A Multi-Component Alcohol and Sex Risk Intervention for College Students
Phase: NA
Conditions: College Drinking
Sponsor: Lehigh University

Title: A Multi-Component Alcohol and Sex Risk Intervention for College Students 
NCT number: NCT05180539 
Document Date: IRB Approval 8/23/21 
 
Study Protocol and Statistical Analysis Plan 
RECRUITMENT  
Participants will be recruited from two university in the USA. All participants will be between 
the ages of 18-24 and will be eligible to participate regardless of drinking or relationship status. 
Students will be recruited from a random sample of students provided by the Registrar's Office 
or Office of Research at each site, stratified by gender and class year. Approximately three 
weeks into the fall semester, students will receive an email with an invitation to participate and a 
link to an IRB approved consent form. Each participant receives a personalized link with a 
random, unique personalized identification number (PIN) embedded in the link. This PIN is used 
instead of identify information to track participation, track incentive payments, and for creating 
ingroup materials (more details below). Before each in-person group session, participants will 
receive emails, phone calls and / or text messages about the time and location of the group 
meeting. 
BASELINE DATA COLLECTION 
After providing consent, participants will be asked to complete a brief survey assessing past 
drinking, sexual behaviors, protective behavioral strategy use, bystander behavior, intentions of 
engaging in protective behavioral strategy use, intentions of engaging in bystander behavior, and 
self-efficacy measures of protective behavioral strategy use and bystander behaviors.  
As part of the consent form, participants will consent to take the survey and participate in the 
groups. After completing the survey questions, participant will be reminded about the content 
and format of the group meetings. They will then be asked to select a time to attend the group 
meetings, alternatively they can indicate that they are still interested but not available to attend 
any of the meeting times, or that they no longer wish to attend the group meetings. Participants 
who sign up for the groups or indicate they are still interested in attending will be redirected to 
an additional survey to input their contact information. At the end of the survey, participants will 
be provided with a link to resources related to sexual assault and alcohol use. Participants will 
receive a $15 Amazon gift card for completing the survey. Participants will be randomized to the 
SPLASH intervention or the control condition (i.e., healthy eating and physical activity 
promotion).  
IN-PERSON GROUP MEETING CONTENT 
Both the SPLASH intervention and control condition comprise of two group sessions that will 
take place approximately two weeks apart. Each group session will take approximately two 
hours. Upon arrival to the session, each participant will be asked to sign an informed consent 
form that includes permission to audiorecord the meeting. During the preamble statement to the 
group, the facilitators will discuss the importance of anonymity of in-group responses, and 

students will be asked to treat the group discussion as a privileged conversation. Participants will 
be asked to use a fictitious name to avoid the use of their real names during the discussion. 
Discussions will be audiorecorded.  
SPLASH CONDITION 
Session 1 will involve normative feedback and protective behavioral strategies training related to 
alcohol use and sexual behaviors. The normative feedback component of the intervention is 
interactive (i.e., using live anonymous polling software participants will be able to text their 
responses to questions related to other same-campus students’ alcohol consumption, alcohol use 
before/during sex, and frequency of unprotected casual sex and immediately view the group’s 
responses). Data collected through the system are anonymous and are not connected to student 
cell phone numbers or any other identifying information. Participation in the polling is voluntary 
and there are no questions about students’ personal behaviors. The normative feedback will 
involve a discussion of, for example, why students hold normative misperceptions.  
In addition to normative feedback, participants in session 1 will receive protective behavioral 
strategies (PBS) training in order to build skills for overcoming barriers and implementing PBS 
to reduce risky alcohol and drinking-related sexual behaviors. The methods we will utilize are 
based on our past research (Kenney, Napper et al., 2014; LaBrie, Napper et al., 2015). More 
specifically, prior to the intervention session students’ responses to the baseline survey are used 
to populate a feedback sheet that describes how often they use a series of protective strategies. 
Each sheet is labeled with a unique participant ID number (the same PIN as that used to identify 
their survey data), and not student names (or any other identifying information). When students 
check into the meeting, their name will be verified and they will be given a folder containing 
their personal feedback sheet(s). The folder provides students with a method to keep their 
responses private if they wish.  
During the intervention, students will be asked to review their responses on the feedback 
sheet(s). They will be asked, for example, to identify strategies they commonly use and strategies 
they would like to use more often. Participants will be encouraged to discuss as a group why they 
find strategies useful, how they use them, barriers to use (including heavy alcohol use), and how 
they overcome barriers to use. Participants will be encouraged to set personal goals about their 
use of strategies in the future and asked to write down these goals. The facilitators will 
encourage participants to provide suggestions and support for each other, and will utilize group 
process strategies (e.g., creative inquiries, circular questioning) to facilitate peer discussion and 
collective brainstorming. Students do not have to share their own personal experiences if they are 
not comfortable and instead they can talk more generally about college students’ experiences or 
not participate in the group discussion. As noted above, participants will be encouraged to use a 
fictitious name for all discussions. Participants are able to take home their folder containing the 
feedback sheets and goals.  
Session 2 will address alcohol use and bystander skills training. At the beginning of the session 
participants will be reminded about the audiorecording and to use fictitious names. Any 
participants who missed session 1 will be asked to sign consent forms. Participants will receive 
interactive normative feedback on the prevalence and acceptability of bystander intervention 

