PNF 2.0: A Novel, Gamified, Facebook-Integrated Personalized Normative Feedback Intervention to Reduce Alcohol Use and Negative Consequences Among Sexual Minority Women
Phase: NA
Conditions: Alcohol Drinking, Alcohol Abuse, Alcohol; Harmful Use
Sponsor: Loyola Marymount University

 
 
 
 
 
Trial Protocol 
 
Approved by the IRB at Loyola Marymount University on August 14th, 2018 
Document First Uploaded 5.5.2021 by Sarah C. Boyle, PhD 
Updated to meet document upload requirements on 8.6.2021 by Sarah C. Boyle, PhD 
 
 
 Study Title: PNF 2.0: A Novel, Gamified, Facebook-Integrated PNF Intervention to Reduce Alcohol Use and 
Negative Consequences among Sexual Minority Women 
 
Trial Registration: ClinicalTrials.gov NCT03884478; 
https://clinicaltrials.gov/ct2/show/NCT03884478 
 

Office for Research Compliance 
Page 2 of 40 
7/26/2018 
 
 
LOYOLA MARYMOUNT UNIVERSITY 
 
IRB Application Questionnaire 
All materials must be typed. 
1. 
RESEARCH BACKGROUND 
 
Please describe the purpose of your research.  Provide relevant background information 
and briefly state your research question(s).  You may provide relevant citations as 
necessary. (300 Word Max.)  
Lesbian, bisexual, and queer-identified (LBQ) women in the United States are more likely to drink 
alcohol, engage in heavy alcohol use, experience alcohol-related problems and become dependent on 
alcohol than are heterosexual women. Although web-based PNF interventions have become popular 
strategies to correct misperceived norms and reduce alcohol use in other populations, lesbian and queer 
women constitute a hidden population not easily reached by traditional intervention efforts. This 
NIAAA-funded project implements and evaluates a novel, gamified, web-based PNF alcohol 
intervention format culturally tailored to appeal to members of the local Los Angeles lesbian and queer 
female community. Packaged as a digital social game about LBQ stereotypes, LezParlay features 
established game mechanics including co-presence, a system of points, chance-based uncertainty, and 
multiple feedback topics to increase appeal and remedy many of the limitations (i.e., defensiveness, 
reactance, and lack of attention) associated with standard web-based PNF interventions. Uniquely, to 
confront both social and coping antecedents of lesbians’ drinking, LezParlay seeks to reduce drinking 
among LBQ women by providing PNF on both alcohol use and coping behaviors utilized by peers to 
navigate sexual minority stigma stressors.  
Multiple strategies will be employed to recruit approximately 1200 lesbian, bisexual, and queer 
identified women residing in the United States to take part in the online LezParlay competition. Topics 
in the game will change from month to month and will feature stigma-coping behaviors and alcohol use, 
among other topics related to familiar lesbian and queer stereotypes (e.g., relationships, sex, identity, 
money, stress, and future plans). Over 8 monthly rounds of play, players will receive PNF on different 
topics and compete for cash prizes as they test the accuracy of their peer perceptions and discover how 
their own attitudes and behaviors compare to actual group norms. Importantly, in Round 3, when 
alcohol use is first assessed as a topic, a sub-sample of 500 players who report moderate drinking will 
be invited to participate in a LezParlay evaluation study. Participants who elect to take part in the study 
will be randomized to receive either PNF on alcohol use + coping behaviors, PNF on alcohol use + 
control topics, or PNF on control topics in subsequent rounds of the game. These study participants will 
be incentivized for playing remaining rounds and completing a follow-up survey about their 
experiences. Analysis of LezParlay efficacy will focus on longitudinal changes in alcohol use and coping 
behaviors associated with condition assignment and subsequent receipt of PNF among study 
participants. Analysis of feasibility associated with the gamified LezParlay format will focus on 
acceptability ratings and other feedback gathered from trial participants as well as basic application 
usage among the pool of players who elect to take part in the competition but do not participate in the 
study, and thus, are not incentivized for their completion of rounds. 
 
2.  
SUBJECT RECRUITMENT 
How will subjects be selected?  What is the sex and age range of the subjects?  
Approximately how many subjects will be studied? 
How will subjects be contacted?  Who will make initial contact with subjects?  
Specifically, what will subjects be told in initial contact?  

Office for Research Compliance 
Page 3 of 40 
7/26/2018 
 
 
The LezParlay competition will be open to ALL lesbian and queer-identified women between 21 years of 
age and older who reside in the United States. Although there is no upper limit on the number of 
women who can take part in the competition, we expect to recruit at least 1,200 LBQ women (400 
women in each age-group; 20s, 30s, 40s, and 50s). 
The game will be promoted via 3 mechanisms. First, flyers will be distributed locally at Los Angeles 
events for LBQ women put on by collaborating partners LezDoBrunch and the Los Angeles LGBT 
Center and Los Angeles Women’s Network. Second, targeted social media advertisements will promote 
LezParlay on Facebook, Instagram, and HER social media platforms to lesbian and queer identified 
female users residing in different regions of the United States.  Third, promotional emails describing 
the game will be sent to the email list of Autostraddle, a popular online blog for queer women. 
Registered players can earn bonus points in initial rounds of the game by inviting friends to play. All 
recruitment materials will link to the LezParlay website which provides information about the game and 
invites participants to register online (www.lezparlayla.com). APPENDIX A includes recruitment ads 
and flyers.  
If subjects will be screened, describe criteria and procedures. 
Two different levels of “participants” will take part in LezParlay: “Evaluation Study Participants” 
(N=500) among whom we will assess efficacy of LezParlay in reducing alcohol use; and, “Non-
Evaluation Study Participants” (N=800+) among whom we will assess feasibility and engagement with 
the LezParlay web app.  
 
