame: 3-, 6-, 9-, and 12-months
|
Number of drinks will be assessed using the daily drinking questionnaire.
Higher scores indicate higher alcohol use.
|
3-, 6-, 9-, and 12-months
|
Changes in Sexual Assault Victimization
Time Frame: 3-, 6-, 9-, and 12-months
|
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.
|
3-, 6-, 9-, and 12-months
|
Changes in Bystander Intervention
Time Frame: 3-, 6-, 9-, and 12-months
|
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.
|
3-, 6-, 9-, and 12-months
|
Changes in Sexual Assault Perpetration
Time Frame: 3-, 6-, 9-, and 12-months
|
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.
|
3-, 6-, 9-, and 12-months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Amanda Gilmore, PhD, Georgia State University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GeorgiaSU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Alcohol Drinking
-
University of North Carolina, Chapel HillNational Institute on Alcohol Abuse and Alcoholism (NIAAA)RecruitingDrinking Behavior | Adolescent Behavior | Drinking, Alcohol | Alcohol Drinking, AdolescentUnited States
-
Boston University Charles River CampusRecruiting
-
University of Auckland, New ZealandTe Hiringa Hauora/Health Promotion AgencyCompletedDrinking, Alcohol | Consumption, AlcoholNew Zealand
-
University of ArkansasRecruitingDrinking Behavior | Drinking Excessive | DrinkingUnited States
-
Butler HospitalNational Institute of General Medical Sciences (NIGMS)CompletedDrinking, AlcoholUnited States
-
Real Prevention, LLCCompletedUnderage Drinking | Alcohol Use, UnderageUnited States
-
University of FloridaNational Institute on Alcohol Abuse and Alcoholism (NIAAA)Active, not recruiting
-
University of North Texas Health Science CenterNational Institute on Alcohol Abuse and Alcoholism (NIAAA)Completed
-
Universidad de GranadaCompletedExercise | Drinking, AlcoholSpain
-
Lehigh UniversityNational Institute on Alcohol Abuse and Alcoholism (NIAAA); Brown UniversityCompletedCollege DrinkingUnited States
Clinical Trials on A healthy lifestyles attention control
-
Johns Hopkins All Children's HospitalCompletedPediatric CancerUnited States
-
Arizona State UniversityNational Institute of Nursing Research (NINR)UnknownHealthy Lifestyle Behaviors | Depressive/Anxiety SymptomsUnited States
-
Brigham and Women's HospitalJohns Hopkins University; Case Western Reserve University; Partners HealthCare; VA Boston Healthcare SystemCompletedCoronary Artery Disease | Cardiovascular Disease | Obstructive Sleep ApneaUnited States
-
University of North Carolina, Chapel HillNational Heart, Lung, and Blood Institute (NHLBI)Completed
-
Guangzhou Women and Children's Medical CenterCompleted
-
Columbia UniversityCompleted
-
Bronx-Lebanon Hospital Center Health Care SystemUnitedHealthcare FoundationUnknownChildhood ObesityUnited States
-
Eunice Kennedy Shriver National Institute of Child...CompletedDevelopmental Disabilities | Mental Retardation | Intellectual DisabilitiesUnited States
-
VA Office of Research and DevelopmentRecruiting
-
Duke UniversityUniversity of North Carolina, Chapel HillCompletedChildhood ObesityUnited States