Piloting a Web App for Sexual and Gender Minority Youth Mental Health
Phase: NA
Conditions: Mental Health
Sponsor: University of Pennsylvania

Social and Behavioral Sciences Human Research Protocol 
Version 4.0 
October14, 2021 
  
PRINCIPAL INVESTIGATOR: José Bauermeister, PhD, MPH 
 
PROTOCOL TITLE: Piloting a Web App for Sexual and Gender Minority Youth Mental Health 
 
INTRODUCTION AND PURPOSE: 
The purpose of this study is to assess the psychosocial effects of a novel web application (web app) 
called “immi” (short for ‘i am me’),” designed to provide sexual and gender minority youth (SGMY) with 
tools for affirming their identities and coping with minority stress. Prior research demonstrates that 
interventions that focus on providing SGMY with resources for adaptively coping with minority stress have 
the potential to improve their mental health and wellbeing. However, few digital resources exist to address 
this need. The goal of the proposed research is to test whether this novel and scalable web-based 
intervention has the potential to impact key psychosocial outcomes among SGMY ages 13-19, such as 
coping self-efficacy and symptoms of anxiety and depression. Please see the Background section of this 
application for more information. 
 
OBJECTIVES:  
Objective 1: To test whether SGMY randomly assigned to use the immi web app report significantly 
higher identity affirmation, subjective connectedness to the LGBTQ+ (Lesbian, Gay, Bisexual, 
Transgender, Queer/Questioning, and other sexual and gender minority identities) community, use of 
adaptive cognitive and behavioral coping skills, and psychosocial wellbeing (e.g. higher positive and 
negative affect, lower symptoms of depression and anxiety, and greater life satisfaction) than youth 
randomly assigned to a ‘resource list’ control group. The resource list control group will receive a list of 
technology-based psychosocial resources that are currently freely available to SGMY. 
  
Objective 2: To assess how individual differences in usage and satisfaction with the immi web app relate 
to the outcomes listed in Objective 1, and to identify areas for further tool optimization. We will achieve 
this by linking web app usage data to outcome data, as well as through collecting quantitative and 
qualitative data measuring user satisfaction and suggestions for improvement. 
  
BACKGROUND: 
Compared to their cisgender, heterosexual peers, sexual and gender minority youth (SGMY) are at 
increased risk of experiencing a wide variety of negative mental health outcomes. SGMY are twice as 
likely as their non-SGMY counterparts to report feeling sad or hopeless, and three times as likely to have 
considered attempting suicide.1 In one recent national survey, 65% of SGMY reported symptoms of 
moderate to severe depression as compared with 31% of their straight, cisgender peers.2    
  
The minority stress model provides a framework for understanding the higher prevalence of psychological 
distress and negative mental health outcomes for SGMY, as well as for identifying interventions to 
improve sexual and gender minority (SGM) mental health. Minority stress theory proposes that SGM 
health disparities can be explained in large part by discrimination from a homophobic and hostile culture, 
 
1 Centers for Disease Control and Prevention Youth Risk Behavior Survey (2017) 
2 Coping With Covid-19: How Young People Use Digital Media To Manage Their Mental Health (2021) 

which creates stressors unique to minority identity, including harassment, victimization, internalized 
homophobia, and expectations of rejection.3 Efficacious mental health interventions for SGMY have 
focused on providing resources for coping with minority stress, including affirming SGM identities, 
teaching cognitive and behavioral coping skills, and strengthening supportive social connections.4,5,6 
  
While prior research suggests that interventions that include these components may improve the mental 
health of SGMY, interventions have primarily been delivered within the context of time intensive, in-
person sessions, limiting their reach. Many SGMY face significant barriers to accessing affirming in-
person services7, an issue that has been exacerbated by the COVID-19 pandemic.8  Digital technologies 
can be utilized to help bridge this gap by meeting a pressing need within a medium in which youth are 
already seeking support. Over half of SGMY report spending over five hours a day online,9,10,11 and 
SGMY are more likely than those who identify as heterosexual to report going online for health 
information, including for support with depression (76% vs. 32%) and anxiety (75% vs. 36%)12. However, 
to date, there is little research examining the efficacy of web-based platforms for helping SGMY cope with 
minority stress.  
  
The proposed research seeks to fill this need by testing the efficacy of a web app for SGM ages 13-19. 
This web app is designed to facilitate SGM identity affirmation, promote a sense of connectedness to the 
LGBTQ+ community, and encourage cognitive and behavioral coping skill practice. This tool was built by 
Hopelab, a nonprofit social innovation lab, in collaboration with CenterLink, an international nonprofit 
organization and member-based association of LGBTQ (Lesbian, Gay, Bisexual, Transgender, and 
Queer) centers serving their local and regional communities. The goal of the proposed research is to 
assess the efficacy of this web app for improving key psychosocial outcomes among SGMY, such as 
coping self-efficacy and symptoms of anxiety and depression. 
 