LezParlay Participant Inclusion Criteria (Applies to all players): 
To take part in the LezParlay competition individuals must: 
1) Self-identify as a lesbian, bisexual, or queer woman 
2) Be 21 years of age or older 
3) Reside in the United States 
4) Accept LezParlay Terms of Service & Privacy Policy 
 
LezParlay Evaluation Study Participant Inclusion Criteria 
To take part in the Evaluation Study, LezParlay Participants must: 
1) Report having had 3+ drinks on one occasion during the past 2 months OR drinking alcohol 
3+ times per week during the past 2 months in response to a Round 3 Alcohol use questions 
2) Review and Accept the Evaluation Study Informed Consent page 
3) Have taken part in at least 1 previous round of the competition 
 
Two questions about alcohol use in the third round of the game will act as a screening item for the 
Evaluation study. Specifically, participants will be quota sampled by Qualtrics in response to a Round 2 
question about the maximum number of drinks consumed on one occasion during the past month. The 
first 150 drinkers in each age-group (i.e., 20s, 30s, 40s, 50s) who provide an answer equal to or above 3 
drinks in response to this question will be invited to become an official tester in a study evaluating 
LezParlay. On screen text will explain that as a participant in this study they can help evaluate 
LezParlay by playing the next 5 rounds of the game and completing a follow-up survey about their 
experiences when the game is over. Further, study participants will be emailed a $40 electronic gift card 
to compensate them for their time and they will still be eligible to compete for performance-based cash 
prizes awarded to the top scorers. 
 “Non-Evaluation Study participants” refer to players who register for LezParlay but either do not 
screen into the study or choose not to participate in the study. Non-Evaluation Study participants are 
not incentivized for round completion but may compete for several performance-based cash prizes 
awarded to the top scorers in each age-group. For these participants, LezParlay web app data analyzed 
for research purposes is limited to aggregated demographic data provided at registration, the number of 

Office for Research Compliance 
Page 4 of 40 
7/26/2018 
 
 
rounds played, number of logins, and number of screen views. Collection and analysis of this data is 
outlined in the web app’s Terms of Service & Privacy Policy which ALL participants must review and 
accept at registration. 
 
3. 
PROCEDURES 
Summarize fully all procedures to be conducted with human subjects. 
All contact with participants will occur digitally via emails, text messages, and Qualtrics surveys 
embedded within the LezParlay web app. All recruitment materials will link to the LezParlay website 
which provides information about the game and button to register. The registration survey will verify 
participants’ geolocation in the United States, prompt participants to review and accept the LezParlay’s 
Terms of Service & Privacy Policy, and create a unique username and password which they will use to 
login to the LezParlay web app. Additional registration items will ask participants to select their sexual 
identity (i.e., lesbian or queer), and provide their mobile phone number, email address, relationship 
status, birthdate and age-group. The registration survey will also present participants with the option of 
uploading a photo avatar to represent them within the web-app. Descriptive text will explain that if they 
elect to provide one, their custom avatar will be visible within the app to other logged in players. If they 
choose not to upload an avatar they will be represented within the app by a default blank avatar (as is 
done across popular social media sites and apps in the absence of a custom user avatar). 
Submitting the registration form will trigger a verification text message to be sent to the mobile 
phone number provided by the participant. Upon receiving the text and clicking on the unique url 
delivered, the participant’s avatar will be updated with a blue check mark and they will receive 100 
Parlay Points to place bets with in Round 1. Simultaneously, verification locks the phone number so that 
it cannot be associated with any future LezParlay registrations and assigns a unique PIN to the 
participant in the registration database. As most individual’s only own a single mobile phone (or 2 at 
the most), this protocol helps ensure that players cannot try to cheat the LezParlay system by creating 
multiple accounts in order to place wagers on all possible combinations of guesses. Further, the unique 
PIN assigned to each verified account then acts as the piece of data used by LezParlay to link 
participants’ guesses, bets, responses, and scores across rounds of play.   
Round Play- upon verification, players will be redirected to a series of instructional screens (See 
Appendix C) that reviews how LezParlay works and explain that points are won and lost by placing bets 
on your perceptions of the behaviors and attitudes of the typical LBQ woman in your age-group. In each 
round there will be between 1 and 3 question topics and each topic will contain approximately 8 
questions. Four questions will ask you to report your own topic-specific behaviors or attitudes and the 
other four will ask you to guess about how other players in your age-group answered the same 
questions. For each guess you will be prompted to select the number of points you would like to bet on 
your guess being correct based on the average responses of other players. Screens will also inform 
participants that there is a variable cash prize between $100 and $500 in each round that will be 
awarded to the player who accumulates the largest number of points in that round. There are also grand 
prizes ($1000, $500, and $250) that will be awarded to the top 3 scorers in each age-group who 
accumulate the largest numbers of points across rounds of play. A final screen will explain that after a 
critical mass (N=300+) in each age-group has played a round, LezParlay will text and email all players 
with a private link to an overview of the points won and lost along with detailed results on one topic. 
Detailed results are intended to help players improve the accuracy of their perceptions and place 
smarter bets in future rounds, as question topics may be repeated. Following this overview, a button 
will allow players to begin round 1. 
The first screen in the round will reveal 2-3 question topics and the amount of the cash prize for the 
round’s top scorer.  Players will report their own answers to the questions then guess and bet points 

