Using Counter Attitudinal Advocacy to Change Drinking Behavior
Phase: NA
Conditions: Alcohol Drinking, Alcohol Abuse
Sponsor: Brown University

Using Counter Attitudinal Advocacy to Change Drinking Behavior 
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Using Counter Attitudinal Advocacy to 
Change Drinking Behavior  
 
National Clinical Trial (NCT) Identified Number:  NCT04042909 
Principal Investigators: Kate B. Carey, Ph.D., Angelo DiBello, Ph.D., Clayton 
Neighbors, Ph.D.  
Sponsor: Brown University 
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA), 
University of Houston 
Grant Title: Using Counter Attitudinal Advocacy to Change Drinking 
Behavior 
Grant Number: R01AA025043 
Funded by: NIAAA 
VERSION 6 
Date: April 30, 2023 
 

Using Counter Attitudinal Advocacy to Change Drinking Behavior 
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TABLE OF CONTENTS 
 
 
 
1 
RESEARCH TEAM……………………………………………………………………………................... 
3 
2 
PROJECT SUMMARY…………………………………………………………………………………… 
3 
3 
STUDY RATIONALE……………………………………………………………………………………. 
3 
4 
AIMS AND ENDPOINTS……………………………………………………………………………….. 
4 
5 
STUDY DESIGN…………………………………………………………………………………………… 
4 
6 
STUDY POPULATION……………………………………………………………………….................. 
5 
6.1  
Target Sample…………………………………………………………............................................ 
5 
6.2  
Inclusion Criteria…………………………………………………………….……......................... 
5 
6.3  
Exclusion Criteria………………………………………………………………............................. 
5 
7  
ENROLLMENT……………………………………………………………………………………………... 
5 
7.1  
Recruitment and Enrollment Procedure Overview………………………..................... 
5 
7.1.1   
Brown recruitment……………………….......................................................................... 
6 
7.1.2   
UH Recruitment………………………...………………………...………………………. 
6 
7.2   
Screening (Brown site) ………………………...………………………...………………………... 
6 
7.2.1   
Screening for in-person (pre-COVID) baseline sessions………………………... 
6 
7.2.2   
Screening for remote (post-COVID) baseline sessions………………………...... 
6 
7.3  
Screening (Houston site) ………………………...………………………...……………………… 
6 
7.3.1   
Screening for in-person (pre-COVID) baseline sessions………………………... 
6 
7.3.2   
Screening for remote (post-COVID) baseline sessions ……………………….... 
6 
7.4  
Scheduling participants………………………...………………………...……………………... 
6 
7.5  
Retention Plan………………………...………………………...………………………...………... 
7 
7.5.1   
Brown COVID adjustment timeline………………………...……………………….. 
7 
7.5.2   
UH recruitment post-COVID (remote baseline sessions) ……………………… 
7 
7.6  
Participant communication………………………...………………………...………………… 
7 
7.6.1   
Brown participant communication pre-COVID (in-person sessions) .. 
7 
7.6.2   
Brown participant communication post-COVID (remote sessions) … 
7 
7.6.3  
UH participant communication pre-COVID (in-person sessions) …… 
8 
7.6.4   
UH participant communication post-COVID (remote sessions) ……… 
8 
8 
INTERVENTIONS………………………...………………………...………………………...…………… 
8 
8.1  
Counter Attitudinal Advocacy Condition………………………...………………………. 
8 
8.2  
Personalized Normative Feedback (PNF) Condition………………………...……… 
8 
8.3  
Assessment-Only Control Condition………………………...………………………...…. 
9 
9  
STUDY ASSESSMENTS AND PROCEDURES………………………...…………………….. 
9 
9.1  
Baseline Assessment………………………...………………………...………………………... 
9 
9.1.1    
Descriptive measures………………………...………………………...…………….. 
9 
9.1.2    
Primary and secondary outcomes………………………...……………………… 
9 
9.1.3    
Potential moderators………………………...………………………........................... 
10 
9.1.4    
Potential mediators………………………...……………………….............................. 
10 
9.2   
Follow-up Assessments………………………...………………………...…………………….. 
11 
10 
STATISTICAL CONSIDERATIONS………………………...………………………...…………... 
11 
10.1  
Sample Size………………………...………………………...………………………...................... 
11 
10.2  
Analysis Plan………………………...………………………...………………………................... 
11 
11  
RISK/BENEFIT ASSESSMENT………………………...………………………...…………………. 
12 
11.1.  
Possible Risks………………………...………………………...……………………….................. 
12 

Using Counter Attitudinal Advocacy to Change Drinking Behavior 
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11.2  
Protection against Possible Risks………………………...………………………................. 
13 
11.3   
Expected Benefits………………………...………………………...……………………….......... 
14 
11.4   
Data Safety and Monitoring Plan………………………...………………………...……….. 
14 
11.5  
Adverse Events and Serious Adverse Events………………………...…………………. 
14 
12 
REGULATORY CONSIDERATIONS………………………...………………………...…………. 
16 
12.1  
Consent………………………...………………………...………………………...…………………. 
16 
12.2  
Research Material Obtained from Human Subjects………………………................... 
17 
12.3  
Access to Individually Identifiable Information…………………...…………………... 
17 
12.4  
Programming Technology and Web Security………………………............................... 
17 
12.5  
Protocol Amendment History………………………...………………………......................... 
18 
13 
REFERENCES………………………...………………………...………………………...…………………. 
24 
APPENDIX A. Recruitment Materials and Participation Communication pre-COVID………. 
27 
APPENDIX B. Recruitment Materials and Participation Communication post-COVID……... 
30 
APPENDIX C. Intervention Scripts………………………...………………………...………………………..... 
33 
APPENDIX D. Consent Forms………………………...………………………...……………………….............. 
41 
APPENDIX E. Data Safety and Monitoring Plan (DSMP) ………………………...…………………... 
51 
 
 
 

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1. RESEARCH TEAM 
 
Kate B. Carey, PhD  
Principal Investigator 
Angelo M. DiBello, PhD  
Principal Investigator 
Clayton Neighbors, PhD  
Principal Investigator 
Andrew Weinstein, BA 
Graduate Research Assistant 
Taylor Simons, M.Ed 
Research Coordinator 
Melissa Hatch, BA 
Senior Research Assistant 
Enyonam Odoom, BS 
Graduate Research Assistant 
Evelyn James, BA 
Graduate Research Assistant 
Alyssa Rice, BS 
Lab and Research Coordinator 
Gabrielle Longo, BS 
Graduate Research Assistant 
Mary Tomkins, PhD 
Postdoctoral Fellow 
Nicole Stidham 
Undergraduate Research Assistant 
Kamran Mohiuddin 
Undergraduate Research Assistant 
Zeshan Mohiuddin 
Undergraduate Research Assistant 
Jacob Moya 
Undergraduate Research Assistant 
Cecilia Nguyen-Do 
Undergraduate Research Assistant 
Vi Cao 
Undergraduate Research Assistant 
Maria Borjas 
Undergraduate Research Assistant 
Ivette Guzman 
Undergraduate Research Assistant 
 
2. PROJECT SUMMARY 
We propose to evaluate the efficacy of a CAA-based intervention to change alcohol-related attitudes in 
support of moderate drinking. Specifically, heavy-drinking college students will be prompted to advocate 
for a counter-attitudinal topic (i.e., benefits of avoiding problems) by responding to a prompt asking them 
to detail how to avoid negative consequences by using self-generated protective behavioral strategies 
(PBS) and why this is a beneficial approach to drinking. With the understanding that their responses will 
inform future prevention programs, participants will then review their statements publicly with a research 
assistant. The new CAA intervention will be compared to (a) an assessment only (AO) control to 
determine absolute efficacy, and to (b) an empirically-supported personalized normative feedback (PNF) 

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intervention to determine relative efficacy, using a non-inferiority design. This study evaluates a novel 
intervention protocol linked to a clearly defined mechanism of behavior change and grounded in basic 
psychological research. If found to be efficacious, or at least non-inferior to the established PNF, the 
CAA approach will advance prevention science by targeting a separate and unique mechanism of change, 
and it will add to the toolbox of strategies available to colleges and universities to prevent harms related 
to drinking. 
 
3. STUDY RATIONALE 
College students drink more and experience more consequences than their same-age, non-college peers 
(White & Hingson, 2014). Brief prevention interventions developed for college drinkers have effectively 
reduced alcohol use and consequences, with small-medium effects (Carey, Scott-Sheldon, Carey, & 
DeMartini, 2007; Carey, Scott-Sheldon, Elliott, Garey, & Carey, 2012; Samson & Tanner-Smith, 2015; 
Scott-Sheldon, Carey, Elliott, Garey, & Carey, 2014). Notably, mechanisms of change targeted by these 
interventions have been dominated by perceived descriptive norms (Reid & Carey, 2015). The strong 
emphasis on normative feedback as a core mechanism of change may have contributed to a dearth of 
attention to alternative paradigms. To this point, research consistently demonstrates associations between 
attitudes toward drinking and drinking behavior (Collins & Carey, 2007; Huchting, Lac, & LaBrie, 2008; 
Stacy, Bentler, & Flay, 1994), and attitudes have been shown to be stronger predictors of drinking than 
norms (DiBello, Miller, Neighbors, Reid & Carey, 2018).  
 
Although attitudes are a key element of many health behavior models (Montano & Kasprzyk, 2008), they 
are rarely directly targeted in individually-focused alcohol interventions. Attitudes are defined as 
evaluative judgments that can range from negative to positive and are subject to situational influences and 
observations of one’s own behavior (Bem, 1967; Higgins, 1987). The present research adapts a classic 
attitude-change paradigm (counter-attitudinal advocacy, or CAA), which has been used widely and 
successfully in other domains such as smoking cessation (e.g., Simmons, Heckman, Fink, Small, & 
Brandon, 2013), for use in alcohol prevention. With CAA, individuals who voluntarily endorse a specific 
position (e.g., disapproval of heavy drinking), that is discrepant from their current attitude and/or 
behavior, come to change their attitude and/or behavior in the direction of the endorsed position. This 
approach is particularly effective when the professed attitude is public, self-generated, and internally 
motivated. (Kim, Allen, Preiss, & Peterson, 2014), and the current procedure incorporates all these 
elements. An advantage of the CAA approach to promoting change in drinking behavior is that 
participants self-generate risk reduction plans without having to self-identify as wanting to change, which 
is an advantage for use in prevention programs. 
 
4. AIMS AND ENDPOINTS 
 
Aim 1. Examine the effects of CAA on alcohol outcomes. Our primary hypothesis is that, 
relative to AO control, the CAA intervention will (a) increase positive moderate drinking 
attitudes, (b) decrease positive heavy drinking attitudes, (c) increase attitude-behavior 
dissonance, and (d) decrease drinks per drinking day, binge frequency, peak BAC, and alcohol 
consequences, and increase the use of PBS.  
Aim 2. Compare the effects of CAA vs. PNF. A secondary hypothesis is that CAA will be no 
less efficacious than (i.e., not inferior to) PNF in reducing alcohol outcomes as measured by 
alcohol consumption and alcohol related consequences.  
Aim 3. Test specific theory-based mediational pathways. Aim 3a. We predict that the effects 
of the CAA intervention on alcohol consumption and consequences will be mediated by 
increases in (a) positive attitudes towards moderate drinking and (b) dissonance (but not 
perceived norms). Aim 3b. We predict that the effects of the PNF intervention on alcohol 

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consumption and consequences will be mediated by decreases in (a) perceived descriptive norms 
and (b) dissonance (but not attitude change). 
Aim 4. Test intervention-specific moderators of outcome.  Aim 4a. We predict that the effect 
of the CAA intervention will be enhanced by stronger drinker identity, greater need for 
consistency, and will not differ by study site. Aim 4b. We predict that response to the PNF 
condition will be enhanced by weaker drinker identity, greater need for consistency, and will be 
stronger within a lighter drinking community (the Houston site).  
 
5. STUDY DESIGN 
 
We will use a multi-site randomized controlled trial (RCT) to evaluate the effects of counter attitudinal 
advocacy (CAA) relative to assessment only (AO) control on drinking and related problems among 
college students, and the relative effects of CAA vs. PNF on relevant drinking outcomes. Eligible 
students will be randomly assigned to one of 3 conditions (personalized CAA or PNF or AO control). 
Hypothesized mechanisms of change (alcohol-related attitudes and dissonance, perceived drinking norms) 
will be evaluated immediately after the intervention (posttest) and drinking outcomes (drinks per week, 
heavy drinking frequency, peak BAC, alcohol-related problems, PBS) will be evaluated at 1-, 3-, and 6-
months post-intervention. All procedures are conducted for the purpose of research only. 
 
We propose to conduct this study at two sites (both Carnegie Tier 1 Research universities) that have 
distinctly different campus and student profiles in order to explicitly test hypotheses about the differential 
efficacy of CAA vs PNF in different campus contexts. Brown University is a private residential 4-year 
college with approximately 6200 undergraduates (51% female and 43% minority) and characteristics 
associated with higher risk of alcohol misuse (e.g., Northeast region, Greek system, athletic tradition). All 
first- and second-year students and most third-year student live together in on-campus dorms. Students at 
Brown report high rates of drinking: 81% of Brown students drank in the past 3 months, and 51% report 
binge drinking in the last two weeks. In contrast, the University of Houston (UH) is a large public 
research university serving more than 34,716 undergraduate students (51% female and 74% minority). 
Roughly 80% of UH students live off campus. Located in America's fourth-largest city, UH was 
designated as the most ethnically diverse metropolitan research university in the United States by Forbes 
in 2010. UH students report a below average drinker profile, with 45% of the students reporting current 
drinking and 23% report binge drinking in the last month. Overall, the base rates for any drinking and 
binge drinking are lower at UH than at Brown. These two sites allow us to test the comparative efficacy 
of CAA vs PNF in contexts with both high and low base rates of heavy drinking. If site does not moderate 
efficacy, then the replication of the effects of CAA across sites will provide evidence of generalizability 
of observed effects. 
 
6. STUDY POPULATION 
 
6.1. Target Sample. The target sample for analyses is N=600 college student drinkers: 300 from Brown 
University, and 300 from the University of Houston. We will randomize 100 eligible students from each 
site to the CAA (n=200), PNF (n=200), and AO (n=200) conditions.  
 
6.2. Inclusion Criteria. Inclusion criteria are: 
(1) Age 18-26. The age range of 18-26 (a) coincides with the distinct developmental period of “emerging 
adulthood” (Arnett, 2005), (b) is characterized by a high prevalence of heavy episodic drinking (Johnson 
et al., 2012), and (c) is representative of college students, the majority of whom are 26 years of age or 
younger (Digest of Education Statistics: 2012). 