3 Meyer, I. H. (2003). Prejudice, social stress, and mental health in lesbian, gay, and bisexual 
populations: conceptual issues and research evidence. Psychological bulletin, 129(5), 674. 
4 Craig, S. L., Austin, A., & McInroy, L. B. (2014). School-based groups to support multiethnic sexual 
minority youth resiliency: Preliminary effectiveness. Child and adolescent social work journal, 31(1), 87-
106. 
5 Craig, S. L., & Austin, A. (2016). The AFFIRM open pilot feasibility study: A brief affirmative cognitive 
behavioral coping skills group intervention for sexual and gender minority youth. Children and Youth 
Services Review, 64, 136-144. 
6 Lucassen, M. F., Merry, S. N., Hatcher, S., & Frampton, C. M. (2015). Rainbow SPARX: A novel 
approach to addressing depression in sexual minority youth. Cognitive and Behavioral Practice, 22(2), 
203-216. 
7 Keuroghlian, A.S.; Ard, K.L.; Makadon, H.J. Advancing health equity for lesbian, gay, bisexual and 
transgender (LGBT) people through sexual health education and LGBT-affirming health care 
environments. Sex. Health 2017, 14, 119–122. [CrossRef] 
8 Fish, J. N., McInroy, L. B., Paceley, M. S., Williams, N. D., Henderson, S., Levine, D. S., & Edsall, R. N. 
(2020). “I'm Kinda Stuck at Home With Unsupportive Parents Right Now”: LGBTQ Youths' Experiences 
With COVID-19 and the Importance of Online Support. Journal of Adolescent Health, 67(3), 450-452. 
9 McInroy, L.B.; Craig, S.L.; Leung, V.W.Y. Platforms and patters for practice: LGBTQ+ youths’ use of 
information and communication technologies. Child Adolesc. Soc. Work J. 2019, 36, 507–520. [CrossRef] 
10 GLSEN; CiPHR; CCRC. Out Online: The Experiences of Lesbian, Gay, Bisexual and Transgender 
Youth on the Internet; GLSEN: NewYork, NY, USA, 2013. Available online: 
https://www.glsen.org/sites/default/files/2020-01/Out_Online_Full_Report_2013.pdf 
11 Lenhart, A. Teens, Social Media and Technology Overview 2015; Pew Research Center: Washington, 
DC, USA, 2015. Available online: http://pewrsr.ch/1aoDmdM (accessed on 11 December 2020). 
12 Rideout, V. & Fox, S. (2018) Digital Health Practices, Social Media Use, and Mental Well-Being Among 
Teens and Young Adults in the U.S. Hopelab and Well Being Trust.  

 

200 
CHARACTERISTICS OF THE STUDY POPULATION: 
  
1. Target Population and Accrual: 
We will recruit 300 participants from across the United States, ages 13-19, who self-identify as sexual or 
gender minorities. To ensure that our results generalize to SGM of color, who face multiple forms of 
intersecting minority stress, we will over-recruit non-white participants such that they comprise 
approximately 75% of our sample (~225 participants). Non-Hispanic white participants will comprise 
approximately 25% of our sample (~75 participants). Participants will be recruited through social-media 
based advertisements posted on platforms such as Facebook, Tumblr, Instagram, Reddit, Jack’d, Grindr, 
and Twitter. Participants will be randomly assigned to a condition [experimental  vs. control] in a 1:1 
fashion. See the statistical analysis section for more details on statistical methods and theoretical 
justification for the sample size.  
 
  
2. Key Inclusion Criteria: 
Participants will be eligible if they: 
1. Are between 13-19 years of age (inclusive) 
2. Self-identify as a sexual or gender minority 
3. Are English literate 
4. Reside within the United States 
5. Have access to a device that has internet access, a web browser, and SMS capabilities, such as 
a smartphone, computer, or tablet 
6. Willingness to participate in study activities 
 
Additionally, given that this is an online intervention, in order to be considered enrolled in the study, 
individuals must pass enrollment verification procedures which are detailed in the attached “SOP-
Applicant Verification.pdf.” If all criteria are met, participants will be randomized into a study arm and 
considered enrolled into the study. 
 
Justification 
We are testing the product with 13-19 year olds because the web app itself was designed in collaboration 
with young people in this age range, and the content of the app developmentally targets their specific 
questions and concerns. Additionally, this age range is critical for this research because adolescence is a 
pivotal period for sexual and gender identity development, and one in which SGM youth exhibit 
significantly higher levels of identity-related mental health problems compared to their straight cis-gender 
peers (Marshal et al., 2011). Thus, interventions aimed at affirming SGM identities and managing identity-
related minority stress--such as the proposed intervention--have the potential for greatest impact when 
delivered to this age group. It is important to study this “vulnerable population” because they are at risk for 
negative cognitive, behavioral, and mental health outcomes. The development and testing of 
interventions targeted to this age group has the potential for significant gains in health for this age group.  
 
The immi web app is specifically designed to teach cognitive and behavioral coping skills for responding 
to minority stress. We are proposing over-recruiting non-white (i.e., those who self-identify as at least one 
race or ethnicity other than white) participants because we want to ensure that our results are 
generalizable to those who face multiple forms of intersecting minority stress. 
 