Office for Research Compliance 
Page 5 of 40 
7/26/2018 
 
 
(i.e., 10, 25, or 50 points) on how other players will answer. Upon placing their bets, a final screen will 
reiterate that results will be sent out when a critical mass has played in their age-group.  Additionally, 
they will be informed that they can help speed this along by inviting friends to play by sharing their 
personalized referral link, displayed below and also available in their account tab. When a critical mass 
has played (>300 in each age-group which we expect to take approximately 3 weeks), average responses 
to questions have been computed, and points won and lost have been calculated, links to view detailed 
results will be sent to players via text message and email. Clicking the private url will take the player to 
a spinner screen which displays their total score and reveals their detailed results topic  initial 
“RESULTS LOADING” screen which summarizes the number of players in the users’ age-group who 
played the round to generate the correct answers (i.e., actual norms). Consistent with co-presence 
features in popular social media and digital apps, this summary consists of an animated that collage 
displays the thumbnail avatars of all the players who completed the round. Recent studies in our lab 
have established that showing participants the peers on whom actual norms are based through such a 
collage increases the believability and credibility of the actual norms to be presented on subsequent 
feedback screens. The next screen encountered when viewing one’s detailed results will feature 3 animated 
graphical doors and instructions to select (tap or click) 2 of the doors in order to reveal either bonus points or 
topics on which detailed results will delivered. For each question topic revealed by the door selection 
mechanic, personalized normative feedback (PNF) for each question will follow. PNF consists of bar 
charts with bars respectively representing 1) the participant’s guess about how other players answered 
(i.e., perceived peer norm); 2) the participant’s own answer to the question; and, 3) the actual average 
answer submitted by other players (i.e., actual peer norm). Text on each PNF screen will highlight an 
interesting statistic related to the actual norm and detail the number of points won/lost based on the 
accuracy of the player’s guess. Following PNF screens, participants will be presented with their total 
score and their age-group’s leaderboard which also crowns the winner of the round’s cash prize. The 
round winner will also be notified by email and text message and have the option of receiving their Visa 
gift card electronically or through the mail. See Appendix B for mockups of app screens. 
After viewing these results screens, participants have the option of beginning the next round or 
being reminded to complete it later. The participant experience and sequence of screens encountered in all 
rounds are the same as detailed above with 2 exceptions: Rounds 3 and 4, which are intervention rounds and 
Rounds 7 & 8 which include REPLAY BONUSES. 
Intervention Rounds 3 and 4. We aim to recruit a minimum of 1200 LBQ women to sign up during the 
first 2 monthly rounds to ensure that meaningful and stable sexual identity– and age group–specific actual 
norms for drinking and coping behaviors can be delivered in intervention rounds 3 and 4. From this larger 
pool of players, 500 will be recruited to participate in a LezParlay evaluation study (RCT) during Round 3. 
Acting as baseline (T1) for the RCT, Round 3 will feature questions about alcohol use, stigma experiences, 
and a group of nonhealth-related control questions submitted by players. Upon submitting answers to 
alcohol-related questions in Round 3, players will be covertly screened for evaluation study eligibility based 
on their answers (i.e., number of drinking days per week and peak drinks on a single day during the past 2 
months) as well as their geolocation and the number of previous rounds played. Those who have played at 
least one previous round, are in the United States, and report drinking alcohol on 3 or more days per week or 
having 3 or more drinks on their peak drinking occasion will be invited to take part in an evaluation study at 
the end of the round. Interested potential participants will advance to an informed consent screen that 
explains that the goal of the study is to evaluate the impact and format of detailed results received in 
LezParlay and gather player feedback to inform the next version of the competition. The information further 
detailed that participation in the evaluation study simply involves playing and viewing detailed results in 
subsequent rounds and completing a brief feedback survey at the end of the competition. Participants can 
earn up to US $40 in electronic gift cards of their choice to play subsequent rounds and complete the 
feedback survey. Those who check a box indicating that they understood what the study participation entails 
and would like to participate will be welcomed into the study.  

Office for Research Compliance 
Page 6 of 40 
7/26/2018 
 
 
Qualtrics Research Suite’s automated randomizer will be used to randomize evaluation study 
participants to a PNF condition at the point of study enrollment in round 3. Randomization will 
determine the sequence of topics on which participants will receive detailed results across intervention 
rounds 3 and 4: alcohol+coping, alcohol+control, or control only. Members of the research team will be 
blinded to participant condition assignment, and the study participants will not be aware that any sort 
of randomization was taking place. Rather, like in other rounds, when detailed results are sent players 
will be prompted to choose among 3 animated, graphical doors to determine the topics on which they 
will view detailed results. Although the results topics will be truly determined via chance in most rounds 
of the competition, the doors of evaluation study participants will be fixed to open to their randomly 
assigned feedback topics regardless of the door they selected in rounds 3 and 4. Upon completing the 
feedback survey at the end of the competition, participants will be debriefed regarding the study’s 
research questions and the fixed sequences of health or control feedback they were randomized to 
receive in rounds 3 and 4. See Appendix D for the Debriefing Statement. 
Replay Bonus Rounds 7 and 8. 
The last 2 rounds of the competition, 7 & 8, will feature new question topics as well as previously 
assessed REPLAY BONUS topics which will allow all players to boost their scores by placing very large 
bets on a topic they already received feedback on and very small bets for topic on which feedback has 
not yet been delivered. PNF will be delivered for the new topics assessed in each round but will not be 
repeated for REPLAY BONUS topics. Instead a single screen will reveal the points earned from REPLAY 
BONUSES. Importantly, answers to REPLAY BONUS questions in Round 7 among intervention study 
participants’ will act as the 2 month post-intervention follow-up for the purpose of the evaluation study 
RCT. 
 
Competition Conclusion 
Following the announcement of winners after Round 8, the LezParlay competition will be over. A 
special sequence of screens follow for Evaluation Study Participants. Study participants will be provided 
the opportunity to complete the follow-up survey for the evaluation study on screen or have the link to 
emailed/texted to them so that they can complete it later. Upon submitting the short follow-up survey, 
participants will be prompted to select a $40 electronic gift card (Amazon, Target, Starbucks, etc.) to 
receive via email. A final screen will thank them for their time and debrief them about the fixed nature 
of the spinners that selected their detailed results topics in Rounds 3 and 4. Text will reveal that this 
was necessary in order to examine the perceptual and behavioral impacts of different combinations of 
detailed results delivered in these rounds. Questions to be featured in Intervention and Replay Bonus 
Rounds are presented in Appendix C. A list of potential control/filler stereotype related questions to 
comprise other rounds of play also follow in Appendix C. APPENDIX D also provides the Evaluation 
study follow-up survey and debriefing statement. 
 