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 (2) Male or female student at Brown University or University of Houston. The present study 
represents a first step in using counter-attitudinal advocacy activities in an attempt to reduce risky 
drinking behavior. As such, we focus on college students because they exhibit high rates of heavy 
episodic drinking (Johnson et al., 2012), and their identification with other college peers facilitates the 
testing of the enhanced manipulation. We recruit at 2 sites that differ in drinking patterns and 
demographics and geographic location to evaluate the generalizability of the study findings. The findings 
could have implications for alcohol abuse prevention both with college students and young adults more 
broadly. 
 (3) Past month heavy episodic drinking (for men, >5 drinks in one day, for women >4 drinks in one 
day). The 4/5 drink cutoff has been widely used as an indicator of risk (Neighbors, Larimer, & Lewis, 
2004; Wechsler & Nelson, 2001) and as a screening criterion in intervention studies targeting heavy 
drinking students. Our preliminary studies show that heavy drinking frequency is significantly correlated 
with attitudes towards moderate (r = -.42) and heavy (r = .45) drinking. By including only drinkers who 
have reported heavy episodic drinking we optimize the likelihood that developing arguments in favor of 
moderate drinking (<4/5 drinks/occasion) will constituted counter-attitudinal advocacy, and create 
dissonance between the espoused attitude in favor of moderation and recent behavior. 
 (4) At least two self-reported negative consequences from drinking in the past month. Because the 
CAA prompt involves writing arguments about avoiding alcohol-related problems, it will be necessary to 
ensure participants report at least two alcohol-related problems. Note that in 2 separate samples of college 
drinkers we found that 91% and 87% of those who met gender-specific binge criteria also reported at least 
2 alcohol-related problems. 
 
6.3. Exclusion Criteria.  Exclusion criteria are: (1) Status as a graduating senior. Any student with 
senior status in the spring semester will be excluded from participating in the RCT, because of potential 
difficulties in contacting graduated students for follow-ups. Also, post-graduation drinking patterns may 
change substantially (White, Labouvie, & Papadaratsakis, 2005). (2) Status as a third-year student at 
Brown (AY 2019-2020 only) During the 2019-2020 academic year ONLY, third-year students will not 
be recruited at Brown University due to a conflict with another study. 
 
7. ENROLLMENT 
 
7.1 Recruitment and Enrollment Procedure Overview 
We aim to recruit 600 heavy drinking students (300 each from UH & Brown), between 18-26 years of 
age, from the general student bodies of both institutions. Interested students who respond to recruitment 
solicitations will have the opportunity to complete a brief confidential web-based survey. Students will be 
eligible to participate in the RCT if they report (a) at least one gender-specific episode of heavy drinking 
in the previous month (4/5 or more drinks on a single occasion for women/men), (b) experiencing at least 
two alcohol-related problems in the previous month, and (c) status as an undergraduate who is not 
graduating within the 6-month study period. Due to conflicts with other studies at Brown University, 
during the 2019-2020 academic year we did not recruit third-year students or any student who has 
participated in a focus group/interview study on alcohol in the past 2 months. Students will be notified at 
the completion of the screening survey of their eligibility to participate. Screening and scheduling of 
baseline assessments (for those who meet screening criteria) will occur online at the same time. At each 
assessment point, participants will have the option to download a Resource Sheet with contact 
information for substance abuse and mental health services.  
 
7.1.1 Brown recruitment  
At Brown University, participants are recruited using several different methods. Primary 
recruitment methods include announcements posted on (a) campus-wide Today@Brown daily 
email listserv, (b) university group listservs serving clubs and student organizations (c) social 

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media platforms (e.g., Facebook, Instagram, etc.), (d) university-managed Facebook pages, (e) to 
the Center for Alcohol and Addiction Studies “Find a Study” page, (f) flyers posted near high 
traffic areas on campus (see representative materials in Appendix A, Recruitment Materials) and 
(g) snowball recruitment, in that participants will be invited to refer others they know to the 
study. Recruitment announcements include study-related information, eligibility requirements, 
and a link to a screener survey. Secondary recruitment methods include placing table slips in the 
dining halls with a study-specific number to text to receive a link to the screener and a QR code 
to scan. No in-person recruitment will occur at Brown. Under supervision and training of the PI, 
the senior Research Assistant and graduate Research Assistant will be responsible for the 
creation of online recruitment advertisements and dispersing/posting of flyers. 
 
7.1.2 UH recruitment  
At the University of Houston, we will invite a random sample of students from UH (without 
replacement) via email. Using email addresses provided by the Registrar, participants will be 
invited through the use of staggered email bursts. We will send the email bursts in cohorts of 
1000- 4000 until the desired N is achieved. Interested students will be able to link to a brief 
confidential web-based screening survey. No in-person recruitment will occur at UH. Under 
supervision of the PI or research coordinator, Research Assistants will recruit participants using 
email addresses provided by the Registrar and posting of flyers. 
 
7.2 Screening (pre-COVID). The screening survey was compiled of questions related to demographics 
(enrollment, age, class year, sex, gender identity), health behaviors (biggest issue affecting students’ 
overall health, stress, sleep habits), drinking behaviors (most alcohol consumed on an occasion in the past 
month, consequences related to drinking) and potential study conflicts (participation in another study, 
interview or focus group on the topic of alcohol use). Participants who were eligible were shown an 
eligibility message and re-routed to an online scheduling module to book an in-person baseline session. 
 
7.3 Screening (post-COVID) 
 
7.3.1 Screening for remote baseline sessions (Brown site) 
To accommodate for online delivery, we changed eligibility criteria, to exclude students who were 
learning remotely away from the campus drinking environment. The following item was added in 
September 2020 to assess the individual’s living and learning situation: “How would you best describe 
your situation this semester?” (taking classes at Brown living at home, taking classes at Brown living in 
the Providence area, Note currently taking any Brown classes, Other:[fill in the blank]). 
 
7.3.2 Screening for remote baseline sessions (Houston site) 
No changes were made to the screening process at the University of Houston, as the majority of students 
commuted to campus prior to the pandemic. 
 
7.4. Scheduling participants. Participants who meet screening criteria will be invited to schedule 
an individual in-person session using an online scheduling module (See Appendix A, 
Recruitment Materials, for details). The scheduling module will direct participants to select a 
date and time for their session and ask participants to provide their name, phone number and 
email address for further research study communications. A staff member will call, text, and/or 
email to confirm the appointment when it is made and will remind students of their appointment 
time and date one or two days before the scheduled appointment. At the in-person session, 
participants will provide written informed consent and complete the online baseline assessment 

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in a private room. Assignment to condition will take place after their baseline assessment; 
students will be stratified across conditions based on gender, a practice that has ensured baseline 
equivalence in drinking across conditions in several prior studies of college drinkers. 
 
7.5. Retention Plan  
 
Reimbursement. A $25 electronic gift card will be provided upon completion of baseline, $25 
electronic gift card for their 1-month follow up, $30 for their 3-month follow up, and $35 for their 6-
month follow up assessment. Participants will only receive compensation upon completion of each phase 
of the study. The compensation will be sent electronically to the email address provided by the participant 
at the beginning of the study. The initial baseline session will take approximately 75-90 minutes and each 
of the follow-up assessments should take approximately 30 minutes to complete. This gradual increase in 
payment ($25, $30, $35) will help ensure we have strong follow-up rates through the 6-month 
intervention period and is consistent with payment schedules used in other studies with this population. 
 
7.5.1 Brown COVID adjustment timeline 
• 
March 6th, 2020 – Last in-person RAVEN session 
• 
March 12th, 2020 - Announcement made about intent to close campus 
• 
March 16th – 20th, 2020 - Classes cancelled 
• 
March 17th, 2020  - Amendment for remote procedures approved 
• 
March 26th, 2020 – First remote RAVEN session 
• 
March 22nd, 2020 - All students off campus 
• 
March 22nd – 27th - Spring break 
• 
March 30th, 2020 - All classes moved to remote 
• 
September 18th – campus re-opens with restrictions, all baseline sessions starting Fall 2020 
semester were conducted remotely 
7.5.2 UH recruitment post-COVID (remote baseline sessions) 
• 
March 5th, 2020 – Last in-person RAVEN session 
• 
March 10th, 2020 – Work remote suggested (not a policy) 
• 
March 11th, 2020 – Classes paused for transition to online, work remotely if possible 
• 
March 17th, 2020 – Social distancing/take-out only dining begins 
• 
March 17th, 2020  - Amendment for remote procedures approved 
• 
March 24th, 2020 – Stay-at-home order official form Harris county 
• 
April 8th, 2020 – First remote RAVEN session 
• 
May 5th, 2020 – Essential (i.e., can’t be done remote) research labs can be opened 
• 
June 1st, 2020 – Campus open to faculty/staff on a limited voluntary basis 
7.6 Participant communications  
 
7.6.1 Brown participant communication pre-COVID (in-person sessions; see Appendix A) 
All participant email communications are sent from the projectraven@brown.edu email address, 
using IRB-approved templates. Appointment text reminders are sent using an online texting application, 
and phone call reminders are made using staff work telephones. 
 
7.6.2 Brown participant communication post-COVID (remote sessions; see Appendix B) 
Several changes to participant communications were made as a result of the change to remote 
baseline administration. (a) Consent is obtained verbally using Zoom, supplemented by confirmation in 

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the form of checking a consent box on an online form of the Consent document, rather than an in-person 
signature (b) Baseline sessions, some of which include a brief computerized intervention and discussion 
with a research assistant, will take place via Zoom rather than in-person (c) Intervention materials, 
including personalized feedback containing no identifying information, that would have been printed and 
given in person will now be emailed electronically 
 
7.6.3 UH participant communication pre-COVID (in-person sessions; see Appendix A) 
All participant email communications are sent from the raven@central.uh.edu email address, using 
IRB-approved templates. Appointment text reminders are sent using an online texting application, and 
phone call reminders are made using staff work telephones. 
 
7.6.4 UH participant communication post-COVID (remote sessions; see Appendix B) 
Several changes to participant communications were made as a result of the change to remote 
baseline administration. (a) Consent is obtained verbally using Zoom, supplemented by confirmation in 
the form of checking a consent box on an online form of the Consent document, rather than an in-person 
signature (b) Baseline sessions, some of which include a brief computerized intervention and discussion 
with a research assistant, will take place via Zoom rather than in-person (c) Intervention materials, 
including personalized feedback containing no identifying information, that would have been printed and 
given in person will now be emailed electronically. Participant communication still occurs via the 
raven@central.uh.edu email address and online texting application, but phone call reminders are no 
longer used. 
 
8. INTERVENTIONS (see Appendix C for intervention scripts) 
 
8.1. Counter Attitudinal Advocacy Condition. In order to prompt participants to express attitudes 
inconsistent with current behavior, we have pilot-tested and refined instructions to articulate how to 
engage in moderate drinking via self-generated PBS in order to avoid negative consequences. By design, 
inclusion criteria will produce a sample that has engaged in heavy episodic drinking (5+/4+ criteria for 
men/women, respectively) and experienced at least two consequences. The examples included in the 
prompt will be personalized to each participant, based on his/her responses to the baseline survey; thus, 
the examples will represent negative consequences actually endorsed by the participant, to optimize the 
chance that the argument will be experienced as counter-attitudinal. Therefore, articulating ways to avoid 
consequences using self-generated PBS strategies is likely to result in dissonance, which can be resolved 
by increasing the use of those strategies and reducing the frequency or quantity of drinking. Reviews 
confirm that use of PBS is associated with fewer alcohol-related problems (Pearson, 2013; Prince et al., 
2013). Therefore, writing about self-generated ways to use PBS during drinking occasions should produce 
dissonance that can be resolved by using more PBS, and this resolution of attitude-behavior discrepancy 
is likely to result in fewer alcohol-related consequences. 
 
8.2. Personalized Normative Feedback (PNF) Condition. Participants in the PNF condition will receive 
gender-identity specific personalized feedback regarding their alcohol use, consistent with previous 
NIAAA-funded trials using trained facilitator-delivered PNF as a brief intervention conducted by this 
team (e.g., R01AA014576). The PNF intervention contains both text and graphic information regarding 
1) the student’s own drinking quantity and frequency of drinking, 2) perceptions of typical drinking by 
same-sex students on campus (i.e., perceived descriptive norms), and 3) actual drinking rates by same-sex 
students’ on campus (i.e., actual descriptive norms). Normative feedback for male or female identifying 
students will use data from same-sex students on campus, whereas normative feedback for non-binary or 
genderqueer students will use data averaged across all students on campus. The actual norms will be 
referenced to the survey from which norms were generated (date, N, and campus), which took place on 
both campuses in March 2019. 

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The RA will present the PNF sheets, populated by the participant’s baseline data and will explain their 
format, where the normative data came from, and engage the participant in interpreting the graphic 
feedback. The RA will ask if the student has any questions about the information before concluding the 
session. This brief discussion is designed to be educational and clarifying, and to roughly equate the 
amount of interpersonal interaction to that in the CAA condition. 
 
8.3. Assessment Only Control Condition. Participants in the assessment only control condition will 
receive no intervention. The only contact will consist of completing the baseline assessment in lab as well 
as email and telephone reminders to complete the 1-, 3-, and 6-month follow-up assessments. 
 
9. STUDY ASSESSMENTS AND PROCEDURES 
 
9.1. Baseline Assessment. (See Appendix C) 
 
9.1.1. Descriptive measures 
Demographics will include class year, current residence, age, race, ethnicity, international student 
status, status as a first-generation college student, height, weight, religion, birth sex, gender identity, 
relationship status, immigration status and involvement in the Greek system.  
Other substance use questions will include the NIDA Modified ASSIST, which assesses lifetime and 
past month use of tobacco products, cannabis, cocaine, prescription stimulants, methamphetamine, 
inhalants, sedatives or sleeping pills, hallucinogens and street opioids. 
 
9.1.2.  Primary and secondary outcomes 
Alcohol consumption will be assessed with the Quantity-Frequency-Peak Alcohol Use Index 
(QFP; Baer, 1993; Marlatt, Baer, & Larimer, 1995), and the Daily Drinking Questionnaire (DDQ; 
Collins, Parks, & Marlatt, 1985; Kivlahan, Marlatt, Fromme, Coppel, & Williams, 1990). The Quantity-
Frequency-Peak Alcohol Use Index is a five-item questionnaire that includes two items characterizing the 
occasion where respondents drank the most during the previous month (from which we calculate peak 
BAC), two items addressing typical weekend drinking in the previous month, and one item addressing 
typical number of drinking days per week in the past month. Typical weekly drinking and typical drinks 
per occasion will be assessed with the DDQ. Participants fill in the average number of standard drinks 
they consumed and the time period of consumption for each day of a typical week in the past month. The 
primary source for assessing drinking outcomes will be the DDQ, and QFP, which we have used in 
several previous RCTs in this population.  
 
