An interventional study of Positive Change (+Change) in Alcohol Drinking and Sexual Assault, sponsored by Georgia State University. Completed at 2 sites in United States. Open to participants aged 18 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-05.
Sponsored by Georgia State University · Not applicable, Interventional, and Prevention
Heavy episodic drinking and sexual assault (SA) are problematic on college campuses. This project will adapt already developed interventions targeting alcohol use and SA to a mHealth format and involve content that incorporates federal guidelines and CDC recommendations to integrate both bystander intervention and risk reduction content with new innovative personalized content for each risk group (cis-gender heterosexual men, cis-gender heterosexual women, and sexual/gender minorities). Alpha testing with key stakeholders, an open pilot trial, and a randomized pilot trial will be conducted to establish acceptability and to estimate sample size for a larger randomized controlled trial.
Specific aims are as follows:
Aim 1 (Stage IA): Modify Alcohol and Sexual Assault Prevention (ASAP) content to an eHealth format to include personalized content for each risk group (1. cisgender heterosexual men; 2. cisgender heterosexual women; and 3. sexual and gender minorities).
Aim 1a: Assess normative behaviors (n = 500) regarding alcohol use and SA for feedback.
Aim 1b: Adapt and assess initial acceptability of a workbook version of the intervention content among key stakeholders (college administrators and students from each risk group [n=5 from each group]).
Aim 2 (Stage IB): Open Pilot Trial. Obtain usability of ASAP among 30 students who engage in HED (10 from each risk group) in an open pilot trial.
Aim 3 (Stage IB): A pilot to assess effect size and variability for planning a randomized trial in the future. Randomize students who engage in HED to ASAP or control condition to observe preliminary effect sizes and estimate the variability using a 3-month follow-up. Sample size was determined to estimate the variability within a reasonable margin of error. This calculation also accounted the low base rates of SA and 20% attrition. This led to a sample size of 162 students (n=54 from each risk group).
701 studies on the registry are indexed under Alcohol Drinking; 133 are open to participants now.
This study's enrollment of 165 is above the median of 122 across 607 interventional studies indexed under Alcohol Drinking.
Browse Alcohol Drinking studies →Georgia State University is the lead sponsor of 56 studies on the registry; 14 are open to participants now.
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Exclusion Criteria:
This is an assessment only control condition.
This is an integrated social norms-based personalized feedback intervention for college students targeting alcohol misuse and sexual assault. This intervention targets alcohol use, sexual assault victimization risk, sexual assault perpetration, and bystander intervention and is tailored by gender and sexual orientation.
Behavioral: Positive Change (+Change)
This is an integrated social norms-based personalized feedback intervention for college students targeting alcohol misuse and sexual assault. This intervention targets alcohol use, sexual assault victimization risk, sexual assault perpetration, and bystander intervention and is tailored by gender and sexual orientation.
Feasibility of Enrollment and Recruitment
Feasibility of enrollment recruitment was assessed by the number of anticipated participants enrolled in the study
Time frame: within 2 year recruitment period
Feasibility of Retention
Feasibility of retention was assessed by the number of participants retained in the study
Time frame: within 3 months of baseline participation
| Milestone | Control | Positive Change (+Change) |
|---|---|---|
| Started | 82 | 83 |
| Completed | 82 | 83 |
| Not completed | 0 | 0 |
Feasibility of enrollment recruitment was assessed by the number of anticipated participants enrolled in the study
| Participants | Control | Positive Change (+Change) |
|---|---|---|
| Feasibility of Enrollment and Recruitment | 82 | 83 |
Feasibility of retention was assessed by the number of participants retained in the study
| Participants | Control | Positive Change (+Change) |
|---|---|---|
| Feasibility of Retention | 71 | 70 |
Collected over Adverse events were monitored throughout the 3-month data were collection period.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control | 0/82 (0%) | 0/82 (0%) | 0/82 (0%) |
| Positive Change (+Change) | 0/83 (0%) | 0/83 (0%) | 0/83 (0%) |
| Age, Continuous(years) | Control | Positive Change (+Change) | Total |
|---|---|---|---|
| Mean | 20.5 ± 1.59 | 20.2 ± 1.66 | 20.35 ± 1.62 |
| Sex/Gender, Customized(Participants) | Control | Positive Change (+Change) | Total |
|---|---|---|---|
| Cisgender heterosexual woman | 27 | 27 | 54 |
| Cisgender heterosexual man | 29 | 28 | 57 |
| Sexual or gender minority | 26 | 28 | 54 |
| Ethnicity (NIH/OMB)(Participants) | Control | Positive Change (+Change) | Total |
|---|---|---|---|
| Hispanic or Latino | 24 | 21 | 45 |
| Not Hispanic or Latino | 58 | 60 | 118 |
| Unknown or Not Reported | 0 | 2 | 2 |
| Race/Ethnicity, Customized(Participants) | Control | Positive Change (+Change) | Total |
|---|---|---|---|
| American Indian/Alaska Native | 1 | 2 | 3 |
| Asian | 6 | 7 | 13 |
| Black or African American | 1 | 2 | 3 |
| White | 63 | 58 | 121 |
| More than One Race | 5 | 4 | 9 |
| Other | 5 | 6 | 11 |
| Prefer not to Answer | 1 | 4 | 5 |
| Region of Enrollment(Participants) | Control | Positive Change (+Change) | Total |
|---|---|---|---|
| United States | 82 | 83 | 165 |
| Enrolled in the study before the COVID-19 pandemic(Participants) | Control | Positive Change (+Change) | Total |
|---|---|---|---|
| Count of participants | 38 | 49 | 87 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — No sharing of individual participant data, only de-identified data.
Ran from Mar 2018 to primary completion in Sep 2021, 41 months.
Results were first posted in Feb 2025, 3 years 4 months after primary completion.
Of 328 non-industry interventional studies with no phase under Alcohol Drinking, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 45. This study's 41 months is above that.
Counting every sponsor, half of 336 studies reached it within 24 months; a quarter within 10 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Georgia State University