4. 
RISKS / BENEFITS 
What are the potential benefits to subjects and/or to others? 
What are the reasonably foreseeable risks to the subjects?  (Risks may include 
discomfort, embarrassment, nervousness, invasion of privacy, etc.)  If there are 
potential risks to subjects, how will they be minimized in advance?  How will problems 
be handled if they occur? 
 Participants will benefit from LezParlay through their receipt of detailed feedback revealing actual 
LBQ community norms and how they compare to LBQ peers on a wide range of behaviors and attitudes 
of interest to this population. Feedback on alcohol use and coping behaviors are anticipated to show 
participants that their peers consume less alcohol and drink to cope with negative affect less than they 
thought. This information is anticipated to have a protective effect on participants’ own alcohol use. For 

Office for Research Compliance 
Page 7 of 40 
7/26/2018 
 
 
some, participation in LezParlay may also satisfy curiosities about the LBQ community or help to 
diminish harmful stereotypes. For others, learning about health and relationship behaviors of LBQ 
peers may benefit their own health behaviors and relationships. Others may simply find entertainment 
in the wagers, scoring and feedback. Participants’ responses to LezParlay questions, in aggregate may 
also help shape future programming by our community partners, which in turn, may benefit their 
future well-being. In addition, participants in the evaluation study may enjoy the opportunity to share 
what they liked about LezParlay, what they hated, and any ideas they have for improvements with the 
game’s founders.  
Psychological risks posed by the research are primarily related to the sensitivity of some of the 
questions. Participants will be prompted to report their alcohol use, coping behaviors, health behaviors, 
future plans, relationship and sexual behaviors, information that may be private. These questions may 
make subjects uncomfortable or be perceived as an intrusion on their privacy. To mitigate these risks, 
all LezParlay question responses will be linked to unidentifiable PIN numbers and participants will be 
able to skip questions they do not feel comfortable answering without penalty. Participants may also 
experience discomfort upon receipt of personalized normative feedback. For example, it may be 
distressing for a participant to learn that other lesbians the same age are drinking much less but 
exercising much more than you. Although igniting such dissonance, or discomfort, is the primary goal 
of PNF interventions in that these feelings motivate healthy behavior change, participants will be 
provided an opportunity to skip the detailed results screens that provide PNF and advance to the next 
round if they wish to do so. 
5. 
CONFIDENTIALITY 
Will subjects be identifiable by name or other means?  If subjects will be identifiable, 
explain the procedures that will be used for collecting, processing, and storing data.  
Who will have access to data?  What will be done with the data when the study is 
completed? If you are collecting visual images of your subjects please justify this. 
Participants will not provide their full names and identifiable data will only be collected in the 
initial registration survey (their initials or a nickname, email address, mobile phone number, birthdate, 
relationship status, sexual identity, and a profile picture if they wish to upload one).  The app’s terms of 
Service and Privacy Policy clarify that displaying a profile photo, describing oneself via descriptive text, 
and entering all profile information with the exception of sexual identity and age group (required for 
round formatting) is optional and not required to take part in the LezParlay competition. It will also be 
clear that player’s contact information entered at registration (email, phone) will not be visible to other 
players. It is important to emphasize that although participants will be able to browse one another’s 
player profiles, no distinction will be made as to who is playing as an intervention study participant 
versus a non-study participant. Thus, while players may recognize one another when viewing profiles, 
participation in the evaluation study entirely remains confidential. 
Submitting the registration form will trigger a verification text message to be sent to the mobile 
phone number provided by the participant. Upon receiving the text and clicking on the unique url 
delivered, the user will be updated with a verification checkmark in the registration database. 
Simultaneously, verification locks the phone number so that it cannot be associated with any future 
LezParlay registrations and assigns a unique PIN to the user in the registration database. As most 
individual’s only own a single mobile phone (or 2 at the most), this protocol reduces players’ ability to 
cheat in LezParlay by creating multiple accounts in order to place wagers on all possible combinations 
of guesses. Further, the unique PIN assigned to each verified account then acts as the piece of data used 
by LezParlay to link participants’ guesses, bets, responses and scores across rounds of play.   
As the LezParlay collects all round data through styled Qualtrics surveys fully embedded into the 
app, all data is protected by Transport Layer Security (TLS) encryption (also known as HTTPS), which 
is a protocol that ensures privacy between communicating applications and their users on the Internet. 
Also used to secure bank and credit card transactions online, TLS ensures that no third party may 

Office for Research Compliance 
Page 8 of 40 
7/26/2018 
 
 
eavesdrop or tamper with submitted data. Further, after data collection concludes and all personalized 
feedback, scores, and incentives, have been received by participants, user photos and identifying 
information will be destroyed. Only datasets containing de-identified LezParlay Round data will be 
downloaded from Qualtrics for analysis, password protected, and stored securely on HeadsUp’s 
internal, further password protected server. Thus, these double password protected files will only be 
accessible to the PI (Joseph LaBrie) and Project Director (Sarah Boyle). 
6. 
INFORMED CONSENT 
Attach an informed consent form or a written request for waiver of an informed consent 
form.  Include waiver of written consent if appropriate.  If your research is being 
conducted in another language, please include copies of the translated “Informed 
Consent” or “Waiver of Written Consent” forms. 
This research requires 2 levels of consent. First, the LezParlay Terms of Service and Privacy Policy must 
be accepted by ALL players at sign-up. Second, players who meet Evaluation Study criteria during 
Round 3 and express interest in taking part in the study will be directed to review and complete the 
Evaluation Study’s informed consent form. These documents are separately attached. 
7. 
STUDENT RESEARCH 
 
When a student acts as principal investigator, a faculty sponsor signature is required on the 
application form. 
N/A 
8.  
RENEWAL APPLICATIONS 
 