Alcohol-related negative consequences will be assessed with the 48-item Young Adult Alcohol 
Consequences Questionnaire (YAACQ; (Read, Kahler, Strong, & Colder, 2006). The YAACQ is a self-
administered checklist of problems related to drinking that is tailored to college drinkers; responses are 
dichotomous (yes/no) and refer to past month. The YAACQ is reliable and free of gender bias.  
 
Protective behavioral strategies will be measured with the 15-item Protective Behavioral 
Strategies Scale (Martens, Pedersen, LaBrie, Ferrier & Cimini, 2007) The PBSS assesses contingent 
frequency of using each strategy when drinking (1=never, 6=always) and is reliable and valid for use with 
college drinkers. This will be supplemented with the 4-item “Alternatives to drinking” factor (e.g., 
“Found other ways besides drinking to reduce stress”) from the Protective Behavioral Strategies 
Questionnaire (Sugarman & Carey, 2007). 
 
Drinking intentions will be assessed using a modified version the daily drinking questionnaire 
(DDQ; Collins, Parks, & Marlatt, 1985; Kivlahan, Marlatt, Fromme, Coppel, & Williams, 1990: Modified 
DDQ Intentions; Young, Rodriguez, & Neighbors, 2013). Participants fill in the average number of 
standard drinks they intend to consume and the time period of intended consumption for each day of a 
typical week in the next month. 

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9.1.3.  Hypothesized moderators 
 
Drinker identity will be assessed using the 5-item Alcohol Self-Concept Scale (ASCS). The ASCS 
was adapted from the Smoker Self-Concept Scale (Shadel & Mermelstein, 1996), and contains statements 
about the extent to which drinking plays a part in one’s life and personality and others’ perceptions of 
alcohol’s role in one’s life (e.g., Drinking is a part of ‘who I am’). The ASCS is anticipated to serve as a 
moderator of the CAA interventions in tests of AIM 4. Specifically, we hypothesize that those higher in 
drinker identity will experience more dissonance and behavior change as a result of the CAA activity. In 
contrast, individual’s who identify more strongly with drinking (Drinking is a part of ‘who I am’) will be 
less likely to change following PNF. 
 
 Preference for consistency will be assessed using the 9-item Preference for Consistency (PFC) 
scale. The PFC (Cialdini, Trost, & Newsom, 1995) contains statements such as, "I am uncomfortable 
holding two beliefs that are inconsistent." The PFC is anticipated to serve as a moderator of the CAA 
intervention in tests of AIM 2. Specifically, we hypothesize that the CAA will be more efficacious for 
those reporting a greater preference for consistency as they will change their attitudes and behavior in the 
argued direction more than those who report a lower preference for consistency. Similarly the PNF should 
be more efficacious for those with stronger preference for consistency because they are less comfortable 
deviating from the campus norms. 
 
9.1.4.  Hypothesized mediators 
 
Attitudes toward moderate consumption and attitudes toward heavy consumption will be assessed 
with measures modified from previous research (Hagger et al., 2012; Norman, 2011). For moderate 
consumption, the stem will read, “Keeping my alcohol drinking within what is considered moderate 
drinking for adults (i.e. at 4 or fewer drinks for men or at 3 or fewer drinks for women) on each individual 
occasion over the next month would be…” For heavy consumption, the stem will read, “Having five or 
more drinks (for males)/four or more drinks (for females) in a sitting over the next month would be…” 
For both measures, there are five semantic differential scales that range from 1 to 5: unenjoyable-
enjoyable, bad-good, harmful-beneficial, foolish-wise, and unpleasant-pleasant. To test AIM 3, changes 
in attitudes toward heavy drinking and attitudes toward moderate drinking are anticipated to serve as a 
mediator of the CAA (but not PNF) intervention effects.  
 
Cognitive dissonance will be assessed using the Dissonance Thermometer (Devine, Tauer, Barron, 
Elliot, & Vance, 1999; Elliot & Devine, 1994; Simmons & Brandon, 2007; Simmons et al., 2004; 
Simmons, et al., 2013). Items include asking participants how uncomfortable, angry at themselves, 
shameful, uneasy, friendly (reverse sored), disgusted with themselves, embarrassed, bothered, optimistic 
(reverse scored), annoyed at themselves, disappointed at themselves, happy (reverse scored), energetic 
(reverse scored), and good (reverse scored) they feel immediately following the CAA activity. The 3-item 
affective discomfort factor has been found to be susceptible to cognitive dissonance inductions 
resembling our CAA procedure, with other target behaviors (Devine et al., 1999; Simmons et al., 2013). 
In Aim 3 we will test dissonance as a mediator of both CAA and PNF interventions. 
 
Perceived descriptive norms will be measured by a modified version of the Drinking Norms Rating 
Form (DNRF; Baer et al., 1991). The gender-specific version (Lewis & Neighbors, 2004) assesses 
perceived typical number of drinks consumed per drinking occasion (e.g., “how many drinks on average 
do you think a typical male/female Brown/UH student consumes on a given occasion?”), and perceived 
frequency of drinking occasions (e.g., “how often do you think a typical male/female Brown/UH student 
consumes alcohol?”). The DNRF assesses perceived typical weekly drinking by having participants fill in 
the average number of standard drinks they think the typical (male/female) Brown/UH student consumes 
for each day of the week over the previous month. The DNRF has been used in multiple studies of college 
drinking and has shown good concurrent and prospective validity (Neighbors, Dillard, Lewis, Bergstrom, 
& Neil, 2006). In Aim 3 we test changes in descriptive norms as mediators of the PNF (but not CAA) 

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12 
 
 
 
 
effects. 
 
Perceived Injunctive norms will also be assessed using an adaptation of the DNRF shown to be 
reliably associated with respondent drinking (Krieger et al., 2016). This drink-based injunctive norms 
assessment includes (a) “maximum number of drinks a typical male/female Brown/UH student approves 
of consuming on one occasion?”, (b) “maximum frequency of drinking a typical male/female Brown/UH 
student would approve of in a week?”), and (c) “what is the maximum number of drinks a typical 
male/female Brown/UH student would consider acceptable to consume on each day of the week?.” 
Neighbors et al. (in preparation) recently demonstrated support for personalized injunctive norms 
feedback based using this measure (see preliminary studies). Additionally, injunctive norms will be 
assessed for negative consequences of drinking. Rating scales will be used to assess how unacceptable 
and acceptable experiencing specific drinking consequences is believed to be (Prince et al., 2015). These 
consequences include driving after drinking, drinking enough to pass out, blacking out due to drinking, 
etc. In Aim 3 we test changes in injunctive norms as mediators of the PNF (but not CAA) effects. 
 
9.2. Follow-up Assessments. At 1-, 3-, and 6- months following their baseline assessment, participants 
receive an email inviting them to complete each follow-up assessment and containing a link to the online 
survey. All follow-up assessments will be completed using web-assessment, and measures will be 
identical to those given at baseline. Participants will receive an additional $25 electronic gift card for their 
1-month follow up, $30 for their 3-month follow up, and $35 for their 6-month follow up. This gradual 
increase in payment will help ensure we have strong follow-up rates through the 6-month intervention 
period. Each follow up assessment should take approximately 30 minutes. 
 
10. STATISTICAL CONSIDERATIONS 
 
10.1.  Sample Size. Power analyses focus on estimating a sample size large enough to detect “true” 
effects, thereby avoiding Type II errors. Sample size estimates were obtained for intervention contrasts. 
Necessary sample sizes were assessed via sample size and power equations for multi-level models using 
the Optimal Design software program. Based on previous findings using CAA and PNF approaches, we 
anticipate intervention effects relative to the neutral control condition to be in the small to medium range 
but at least comparable to effects which have been reported for personalized normative feedback, which 
are typically in the .28 range (e.g., Dotson et al., 2015). Based on the proposed sample size of 600, given 
four assessment points, we anticipate the ability to detect effects of intervention contrasts and moderation 
effects across the small to medium range. Considering maximum anticipated attrition rates of 15% 
(N=510) we will have .70, .80, and .90 power to detect effects sizes of delta = .24, .27, and .32, 
respectively. 
 
10.2.  Analysis Plan. Aims will be evaluated using generalized linear mixed models, an extension of 
general linear models allowing for multi-level data with non-normal distributions (e.g. Atkins, Baldwin, 
Zheng, Gallop, & Neighbors, 2013; Hedeker & Gibbons, 2006). With respect to evaluating main effects 
of experimental conditions on drinking, each participant will provide up to four assessments (baseline, 1-
month, 3-month, and 6-month follow-up data). Hypotheses will be tested using specific contrast vectors, 
using a general linear hypothesis framework (Fox, 2008).  
 
Hypotheses associated with Aim 1 will be evaluated examining outcomes as a function of two 
dummy coded variables representing CAA and PNF with control as the reference group. Time X CAA 
outcomes will provide direct tests of differences in change between CAA and control groups. We will 
utilize a Bonferroni correction with Šídák adjustment for correlated outcomes to reduce alpha inflation 
associated with multiple outcomes (i.e., moderation attitudes, heavy drinking attitudes, dissonance, drinks 
per drinking day, binge frequency, peak BAC, alcohol consequences, and PBS use. 
 
For these analyses, each participant will provide up to 4 repeated measures (i.e., baseline, 1-
month, 3- months, 6-months), yielding up to 2400 Level 1 cases (repeated-measures) across 600 Level 2 

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13 
 
 
 
 
cases). Assuming outcomes follow a negative binomial distribution with a natural log link, the following 
model will be the basis for evaluating intervention effects as specified in Aim 1 hypotheses: 
Level 1: 
log (E[DV]ti) = p0i + p1i(Time)ti + εti  
εti ~ N(0, 
) 
 
Level 2: 
p0i = b00 + b01(site)i + b 02(CAA)i + b 03(PNF)i +b +r00i  
p1i = b10 + β11(site)i + b12(CAA )i +b 13(PNF)i + r10i 
 
where t indexes repeated-measures and i indexes participants. Campus represents the differences between 
Brown and UH, CAA represents the difference between CAA and the Control group, and PNF represents 
the difference between PNF and the control group. DVti represents the outcome vector for each individual 
at each assessment point. Time ti measures weeks since baseline. Hypotheses associated with Aim 2 will 
test the relative efficacy of CAA vs. PNF using a non-inferiority design. Following the procedures 
outlined by Schumi & Wittes (2011), we have consulted a recent metaanalysis to obtain an effect size 
estimate of PNF efficacy (vs. Control) on drinking quantity (d = .289, 95% CI [0.117, 0.451]) and 
consequences (d = .157, 95% CI[0.037, 0.278]) (Dotson, Dunn, & Bowers, 2015). Next, we use the lower 
bound of each confidence interval as the basis for deriving our margin with respect to declaring non-
inferiority. Thus M1= 0.117 for quantity and M1=.037 for consequences; these represent the most 
conservative estimate of the PNF effect. Then we select a smaller margin (M2) that represents the largest 
acceptable loss of effect when CAA is compared to PNF. Using a conservative estimate of M2 (50% of 
M1; USFDA, 2016), we establish non-inferiority if we retain at least half of the effect of PNF. Thus, if 
the lower bound confidence interval for the effect of CAA vs PNF is larger than half the lower bound 
estimate of the effects on drinking quantity (.117/2 = .0585) and consequences (.037/2 = .0185), we will 
be able to declare CAA is non-inferior to PNF. 
 
Hypotheses associated with Aim 3 will evaluate mediators of intervention effects. We will follow 
procedures described by MacKinnon and colleagues (e.g., MacKinnon, Fairchild, & Fritz, 2007) to assess 
mediation. Mediation will test indirect effects using the AB products method with bootstrapped standard 
errors where A will represent effects of intervention contrasts by time interactions on mediators. B will 
represent the associations of mediators on subsequent drinking outcomes. Both A and B paths will control 
for baseline outcomes. Hypotheses associated with Aim 4 will follow a similar approach but will add 
prospective moderators and products of prospective moderators and contrasts 
 
11. RISK/BENEFIT ASSESSMENT 
 
11.1. Possible Risks. The level of risk that our volunteer participants will be exposed to by completing 
online surveys of their drinking practices and related cognitions, or by engaging in writing or computer 
feedback activities about promoting safer drinking practices on campus is minimal. The main risks of 
participation include (a) a breach of confidentiality or (b) discomfort or distress answering questions 
about drinking behavior and/or consequences.  
 
Confidentiality could be breached by research staff or if data stored electronically were accessed 
by an unauthorized source. The seriousness of the consequences of a breach of confidentiality would 
depend on the nature of the information revealed and to whom the information was revealed. Some 
participants will be under the legal drinking age of 21, and will be reporting past episodes of underage 
drinking. However, this is a relatively small risk because, as a general rule, reports of past drinking carry 
minimal legal liability because of the difficulty in proving the behavior after the fact. Given the numerous 
steps we take to protect participant confidentiality (as described below), we think the risk of a breach of 
confidentiality is low.  
 
Participants may feel uncomfortable or distressed answering questions about their drinking 
behavior on surveys. Participants will have been informed of the types of questions they will be asked to 
answer, and they likely would not choose to participate if these types of questions made them feel 
uncomfortable. Participants have the option of refusing to answer the questions or withdrawing from the 
2
e
s
I

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study if they think the questions are too personal. In our previous research using similar survey questions 
with thousands of college students, none of the participants reported being significantly distressed by the 
questions. At each assessment point, participants will have the option to download a Resource Sheet with 
contact information for substance abuse and mental health services (see Appendix C, Mental Health 
Safety Plan). 
 