  
3. Key Exclusion Criteria: 
Exclusion criteria for enrollment into the study include: 
1. Age younger than 13 or older than 19 
2. Do not self-identify as SGM 
3. Not English-literate 
4. Reside outside of the United States 
5. Do not have access to a device that has internet access, a web browser, and SMS capabilities, 
such as a smartphone, computer or tablet 
6. Are not willing to participate in study activities 
 
  
4. Subject Recruitment and Screening: 
We will reach the study population using social media ads on platforms including Facebook, Tumblr, 
Instagram, Reddit, Jack’d, Grindr, and Twitter, and other comparable social media platforms (see 
example copy and images in “Recruitment materials.pdf”). Social media platforms allow us to specify our 
audience based on socio-demographic characteristics (e.g., age, race/ethnicity) to increase their 
specificity to our population. 
Ads will link interested individuals to a 5-10 minute uncompensated Qualtrics screener where they may 
verify their eligibility or email the team if they have questions. The screener survey will provide potential 
participants with basic information about the study purpose, procedures, and compensation. Individuals 
will then be asked for consent to take the screener. Those who consent will be asked questions to 
determine their eligibility, and asked to provide their first name, email address, and phone number. Those 
who do not consent to take the screener will be routed to a public site (e.g., Google).  
All individuals who complete the screener will be asked if they would like to be contacted about other 
research studies in the future, then will be routed to a public site (e.g., Google). For those who are eligible 
based on their screener responses and pass the initial fraud verification process, we will email them with 
a link to the informed consent form. Individuals who consent will complete a 30- to 40-minute baseline 
survey. Compared to the gold standard (in-person interviewing), a limitation of online research – like mail 
and phone surveys – is the challenge of verifying a respondent’s authenticity. Using best practices1314 
(see SOP-Applicant Verification.pdf), we will attentively reduce the likelihood of duplicative entries, bots, 
and/or catfishing (fake online personas). Verified participants will be randomized into one of the two study 
arms. 
Web-based recruitment screener: The online survey is hosted by Qualtrics. It will include the eligibility 
script, consent/assent to be screened, and the screener questions. It will ask for the first name, email, and 
phone number of the applicant. We use Secure Socket Layer (SSL) encryption for online transfers of 
information, and data will be stored on Qualtrics’ secure, HIPAA-compliant servers. 
 
13 Teitcher JEF, Bockting WO, Bauermeister JA, Hoefer CJ, Miner MH, Klitzman RL. Detecting, preventing, and 
responding to "fraudsters" in internet research: Ethics and tradeoffs. J Law Med Ethics 2015;43:116-33. 
14 Bauermeister J, Pingel E, Zimmerman M, Couper M, Carballo-Dieguez A, Strecher VJ. Data Quality in web-
based HIV/AIDS research: Handling Invalid and Suspicious Data. Field methods 2012;24:272-91. 

 
5. Early Withdrawal of Subjects: 
Participants are told in the consent form that they can withdraw from the study by contacting Dr. José 
Bauermeister at the University of Pennsylvania by email (bjose@nursing.upenn.edu).  
Participants may also be withdrawn by the study PI at any time for the following reasons: 
● 
A participant is flagged to have a duplicate or fraudulent registration during the fraud detection 
process. Fraudulent entries will not be counted towards study recruitment totals. 
● 
Failure to follow study instructions 
● 
Other circumstances in which a PI determines that continued study participation is not in the best 
interest of a participant 
● 
The subject becomes incarcerated or placed in detention during the study 
● 
Death of the subject 
No further data collection will occur from the date the decision is made to permanently discontinue the 
subject from the study. 
  
6. Vulnerable Populations: 
This research specifically targets a vulnerable population, children (ages 13-17). Please see “Vulnerable 
populations - children.doc” attached to this application for more information. 
 
7. Populations vulnerable to undue influence or coercion: 
Using online recruitment methods and consent processes where the intervention is not pitched by a 
recruiter minimizes the risk of potential coercion. Instead, individuals will be able to click on the 
recruitment advertisement and decide if they wish to learn more or not. Consent documents will fully 
explain the study procedures, potential risks, and potential beneﬁts. Participants will also be reminded 
that the study participation is voluntary and that refusing to participate in the study or withdrawing from 
the study is an option at any time. 
  
STUDY DESIGN: 
The research activities involve a two-arm prospective RCT enrolling a sample of 300 SGMY (ages 13-19). 
After consent and completion of the online baseline survey, SGMY will be randomized to either the 
control or experimental condition (Control, n=150; Experimental, n=150). A self-completed online follow-
up survey will be conducted at 4 weeks for all participants.  
 
Participants randomized to the control group will be given access to a website that includes a list of freely 
available web-based resources for SGMY. They will have access to resources on this list for the 4-week 
active study period, but will not receive any engagement reminders, matching the conditions present in 
real world contexts in which web-based resource lists are available to SGMY. 
 
Participants randomized to the experimental group will be given access to the study web app and will be 
encouraged to engage with the web app as much as they like over the four-week active study period. 
During the active study period, they will receive periodic reminders via SMS and/or email to visit the web 
app.  

 
The goal of the proposed research is to test whether a novel and scalable web application (app) designed 
to provide SGMY with tools for affirming their identity and coping with minority stress has the potential to 
impact key psychosocial outcomes (e.g., coping self-efficacy and symptoms of anxiety and depression) 
among a sample of 300 SGMY. 
 
Overall, the estimated data collection time for participants includes 10 mins for the initial recruitment, and 
two online surveys that are each approximately 30-40 mins. Thus, the total amount of time spent on the 
study activities (not including web app or online resource site usage) would be approximately 1-1.5 hrs. 
The amount of time spent using the web app will vary, depending on the interest and engagement of the 
participants. The web app is designed to facilitate delivery of SGMY identity affirming content and 
cognitive and behavioral coping skills exercises that average 5-10 minutes in length. However, the 
participants are free to use the guides as little or as much as they like. The amount of time experimental 
participants spend using the web app is unrelated to their compensation. 
 
The study is funded for 8 months (Project Period: 07/01/2021 to 02/28/2022). Once consented, 
participants will be active in the study for 4 weeks. 
 
