Text Message Intervention for Alcohol Use and Sexual Violence in College Students (STUDY00010873)
Phase: NA
Conditions: Alcohol Use, Unspecified, Sexual Violence, Sexual Assault
Sponsor: University of Arkansas

Text Message Intervention for Alcohol Use and Sexual Violence in College Students
NCT05065918
June 29, 2023

Study Protocol
A randonmized control trial to assess the full trial protocol and to generate estimates of
multi-target intervention efficacy compared to an alcohol use reduction TM intervention. This
aim will also explore gender and SV exposure as potential moderators of the intervention’s
effects.
Scientific Premise: Data from Aim 2 student participants will be used to systematically review
message content and decision trees by the mentorship team and SAG. Study procedures will also
be reviewed and revised using data obtained from campus faculty/staff during Aim 2. The pilot
randomized trial will examine the potential efficacy of the multi-target TM-delivered
intervention among college students seeking care from campus health centers. We will also begin
to explore two hypotheses, that the multi-target intervention will show: 1) greater decrease in
alcohol use than the alcohol use reduction condition and 2) greater increase in the use of SV
harm reduction behaviors than the alcohol use reduction control condition. Intermediate
outcomes of SV harm reduction behavior knowledge and self-efficacy will also be assessed.
Exploratory analysis will be conducted to examine potential moderation effects of gender and SV
history on the intervention’s effectiveness. To achieve this aim, we will recruit 200 students from
campus health centers. Findings from this aim will inform an R01-scale RCT of the multi-target
TM intervention. Following intervention completion, a sub-group of participants will be invited
to participate in semi-structured interviews to elicit feedback on their experiences participating in
the intervention.
Setting: This phase of the intervention will continue to build on existing relationships from Dr.
Miller’s campus health center work (See stakeholder letter of support). Student recruitment,
eligibility requirements, screening and consent procedures will be as described in Aim 2 (the
addition of recruitment sites will be used, as needed, to achieve the proposed sample size).
Eligible students will complete baseline measures and be randomized via computer to the
intervention (multi-target SV/alcohol use messaging) or control (alcohol use reduction
messaging alone) condition. To examine potential moderators of intervention effect, stratified
randomization will be used to ensure an equal distribution of students by gender and SV history.
Intervention condition: The multi-target intervention will use a similar model to the
alcohol use reduction intervention developed by Dr. Suffoletto.13-15 Students will be: 1) queried
via TM prior to planned drinking days regarding both alcohol use and SV harm reduction goal
setting; 2) provided with goal reminders during drinking period; and 3) assessed for goal
attainment and given feedback following drinking episodes. Message library tailoring based on
gender and prior SV victimization is anticipated, and will be developed and modified with
feedback obtained during Aim 1 focus groups and from the SAG. Gender-based tailoring will
likely include addressing risks/fears that are associated with or specific to different sex/gender
categories (e.g. risk of pregnancy for women, fear of being accused of SV among men,
gender-specific statistics). Development of gender neutral bystander intervention, help seeking,
and harm reduction behavior language is anticipated. Prior SV victimization tailoring is
anticipated to include messaging regarding coping with trauma and sharing of campus and
community resources, while SV perpetration history tailoring will remain focused on universal

education regarding consent, and risk reduction techniques such as alcohol use reduction and use
of social support mechanisms to monitor behavior while drinking (e.g. planning with friends how
the group will get home after a night out).
Control condition: The control condition will be the TM-delivered alcohol use reduction
intervention developed by Dr. Suffoletto.13-15 This intervention has been tested in young adults
(age 18-25) recruited from Emergency Department and college settings, and will be used to
provide an attention control group for efficacy testing. Prior to typical drinking occasions,
individuals planning a drinking event are prompted to consider committing to a drinking limit
goal, i.e.: “Would you be willing to set a goal to drink less than X drinks when drinking?”. Based
on willingness to commit to the goal, a feedback message is provided. During typical drinking
periods, individuals receive a goal reminder. The following day, the program provides goal
success/failure feedback or drinking quantity feedback. For example, those occasions where an
individual committed to a drinking limit goal triggers either messages to reinforce goal successes
or reframe goal failures. When an individual did not commit to a drink limit goal, they are
provided feedback based on alcohol quantity (e.g. abstinence feedback, high risk drinking
feedback).
Sample, data collection, and measures: Inclusion criteria, data collection time periods and
measures for the efficacy pilot will occur as detailed in the Aim 2 feasibility pilot, with the
addition of a third time point three months following the end of the intervention (T3).
Analysis: Assessment of the full trial protocol will be conducted using descriptive statistics,
including proportion of those recruited who are willing to be randomized, proportion adherent to
the intervention and control treatments, and proportion who are retained three months
post-intervention. These estimates will be crucial to design and success of a larger R01-scale
study. In addition to descriptively assessing the full RCT protocol, we will conduct analyses of
the specified exploratory outcomes, which serve as the basis for the full-scale study. Each
exploratory outcome: 1) number of drinking days per month, 2) number of binge drinking days
per month, 3) use of SV harm reduction strategies, 4) knowledge of sexual violence and alcohol
risk, 5) self-efficacy to obtain sexual consent, and, will be tested for differences between the
intervention and control conditions at T2 and T3 using generalized linear modeling. All models
will be adjusted for age, SV history, and gender. Imbalances between groups on additional
baseline characteristics (e.g., relationship status, residence, other substance use) will be assessed,
and if differences are noted, variables will be included in multivariable models. Following
intention-to-treat principles, analyses will be conducted on all who were randomized to a
condition regardless of degree to which they interacted with the intervention. The estimates
found in these analyses, including baseline prevalence estimates and confidence intervals, will be
used as the basis for sample size considerations in a larger R01-scale study. Due to the small
sample size of this pilot study, we do not expect to be powered at ∝of 0.05, and will thus
consider interactions terms at p<0.2 worth exploring in stratified analyses. To assess the impact
of missing data, we will compare the primary models (maximum likelihood) to full information
maximum likelihood models; differences in results between the two models will be described.
Participation biases and attrition analyses will be completed to inform future study design. The

effect sizes calculated from these data will be used to estimate sample size needed for each
outcome at of 0.2 and two-sided ∝of 0.05 for subsequent study.
Sample size considerations: Assessing 70 students per arm (total n=140) that have completed the
program and follow up would provide sufficient data on the full RCT protocol across multiple
campuses as well as estimates of intervention effects. Assuming a conservative retention rate of
70% for the three-month post-intervention follow up, we would need to enroll 200 participants at
baseline. While we do not anticipate having sufficient power in this pilot to detect statistically
and clinically significant results, preliminary sample size calculations for each outcome of
interest is provided in the Statistical Design and Power attachment.