11.2. Protection against Possible Risks 
Minimization of risk -- Confidentiality. Several steps will be taken to ensure that data remain 
confidential. These steps have successfully maintained confidentiality in our previous work with college 
student drinkers. 
(a) Identification numbers. All participants will be assigned a unique study identification (ID) 
number upon enrollment, and the study ID will be the only identifier linked to participant 
responses on the online surveys and digitized audio versions of the orally delivered CAA 
essays and PNF feedback sessions. For participants in the RCT this ID number will be the only 
identifier in the database containing participant responses; the study ID number will be stored 
electronically in a tracking database with contact information and used to link the baseline, 
posttest, and follow-up surveys. The tracking database will be stored on a password-protected 
computer, and only study personnel will have access to the database linking names, contact 
information, and ID numbers. All identifying information will be destroyed upon completion 
of data collection. 
(b) Data storage. All data will be stored electronically on secure servers by Qualtrics and then 
downloaded to the secure server at the Brown Center for Alcohol and Addiction Studies. A 
password will be required to access data that are stored electronically, and only personnel 
involved with the project will have access to the electronic data. In the RCT, names and 
identifying information required for follow-up reminders and follow-up payments will always 
be kept separate from research data. The data generated in the RCT will remain confidential 
until the final follow-up is completed, and then identifying information will be removed and 
the data de-identified. 
(c) Staff training. All study staff will receive training in maintaining confidentiality. Training 
will focus on procedures for making sure data are not accessed by individuals outside of the 
research team, keeping identifying information separate from data, and not disclosing 
participant information or participant names to individuals outside of the research team. All 
staff will complete an online CITI ethics training, and will sign an agreement to keep all 
research information confidential. When hiring project staff, we will recruit individuals with 
previous research experience who demonstrate understanding of the importance of 
confidentiality and research ethics and convince the research team of their high personal 
integrity. 
(d) Presentation of published data. Quantitative data will be published in aggregate form only. 
Data from individual participants will not be identifiable in reports or manuscripts. 
 
Minimization of risk -- Distress. We will take several steps to reduce the possible discomfort or 
distress participants may feel about answering the survey questions or participating in the experimental 
manipulations. 
(a) Screening questions and study clearly explained. Before answering screening questions, 
participants will be informed that responses are confidential, and they will only be used to 
identify who is eligible to proceed to consent to the study. None of the screening questions 
will be set to “force response” in Qualtrics, but if key eligibility criteria are skipped, the 
student will see a pop-up message acknowledging that they can’t be determined to be eligible 
or not if the item is skipped. For those who are eligible, a detailed explanation of the study, 
including what study participation would involve, the nature of the questions participants will 

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be asked to answer, their right not to answer any question, the structure of the in-person 
session, and the right to withdraw from the study at any time without penalty will be provided 
to the participants, both in writing (through the informed consent form) and verbally (by the 
RA). Participants will be encouraged to ask questions about the study. Participants who are 
uncomfortable answering these types of questions or participating in this type of intervention 
can choose not to participate. Those who elect to participate but are uncomfortable with the 
procedures can choose to withdraw from the study. 
(b) Privacy. Participants will also have the right to decide what they want to reveal about 
themselves. Participants will be told they have the right to refuse to answer any survey 
question, and they do not have to engage in any personal discussions that they are 
uncomfortable with during the experimental procedures. 
(c) Referrals. At the end of each online survey (at baseline and all follow-ups), participants will 
be provided with a list of counseling centers and alcohol and drug resources, including ones 
both inside and outside of the university, and the phone number for a 24-hour crisis hotline. 
(d) Staff training. We will hire staff with strong interpersonal and communication skills and the 
ability to empathize with others. Study team members will receive extensive training in 
respectful treatment of human subjects (i.e., CITI certification) and close supervision from Dr. 
Carey (a licensed clinical psychologist) and Drs. Neighbors and DiBello, all experienced 
researchers. 
 
11.3. Expected Benefits. The research may directly benefit participants in several ways. First, in our 
previous research with college students, participants frequently report that they enjoyed completing self-
report surveys that increase their awareness of their health behaviors. Some also report that completing 
the surveys led to their engaging in fewer health-risk behaviors. Second, participants who receive the 
counter attitudinal advocacy manipulation or the personalized normative feedback are expected to benefit 
from these “interventions” and reduce their risk of heavy episodic drinking. Third, some participants will 
find participating in the research is fulfilling because it affords them an opportunity for altruism, that is, 
they appreciate the chance to contribute to a prosocial activity that may help others like themselves reduce 
their risk of alcohol-related consequences. 
 
The study will also benefit the public health community and society in general. Indeed, the overall 
goal of the research is to develop an intervention that will help college students to avoid drinking related-
harms (injury, assault, property damage) to themselves and to others. Based on our findings, campus 
communities may be better prepared to prevent the onset of risky drinking practices. 
 
11.4 Data Safety and Monitoring Plan. (See Appendix D) 
 
11.5. Adverse Events and Serious Adverse Events.  
 
We notified the Brown IRB, which is the lead IRB for this study, about two reportable events as 
described below. The IRB determined that no further action was needed.  
 
Adverse Event #2 
Date of event: 
12/2/2020 
Date PI became aware 
12/2/2020 
Nature of event 
Any breach of privacy or confidentiality, 
including lost or stolen confidential information. 
Detailed description of event 
On 12/2/2020, an appointment reminder via text 
message was sent to the appropriate party 
including the participant’s first name and 

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appointment time. However, due to a subsequent 
copy and paste error, an additional appointment 
reminder text was then sent to this same 
participant’s phone number with an incorrect first 
name and appointment time. 
 
 
Corrective action or change to the protocol, planned 
or already taken, to ensure that the Reportable 
Event is corrected and will not occur again. 
In order to avoid the possibility of this event 
occurring in the future, all future participant 
communication via text messaging will exclude 
first names in the greeting. 
 Before sending the reminder text, double-check 
that the appointment information in the text is 
correct and corresponds to the participant you are 
scheduling. 
Because this is a multisite study, this will be 
added to the protocol at both sites and 
implemented by all research assistants. 
 
Assessment of whether any subjects or others were 
placed at risk as a result of the Reportable Event, or 
suffered any physical, social, or psychological harm 
and (ii) any plan to address these consequences, and 
any other relevant information. 
(i)              We do not believe any subjects were 
placed at risk as a result of this event. 
Only a first name was disclosed. 
Additionally, because this was a baseline 
session reminder text message, there is no 
way of the participant knowing if said 
individual joined the study. 
(ii)            We do not plan to take any additional 
action other than correcting our text 
message protocol as laid out above in 
Section III, as we do not believe any 
subjects were placed at risk as a result of 
this event. 
 
 
 
Adverse Event #1 
Date of event: 
4/24/2020 
Date PI became aware 
4/24/2020 
Nature of event 
Any breach of privacy or confidentiality, 
including lost or stolen confidential information. 
Detailed description of event 
On April 24th a participant was mistakenly sent a 
baseline session reminder email that contained the 
first name of another participant. The error was in 
the greeting line of the email, “Hi [participant 
name]”. Only the first name of the participant was 
used. 
 
Corrective action or change to the protocol, planned 
or already taken, to ensure that the Reportable 
Event is corrected and will not occur again. 
The following text has been added to our study 
protocol for baseline session reminder emails. 
“Open the Zoom Invitation email template. 
Fill in the participant’s name in the greeting. 

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Copy and paste their individualized Zoom 
meeting information into the body of the email. 
Sign your name in the signature line of the email. 
 Before sending the reminder email, double-check 
that the information in the email is correct and 
corresponds to the participant you are 
scheduling.” 
Because this is a multisite study, this will be 
added to the protocol at both sites and 
implemented by all research assistants. 
 
Assessment of whether any subjects or others were 
placed at risk as a result of the Reportable Event, or 
suffered any physical, social, or psychological harm 
and (ii) any plan to address these consequences, and 
any other relevant information. 
(i)              We do not believe any subjects were 
placed at risk as a result of this event. 
Only a first name was disclosed. 
Additionally, because this was just a 
baseline session reminder email, there is 
no way of the participant knowing if said 
individual actually joined the study. 
(ii)            We do not plan to take any action, as 
we do not believe any subjects were 
placed at risk as a result of this event. 
 
 
12. REGULATORY CONSIDERATIONS 
 
12.1. Consent. Prior to COVID, participants consented to partake in the in-person baseline session via 
hardcopies of a consent form. The research assistant described the main points of the consent form 
verbally (as outlined in the Consent Script Checklist below) and the participant had an opportunity to read 
the consent form in its entirety before choosing to sign and date the form. Consent forms at both UH and 
Brown (see Appendix D) were kept in a secure location in the lab as well as scanned and saved to a 
secure folder in the respective PI’s network drive as a permanent record.  
 
Consent forms were altered slightly at both sites to accommodate a virtual format via Zoom baseline 
sessions post-COVID (see Appendix D). 
 
Consent Script Checklist (read verbally by research assistant both during in-person and virtual 
baseline session) 
    The consent form generally covers what to expect of the study and your rights as a participant 
    The purpose of the study is to compare health promotion activities for college students 
    Participation is voluntary, you may withdraw at any point without penalty 
    Participants are assigned to 1 of 3 possible conditions randomly 
    If asked to participate in an activity condition, the activity will take about 20-30 minutes 
    If asked to participate in an activity condition, interactions with the RA may be recorded to ensure 
that research assistants are following the appropriate procedures 
    Following the activity, there will be an additional 10-minute survey 
    This study has been approved by an overseeing Institutional Review Board 
    For completing today’s session they will receive a $25 amazon gift card code 
    Compensation for completing all parts of the study (Including follow-ups) will total $115 worth of 
amazon gift card codes 
    Do you have any questions about the study? 
 

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12.2. Research Material Obtained from Human Subjects.  
Participants will be the sole source of data for this study and all data will be obtained specifically and 
exclusively for research purposes. Data collection will take place during in-person or remote baseline 
sessions, and remotely via online follow-up surveys.  All collected data will be held confidential. Survey 
software Qualtrics ensures protection of information through its firewall systems and regular scans for 
vulnerabilities. The confidential system component design restricts access to outside parties and 
Qualtrics’ use of Transport Layer Security (TLS) encryption protects all transmitted data.    
 
12.3. Access to Individually Identifiable Information.  
All participants will be assigned a unique ID. These IDs will be used to identify all participants on all 
research materials, surveys, tracking forms, as well as the database. Participants’ names will never appear 
in any report resulting from the project. Separate from research records, an identifier key will be created 
that will link the participant ID to subject names and contact information, to facilitate follow-up with 
participants; contact information will have participant ID numbers but will not have any data. All data 
will be stored separately from identifying documents (e.g., participant tracking data base with names and 
phone numbers). Only the PIs and the research assistants will have access to project data until it is de-
identified. Electronic data will be secured and accessible only through password protected computers. We 
will adopt the following measures to safeguard the data and participant confidentiality:  
• 
All staff will be trained in procedures for maintaining confidentiality of participant information 
• 
Electronic data collection forms will be identified by a unique identification number linked to an 
identifier list;  
• 
The identifier key will be stored separately from the data collection forms and accessible by the 
only the research staff;  
• 
Data will be stored on our password-protected computers and backed up to a secure server. Access 
to this server is password protected and only known to the PIs and RAs and backed up daily. 
• 
We recommend that participants respond to follow-up surveys in a private location, and upon 
completion they close their browser to protect their privacy. 
• 
At the end of the study, all personally identifying information will be erased. The data may be 
posted online when research results are published but it will not contain any information that could 
identify an individual or their participation in this research study. 
 
12.4. Programming Technology and Web Security.  
Information submitted via web-based surveys at baseline and at the follow-up assessments will be stored 
in a secure server at Brown University.  The technology for transmitting and storing data includes 
Transport Layer Security (TLS) encryption (also known as HTTPS) and firewalls to protect the data and 
to prevent unauthorized access. We will download data from the Qualtrics website, and upload it to the 
secure Brown servers, at the end of each semester. When the study is over, we will ensure that the data 
are all removed from Qualtrics servers. 
The screening survey will be completed anonymously, and screening data are unlinked to contact 
information obtained in the scheduler, so that we will not know the identities of students who complete 
the screener. During the RCT, face-to-face contact with participants is limited to the baseline/intervention 
session; research staff will be trained to identify adverse events (defined below) and report the to the site-
specific contact. Similarly, any safety concerns raised by participants through study-related 
electronic/phone communications will be reported by research staff to the site-contacts, who will be 
prepared to provide referrals to their respective campus counseling centers. Finally, electronic surveys 
completed by participants will not be monitored at an individual basis, because of assurances that 

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19 
 
 
 
 
responses to questions will not be associated with names, but each will end with a list of counseling 
centers and alcohol and drug services, as well as the number for a 24-hour crisis hotline. 
All data will be stored electronically on the secure server at the Brown Center for Alcohol and Addiction 
Studies. A password will be required to access data that are stored electronically, and only personnel 
involved with the project will have access to the electronic data. 
 