When the submission is a Renewal Application, include a summary of the research activities during 
the previous granting period specifically addressing:  number of subjects studied and any adverse 
reactions encountered, benefits which have been derived, any difficulty in obtaining subjects or in 
obtaining informed consent, and approximate number of subjects required to complete the study. 
N/A 
9. 
PAYMENTS 
If subjects are to be paid in cash, services, or benefits, include the specific amount, 
degree, and basis of remuneration. 
All participants will have the opportunity to compete for a cash prize in each round (one prize 
ranging from $100 to $500) as well as cumulative cash prizes to be awarded to top scorers in each age-
group (1st place=$1000; 2nd place=$500, 3rd place=$250) at the end of the game. These prizes will take 
the form of Visa gift cards. Winners will be notified via text message and email and will be asked 
whether they prefer to have an electronic Visa gift card emailed to them or have a physical version 
mailed to them. Those who elect to have a physical version mailed will be asked to provide their postal 
address.  
Evaluation study participants (N=500) who play the majority of rounds and complete the follow-
up survey will receive $40 in e-gift cards of their choice (iTunes, Amazon, Target or Starbucks). 
Consistent with other university and NIH sponsored research conducted by our team, giftcards will be 
sent via GiftBit. Players will receive a $20 giftcard for completion of rounds and a $20 giftcard for 
completion of the post-competition feedback survey. 

Office for Research Compliance 
Page 9 of 40 
7/26/2018 
 
 
10. PSYCHOLOGY SUBJECT POOL 
When students from the Psychology Subject Pool (PSP) are to be involved as subjects, permission 
must be obtained from the PSP prior to running subjects.   
Forms are available from the Psychology Office in 4700 University Hall.  It is not necessary to 
inform the IRB of approval from the PSP, however the PSP requires IRB approval prior to 
permission for using the pool being granted. 
N/A  
11. QUALIFICATIONS AND TRAINING 
Describe the qualifications of, or method of training and supervision afforded student 
experimenters. This includes past experience, type and frequency of student/sponsor interactions 
during the experiment, and Human Subjects Protections Training. 
N/A 
12. RANDOMIZATION 
Describe criteria for assigning subjects to sub-groups such as “control” and “experimental.” 
As described previously, Qualtrics Research Suite’s automated randomizer will be used to randomize 
evaluation study participants to a PNF condition at the point of study enrollment in round 3. 
Randomization determined the sequence of topics on which participants received detailed results 
across intervention rounds 3 and 4: alcohol+coping, alcohol+control, or control only. Members of the 
research team will be blinded to participant condition assignment, and the study participants will not 
be aware that any sort of randomization was taking place. Rather, when detailed results were sent at the 
end of each round, players will be prompted to choose among 3 animated, graphical doors to determine 
the 1 to 2 round topics on which they would view detailed results. Although the results topics will be 
truly determined via chance in most rounds of the competition, the doors of evaluation study 
participants will be fixed to open to their randomly assigned feedback topics regardless of the door they 
selected in rounds 3 and 4. Upon completing the feedback survey at the end of the competition, 
participants will be debriefed regarding the study’s research questions and the fixed sequences of health 
or control feedback they were randomized to receive in rounds 3 and 4. 
13. USE OF DECEPTION 
If the project involves deception, describe the debriefing procedures that will be used.   
Include, verbatim, the following statement in the consent form: "Some of the information with 
which I will be provided may be ambiguous or inaccurate.  The investigator will, however, inform 
me of any inaccuracies following my participation in this study." 
Although none “of the information which participants will be provided will be ambiguous or inaccurate” 
under any circumstances, the fixed nature of the feedback selection mechanism encountered by 
Evaluation Study participants in Rounds 3 and 4 may be considered minor deception. Thus, upon 
completion of the follow-up survey intervention study participants will be debriefed regarding the non-
random nature of these mechanisms. (See APPENDIX D for debriefing statement) 

Office for Research Compliance 
Page 10 of 40 
7/26/2018 
 
 
14. QUESTIONNAIRES AND SURVEYS 
Include copies of questionnaires or survey instruments with the application (draft form is 
acceptable).   
If not yet developed, please so indicate and provide the Committee with an outline of the general 
topics that will be covered.  Also, when the questionnaire or interview schedule has been compiled, 
it must be submitted to the Committee for separate review and approval.  These instruments must 
be submitted for approval prior to their use. 
Consider your population. If they are foreign speakers, please include copies in the foreign 
language. 
See APPENDIX C for questions to be asked in LezParlay rounds, and APPENDIX D for the post-
competition feedback survey to be completed by Evaluation Study participants. 
15. PHYSICIAN INTERACTIONS 
To ensure that all patients receive coordinated care, the principal investigator is obligated to inform 
the primary physician (when not the principal investigator) of all studies on his/her patients. 
 
N/A 
16. SUBJECT SAFETY 
Describe provisions, if appropriate, to monitor the research data collected, to ensure continued 
safety to subjects. 
 
N/A 
17. REDUNDANCY 
To minimize risks to subjects, whenever appropriate, use procedures already being performed on 
the subjects for diagnostic or treatment purposes.  Describe provisions. 
 
N/A 
18. COUNSELING 
In projects dealing with sensitive topics (e.g., depression, abortion, intimate relationships, etc.) 
appropriate follow-up counseling services must be made available to which subjects might be 
referred.   
The IRB should be notified of these services and how they will be made available to subjects. 
N/A 
19. SAFEGUARDING IDENTITY  
When a research project involves the study of behaviors that are considered criminal or socially 
deviant (i.e., alcohol or drug use) special care should be taken to protect the identities of 
participating subjects.  
In certain instances, principal investigators may apply for "Confidentiality Certificates" from the 
Department of Health and Human Services or for "Grants of Confidentiality" from the Department 
of Justice. 
N/A… All participants in this study will be of the legal drinking age. 

Office for Research Compliance 
Page 11 of 40 
7/26/2018 
 
 
20. ADVERTISEMENTS 
If advertisements for subjects are to be used, attach a copy and identify the medium of display. 
See Appendix A for recruitment/promotional ads. 
21. FOREIGN RESEARCH 
When research takes place in a foreign culture, the investigator must consider the ethical 
principles of that culture in addition to the principles listed above. 
 
N/A  
22. EXEMPTION CATEGORIES (45 CFR 46.101(b) 1-6) 
If you believe your study falls into any of the Exemption Categories listed below, please explain 
which category(ies) you believe it falls into and why.  
 
