Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
NCT number |
NCT05281874 |
Other study ID # |
GeorgiaSU |
Secondary ID |
|
Status |
Enrolling by invitation |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
October 3, 2022 |
Est. completion date |
May 31, 2026 |
Study information
Verified date |
May 2023 |
Source |
Georgia State University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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).
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).