     
METHODS: 
  
1. Study Instruments: 
Participants will complete two online surveys during the trial (baseline and a follow-up survey on Day 28). 
Assessments will take 30-40 minutes to complete. Assessment measures fall into four categories: 1) 
psychological targets, 2) psychosocial wellbeing and mental health, 3) intervention acceptability and 
satisfaction, and 4) demographics and other baseline assessments.  
 
Psychological Targets. The immi web app is designed to 1) affirm SGM identities, 2) promote a sense of 
connectedness to the SGM community, and 3) teach adaptive cognitive and behavioral coping skills. 
Aligned with our theory of change, we will measure psychological targets that map onto each of these 
three constructs at baseline and at follow-up.   
 
Specifically, to measure change in SGM identity related constructs, we will administer the identity 
affirmation subscale from Lesbian Gay and Bisexual Positive Identity Measure.15 We will also administer 
the concealment motivation, internalized homonegativity, and acceptance concerns subscales of the 
Lesbian Gay and Bisexual Identity Scale.16 A single item measure of ‘outness’ to friends and family will be 
included to assess change in willingness to disclose one’s SGM identity.17 
  
 
15 Riggle, E. D., Mohr, J. J., Rostosky, S. S., Fingerhut, A. W., & Balsam, K. F. (2014). A multifactor 
lesbian, gay, and bisexual positive identity measure (LGB-PIM). Psychology of Sexual Orientation and 
Gender Diversity, 1(4), 398-411. 
16 Mohr, J. J., & Kendra, M. S. (2011). Revision and extension of a multidimensional measure of sexual 
minority identity: The Lesbian, Gay, and Bisexual Identity Scale. Journal of counseling psychology, 58(2), 
234-245. 
17 Quinn, D. M., Williams, M. K., Quintana, F., Gaskins, J. L., Overstreet, N. M., Pishori, A., ... & Chaudoir, 
S. R. (2014). Examining effects of anticipated stigma, centrality, salience, internalization, and outness on 
psychological distress for people with concealable stigmatized identities. PloS one, 9(5), e96977. 

To measure change in a sense of connectedness to the SGM community, we will administer the 
community subscale from the Lesbian Gay and Bisexual Positive Identity Measure.18 To assess change 
in coping and coping self-efficacy we will administer the Brief Coping Orientations to Problems 
Experienced Inventory19 which measures the use of specific cognitive and behavioral coping skills; the 
Coping with Discrimination Scale20 which measures coping in response to instances of SGM related 
discrimination, and the Stress Appraisals Measure for Adolescents,21 which measures coping self-
efficacy.   
 
Psychosocial Wellbeing and Mental Health Measures. To determine the effect of the intervention on 
psychosocial wellbeing and mental health, we will assess the following constructs at baseline and follow 
up: 1) perceived stress (4-item Perceived Stress Scale)22 2) symptoms of anxiety (Generalized Anxiety 
Disorder Screening (GAD-7)23, 3) symptoms of depression (Patient Health Questionnaire (PHQ-8))24, 4) 
positive and negative affect (The 10-item Positive and Negative Affect Scale for Children (PANAS-C))25, 
5) feelings of shame and guilt (Shame and Guilt Scale)26, 6) perceived belonging (the Thwarted 
Belongingness subscale of the Interpersonal Needs Questionnaire (INQ))27, and 7) subjective wellbeing 
(the Flourishing Scale)28. We will also measure change in substance use behaviors from pretest to 
posttest using the Car, Relax, Alone, Forget, Friends, Trouble Screening Test (CRAFFT).29 
 
Intervention Acceptability and Satisfaction. At follow-up, participants in the experimental group will report 
on the acceptability of the intervention. We will ascertain participants' opinions about the relevancy and 
appropriateness of the intervention to SGM young people using a modified version of LGBTQ 
 
18 Riggle, E. D., Mohr, J. J., Rostosky, S. S., Fingerhut, A. W., & Balsam, K. F. (2014). A multifactor 
lesbian, gay, and bisexual positive identity measure (LGB-PIM). Psychology of Sexual Orientation and 
Gender Diversity, 1(4), 398-411. 
19 Carver, C. S. (1997). You want to measure coping but your protocol is too long: Consider the brief 
cope. International journal of behavioral medicine, 4(1), 92-100. 
20 Ngamake, S. T., Walch, S. E., & Raveepatarakul, J. (2014). Validation of the coping with discrimination 
scale in sexual minorities. Journal of homosexuality, 61(7), 1003-1024. 
21 Rowley, A. A., Roesch, S. C., Jurica, B. J., & Vaughn, A. A. (2005). Developing and validating a stress 
appraisal measure for minority adolescents. Journal of Adolescence, 28(4), 547-557. 
22 Lee, E. H. (2012). Review of the psychometric evidence of the perceived stress scale. Asian nursing 
research, 6(4), 121-127. 
23 Spitzer, R. L., Kroenke, K., Williams, J. B., & Löwe, B. (2006). A brief measure for assessing 
generalized anxiety disorder: the GAD-7. Archives of internal medicine, 166(10), 1092-1097. 
24 Kroenke, K., Strine, T. W., Spitzer, R. L., Williams, J. B., Berry, J. T., & Mokdad, A. H. (2009). The 
PHQ-8 as a measure of current depression in the general population. Journal of affective disorders, 
114(1-3), 163-173. 
25 The 10-Item Positive and Negative Affect Schedule for Children, Child and Parent Shortened Versions: 
Application of Item Response Theory for More Efficient Assessment 
26Diener, E., Smith, H., & Fujita, F. (1995). The personality structure of affect. Journal of personality and 
social psychology, 69(1), 130-141. 
27 Van Orden, K. A., Cukrowicz, K. C., Witte, T. K., & Joiner Jr, T. E. (2012). Thwarted belongingness and 
perceived burdensomeness: construct validity and psychometric properties of the Interpersonal Needs 
Questionnaire. Psychological assessment, 24(1), 197-215. 
28 Diener, E., Wirtz, D., Tov, W., Kim-Prieto, C., Choi, D. W., Oishi, S., & Biswas-Diener, R. (2010). New 
well-being measures: Short scales to assess flourishing and positive and negative feelings. Social 
indicators research, 97(2), 143-156. 
29 Knight, J. R., Sherritt, L., Shrier, L. A., Harris, S. K., & Chang, G. (2002). Validity of the CRAFFT 
substance abuse screening test among adolescent clinic patients. Archives of pediatrics & adolescent 
medicine, 156(6), 607-614. 