12.5. Protocol Amendment History 
 
IRB submissions 
Project: CAA R01, Using Counter Attitudinal Advocacy to Change Drinking Behavior 
(R01AA025043) 
Year 1 start date: 9/15/18 
Year 2 start date: 7/1/19 
 
IRB Submissions 
Project: PROJECT RAVEN: Using Counter Attitudinal Advocacy to Change Drinking Behavior 
  
Brown # 1906002478 
  
  
  
Submission 
type 
  
 
Content 
Date 
submitted 
or revised 
Date 
approved 
Initial 
application 
Full application for RCT at Brown and UH; Brown IRB 
leads 
6/28/19 
  
Revisions 
requested by 
IRB 
Questions/Requests:  
§ 
The application is checked that you have completed 
GCP training, but I don't see that certification in CITI. 
If you completed GCP through another institution in the 
past 3 years, would you forward that certificate to me? 
If not, would you complete one of Brown's CITI GCP 
modules? 
§ 
In the Baseline Survey - Demographics, #18 
(Immigration Generation), what is the justification for 
asking about the immigration status of the participant 
and their parents? Although written in general terms, 
this question has the potential to cause discomfort or 
distress. 
§ 
The consent document with my comments and track-
changed recommended revisions is attached. Please 
accept the recommendations you like, address the 
question, and correct the document for any errors 
caused by the track changes.     
Application Revisions: 
§ 
Part III, #3 (Intervention) states that "the oral 
presentation component of the CAA activity serves (a) 
to make the statement public." Do you intend to make 
these presentations publicly available? If so, please 
confirm that all identifiable information will be 
redacted before release. 
8/12/2019 
  
8/21/19 

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§ 
Part III, #5 (Recruitment Methods) states that this study 
does not involve an intervention, but the study meets 
the definition of a clinical trial and involves a 
behavioral intervention. Would you update this section 
with the applicable information? 
§ 
Part V, #2 (Facilitating Understanding) states that only 
English-speaking participants will be enrolled. 
Considering this is a large clinical trial, what is the 
justification for excluding non-English speakers? 
§ 
The checked box in Part VII, #1D is not clear on 
whether the data meets Level 2 or Level 3 risk. Would 
you clarify this section? 
Recruitment and Communication Material Revisions: 
§ 
In all Brown and UH recruitment material, please 
remove all references to compensation in titles/headers 
and language throughout that may cause undue 
influence (for example, "Help advance" or "Help 
improve"), as this type of language is not allowable per 
the HRPP recruitment policy. 
§ 
In the CAAS Find A Study, please add "research," as it 
does not specify the recruitment is for a research study. 
§ 
In the Flyer Text, please remove any language 
throughout that may cause undue influence (for 
example, "advance" or "improve"), as this type of 
language is not allowable per the HRPP recruitment 
policy. 
§ 
In the Post on Facebook Class Pages, it says "(If from 
personal account...)." Will research staff recruit 
prospective participants from their personal Facebook 
accounts? If so, what is the rationale behind this, as 
opposed to creating a Project RAVEN Facebook page? 
§ 
In the Electronic Communications with Participants, 
please ensure the e-mails consistently specify the 
communication is for a "research" study. 
Amendment 1 
submitted by us § 
To establish an IAA with Houston using Brown as the 
IRB of Record 
8/12/2019 
 9/26/2019 
Amendment 2 
submitted by us § 
Changed one item on the screener survey 
§ 
Removed one sentence from consent 
9/27/2019; 
revision 
requested 
and 
resubmitted 
on 
10/25/19 
10/25/201
9 
Amendment 3 
submitted by us § 
Addition of remote procedures 
§ 
Remote/Online consent form 
3/13/2020; 
revision 
request & 
3/17/2020 

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§ 
Remote recruitment materials (revised appendix A) 
resubmitted 
on 
3/17/2020 
Amendment 4 
submitted by us § 
At all timepoints: Addition of COVID-specific 
measures, Perceived Stress Scale, study abroad 
intentions 
§ 
At 6-month timepoint: study recall, Attempted Control 
Scale 
§ 
At remote baseline: environmental description 
4/15/2020; 
revision 
request & 
resubmitted 
on 
5/15/2020 
 5/18/2020 
 
Revisions Requested: 
§ 
Addition of a risk assessment about the impact of 
COVID-19, as well as provide a list of relevant support 
resources (new Brown COVID policy) 
§ 
Will the addition of these questions to the surveys 
increase the time involved in the study? If so, do the 
consent documents and recruitment materials also need 
to be revised to reflect the added time involved in each 
study session? (Response: No) 
 
 
Reportable 
Event 1 
§ 
Event Description: On April 24th a participant was 
mistakenly sent a baseline session reminder email that 
contained the first name of another participant. The 
error was in the greeting line of the email, “Hi 
[participant name]”. Only the first name of the 
participant was used. 
4/28/2020 
5/5/2020 
Amendment 5 
submitted by us § 
Updated screener survey 
§ 
Updated recruitment materials (new Recruitment email 
and text reminders added at Houston site for 
participants who have been determined eligible via the 
screening survey but have not yet scheduled an 
appointment  
§ 
Addition of a brief consent form to the screener survey 
(Houston site; Version 1, 8/20/20) 
§ 
Include additional items to all surveys in order to 
measure the impact of COVID on participants (BIDR at 
baseline, WHO and Conway COVID items in post-
intervention and 3 follow-up surveys) 
§ 
Addition of the Balanced Inventory of Desirable 
Responding Short Form to baseline surveys 
§ 
Updated Mental Health Safety Plan and participant 
resource list. 
8/27/2020 
9/24/2020 
Revisions 
requested by 
IRB 
§ 
Requested addition of protocol # (1906002478) and 
PI’s names or other contacts to all recruitment materials  
9/10/2020 
9/24/2020 

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§ 
Requested to remove “Paid” from subject line of UH 
Recruitment and that Reminder Emails will include in 
the email text that Brown is a research partner in the 
study and that it was “approved by the Brown 
University IRB”  
§ 
Requested to remove emphasis on compensation line 
“Earn $115” in flyers for Brown  
§ 
Requested copies of parallel version of recruitment 
materials (e.g., flyers) for UH (in lieu of this request, 
study team decision was made to remove flyers as 
recruitment materials for UH)  
§ 
Recommended: two updated scheduling templates have 
been provided, which remove the location and provide 
a link to the Zoom call  
§ 
Requested submission of screenshots of what scheduler 
page looks like to participants  
§ 
In 12B ineligible text, IRB requested we add that 
participants may remove their information from the 
student database at any time by contacting [provide 
contact info]  
§ 
Recommended: confirm whether the added “How 
would you best describe your situation this semester” 
question will also be administered to UH students 
(answer: yes. Study team decision was made that UH 
students doing either remote or in-person instruction are 
eligible, while only Brown students doing in-person 
instruction will be eligible)  
§ 
Recommended: clarify if Question 11 (“Have you been 
in a study involving…”) only applies to Brown 
students? (clarification: yes, the question is asked in 
UH surveys just with no study examples)  
§ 
Requested an updated Mental Health Safety Plan  
§ 
Personal Impact of COVID-19 and WHO Survey Tool 
are now added to the mental health safety plan)  
§ 
The statement “These assessments will not be 
reviewed immediately. Everyone participating in this 
research study will receive a list of contacts if they 
want to speak to someone about any health concerns or 
abuse” is now added on the first and last assessments.  
Reportable 
event 2 
§ 
On 12/2/2020, an appointment reminder via text 
message was sent to the appropriate party including the 
participant’s first name and appointment time. 
However, due to a subsequent copy and paste error, an 
additional appointment reminder text was then sent to 
this same participant’s phone number with an incorrect 
first name and appointment time. 
12/2/2020 
12/9/2020 
Amendment 6 
submitted by us 
§ 
Sharing deidentified data between Brown and 
University of Houston using a secure DropBox folder 
shared only with study personnel directly involved with 
12/18/2020 
1/14/2021 

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the project (principal investigators and the project 
manager at each site) 
§ 
Addition of Edward James as a research assistant 
Revisions 
requested by 
IRB 
§ 
Proof of investigator CITI training and request that Dr. 
Neighbors be added as a COI (Appendix G was sent to 
display that he was included on the original submission) 
 
 
Amendment 7 
submitted by us 
§ Addition of a question to all assessments time points 
(baseline, 1-, 3-, and 6-month follow ups) asking about 
COVID vaccination status 
§ Addition of alternate recruitment announcements and 
language at the Brown site only. 
2/18/2021 
3/02/2021 
Amendment 8 
submitted by us 
§ addition of alternate recruitment announcements to 
recruit more male participants at the Brown site 
§ Corresponding update to Recruitment Materials (pp. 2-
3), which include edits to Today@Brown subject lines 
§ Use of Microsoft OneDrive to store deidentified study 
data at the Houston site 
4/23/2021 
5/6/2021 
Administrative 
Acceptance 1 
submitted by us 
§ Request for the substitution of a new contact person at 
the Brown and Houston sites in the Consent form 
§ Corresponding change in Online Recruitment Materials 
at the Brown site 
8/11/2021 
8/19/2021 
Amendment 9 
submitted by us 
§ Revised procedures to remove Microsoft TEAMS for 
remote participation 
§ Corresponding revised HRPP Consent Form for the 
Houston site 
8/26/2021 
9/2/2021 
Reportable 
Event NOT 
submitted by us 
§ Event description: On 09/20/2021 a participant at our 
Houston site expressed feeling distressed after 
completing baseline questionnaires. This participant 
explained that the questions made her realize how poor 
her current mental health was and gave specific 
examples of current (and recent) stressors. The 
participant did not endorse the intent or impulse to self-
harm, and noted that she is under the current care of a 
Psychiatrist, with whom she has an appointment this 
week. The participant was given a NAMI resource guide 
as well as a campus-specific mental health resources list 
at the conclusion of the session. 
§ This Event was deemed not an unanticipated adverse 
event by Brown IRB, and the PIs decided not to pursue 
this issue further. 
9/20/2021 
 
Administrative 
Acceptance 2 
§ Request to change the University of Houston designee at 
the Houston site on our Data and Safety Monitoring 
Board Plan who will take responsibility for 
distinguishing serious adverse events from non-serious 
adverse events. 
9/27/2021 
9/29/2021 
Protocol closed 
Submitted closure form to Brown IRB 
4/26/2023 
4/27/2023 
 
 
 

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13. REFERENCES 
Atkins, D. C., Baldwin, S., Zheng, C., Gallop, R. J., & Neighbors, C. (2013). A tutorial on count 
regression and zero-altered count models for longitudinal substance use data. Psychology of Addictive 
Behaviors, 27, 166-177.  
Baer, J. S. (1993). Etiology and secondary prevention of alcohol problems with young adults. In J. S. 
Baer, G. A. Marlatt & R. J. McMahon (Eds.), Addictive behaviors across the life span: Prevention, 
treatment, and policy issues (Vol. ix, pp. 111-137). Thousand Oaks, CA: US: Sage Publications, Inc. 
Bem, D. J. (1967). Self-perception: An alternative interpretation of cognitive dissonance phenomena. 
Psychological Review, 74(3), 183-200.  
Carey, K. B., Scott-Sheldon, L. A., Carey, M. P., & DeMartini, K. S. (2007). Individual-level 
interventions to reduce college student drinking: A meta-analytic review. Addictive Behaviors, 
32(11), 2469-2494. doi: 10.1016/j.addbeh.2007.05.004 
Carey, K. B., Scott-Sheldon, L. A., Elliott, J. C., Bolles, J. R., & Carey, M. P. (2009). Computer-delivered 
interventions to reduce college student drinking: a meta-analysis. Addiction, 104(11), 1807-1819. doi: 
ADD2691 [pii]10.1111/j.1360-0443.2009.02691.x 
Cialdini, R. B., Trost, M. R., & Newsom, J. T. (1995). Preference for Consistency - the Development of a 
Valid Measure and the Discovery of Surprising Behavioral-Implications. Journal of Personality and 
Social Psychology, 69(2), 318-328. doi: Doi 10.1037/0022-3514.69.2.318 
Collins, R. L., Parks, G. A., & Marlatt, G. A. (1985). Social determinants of alcohol consumption: The 
effects of social interaction and model status on the self administration of alcohol. Journal of 
Consulting and Clinical Psychology, 53, 189-200.  
Collins, S. E., & Carey, K. B. (2007). The theory of planned behavior as a model of heavy episodic 
drinking among college students. Psychology of Addictive Behaviors, 21(4), 498-507. doi: Doi 
10.1037/0893-164x.21.4.498 
Devine, P. G., Tauer, J. M., Barron, K. E., Elliot, A. J., & Vance, K. M. (1999). Moving beyond attitude 
change in the study of dissonance-related processes. In E. Harmon-Jones & J. Mills (Eds.), Cognitive 
dissonance: Progress on a pivotal theory in social psychology (pp. 297-323). Washington, D.C.: 
American Psychological Association. 
DiBello, A. M., Miller, M. B., Neighbors, C., Reid, A., & Carey, K. B. (2018). The relative strength of 
attitudes versus perceived drinking norms as predictors of alcohol use. Addictive behaviors, 80, 39-
46. 
Dotson, K. B., Dunn, M. E., & Bowers, C. A. (2015). Stand-alone personalized normative feedback for 
college student drinkers: a meta-analytic review, 2004 to 2014. PloS one, 10(10), e0139518. 
Elliot, A. J., & Devine, P. G. (1994). On the Motivational Nature of Cognitive-Dissonance - Dissonance 
as Psychological Discomfort. Journal of Personality and Social Psychology, 67(3), 382-394. doi: Doi 
10.1037//0022-3514.67.3.382. 
Fox, J. (2008). Applied regression analysis and generalized linear models: Sage Publications. 
Hagger, M. S., Lonsdale, A., Koka, A., Hein, V., Pasi, H., Lintunen, T., & Chatzisarantis, N. L. D. 
(2012). An intervention to reduce alcohol consumption in undergraduate students using 
implementation intentions and mental simulations: A cross-national study. International Journal of 
Behavioral Medicine, 19(1), 82-96.  
Hedeker, D., & Gibbons, R. D. (2006). Longitudinal data analysis. Hoboken, NJ: John Wiley & Sons. 
Higgins, E. T. (1987). Self-discrepancy: a theory relating self and affect. Psychological Review, 94(3), 
319-340.  
Huchting, K., Lac, A., & LaBrie, J. W. (2008). An application of the Theory of Planned Behavior to 
sorority alcohol consumption. Addictive Behaviors, 33(4), 538-551. doi: 
10.1016/j.addbeh.2007.11.002 

Using Counter Attitudinal Advocacy to Change Drinking Behavior 
APRIL 2023-FINAL 
 
25 
 
 
 