using the same polling software as in Session 1. Participants will also be presented with 
bystander scenarios related to excess alcohol use and sexual assault situations. In small groups, 
participants will be asked to identify possible dangers in the scenarios and specific strategies that 
could be used to intervene. The session will end with a group discussion on the intersection of 
alcohol use and bystander behaviors (e.g., how alcohol use inhibits intervention). At the end of 
both Session 1 and 2 participants will be offered an information sheet with information about 
alcohol and sex-assault related resources. 
CONTROL CONDITION 
The procedures for the control condition are the same as those described above; however, the 
content of intervention focuses on promoting healthy eating and physical activity. For example, 
during Session 1 participants receive interactive normative feedback regarding healthy eating 
behaviors, review and discuss strategies for eating healthily. In Session 2, participants receive 
interactive normative feedback related to physical activity, discuss barriers to exercise and 
strategies to promote physical activity. They are presented with scenarios about other students 
who are struggling to exercise and asked how they could intervene to promote a healthy college 
community. 
DATA COLLECTION DURING IN-PERSON MEETINGS 
At the end of each session participants will complete post-intervention assessment measures in 
order to determine participants’ perceptions of the helpfulness of the intervention and acceptance 
of the intervention content. Participants will receive a $20 gift card for attending each in-person 
group session and completing post-session measures.  
MITIGATING RISK 
Participants will be informed that their participation is voluntary, that they can decline to answer 
any questions they do not feel comfortable answering, and that they can withdraw from the study 
at any time without penalty. In addition, efforts will be taken to ensure all participant data is kept 
confidential. While some of the topics in the survey are sensitive in nature, the questions do not 
fall outside of the bounds of questions that might come up during a routine doctor's visit, and 
thus do not pose more than a minimal risk. During group meetings, participants will not be 
required to share personal alcohol or sex related information. During the group discussions, 
participants will be asked to use a fictitious name. Participants will be reminded that it is their 
choice what they disclose during group discussions. At the end of the group, students will be 
offered information about alcohol and sex-assault related resources. 
STATISTICAL ANALYSIS PLAN 
Preliminary analyses will examine patterns of missing data, dropout rates, and differences 
between the two sites. Before commencing analyses, variable distributions will be assessed and 
outliers dealt with appropriately when necessary. We will assess the effectiveness of the 
randomization procedure by comparing groups on relevant variables. If meaningful differences 
are observed between conditions, individual-level covariates will be used.  

Study Feasibility and Treatment Feasibility/Acceptability. We will assess the feasibility of 
procedures by examining study recruitment, refusal rates, follow-up rates. We will assess the 
feasibility and acceptability of SPLASH and the general health promotion control by examining 
rates of session attendance, completion (attending both sessions, drop-outs), and descriptive 
analysis of satisfaction data.  
Intervention Effects: In examining preliminary intervention effects, we will investigate the effect 
of condition on outcomes (i.e., alcohol use, safe sex behaviors, use of PBS and bystander 
behaviors, perceived norms, self-efficacy, and willingness). Given that effect size estimates may 
be unreliable for small pilot studies we will assess effect size ranges (e.g., 95% CIs) and 
direction of effects between conditions. We will explore correlations among condition, alcohol 
and sex-related outcomes. 
Between-Group Comparisons and Power: Given the pilot nature of the study and the smaller 
sample size, our focus will be on ascertaining whether the direction of the results are consistent 
with proposed hypotheses, and whether the strength of effect sizes for differences between 
conditions (e.g., Cohen’s d and it’s 95% CIs) are of practical magnitude. In addition, we will 
conduct a series of independent t tests, as a function of treatment vs. control group, on dependent 
measures for each of the post-intervention time points. If relevant baseline covariates are 
identified, analyses of covariance (ANCOVA) will be used instead.  
While our primary goal is to test feasibility and acceptability of interventions and to generate 
data supporting the direction of effects to indicate the potential for a large-scale randomized trial, 
we will use mixed models (normally distributed variables) and generalized estimating equation 
analysis (count / binary outcomes) to examine longitudinal differences in outcomes between 
conditions.