Appropriateness Scale30. We will assess the perceived usability of the web app with the Systems 
Usability Scale31. A measure of intervention satisfaction and suggestions for intervention improvement 
that was created in-house for the purpose of this study will also be included. This measure consists of 
multiple choice questions (e.g. ‘How would you rate your overall experience of this product?’ (1 = 
excellent to 7 = very bad) and free text responses (e.g. How could this product be more helpful to you? 
[text box]). We will measure intervention exposure using paradata from the intervention, including counts 
of user sessions, session lengths, and pages visited. 
 
Demographics and other baseline assessments. To describe our sample and examine whether the 
experimental and control groups differ on any key demographic characteristics at baseline, we will include 
standard demographic measures (e.g. age, race, ethnicity etc.) as well as measures of gender identity, 
sexual orientation, preferred pronouns, sex assigned at birth, educational attainment, educational status, 
socioeconomic status, and living situation. To characterize our sample and to examine whether the 
effects of the intervention differ for adolescents experiencing differing levels of minority stress, we will 
include a short version of the Sexual Minority Adolescent Stress Inventory32 at baseline. We will also 
include a measure of mental health and other affirmative LGBTQ+ resources accessed in the last 12 
months at baseline to better characterize the degree to which our sample already has access to 
supportive resources (adapted from McInroy et al. 2019 & the Trevor Project, 2021)3334. 
  
 
2. Group Modifications: 
We modified the language in the following study instruments to make the instruments more inclusive of a 
range of SGM identities (e.g., the original question, “I prefer to keep my same-sex romantic relationships 
rather private” has been changed to, “I prefer to keep my LGBTQ+ identity rather private”):  
 
Lesbian Gay and Bisexual Identiy Scale (LGBIS) 
Lesbian, Gay, Bisexual Positive Identity Measure (LGB-PIM) 
 
We also updated the wording in the Systems Usability Scale (SUS) to specify the name of our web app. 
 
  
3. Method for Assigning Subjects to Groups: 
Those who complete a baseline assessment and pass fraud checks will be randomized to the 
experimental or resource list control group on a 1:1 basis.  
 
 
 
30 Lyons, A., Rozbroj, T., Pitts, M., Mitchell, A., & Christensen, H. (2015). Improving e-therapy for mood 
disorders among lesbians and gay men: A practical toolkit for developing tailored web and mobile phone-
based depression and anxiety interventions. Monograph Series No. 102. The Australian Research Centre 
in Sex, Health and Society, La Trobe University: Melbourne, Australia. 
31 Brooke, J. (1996). SUS-A quick and dirty usability scale. Usability evaluation in industry, 189(194), 4-7. 
32 Schrager, S.M., Mamey, M.R., Rusow, J., & Goldbach, J.T. (2021). The Sexual Minority Adolescent 
Stress Inventory – Short Form (SMASI-SF). [Manuscript submitted for publication]. 
33 McInroy, L. B., McCloskey, R. J., Craig, S. L., & Eaton, A. D. (2019). LGBTQ+ youths' community 
engagement and resource seeking online versus offline. Journal of Technology in Human Services, 
37(4), 315-333. 
34 The Trevor Project. (2021). 2021 National Survey on LGBTQ Youth Mental Health. West Hollywood, 
California: The Trevor Project.  

4. Administration of Surveys and/or Process: 
We will collect survey data via online self-completed Qualtrics surveys administered at baseline and 4 
weeks. Participants will enter their own responses to questions directly into the survey on their personal 
computer, smartphone or tablet. 
 
Individuals who complete the screener survey and are eligible will be sent a link to the informed consent 
form. Those who provide their consent will complete a baseline assessment which will take approximately 
30-40 minutes. At the end of the 4-week active study period, participants will complete an online survey to 
assess key psychosocial outcomes. This follow-up survey will take participants approximately 30-40 
minutes to complete.  
 
The incentive for completing the baseline survey is $30 and the follow-up survey incentive is $40. These 
incentives are small enough to avoid coercion, yet sufﬁciently substantial to promote retention. In order 
for interventions to be evaluated as potential best evidence-based interventions through CDCs Prevention 
Synthesis Research activity, data must be available for at least a single follow-up time point for at least 
70% of participants. As described below, a detailed retention plan for the study will draw on previously 
successful retention protocols to achieve at least an 80% retention rate for the follow-up survey. 
  