 
Johnson, L. D., O'Malley, P. M., Bachman, J. G., & Schulenberg, J. E. (2012). Monitoring the Future 
national survey results on drug use, 1975-2011. (Vol. II, pp. 314). . Ann Arbor, MI: Institute for 
Social Research, The University of Michigan. 
Kim, S. Y., Allen, M., Preiss, R. W., & Peterson, B. (2014). Meta-Analysis of Counterattitudinal 
Advocacy Data: Evidence for an Additive Cues Model. Communication Quaterly, 52(5), 607-620.  
Kivlahan, D. R., Marlatt, G. A., Fromme, K., Coppel, D. B., & Williams, E. (1990). Secondary 
prevention with college drinkers: Evaluation of an alcohol skills training program. Journal of 
Consulting and Clinical Psychology, 58(6), 805-810.  
Krieger, H., Neighbors, C., Lewis, M. A., LaBrie, J. W., Foster, D. W., & Larimer, M. E. (2016). 
Injunctive norms and alcohol consumption: a revised conceptualization. Alcoholism: Clinical and 
Experimental Research, 40(5), 1083-1092. 
Lewis, M. A., & Neighbors, C. (2007). Optimizing Personalized Normative Feedback: The Use of 
Gender-Specific Referents. Journal of studies on alcohol and drugs, 68(2), 228-237. 
doi:10.15288/jsad.2007.68.228 
MacKinnon, D. P., Fairchild, A. J., & Fritz, M. S. (2007). Mediation analysis. Annual Review of 
Psychology, 58, 593-614. doi: 10.1146/annurev.psych.58.110405.085542 
Marlatt, G. A., Baer, J. S., & Larimer, M. (1995). Preventing alcohol abuse in college students: A harm-
reduction approach. In G. M. Boyd, J. Howard & R. A. Zucker (Eds.), Alcohol Problems Among 
Adolescents: Current Directions in Prevention Research (pp. 147-172). Northvale, NJ: Lawrence 
Erlbaum. 
Martens, M. P., Pedersen, E. R., LaBrie, J. W., Ferrier, A. G., & Cimini, M. D. (2007). Measuring 
alcohol-related protective behavioral strategies among college students: further examination of the 
Protective Behavioral Strategies Scale. Psychology of Addictive Behaviors, 21(3), 307 
Montano, D. E., & Kasprzyk, D. (2008). Theory of reasoned action, theory of planned behavior, and the 
integrated behavioral model. In K. Glanz, B. K. Rimer & K. Viswanath (Eds.), Health behavior and 
health education (4 ed., pp. 67-96). San Francisco. 
Neighbors, C., Dillard, A. J., Lewis, M. A., Bergstrom, R. L., & Neil, T. A. (2006). Normative 
misperceptions and temporal precedence of perceived norms and drinking. Journal of studies on 
alcohol, 67(2), 290-299. 
Neighbors, C., Larimer, M. E., & Lewis, M. A. (2004). Targeting misperceptions of descriptive drinking 
norms: efficacy of a computer-delivered personalized normative feedback intervention. Journal of 
Consulting and Clinical Psychology, 72(3), 434-447. doi: 10.1037/0022-006X.72.3.434 
Norman, P. (2011). The theory of planned behavior and binge drinking among undergraduate students: 
Assessing the impact of habit strength. Addictive Behaviors, 36(5), 502-507.  
Pearson, M. R. (2013). Use of alcohol protective behavioral strategies among college students: A critical 
review. Clinical Psychology Review, 33(8), 1025-1040.  
Prince, M. A., Carey, K. B., & Maisto, S. A. (2013). Protective behavioral strategies for reducing alcohol 
involvement: A review of the methodological issues. Addictive Behaviors, 38(7), 2343-2351. doi: 
10.1016/j.addbeh.2013.03.010 
Prince, M. A., Maisto, S. A., Rice, S. L., & Carey, K. B. (2015). Development of a face-to-face injunctive 
norms brief motivational intervention for college drinkers and preliminary outcomes. Psychology of 
addictive behaviors, 29(4), 825. 
Read, J. P., Kahler, C. W., Strong, D. R., & Colder, C. R. (2006). Development and preliminary 
validation of the young adult alcohol consequences questionnaire. Journal of studies on 
alcohol, 67(1), 169-177. 
Reid, A. E., & Carey, K. B. (2015). Interventions to reduce college student drinking: State of the evidence 
for mechanisms of behavior change. Clinical Psychology Review, 40, 213-224. doi: 
10.1016/j.cpr.2015.06.006 
Samson, J. E., & Tanner-Smith, E. E. (2015). Single-Session Alcohol Interventions for Heavy Drinking 
College Students: A Systematic Review and Meta-Analysis. J Stud Alcohol Drugs, 76(4), 530-543.  

Using Counter Attitudinal Advocacy to Change Drinking Behavior 
APRIL 2023-FINAL 
 
26 
 
 
 
 
Schumi, J., & Wittes, J. T. (2011). Through the looking glass: understanding non-
inferiority. Trials, 12(1), 106. 
Scott-Sheldon, L. A., Carey, K. B., Elliott, J. C., Garey, L., & Carey, M. P. (2014). Efficacy of alcohol 
interventions for first-year college students: a meta-analytic review of randomized controlled trials. 
Journal of Consulting and Clinical Psychology, 82(2), 177-188. doi: 10.1037/a0035192 
Shadel, W. G., & Mermelstein, R. (1996). Individual differences in self-concept among smokers 
attempting to quit: Validation and predictive utility of measures of the smoker self-concept and 
abstainer self-concept. Annals of Behavioral Medicine, 18(3), 151-156. doi: Doi 10.1007/Bf02883391 
Simmons, V. N., & Brandon, T. H. (2007). Secondary smoking prevention in a university setting: a 
randomized comparison of an experiential, theory-based intervention and a standard didactic 
intervention for increasing cessation motivation. Health Psychology, 26(3), 268-277. doi: 
10.1037/0278-6133.26.3.268 
Simmons, V. N., Heckman, B. W., Fink, A. C., Small, B. J., & Brandon, T. H. (2013). Efficacy of an 
experiential, dissonance-based smoking intervention for college students delivered via the internet. 
Journal of Consulting and Clinical Psychology, 81(5), 810-820. doi: 10.1037/a0032952 
Simmons, V. N., Webb, M. S., & Brandon, T. H. (2004). College-student smoking: an initial test of an 
experiential dissonance-enhancing intervention. Addictive Behaviors, 29(6), 1129-1136. doi: 
10.1016/j.addbeh.2004.03.005 
Stacy, A. W., Bentler, P. M., & Flay, B. R. (1994). Attitudes and Health Behavior in Diverse Populations 
- Drunk Driving, Alcohol-Use, Binge-Eating, Marijuana Use, and Cigarette Use. Health Psychology, 
13(1), 73-85. doi: Doi 10.1037/0278-6133.13.1.73 
Sugarman, D. E., & Carey, K. B. (2007). The relationship between drinking control strategies and college 
student alcohol use. Psychology of Addictive Behaviors, 21(3), 338-345.  
USDHHS Food and Drug Administration (2016). Non-inferiority clinical trials to establish effectiveness: 
Guidance for industry 
Wechsler, H., & Nelson, T. F. (2001). Binge drinking and the American college student: What’s five 
drinks? Psychology of Addictive Behaviors.  
White, A., & Hingson, R. (2014). New research findings since the 2007 Surgeon General's Call to Action 
to Prevent and Reduce Underage Drinking: a review. J Stud Alcohol Drugs, 75(1), 158-169.  
White, H. R., Labouvie, E. W., & Papadaratsakis, V. (2005). Changes in substance use during the 
transition to adulthood a comparison of college students and their noncollege age peers. Journal of 
Drug Issues, 35(2), 281-305.  
Young, C. M., Rodriguez, L. M., & Neighbors, C. (2013). Expressive writing as a brief intervention for 
reducing drinking intentions. Addictive Behaviors, 38(12), 2913-2917. doi: 
10.1016/j.addbeh.2013.08.025 
 

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APPENDIX A. Recruitment Materials and Participant Communications at both sites (pre-COVID) 
UH Registrar Recruitment Email + Follow up emails 
1. UH Recruitment Email: 
Subject line: Paid Online Heath Behaviors Study at UH 
Dear <<student name>>, 
The Psychology Department on campus is inviting University of Houston students to participate in a confidential, multi-
part research study called “RAVEN” that examines campus health beliefs and behaviors.  
Please take a brief, 3-minute online survey to see if you qualify for a study that could earn you up to $115 in Amazon gift 
cards.  
Please visit <<SURVEY LINK>> to complete this mobile-friendly survey.   
Participation is voluntary and your answers will be kept confidential.  
For any related questions or concerns, please contact Dr. Clayton Neighbors at 713-743-3301 or by emailing 
raven@central.uh.edu. 
This study was approved by the Institutional Review Board. 
Thank you!  
Clayton Neighbors, Ph.D. & the UH Project RAVEN Team, 
*We cannot guarantee the confidentiality of email communication. 
 
2. UH Reminder Screening Emails  
Subject Line: REMINDER: Paid Online Heath Behaviors Study at UH 
Dear <<student name>>, 
Greetings from Project RAVEN! We recently invited you to participate in Project RAVEN, a confidential, multi-part 
research study being conducted through the Psychology Department on campus that examines campus health beliefs and 
behaviors. This is just a reminder to let you know that there is still time to participate in our survey!  
Please take our brief, mobile-friendly, online survey to see if you qualify for a study that could earn you up to $115 in 
Amazon gift cards. 
 
<<SURVEY LINK>> 
Participation is voluntary and your answers will be kept confidential.  

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For any related questions or concerns, please contact Dr. Clayton Neighbors at 713-743-3301 or by emailing 
raven@central.uh.edu. 
This study was approved by the Institutional Review Board. 
Thank you, 
Clayton Neighbors, Ph.D. & the UH Project RAVEN Team 
*We cannot guarantee the confidentiality of email communication. 
 
3. UH Confirmation of Registration Email 
Subject Line: Project RAVEN Appointment Confirmation 
Greetings from the Project RAVEN team, 
Thank you for taking part in our study! You are scheduled for an in-lab session on <<TIME/DATE>> in the Fred J. 
Heyne Building (H), Room 208. Please contact our office at 713-743-3301 if you have questions. We look forward to 
seeing you. 
Thank you, 
Clayton Neighbors Ph.D. & the UH Project RAVEN team 
*We cannot guarantee the confidentiality of email communication. 
 
Electronic Communications with Participants (Brown) 
Drafts of electronic communications with participants. 
All study emails will come from the ProjectRAVEN@brown.edu or RAVEN@central.uh.edu email addresses issued to 
this project. The following templates were developed for use at Brown and will be adapted for use at UH. 
 
4. Brown Project RAVEN Baseline Email 1: 
Subject Line: Project RAVEN Study Appointment 
Dear Student, 
Thank you for your interest in the Project RAVEN research study! Your on-campus appointment is scheduled for DATE 
@ TIME in LOCATION. This appointment should take about 75-90 minutes, and your $25 Amazon e-gift card will be 
emailed to you upon completion of the appointment. Please remember to bring your student ID. If you have any questions, 
please feel free to email us at ProjectRAVEN@brown.edu. We look forward to meeting you! 

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Best, 
Study Staff: Melissa Hatch, BA 
Project RAVEN Study 
 
5. Brown Project RAVEN Baseline Email 2 (Reminder): 
Subject Line: REMINDER: Project RAVEN Study Appointment 
Dear Student, 
As a reminder, your research study appointment is tomorrow DATE @ TIME in LOCATION. This appointment should 
take about 75-90 minutes, and your $25 Amazon e-gift card will be emailed to you upon completion of the appointment. 
Please remember to bring your student ID and check in at the front desk in the lobby (if in the School of Public Health 
location). If you have any questions, please feel free to email us at ProjectRAVEN@brown.edu. We look forward to 
meeting you tomorrow! 
Best, 
Study Staff: Melissa Hatch, BA 
Project RAVEN Study 
 
 
 
 

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 APPENDIX B. Recruitment Materials and Participant Communications at both sites (post-COVID) 
UH Registrar Recruitment Email + Follow up emails 
1. UH Recruitment Email: 
Subject line: Paid Online Heath Behaviors Study at UH 
Dear <<student name>>, 
The Psychology Department on campus is inviting University of Houston students to participate in a confidential, 
multi-part research study called “RAVEN” that examines campus health beliefs and behaviors. This study can be 
completed remotely and is entirely online! 
Please take a brief, 3-minute online survey to see if you qualify for a study that could earn you up to $115 in 
Amazon gift cards.  
 
Please visit <<SURVEY LINK>> to complete this mobile-friendly survey.   
Participation is voluntary and your answers will be kept confidential.  
For any related questions or concerns, please contact Dr. Clayton Neighbors at 713-743-3301 or by emailing 
raven@central.uh.edu. 
This study was approved by the Institutional Review Board. 
Thank you!  
Clayton Neighbors, Ph.D. & the UH Project RAVEN Team, 
 
*WE CANNOT GUARANTEE THE CONFIDENTIALITY OF EMAIL COMMUNICATION. 
 
2. UH Reminder Screening Emails  
Subject Line: REMINDER: Paid Online Heath Behaviors Study at UH 
Dear <<student name>>, 
Greetings from Project RAVEN! We recently invited you to participate in Project RAVEN, a confidential, multi-
part research study being conducted through the Psychology Department on campus that examines campus health 
beliefs and behaviors. This is just a reminder to let you know that there is still time to participate in our survey!  
Please take our brief, mobile-friendly, online survey to see if you qualify for a study that could earn you up to 
$115 in Amazon gift cards. 
 
<<SURVEY LINK>> 
Participation is voluntary and your answers will be kept confidential.  
For any related questions or concerns, please contact Dr. Clayton Neighbors at 713-743-3301 or by emailing 
raven@central.uh.edu. 
This study was approved by the Institutional Review Board. 
Thank you, 

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31 
 
Clayton Neighbors, Ph.D. & the UH Project RAVEN Team 
  
*We cannot guarantee the confidentiality of email communication. 
 
3. UH Confirmation of Registration Email 
Subject Line: Project RAVEN Appointment Confirmation 
Greetings from the Project RAVEN team, 
Thank you for taking part in our study! You are scheduled for an online session on <<TIME/DATE>> . Please 
contact our office at 713-743-3301 if you have questions. We look forward to seeing you. 
Thank you, 
Clayton Neighbors Ph.D. & the UH Project RAVEN team 
*We cannot guarantee the confidentiality of email communication. 
 
 
4. Brown Electronic Communications with Participants 
Drafts of electronic communications with participants. 
All study emails will come from the ProjectRAVEN@brown.edu or RAVEN@central.uh.edu email addresses 
issued to this project. The following templates were developed for use at Brown and will be adapted for use at 
UH. 
 