1) Research conducted in established or commonly accepted educational settings, involving 
normal educational practices, such as (i) research on regular and special instructional 
strategies, or (ii) research on the effectiveness of or the comparison among instructional 
techniques, curricula, or classroom management methods. 
 
2)  Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), 
if information taken from these sources is recorded in such a manner that subjects cannot be 
identified, directly or through identifiers linked to the subjects. 
3)  Research involving survey or interview procedures, except where all of the following conditions 
exist: (i) responses are recorded in such a manner that the human subjects can be identified, 
directly or through identifiers linked to the subjects, (ii) the subject's responses, if they became 
known outside the research, could reasonably place the subject at risk of criminal or civil 
liability, or be damaging to the subject's financial standing, employability, or reputation, and 
(iii) the research deals with sensitive aspects of the subject's own behavior, such as illegal 
conduct, drug use, sexual behavior, or use of alcohol. 
 
All research involving survey or interview procedures is exempt, without exception, when the 
respondents are elected or appointed public officials, or candidates for public office. 
4)  Research involving the observation (including observation by participants) of public behavior, 
except where all of the following conditions exist: (i) observations are recorded in such a 
manner that the human subjects can be identified, directly or through the identifiers linked to 
the subjects, (ii) the observations recorded about the individual, if they became known outside 
the research, could reasonably place the subject at risk of criminal or civil liability, or be 
damaging to the subject's financial standing, employability, or reputation, and (iii) the research 
deals with sensitive aspects of the subject's own behavior such as illegal conduct, drug use, 
sexual behavior, or use of alcohol. 
5)  Research involving the collection or study of existing data, documents, records, pathological 
specimens, or diagnostic specimens, if these sources are publicly available or if the information 
is recorded by the investigator in such a manner that subjects cannot be identified, directly or 
through identifiers linked to the subjects. 

Office for Research Compliance 
Page 12 of 40 
7/26/2018 
 
 
6)  Unless specifically required by statute (and except to the extent specified in paragraph (1)), 
research and demonstration projects which are conducted by or subject to the approval of the 
Department of Health and Human Services, and which are designed to study, evaluate, or 
otherwise examine: (i) programs under the Social Security Act or other public benefit or 
service programs, (ii) procedures for obtaining benefits or services under those programs, (iii) 
possible changes in or alternatives to those programs or procedures, or (iv) possible changes 
in methods or levels of payment for benefits or services under those programs. 
N/A 
 
Please deliver to: Julie Paterson, IRB Coordinator, University Hall, Suite 1718 or 
jpaterso@lmu.edu. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Office for Research Compliance 
Page 15 of 40 
7/26/2018 
 
 
 
Figure A3. LezParlay multi-image carousel ad mockups for Facebook and Instagram 

Office for Research Compliance 
Page 16 of 40 
7/26/2018 
 
 
 
Figure A4. Additional drafts of Facebook & Instagram ads. 

Office for Research Compliance 
Page 17 of 40 
7/26/2018 
 
 
 
 
 
 
 
 
Figure A5. Google Search Ad Preview targeting searches of terms and phrases including “lesbian chat”, 
“lesbian dating site” “queer dating” “bisexual dating” “LGBTQ pride events” “queer chat” “lesbian bar” 
“queer nightclub” “lesbian party” “queer party” 
 
 

Office for Research Compliance 
Page 18 of 40 
7/26/2018 
 
 
Appendix B 
App Screen Mockups and Overview from LezParlay Landing Page 
All app screens (with Round 1 programmed) can also be viewed at www.lezparlay.com 
 
 
 
 
 
 
 
 
 
 

Office for Research Compliance 
Page 19 of 40 
7/26/2018 
 
 
 
 
 
 
 
 
 
 
 

Office for Research Compliance 
Page 20 of 40 
7/26/2018 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Office for Research Compliance 
Page 21 of 40 
7/26/2018 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Office for Research Compliance 
Page 22 of 40 
7/26/2018 
 
 
APPENDIX C 
 
Norm questions to be featured in intervention rounds or potentially featured as 
control/filler questions in LezParlay Rounds 
 
• 
Parallel Questions will also ask participants to report their own corresponding 
behavior/attitude/experience 
• 
All questions will pipe the sexual identity (lesbian, bisexual, queer) and age-group (20s, 30s, 
40s, 50s) of the user 
• 
Some question topics and questions to appear in rounds will be voted on by players.  
• 
Players can also submit their own questions to be voted on and potentially featured in some 
rounds.  
• 
If any top voted user-submitted materially differ from those submitted in this exhaustive 
potential question list, we will submit an addendum to the IRB and get approval before any are 
featured in a round.  
 
 
Alcohol Use Questions (Round 3 & Replay Bonus in Round 7) 
During the past 2 months, on average, how many days per week did the Typical Lesbian drink alcohol? 
 0 
 1 
 2 
 3 
 4 
 5 
 6 
 7 
 
During the past 2 months, on average, how many drinks did the Typical Lesbian have each time she drank? 
 0 
 1 
 2 
 3 
 4 
 5 
 6 
 7 
 8 
 9 

Office for Research Compliance 
Page 23 of 40 
7/26/2018 
 
 
 10 or more 
 
 
On the day she drank the MOST during the past 2 months, how many drinks did the Typical Lesbian have? 
 0 
 1 
 2 
 3 
 4 
 5 
 6 
 7 
 8 
 9 
 10 
 11 
 12 or more 
 
 
During the past 2 months, how many of the 8 things above has the typical lesbian experienced due to drinking/partying? 
 0 
 1 
 2 
 3 
 4 
 5 
 6 
 7 
 
 

Office for Research Compliance 
Page 24 of 40 
7/26/2018 
 
 
Stigma Questions (Round 3 & Replay Bonus in Round 7) 
During the past 2 months, what % of lesbians have been physically assaulted due to their sexual identity? 
0% -----------------------------------------------------------------------------------------------100% 
 