If a participant does not complete their follow-up survey by Day 31, we will send a reminder message via 
email, SMS, or direct message via social media (depending on the participant's communication 
preferences). The participant will be recontacted using the same methods on Day 35, 39, and 42 if they 
still have not completed the survey. Each contact will be logged in a spreadsheet.  
 
 
5. Data Management: 
Qualtrics security 
We will implement several strategies to offset risks of loss of conﬁdentiality related to web survey data 
collection. Only authorized research team members with a login name and password will be able to 
access and open the survey through the Qualtrics site. All data files will have encryption and password 
protection. Any identifiable data will either be stored on University of Pennsylvania secure servers or will 
be on fully encrypted laptops. Surveys and online eligibility screening will take place on an encrypted 
commercial survey website, Qualtrics. This site has been used by the investigators for numerous online 
surveys with SGM participants with no data security breaches. Access to data will be on a role-based 
standard; only those study staff who require access to each type of data to complete their study-related 
roles will be allowed access. All study staff will be trained in security and confidentiality procedures. 
 
We use SSL encryption for transfers of information online. Qualtrics uses Transport Layer Security (TLS) 
encryption (also known as Hypertext Transfer Protocol Secure (HTTPS)) for all transmitted data. Survey 
data are protected with passwords and HTTPS referrer checking. The data is hosted by third party data 
centers that are Statement on Standards for Attestation Engagements (SSAE)-16 Service Organization 
Control (SOC) II certified. All data at rest are encrypted, and data on deprecated hard drives are 
destroyed by U.S. Department of Defense methods and delivered to a third-party data destruction 
service. 
 
Qualtrics deploys the general requirements set forth by many Federal Acts including the Federal 
Information Security Management Act (FISMA) of 2002. They meet or exceed the minimum requirements 

as outlined in Federal Information Processing Standards (FIPS) Publication 200. All client data are 
considered confidential, and treated as such. 
 
Related to HIPAA, Health Information Technology for Economic and Clinical Health Act (HITECH) are 
updated assessment rules to ensure that data are properly protected and best security practices are 
followed. By using secure and certified data centers, Qualtrics ensures the highest protection and testing 
as per HITECH requirements. 
 
Participant survey data will be collected and stored separately from the web app intervention data, and 
will only be accessible to study staff. Survey and intervention data will be identified using study ID 
numbers, assigned by study staff, which will be unrelated to the participant’s name or email address.  
 
Memberspace security 
After a participant completes their baseline survey and passes fraud checks, they will be randomly 
assigned to the experimental or control condition. At this point, we will securely pass study ID to 
MemberSpace. MemberSpace is the system on which participants will complete the enrollment process 
(by creating an account) for the study web app they are randomly chosen to receive. 
 
MemberSpace secures all member login details using modern SSL encryption. Their primary data and 
servers are hosted on Amazon’s AWS data centers in the United States and all access to 
MemberSpace's backend is secured over SSL (HTTPS), which ensures that the information is encrypted. 
Memberspace uses Bcrypt and a per user salt to save user passwords in the form of a hash value. They 
also use Cloudflare to protect against numerous types of potential attacks.  
 
Memberspace also ensures that all employees and contractors have read, understood, and signed their 
customer data NDA and Company Handbook documents. They have a DevOps team that monitors their 
network traffic and data sources for abnormal issues and performs regular reviews such as: 
 
● 
Review of all personnel security access 
● 
Review any security measure updates personnel need to know about 
● 
Review of backup procedures for all stored media 
● 
Review of all 3rd party sub-processors 
 
The study web app is built on SquareSpace so once a participant signs up, they will be interacting with 
content built on this platform. However, no data is stored or processed by SquareSpace. 
 
Typeform security 
While interacting with the web app, participants will be prompted to interact with/fill out embedded forms 
powered by Typeform. Typeform will store the participants’ form responses and their study ID. Typeform 
is ISO 27001, SOC II, and HIPAA compliant. They hire well recognized security research firms to perform 
regular penetration tests on their platform. Their infrastructure is hosted on Amazon Web Services with 
their main servers sitting in the USA and backup servers in Frankfurt, Germany.  
 
Typeform’s environments are hosted in a Virtual Private Cloud (VPC) in AWS where their production 
networks are separated between public and internal services. No inbound internet traffic is allowed on the 
private subnets, and all application servers only reside in private subnets without public IP addresses. 
Only Amazon managed and maintained load balancers have ingress access to the application internal 
servers. Tight security groups control inbound and outbound access to the servers. 

 
Firewalls, Intrusion Detection Systems, Web Application Firewalls, and other security state of the art 
perimetral controls are installed at the edge locations to provide an additional layer of internal and 
external network security. In short, all the networks that Typeform uses are as secure as they can 
manage. Access to their servers is strictly limited, and no outside traffic is permitted on them.  
 
Fivetran security  
We use Fivetran, a data collection and integration platform, to unify participant data that we are collecting 
through disparate systems (web hooks, Typeform, etc.). Fivetran follows the principle of least privilege 
within their system. Their data pipeline and web hooks are designed to ensure that data is always 
encrypted, whether at rest or in motion. Fivetran relies on a combination of ephemeral keys and HSM-
backed customer master keys to protect data transiting through their system, as well as metadata and 
configuration data stored long-term. They deploy log-based monitoring and anomaly detection to enable 
their team to respond to threats in real-time and, to reduce the risk of accidental exposure, have 
implemented security protocols to ensure that pipeline data never remains after arrival at the destination. 
Fivetran undergoes an independent SOC II (Type 2) review every year.  
 