5. Brown Project RAVEN Baseline Email 1: 
Subject Line: Project RAVEN Study Appointment 
Dear Student, 
Thank you for your interest in the Project RAVEN research study! Your Zoom appointment is scheduled for 
DATE @ TIME in LOCATION. This appointment should take about 75-90 minutes, and your $25 Amazon e-
gift card will be emailed to you upon completion of the appointment. Please remember you will need access to a 
computer with Zoom, a video camera and a quiet space for 90 minutes. Please have your student ID to display. 
If you have any questions, please feel free to email us at ProjectRAVEN@brown.edu. We look forward to 
meeting you! 
Best, 
Study Staff: Melissa Hatch, BA 
Project RAVEN Study 
 
6. Brown Project RAVEN Baseline Email 2 (Reminder): 
Subject Line: REMINDER: Project RAVEN Study Appointment 
Dear Student, 
As a reminder, your Zoom research study appointment is tomorrow at DATE @ TIME. This appointment 
should take about 75-90 minutes, and your $25 Amazon e-gift card will be emailed to you upon completion of 
the appointment Please remember you will need access to a computer with Zoom, a video camera and a quiet 
space for 90 minutes. Please have your student ID to display. If you). If you have any questions, please feel free 
to email us at ProjectRAVEN@brown.edu. We look forward to meeting you tomorrow! 
Best, 
Study Staff: Melissa Hatch, BA 
Project RAVEN Study 

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32 
 
 
 
7. Brown Email for participants who do not show up for scheduled baseline session: 
Subject Line: Reschedule Project RAVEN Appointment 
Dear Student, 
We missed you today and are sorry you couldn’t make your scheduled Project RAVEN Zoom session. We hope 
you are still interested in participating! If so, please visit <scheduling link> to re-schedule your research 
appointment at a time that works better for you. We would still love the opportunity to get your input on these 
health promotion programs!  
If you no longer wish to participate, we understand, but please reply to this email in order to let us know, and 
we will remove you from our list. 
Best, 
Study Staff: Melissa Hatch, BA 
Project RAVEN Study 
 
 
 
 

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APPENDIX C. Intervention scripts (PNF & CAA)  
 
Remote (Zoom) Baseline Sessions Post-COVID Scripts 
 
Remote Baseline Session Protocol 
This protocol is to be used in the circumstance that a participant cannot come into the lab for an in-person 
baseline session. 
Pre-Baseline 
a.     When a participant schedules a session, create a Zoom meeting using the information in the confirmation 
email. 
                                               i.     Log into The UH Project RAVEN Zoom account 
                                             ii.     Click “meetings” tab on the left, then “Schedule a new meeting” 
                                            iii.     Topic: “Project RAVEN Research Session” 
                                            iv.     Description: “This appointment should take about 60-90 minutes, and your $25 Amazon e-
gift card will be emailed to you upon completion of the appointment. Please note that to 
participate in this study remotely you will need internet access, a computer with 
videoconferencing capabilities and a quiet, private space for 1.5 hours where you feel 
comfortable discussing your health behaviors with a research assistant. If you do not have 
access to these resources, please contact us and we will discuss scheduling an in-person 
session when classes resume in the fall.” 
                                             v.     When: Enter date and time selected on Setmore 
                                            vi.     Duration: 1hr 30 min 
                                          vii.     Meeting ID: Generate Automatically 
                                         viii.     Meeting Password: Check “Require meeting password” and enter their participant ID 
                                            ix.     Video: Host: on; Participant on 
                                             x.     Audio: Telephone and computer audio 
                                            xi.     Meeting Options: Enable join before host 
                                          xii.     Save 
b.     Email the participant the Zoom Invitation email template. Include their individualized Zoom link. 
c.     10 minutes prior to their scheduled time, email the participant the Zoom Reminder email template (see 
below) which should include their individualized zoom link and a link to the Qualtrics baseline survey 
 
 
  
Orientation to Session and Consent 
1. Begin the Zoom meeting and confirm that you and the participant can see and hear each other 
2.     Ask the participant about their environment. “Okay, before we begin our session, I need to make sure you’re 
in an appropriate environment for our call. Could you tell me where you are?” “Okay, is this somewhere 
private where you feel comfortable discussing your health behaviors with me?” 
3.     Record the participant’s responses in the tracking excel sheet. If the participant is in a public location or a 
location with too many distractions, ask that they reschedule their appointment for another time when they 
can arrange for a more private space. 
a.     Instruct them to open the survey link included in their confirmation email. 

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                                               i.     What the participant sees: 
1.     Instruct the participant to enter the password 1540 and then click the blue arrow. Ask them to follow along 
on their screen as you outline the main points from the Consent Form: 
- This consent form describes your rights as a participant and what participation in this study entails 
- The purpose of this study is to compare health promotion activities for college students 
- Participants in this study are asked to answer several questionnaires and then are randomly assigned to 1 of 3 
conditions, two of which entail brief activities 
- If you are asked to participate in an activity condition today, the activity will take about 20-30 minutes and 
will be recorded to ensure that I am following the appropriate study procedures 
- This study has been approved by Brown University’s Institutional Review Board 
- Your participation is voluntary, you may withdraw at any point without penalty 
- For completing today’s session you will receive a $25 amazon gift card code via email 
- If you complete all parts of the study (Including the follow-up questionnaires) you will receive a total of $115 
in amazon credit 
- Do you have any questions about the study? 
2.     Once all questions are answered, ask that the participant click “agree” to certify that they understand and 
agree to participate in the study then 
3.     Ask them to click the next arrow 
                                               i.     What the participant sees: 
 
 

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1.     “We’ll get you started by filling out a set of questionnaires that’ll take about 30-45 minutes. Let’s turn off 
our cameras while you respond to the survey, but I’ll remain on the call to answer any questions you have. 
When you reach the end of the survey, let me know and we can go over the next part of the study” 
2.     Ask them to click the blue arrow and enter their Participant ID (with an 9 representing a remote participant 
(e.g., 91040) and select RA Identifier [1 = PNF, 2 = CAA, 3 = Control; based on condition] 
                                               i.     What the participant sees: 
 
 
 
1.     Turn off your camera and have the participant do the same if they like, but leave the Zoom call on in the 
background while the participant answers baseline in case they have any questions. 
2.     When the participant informs you that they have completed their session, proceed based on condition: 
 
 
  
CAA Condition 
1.     When the participant reaches the end of the baseline survey and the password page appears, say “Okay, let’s 
turn our cameras back on and I’ll explain the next part of the study”. 
                                               i.     What the participant sees: 

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1.     Explain the CAA activity to the participant: 
- Thank them for completing survey, "now we will ask you to do a brief writing activity that reflects student 
perspectives on campus health and safety issues" 
       - Choose one of three topics 
       - At least 15 minutes to write 
 
       - Instruct them to type “raven” into the textbox and click the blue arrow. 
 
 
- I’m going to turn the camera off. Let me know when you're finished writing & we'll discuss it to make sure I 
understand what you've written” 
2. Turn the camera off while the participant does the writing activity 
3. When the participant tells you that they have completed the writing activity, 
“Okay, let’s turn our cameras back on so that we can discuss what you wrote. What do you see on your screen?”      
4.  If they are not on the password page yet, instruct them to click the blue arrow to proceed. Next ask them to 
type “houston” in the RA Identifier box and click next. 
                                               i.     
What the participant sees: 
 

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37 
 
  
5. Remind the participants “I am going to record our discussion to confirm that I am doing my job” 
6. Turn recorder on and set it on the desk near the speaker 
       - “So which topic did you select?” (TOPIC is piped in at the top of the page) 
       - "Okay, what more specifically were you asked to write about?" 
- “So it sounds like the prompt had multiple parts, could you tell me what you wrote about the first one?” 
       - “So it sounds like a good reason to avoid problems is…” 
-“Okay, were you asked to write about anything else?” then, “Okay, and what did you say were some ways 
students could do that?” 
- "Thanks. So, if I follow correctly, your advice to other students would be to… [two personally relevant, 
effective and feasible strategies]. Do I have that right?” 
- “Great! Now you’ll be given the chance to edit or add to what you wrote and then there are a few more 
questions for you to answer before we conclude today’s session. Just let me know when you complete the 
survey and I’ll turn the camera back on to discuss your compensation.” 
What the participant sees: 
 
 
6. Turn the recorder and your camera off while the participant answers the follow-up survey 

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38 
 
 
 
  
PNF Condition 
1.     When the participant reaches the end of the baseline survey and the password page appears, turn the camera 
back on and ask that the participant do the same. Explain the PNF activity to the participant 
                                               i.         
What the participant sees: 
 
 
  
2.     Let them know you will be screen sharing so that you can discuss the feedback together 
3.     Instruct them to type “raven” in the RA Identifier box and that another tab will open, but not to proceed 
while you set up the presentation. 
4.     Open the baseline completion email and click on the link to open the PNF in a new window (it default opens 
in a new tab). Move this tab to a new window, Share your screen with the participant, then make the 
presentation full screen. *Note that if you need to refer to the script/protocol you should have a pre-printed 
version* Confirm they can see your screen and the graph clearly. 
5.     Remind the participant “I am going to record our discussion to confirm that I am doing my job“ 
6.     Walk the participant through the PNF activity as you would in person. At the end of each slide, ask the 
participant what questions/thoughts they have and ask them to let you know when they are ready to proceed. 
“Im going to give you a minute to look over this graph” PAUSE “What questions do you have/does this 
make sense/thoughts?” 
7.     Once you finish the PNF activity, inform the participant that they will now have the opportunity to click 
through the PNF on their own screen and then continue on to finish a few more questions. End the 
screenshare and turn your camera off. 
8.     Ask them to let you know when they complete the survey and you’ll turn the camera back on to discuss their 
compensation. 
9.     While the participant finishes viewing the PNF and completes the post-intervention survey: Save their PNF 
slides as PDFs and combine the files into one. Do this by right clicking each PNF page and selecting 
“Print”, then “Save as PDF”. Save as “RAVEN Feedback_ID_page#” on the server. 

Using Counter Attitudinal Advocacy to Change Drinking Behavior 
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39 
 
10.  Once saved, merge the three PNF PDF pages together in Adobe and add the composite file to the debrief 
email to send the participant upon completion. 
 
 
Control Condition 
1. When the participant reaches the end of the baseline survey and the password page appears, turn the camera 
back on and explain that there are just a few more questions for them to answer. Ask them to type “raven” in the 
RA Identifier box to proceed. Tell them to let you know when they complete the survey and you’ll turn the 
camera back on to discuss their compensation. 
i. What the participant sees: 
After finishing the questionnaire 
 
 
 
Debrief 
1.      Ask the participant to click the blue arrow and ensure that their screen reads “We thank you for your time 
spent taking this survey. Your response has been recorded.” 
i. What the participant sees: 
 
 

Using Counter Attitudinal Advocacy to Change Drinking Behavior 
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40 
 
 
1.     Verbally confirm their preferred email address 
“You will be contacted in around 1-,3- and 6-months from now to complete follow-up surveys, for which you 
will receive $25, $30 & $35 to Amazon, respectively, for completing. These surveys are much shorter than the 
one you completed today and should take less than 20 minutes. Do you have any questions about the study?” 
2.     Tell them that you will email them a resource list now that we give to all participants along with our contact 
information in case they have any questions about the study 
3.     Thank them for participating in the study and close out the Zoom call 
4.     Email the participant the debrief email template, the resource list and the PNF PDF if applicable. Bcc the 
other RA on this communication, as a back up record in case the tracking document glitches. 
5.     Fill out the “Appt. Notes” column, if applicable (i.e. notable remarks, demeanor, late arrival, suggestions. 
Record any questions the participant asked and how you responded here, as well as in “Participant Question 
List and CAA Notes” on the DropBox) 
6.     Upload and save the recording on the server here: (‘Z:\Project Raven\audio files’ on the NeighborsLab$ 
drive) with the ID, Condition, your initial and the date recorded (e.g. 1000_CAA_AW_11.13.2019) 
 

 
41 
 
APPENDIX D. Consent Forms 
 
 
In-person consent form pre-COVID at UH 
 

 
42 
 
 
 
 
 
 
 
 

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44 
 
 
• 
TIME INVOLVED: The time commitment to this study will be approximately 3 hours over a 
period of 6 months. Specifically, today you will be asked to complete a 40-60-minute 
baseline questionnaire and then you may be asked to participate in one of the student 
health behavior activities described above, which can take another 20-30 minutes. Then 
over the next 6 months you will be invited to complete three 30-minute online surveys on 
the following schedule: one month from today, three months from today, and the last 6 
months from today. 
 
• 
COMPENSATION: You can receive up to $115 for participating in this study: $25 for today’s 
session (completing the baseline questionnaire and a health behavior activity), and $25 for 
completing the one- month follow-up survey, $30 for completing the 3-month follow-up 
survey, and $35 for completing the final 6-month follow-up survey. 
Payment for participating in this study will be made using electronic gift cards to 
Amazon.com. Upon completion of this session, a link with your Amazon gift card will be 
emailed to the Brown-affiliated [UH-affiliated] email address you provided us with to 
schedule this appointment. Subsequent gift cards will be delivered through the same 
process upon completion of the brief 1-, 3- and 6-month follow-up surveys. There is 
information about how to use this gift card on Amazon.com and you can call [for Brown: 
Melissa Hatch at (401) 863-6631; for UH: Pelin Cunningham-Erdogdu at (713) 743-3301] 
if you have any questions regarding redeeming your gift card. 
 
• 
RISKS: The risks in this study are minimal. The surveys and activities ask about your social 
and health behaviors and related beliefs and attitudes. It is possible that answering some 
of the questions in this study might cause some discomfort. You may withdraw from the 
study at any time without penalty. In the event that participation in this study triggers the 
desire to further discuss your health behaviors or other issues with a professional, a list 
containing contact information for confidential counseling and other student resources will 
be provided to all participants in this study. 
 
• 
BENEFITS: We cannot and do not guarantee or promise that you will receive any direct 
benefits from this study. However, you will be contributing to research that may lead to 
better programs for future college students at institutions like Brown and UH. 
 
• 
CONFIDENTIALITY: Your participation in this study and information gathered from the 
study will be kept confidential. This means that your answers to research questions will not 
be shared with anyone outside of the trained members of the research team. We take 
several steps to protect your privacy. For example, we will not connect your name to any 
research data. Instead, we will assign a code number to your information. We recommend 
that you respond to follow-up surveys in a private location, and upon completion you close 
your browser to protect your privacy. We will keep the master list that links your name to 
your code number separate from your questionnaire responses. At the end of the study, all 
personally identifying information will be erased. The data may be posted online when 
research results are published but it will not contain any information that could identify you 
or your participation in this research study. 
 
This research is covered by a Certificate of Confidentiality from the National Institutes of 
Health. The researchers can use this certificate to legally refuse to disclose information 
that may identify you in any federal, state, or local civil, criminal, administrative, legislative, 

 
45 
 
or other proceedings (for example, if there is a court subpoena) without your consent. You 
should understand that a Certificate of Confidentiality does not prevent you from 
voluntarily releasing information about yourself or your involvement in this research. If you 
want your research information released to any person not connected with the research, 
you must provide consent to allow the researchers to release it. 
There are a few exceptions to confidentiality protections. Because this study is regulated by 
the Brown University Institutional Review Board (IRB), the IRB may choose to inspect 
research records that identify you. Also, we cannot refuse a request from United States 
Government personnel for information that is needed for auditing or evaluation of federally 
funded projects. Lastly, the Certificate of Confidentiality does not prevent us from disclosing 
to state or local authorities if you reveal any intention to hurt yourself or anyone else, or 
child and elder abuse. 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as 
required by U.S. Law. This website will not include information that can identify you. At 
most, the website will include a summary of the results. You can search this Web site at any 
time. 
 
• 
VOLUNTARY: The decision whether to be in this study is entirely up to you. Even if you 
decide to be in this study, you can change your mind and stop at any time with no penalty.  
 