During the past 2 months, what % of lesbians have been verbally harassed or threated online or in person due to their sexual identity? 
0% -----------------------------------------------------------------------------------------------100% 
 
During the past 2 months, what  of lesbians have overheard negative LGBTQ-related comments, jokes, or slurs? 
0% -----------------------------------------------------------------------------------------------100% 
 
During the past 2 months, what % of lesbians have felt unwelcome or uncomfortable in a public place (gym locker room, store, restaurant, 
etc., due to their sexual identity? 
0% -----------------------------------------------------------------------------------------------100% 
 
Coping Behaviors (Round 4)  
 
When experiencing stress & stigma during the past month, what % of the time did the typical lesbian cope by drinking alcohol? 
0% -----------------------------------------------------------------------------------------------100% 
 
When experiencing stress & stigma during the past month, what % of the time did the typical lesbian cope by taking a drug? 
0% -----------------------------------------------------------------------------------------------100% 
 
When experiencing stress & stigma during the past month, what % of the time did the typical lesbian cope by meditating, using relaxation 
techniques, or exercising? 
0% -----------------------------------------------------------------------------------------------100% 
 
When experiencing stress & stigma during the past month, what % of the time did the typical lesbian cope by talking to a close friend, 
family member, or mental health professional?  
0% -----------------------------------------------------------------------------------------------100% 
 
How acceptable or unacceptable does the Typical lesbian find using alcohol and drugs to cope with problems or negative emotions? 
Extremely Unacceptable ----------------------------------------------------------------------------------------------------------------- Extremely Acceptable 
 
How acceptable or unacceptable does the Typical Lesbian find seeing a mental health professional for help coping with problems or 
negative emotions? 
Extremely Unacceptable ----------------------------------------------------------------------------------------------------------------- Extremely Acceptable  
 
 
Health related questions to be featured in the final round for norm documentation purposes 
 
In the past month, how many days per week did the Typical Lesbian exercise for 45 minutes or longer (e.g., run, cycle, spin, lift weights, 
swim, etc.)? 
 0 
 1 
 2 
 3 
 4 
 5 

Office for Research Compliance 
Page 25 of 40 
7/26/2018 
 
 
 6 
 7 
 
How long ago was the Typical lesbian’s last routine wellness check-up? 
 less than 5 months ago 
 6-11 months 
 1 year 
 2 years 
 3 years 
 4 years 
 5 years or longer 
 
How long has it been since the Typical Lesbian last had a pap test? 
 6 months or less 
 7-12 months 
 1.5 years 
 2 years 
 2.5 years 
 3 years or longer 
 She has never had one! 
 
What percent of typical Lesbians are “out” to their doctor? 
0%----------------------------------------------------------------------%100 
 
What percent of lesbians currently smoke cigarettes or vape?  
0%----------------------------------------------------------------------%100 
 
What percent of lesbians used to smoke but successfully quit? 
0%----------------------------------------------------------------------%100 
 
What percent of lesbian smokers, regret ever having started smoking? 
0%----------------------------------------------------------------------%100 
 
What percent of lesbians would NOT date a smoker? 
0%----------------------------------------------------------------------%100 
 
 
 
 
 

Office for Research Compliance 
Page 26 of 40 
7/26/2018 
 
 
Potential non-health related control and filler questions to appear in rounds  
How many uhaul (cohabitating) relationships has the typical lesbian had? 
 0 
 1 
 2 
 3 
 4 
 5 
 6 
 7 
 8 
 9 
 10 or more 
 
How many ex-girlfriends has the typical lesbian in her 30s talked to in the past month? 
 0 
 1 
 2 
 3 
 4 
 5 
 6 
 7 
 8 
 9 
 10 or more 
 
What percent of lesbians currently have 1 or more cats in their household? 
0% -----------------------------------------------------------------------------------------------100% 
 
What percent of lesbians currently have 1 or more dogs in their household? 
0% -----------------------------------------------------------------------------------------------100% 
 
What percent of lesbians like cats more than dogs? 
0% -----------------------------------------------------------------------------------------------100% 
 
What percent of lesbians have rescued a pet? 
0% -----------------------------------------------------------------------------------------------100% 

Office for Research Compliance 
Page 27 of 40 
7/26/2018 
 
 
What percentage of lesbians see themselves living in their current state for the rest of their lives? 
0% -----------------------------------------------------------------------------------------------100% 
 
What percentage of lesbians see themselves getting married or are already married? 
0% -----------------------------------------------------------------------------------------------100% 
 
What percentage of lesbians see themselves raising children or are already raising children? 
0% -----------------------------------------------------------------------------------------------100% 
 
What percentage of lesbians want to give birth or already have?  
0% -----------------------------------------------------------------------------------------------100% 
 
What percentage of lesbians own a pair of Birkenstocks? 
0% -----------------------------------------------------------------------------------------------100% 
 
What percentage of lesbians have worn a beanie or a fedora during the past month? 
0% -----------------------------------------------------------------------------------------------100% 
 
What percentage of lesbians have worn a flannel shirt in the past month? 
0% -----------------------------------------------------------------------------------------------100% 
 
What percentage of lesbians own a black leather jacket? 
0% -----------------------------------------------------------------------------------------------100% 
 
What percentage of lesbians have short hair? 
0% -----------------------------------------------------------------------------------------------100% 
 
How many tattoos does the typical lesbian have? 
 0 
 1 
 2 
 3 
 4 
 5 
 6 
 7 
 8 
 9 
 10 or more 
 
How many flannel shirts does the typical lesbian own? 
 0 
 1 
 2 

Office for Research Compliance 
Page 28 of 40 
7/26/2018 
 
 
 3 
 4 
 5 
 6 
 7 
 8 
 9 
 10 or more 
 
How many piercings does the typical lesbian have? 
 0 
 1 
 2 
 3 
 4 
 5 
 6 
 7 
 8 or more 
 
How many times has the Typical Lesbian been in love? 
 0 
 1 
 2 
 3 
 4 
 5 
 6 
 7 
 8 or more 
 