BigQuery Security 
Fivetran delivers all connected data to our central data warehouse, BigQuery. BigQuery automatically 
encrypts all data before it is written to disk. The data are automatically decrypted when read by an 
authorized user. To protect data as it travels over the Internet during read and write operations, Google 
Cloud uses Transport Layer Security (TLS).  
 
Sigma Security 
Sigma is a business intelligence and analytics tool that sits on top of BigQuery. Sigma is HIPAA, SOC II, 
GDPR, and CCPA compliant. Encryption is enforced between clients and Sigma and all components of 
the Sigma platform are using at least TLS 1.2. Sigma does not connect their cloud networks to their office 
networks and undergoes various forms of internal as well as third-party vulnerability checking on a regular 
basis to ensure maximum security.  
 
 
6. Subject Follow-up:  
This study involves one follow-up at 4 weeks after baseline survey completion. A detailed retention plan 
(see “SOP-Participant Retention.pdf”) will draw on our prior successful protocols with hard to reach 
populations to achieve ≥80% retention rate for the 4-week assessment. We will use best practices to 
retain participants while being sensitive to undue disclosure of SGMY participating in the study. Every 
effort will be made to reduce attrition as retention is critical to our study efforts. Correlates of missing data 
and attrition will be carefully examined. We will compare those who completed the follow-up survey with 
those who did not on key predictors from the baseline assessment to check for possible sample bias.  
Participants will be discontinued from the study in the event that we are notified that they are imprisoned, 
committed to a mental hospital, hospitalized for long term care, admitted to a drug/alcohol residential 
program, or a residential living facility. 
 
 
 

STUDY PROCEDURES 
  
1. Detailed Description: 
The research activities involve a two-arm prospective RCT enrolling a sample of 300 SGMY. After 
consent and completion of the baseline survey, SGMY are randomized to either the control or 
experimental condition (Control, n=150; Intervention: n=150). A self-completed online follow-up survey 
will be conducted at 4 weeks for all participants.  
 
Attention Control Condition: Participants randomized to the control group will be given access to a 
website that includes a list of freely available web-based resources for SGMY. They will have access to 
resources on this list for the 4-week active study period, matching the conditions present in real world 
contexts in which web-based resource lists are available to SGMY. 
 
Experimental Condition: The intervention component of the app aims to facilitate LGBTQ+ identity 
affirmation, promote connectedness to the LGBTQ+ community, and encourage cognitive and behavioral 
coping skill practice. Participants in the experimental arm will receive access to immi, a web app with four 
main content areas: 1) gender identity (the gender guide), 2) sexual orientation (the queerness guide), 3) 
stress and coping (the stress guide), and 4) internalized stigma (the internalized stigma guide). The web 
app content can be engaged with at the discretion of the participant, in any order. See a short description 
of the content of each guide below.  
  
● 
The gender guide allows young people to explore their gender identities and expression through 
a wide range of activities. For example, one activity uses a chatbot to let users experiment with 
different names and pronouns that fit their gender identity and to reflect on how they feel using 
different names.  
● 
The queerness guide allows users to reflect on different aspects of their sexual identities as well 
as to read the stories of other LGBTQ+ young people. For example, in one exercise, the user 
interacts with a chatbot to explore their own definition of queer through questions like, “What is a 
quote, picture, book, or other piece of content that embodies and affirms queerness for you?” 
● 
The stress guide teaches cognitive and behavioral coping skills through activities, such as a 
guided breathing exercise, and an activity about how stress shows up in the body.  
● 
The internalized stigma guide introduces the concept of internalized stigma and allows users to 
explore how internalized stigma shows up for them. For example, one activity uses a chatbot to 
explore positive self-talk to combat internalized stigma. 
 
Within each of these four guides, there are exercises and informational resources aimed at:  
1.) Affirming LGBTQ+ identities. For example, the following exercise, within the gender guide, 
allows users to experiment with and affirm their LGBTQ+ identities by prompting them to reflect 
on how wearing various types of clothing helps them experiment with and express their gender 
identity. 
 

 
 
2.) Promoting connectedness to the LGBTQ+ community. For example, the product includes 
quotes and videos in which LGBTQ+ young people discuss their experiences. Below is an activity 
in the queerness guide that introduces the idea of intersectional identities and allows the user to 
flip through profiles that tell the stories of other LGBTQ+ teens. 
 
 

  
 
3.) Teaching cognitive and behavioral coping skills. For example, the stress guide introduces 
the following interactive breathing exercise along with a description of why it is helpful.  
 
 
 
App navigation  
At the top of the screen, users will see a navigation bar with the names of the different guides. The guides 
also appear as “cards” on the home screen that users can click on. The cards and navigation bar items 
are labeled with the names of the guides: “Gender,” “Queerness,” “Stress,” “Internalized Stigma.” 
Additional features of the website include a crisis disclaimer and a link to the footer where crisis resources 
are listed and a quick exit button on the top right that is accessible in one click.  
 