• 
CONTACT INFORMATION: If you have any questions about your participation in this 
study, you can contact Dr. Kate Carey at kate_carey@brown.edu or (401) 863-6558, [or 
Dr. Clayton Neighbors at cneighbo@central.uh.edu or 713-743-2616]. Research staff can 
be contacted by email at ProjectRAVEN@brown.edu [RAVEN@central.uh.edu]. 
 
• 
YOUR RIGHTS: The Brown University Human Research Protection Program is 
responsible for monitoring human subjects protections for this joint study. If you have any 
questions concerning your rights as a research participant, you may contact them at 
(401) 863-3050 or email them at IRB@Brown.edu. 
 
• 
CONSENT TO PARTICIPATE: Signing below confirms that you have read and 
understood the information in this document, are at least 18 years of age and that you 
agree to volunteer as a research participant for this study. 
You will be offered a copy of this form for your records. 
 
 
Participant's Signature 
/ 
Date 
/ 
PRINTED NAME 
 
 
 
 
 
 
 

 
46 
 
Virtual consent form post-COVID at UH (via Qualtrics) 
 
 

 
47 
 
 

 
48 
 
 
 
 
 
 

 
49 
 
Virtual consent form post-COVID at Brown (via Qualtrics) 
 
 

 
50 
 
 
 
 
 
 

 
51 
 
 
Appendix E. Data Safety Monitoring Plan (DSMP) 
 
Instructions: At a minimum, the DSMP must include the following critical elements as outlined on the 
NIAAA website and provided below. Please provide an answer addressing each critical element. If one of 
the elements does not apply to your study, please respond N/A. 
1. A description of the entity(ies) responsible for monitoring the trial (e.g., an 
independent monitoring group or person, DSMB, etc.) and procedures for 
monitoring subject safety. 
 
Dr. Carey, Contact PI, will have primary responsibility for monitoring the trial assisted by the other PIs 
who will meet as a team biweekly, as well as the DSMB that convenes twice per year. 
The project coordinator will download and review all data on a monthly basis. Our data management plan 
contains periodic data quality checks, early generation of analysis variables, and interim data summaries 
to provide a check on completeness of study data. The full analysis plan will be executed on collected 
data at the end of the RCT to ensure that we have correct variables and fix errors so final analyses can 
be completed quickly. 
The screening survey will be completed anonymously, and screening data are unlinked to contact 
information obtained in the scheduler, so that we will not know the identities of students who complete 
the screener. During the RCT, face-to-face contact with participants is limited to the baseline/intervention 
session; research staff will be trained to identify adverse events (defined below) and report the to the site-
specific contact. Similarly, any safety concerns raised by participants through study-related 
electronic/phone communications will be reported by research staff to the site-contacts, who will be 
prepared to provide referrals to their respective campus counseling centers. Finally, electronic surveys 
completed by participants will not be monitored at an individual basis, because of assurances that 
responses to questions will not be associated with names, but each will end with a list of counseling 
centers and alcohol and drug services, as well as the number for a 24-hour crisis hotline. 
 
 
Version: DSMP V1 
Effective Date: 01JUN17 
NIAAA Data and Safety Monitoring Plan (DSMP) 
PI Name: Carey, Kate 
Grant Number: 1R01AA025043-01A1 
Approval Date: LEAVE BLANK 
LEAVE BLANK 

 
52 
 
 
A. DSM BOARD PLAN 
Because this multisite prevention study involves a relatively low risk protocol and a non- clinical participant 
pool, we propose to rely on the standing DSMB that meets monthly at the Center for Alcohol and Addiction 
Studies. The members will consist of 3 faculty members with experience in conducting clinical trials, who 
have no conflict or role with the current study. This project will be reviewed every 6 months, and at these 
meeting the DSMB will evaluate the progress of the trial, review recruitment and retention rates, and 
examine any factors that may affect outcome. The DSMB reviews compliance with eligibility criteria and 
adherence to protocol safety rules. The DSMB will also review the rates of adverse events and serious 
adverse events to determine any changes in participant risk. DSMB members will be local to the prime 
site, permitting rapid communication with both research teams and IRB and the ability to convene quickly 
on issues related to participant safety or other problems, if necessary. 
B. CONFLICT OF INTEREST 
Before being asked to serve on the DSMB, the PI will ensure that members do not have a conflict of 
interest. The PI will also check that members are not in conflict prior to all Board meetings in case 
something with respect to their status has changed 
 
C. 
PROTECTION OF CONFIDENTIALITY 
Participants will only be identified by number during review of study progress by the DSMB. We 
are not collecting data requiring that confidentiality be breached. 
 
D. COMMUNICATION PLAN 
A report will be submitted by the investigators to the DSMB twice a year, containing 
the following categories: 
i. Brief description of the trial 
ii. Baseline sociodemographic characteristics 
iii. Recruitment rates 
iv. Retention and disposition of study participants 
v. Q.A. and data monitoring Issues 
vi. Summary of AEs and SAEs and actions taken 
vi. Summary of changes to participant risk and to protocol 
The report submitted after each DSMB meeting to the IRB and NIAAA PO will include: 
i. Brief description of the trial 
ii. Summary of discussion 
iii. DSMB recommendations/action items 
iv. signature of DSMB members 
 
2. Name of the responsible party (e.g., Principal Investigator, Study Physician if 
different than PI) who will distinguish a serious adverse event (SAE) from a non- 
serious adverse event (AE) and provide attributions (causality and severity). Provide 
a detailed accounting of how SAEs, AEs, and unanticipated problems will be 
managed consistent with local IRB guidelines (e.g. reporting requirements). 
 

 
53 
 
Each site has a designee who will take responsibility for distinguishing serious adverse events from 
non-serious adverse events: Dr. Carey (licensed clinical psychologist) for the Brown sample and Pelin 
Cunningham-Erdogdu for the Houston sample. Dr. DiBello (who also holds a masters in clinical 
counseling) will serve as back-up for both sites, due to his familiarity with both. In the proposed study 
we will use the FDA definition of adverse events (AE) and serious adverse events (SAE). An adverse 
event is any untoward (unexpected and undesirable) physical or psychological occurrence, serious and 
non- serious, in a participant that may have a causal relationship with study participation. 
Symptoms or conditions present at or before the assessment that manifest themselves with the same 
intensity or frequency after study participation will not be recorded as adverse events. Although deemed 
highly unlikely, research staff will be trained to observe and report any unanticipated or adverse reactions 
reported by participants. The baseline session represents the only instance of face to face contact with 
participants. All other assessments are completed remotely online. Any concerns will be immediately 
reported to the investigators, who will review the information and classify the relationship of the study 
protocol to the event as: 
 
• Not related: The event is clearly related to the participant’s clinical state, not with 
the study protocol 
• Remote: Event was most likely related to the participant’s clinical state, not with the 
study protocol 
• Possible: Event follows a reasonable temporal sequence associated with 
participating in the study but is possibly related to the participant’s clinical state. 
• Probable: Event follows a reasonable temporal sequence associated with participating 
in the study and cannot be explained by the participant’s clinical state. 
The scale below will be used to estimate the grade of severity of the adverse event: 
 
• Grade 1 Mild: Transient or mild discomfort, no limitation of activity, no or minimal 
intervention/therapy required. 
• Grade 2 Moderate: Mild to moderate limitation in activity; some assistance may be 
needed; no or minimal intervention/therapy required. 
• Grade 3 Severe: Marked limitation in activity; some assistance usually required; 
intervention/therapy required; hospitalization possible. 
• Grade 4 Life –threatening: Extreme limitation in activity; significant assistance required; 
significant intervention/therapy required; hospitalization probable (SAE).

 
54 
 
 
3. A description of the follow-up plans for SAE and unresolved 
unanticipated problems. 
During the intervention phase of the study the research staff will convene separately at both sites on a 
weekly basis to discuss study progress and potential problems. Informed consent forms will list the 
contact phone numbers for site PIs so that any potential adverse events or complaints can be reported 
by the students directly to the site PI or designee. In addition, the consent form will include the contact 
phone numbers for appropriate Brown University IRB personnel so that participants can directly report 
any complaints or potential adverse events. 
 
4. Risks associated with study participation. 
In our previous research in similar research projects at similar venues, no adverse events have 
occurred; therefore, in the proposed project, we anticipate the likelihood of an adverse event to be 
minimal. 
 
5. Confirmation that SAEs and unanticipated events which are considered “at least 
possibly related” during the treatment and follow-up phases will be reported to 
the local IRB and to NIAAA within 48 hours of knowledge of the SAE and all 
other SAEs and unanticipated events must be reported within the time period 
mandated by the local IRB. 
Yes. In the case of a serious event, a written report will be provided to the Brown University IRB (as 
Brown will serve as the IRB of record for both sites), and to the NIAAA project officer within 48 hours of 
the initial reporting of the event. Any actions determined by the Brown University IRB as a result of any 
adverse event also will be reported to NIH 
 
6. A statement confirming that the Annual Report will include the following: a summary of 
all AEs, confirmation of adherence to the DSMP, a summary of any data and safety 
monitoring issues since prior reporting period, a description of the changes in the 
research protocol or DSMP and all new and continuing IRB approvals. 
The annual report to NIAAA will include all AEs, confirmation of adherence to the DSMP, a summary of 
any data and safety monitoring issues since prior reporting period, a description of the changes in the 
research protocol or DSMP and all new and continuing IRB approvals. 

 
1 
Appendix E 
 
 
1 
 
 
 
7. Study inclusion and exclusion criteria 
 
Inclusion criteria for RCT: 
(1) Age 18-26 
(1) Male or female student at Brown University or University of Houston 
(2) Past month heavy episodic drinking (for men, >5 drinks in one day, for women >4 drinks in one 
day) 
(3) At least two self-reported negative consequences from drinking in the past month 
Exclusion criteria for RCT: 
(1) Students that have requested that the university not share information about them will not be 
contacted during recruitment 
(2) status as a senior graduating in the next 6 months 
 
8. A statement confirming that trained clinical staff will be present or on call when study procedures 
take place, based on level of risk and consistent with approved protocol, policies and guidance from 
the local IRB and/or other regulatory and monitoring entities. Examples include (but are not limited 
to) the administration of alcohol, other drugs and/or medications; invasive or other study 
procedures or testing; etc. The types of trained personnel (e.g.: nurse, nurse practitioner, physician 
assistant, physician, etc.) should be stated. 
 
The current study involves no invasive procedures requiring trained clinical staff, as participants will be engaged in 
completing survey questionnaires, engaging in self-directed writing tasks and discussing them with a research 
assistant. Nonetheless, we will designate a responsible person at each site who can be on call in the event of an 
adverse event. At the Center for Alcohol and Addiction Studies at Brown, Dr. Carey, is a licensed clinical psychologist 
has relevant experiences in clinical research, and staff training and supervision. At Houston, the designee will be Pelin 
Cunningham-Erdogdu, a research staff member. 
 
9. For studies in which alcohol is administered, provide assurance that NIAAA guidelines for the 
administration of alcohol will be followed. These guidelines can be found here: Alcohol 
Administration Human Laboratory Studies. 
 
N/A 
 
10. Describe the plan for referral to treatment during follow-up phases for any research participant who 
requires additional intervention due to significantly increased alcohol consumption or serious 
psychiatric/medical symptoms. 
The follow-up phases of this research involve electronic communications with participants and online surveys. Data will 
not be monitored at the individual level for changes in clinical status. However, at the end of each online survey, 
participants will be provided with the phone number for a 24-hour crisis hotline, as well as a list of counseling centers 
and alcohol and drug resources, including ones both inside and outside of the Universities. 

 
2 
Appendix E 
 
 
2 
 
 
11. Describe procedures for data quality assurance and protecting confidentiality of participant 
data (e.g., Certificate of Confidentiality). 
 
We will follow data collection, storage, and management procedures that protect participant confidentiality. All data will 
be identified only by a unique subject identification number, which will be stored separately from identifying information. 
In addition, contact information will be collected and stored separately from survey responses, and will only be 
accessible to trained research staff that need to use it. Assessment data are stored on a secure server with a firewall to 
protect the data and to prevent unauthorized access. 
Databases on the server are password protected and will be accessed only by research staff who have met the Brown 
University or University of Houston requirement for training in Human Subjects Protections. We will not share any 
specific information about participants with any other departments or offices at Brown University or the University of 
Houston. 
 
12. Provide a statement indicating certification of IRB approval(s) of the study protocol will be provided 
to NIAAA prior to screening study participants. IRB approvals should be submitted (preferably 
electronically) to the NIAAA Grants Management Officer (GMO) before initiating a proposed clinical 
trial. For multi-site studies, the Data Coordinating Center (DCC) and associated study sites must 
submit certification of IRB approval as well as assurance that IRB approvals have been obtained for 
all study sites, are on file at the clinical site and DCC, and are available to the NIAAA upon request. 
 
We confirm that an IRB application will be submitted through Brown University. Brown University will serve as the 
IRB of record and an IAA has been set up between Brown University and the University of Houston indicating that 
Brown University is the IRB of record. No recruitment or data collection will take place prior to full IRB approval. 
 
13. Provide the analysis plan including the power calculation(s). There should be discussion of any 
planned interim and/or futility analyses, including adjustments for allocating “alpha” on “multiple 
looks” at the data. 
Sample size and power calculations. Power analyses focus on estimating a sample size large enough to detect “true” 
effects, thereby avoiding Type II errors. Sample size estimates were obtained for intervention contrasts. Necessary 
sample sizes were assessed via sample size and power equations for multi-level models using the Optimal Design 
software program. 
Based on previous findings using CAA and PNF approaches, we anticipate intervention effects relative to the neutral 
control condition to be in the small to medium range but at least comparable to effects which have been reported for 
personalized normative feedback, which are typically in the .28 range (e.g., Dotson et al., 2015). Based on the 
proposed sample size of 600, given four assessment points, we anticipate the ability to detect effects of intervention 
contrasts and moderation effects across the small to medium range. 
Considering maximum anticipated attrition rates of 15% (N=510) we will have .70, .80, and .90 power to detect effects 
sizes of delta = .24, .27, and .32, respectively. 
 

 
3 
Appendix E 
 
 
3 
 
14. Provide the study stopping rules part of the study protocol. Generally, stopping rules reflect one 
of the following conditions: 1) there is clear evidence of harm; 2) there is no likelihood of 
demonstrating treatment benefit (futility); 3) there is overwhelming evidence of the benefit of 
treatment. 
 
There are no study stopping rules associated with the current protocol. Based on prior research, there is no reason to 
believe that the interventions used in this study could cause harm. Therefore, we do not plan interim analyses prior to 
achieving our full sample. We anticipate that the full sample will be needed to have sufficient power to detect 
significant group differences.