What percent of lesbians have had a relationship with someone they met online?  
0%----------------------------------------------------------------------%100 
 
How acceptable or unacceptable would the typical lesbian find only seeing a new love interest twice a week for the first few months of 
dating? 
 Very Unacceptable 
 Moderately Unacceptable 
 Slightly Unacceptable 

Office for Research Compliance 
Page 29 of 40 
7/26/2018 
 
 
 Neither Unacceptable or Acceptable 
 Slightly Acceptable 
 Moderately Acceptable 
 Very Acceptable 
 
 
How acceptable or unacceptable would the typical lesbian find waiting at least 12 months to move in with a new girlfriend? 
 Very Unacceptable 
 Moderately Unacceptable 
 Slightly Unacceptable 
 Neither Unacceptable or Acceptable 
 Slightly Acceptable 
 Moderately Acceptable 
 Very Acceptable 
 
 
How acceptable or unacceptable would the typical lesbian find getting to know a love interest for 4 weeks before having sex with her? 
 Very Unacceptable 
 Moderately Unacceptable 
 Slightly Unacceptable 
 Neither Unacceptable or Acceptable 
 Slightly Acceptable 
 Moderately Acceptable 
 Very Acceptable 
 
Sex 
How many female sexual partners has the Typical Lesbian had? 
1 
13 
2 
14 
3 
15 
4 
16 
5 
17 
6 
18 
7 
19 
8 
20 or more 
9 
10 
11 
12 
 
During the past month, on average, how many days per week did the Typical Lesbian have sex? 
 0 
 1 
 2 

Office for Research Compliance 
Page 30 of 40 
7/26/2018 
 
 
 3 
 4 
 5 
 6 
 7 
 
During the past month, how long in duration was the Typical Lesbian's average sexual encounter? 
 10 minutes or less 
 11-20 minutes 
 21-30 minutes 
 31-40 minutes 
 41-50 minutes 
 51-60 minutes 
 61-70 minutes 
 71 minutes or more 
 
What percent of lesbians have experienced “lesbian bed death” or an extremely low frequency of sex in a serious relationship? 
0%----------------------------------------------------------------------%100 
 
What percent of lesbians scissor?  
0%----------------------------------------------------------------------%100 
 
What percent of lesbians have all 3 of the following social media accounts: Facebook, Twitter, Instagram? 
0%----------------------------------------------------------------------%100 
 
What percent of lesbians have used HER social app? 
0%----------------------------------------------------------------------%100 
 
What percent of lesbians read IntoMore or Autostraddle? 
0%----------------------------------------------------------------------%100 
 
How many seasons of the LWord has the typical lesbian seen? 
 0 
 1 
 2 
 3 
 4 
 5 

Office for Research Compliance 
Page 31 of 40 
7/26/2018 
 
 
 6 
 
How many times per day does the typical lesbian check Facebook? 
 0 
 1 
 2 
 3 
 4 
 5 
 6 
 7 or more 
 
 
How many times per day does the typical lesbian check Instagram? 
 0 
 1 
 2 
 3 
 4 
 5 
 6 
 7 or more 
 
How many times per day does the typical lesbian check Twitter? 
 0 
 1 
 2 
 3 
 4 
 5 
 6 
 7 or more 
 
 

Office for Research Compliance 
Page 32 of 40 
7/26/2018 
 
 
What percent of lesbians voted in the midterm election? 
0%----------------------------------------------------------------------%100 
 
What percent of lesbians have attended a political march or protest during the past year? 
0%----------------------------------------------------------------------%100 
 
What percent of lesbians consider themselves to be a feminist? 
0%----------------------------------------------------------------------%100 
 
What percent of lesbians hate men? 
0%----------------------------------------------------------------------%100 
 
What percent of lesbians have negative attitudes toward transwomen? 
0%----------------------------------------------------------------------%100 
 
What percent of lesbians are good at household repairs? 
0%----------------------------------------------------------------------%100 
 
What percent of lesbians have visited a home improvement store in the past month? 
0%----------------------------------------------------------------------%100 
 
What percent of lesbians consider themselves to be athletic? 
0%----------------------------------------------------------------------%100 
 
What percent of lesbians played a varsity sport in high school or college? 
0%----------------------------------------------------------------------%100 
 
What percent of lesbians own a toolbox? 
0%----------------------------------------------------------------------%100 
 
What percent of lesbians would change their own flat tire rather than calling AAA? 
0%----------------------------------------------------------------------%100 
 
What percent of lesbians are vegan or vegetarian? 
0%----------------------------------------------------------------------%100 
 
What percent of lesbians have been confused for sisters while out with a significant other? 
0%----------------------------------------------------------------------%100 
 
What percent of lesbians have been told their sexual identity is “just a phase” 
0%----------------------------------------------------------------------%100 
 
What percent of lesbians have seduced a straight woman? 
0%----------------------------------------------------------------------%100 
 
What percent of lesbians have had a threesome?  
0%----------------------------------------------------------------------%100 
 
What percent of lesbians have been in a polyamorous relationship? 
0%----------------------------------------------------------------------%100 
 

Office for Research Compliance 
Page 33 of 40 
7/26/2018 
 
 
Appendix D 
LezParlay Post-Competition Feedback Survey 
 
 
 

Office for Research Compliance 
Page 34 of 40 
7/26/2018 
 
 
 
 
 
 
 

Office for Research Compliance 
Page 35 of 40 
7/26/2018 
 
 
 

Office for Research Compliance 
Page 36 of 40 
7/26/2018 
 
 
 
 
 
 
 
 

Office for Research Compliance 
Page 37 of 40 
7/26/2018 
 
 
 
 
 
 
 
 

Office for Research Compliance 
Page 38 of 40 
7/26/2018 
 
 
 
 
 

Office for Research Compliance 
Page 39 of 40 
7/26/2018 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Office for Research Compliance 
Page 40 of 40 
7/26/2018 
 
 
 
[End of Survey Debriefing Statement]