Strategies to Ensure Sample Diversity: We will reach the population using social media ads on sites 
including Facebook, Tumblr, Instagram, Reddit, Jack’d, Grindr, and Twitter. Ad targeting within social 
media sites allows us to specify the age range and other socio-demographic characteristics of individuals 
who will see the ads based on the information they provide in their online profiles. We will develop ads 
that promote our target population’s interest by including diverse images of youth (i.e., images of different 
ages, portraying diverse race/ethnicity), as well as using ad-targeting specific to socio-demographic 
characteristics (e.g., delivering Facebook/Instagram ads only to youth based on their age, race/ethnicity 
and sex) and interests (e.g., TV shows with LGBT themes). Ads will link interested individuals to the study 
screener where they may verify their eligibility or email the team if they have additional questions about 
the study. 
Data Collection & Retention: SGMY will click on social media advertisements and be taken to a 
Qualtrics page containing basic study information and a short description of study activities. Screening: 
Interested individuals will be asked to consent to and complete an online screener. We will use this 
approach as one of our strategies for filtering fraudulent or duplicate entries. Individuals who do not meet 
the eligibility criteria will be thanked for their interest and automatically routed to the Google page. We will 
not indicate why they were ineligible to avoid unintentional disclosure and to protect against fraud. 
Consent: Individuals who screened eligible and passed initial verification (see SOP-Applicant 
Verification.pdf) will be sent a link to the study consent form (a waiver of parental consent will be obtained 
for minor participants). SGMY who do not consent will be taken to a screen thanking them for their 
interest. Baseline & Randomization: Those who consent will complete the baseline survey. Study staff 
will perform a second round of verification once a baseline survey has been completed. Those who pass 
verification will be randomized 1:1 into the control or experimental condition. Registration: After 
randomization, participants will be sent a link to either the control condition website or the intervention 
web app. Once a participant registers for an account on the website or web app, they will receive their 
baseline incentive. 
Measures to protect against fraud and hacking: We will use best practices to reduce the likelihood of 
online fraud: (1) Keep compensation sufficiently low (i.e., balance incentives with the effort required from 
respondents) to reduce the chances of respondents participating solely to gain incentive payments. (2) 
Cross-check information between the screener and baseline surveys (e.g., compare zip code entered on 
screener with City and State entered on baseline). This verification process is commonly used in online 
research and aims to prevent individuals from being enrolled in a study more than once, and to prevent 
bots from enrolling. (3) Verify IP address location is located in the United States. See “SOP-Applicant 
Verification.pdf” for detailed procedures. 
 
2. Data Collection: 
Not applicable  
  
 
3. Genetic Testing: 
Not applicable 
  
 
4. Use of Deception: 
Not applicable 

  
5. Statistical Analysis: 
Descriptive statistics of the psychosocial and demographic characteristics of the participants will be 
described for all and by intervention group. These will be compared between treatment groups using t-
tests or Wilcoxon rank sum tests for continuous variables and chi-square tests for categorical variables.  
  
Main intent-to-treat analyses will compare the experimental to the control group on self-assessed 
psychosocial outcomes immediately post-intervention, controlling for baseline values on those variables. 
For each construct (e.g. anxiety, depression, positive/negative emotions), a separate analysis will be 
used to evaluate the difference in magnitude of change from baseline to the week 4 follow-up assessment 
as a function of intervention condition (experimental vs control). We will also examine if there is a 
difference in change over time by examining the interaction of time by condition.  
  
Descriptive statistics of the psychosocial and demographic characteristics of the participants will be 
described for all and by intervention group. We will also examine participants’ web app usage, satisfaction 
with the web app, and how web app usage and satisfaction correlates with improvements in psychosocial 
wellbeing. We will report descriptive statistics for web app usage and satisfaction (e.g. means, medians, 
standard deviations, IQR), and will conduct pearson’s or spearman’s correlations to explore whether 
greater engagement with the web app (e.g. indexed by number of pages viewed, time spent in the web 
app) etc. is positively correlated with improvement in each outcome variable from week 0 to 4 within the 
experimental group.  
  
In order to adequately power this trial to detect effects that are medium-in-size or larger (Cohen’s d > = 
.50), we plan to recruit 300 participants, and randomly assign them to conditions in a 1:1 fashion. Medium 
effect sizes are roughly in line with those observed in prior psychosocial interventions for SGM teens and 
young adults (Craig et al. 2012; Craig et al., 2021; Lucassen et al. 2015; Pachankis et al., 2015).  A 
sample of 300 participants was selected to account for a non-compliance and/or attrition rate of up to 
35% of the recruited sample, a rate which is in line with conservative estimates of participant attrition from 
the trials cited above. This sample size will serve as a buffer to ensure that any participant loss will not 
undermine the power of the statistical analyses. After accounting for the potential loss to follow-up, a 
sample size of ~97 participants per group is necessary in order to detect moderately small to medium 
effect sizes for a two-sample comparison of means. 
  
For all analyses, data will be reported as aggregated groups, and no individual identifying information will 
be used. 
 
  
RISK/BENEFIT ASSESSMENT: 
  
1. Risks: 
The potential risks to participants are detailed as follows: 
Emotional discomfort: This study involves asking questions about sexual and gender identity, one’s 
thoughts and feelings about one’s sexual and gender identity, psychosocial well-being, emotional states, 
and states of depression and anxiety. It is possible, although unlikely, that reflection in response to these 
psychosocial questions could result in psychological distress. However, the probability and magnitude of 
harm or discomfort anticipated in the research are not greater, in and of themselves, than those ordinarily 
encountered in daily life. To mitigate these risks and discomforts, participants will be informed in the 

informed consent form that their participation is voluntary and that they can stop the study at any time 
without penalty. In addition, participants can choose to interact with the web app as much or as little as 
they want. The primary possible risk is a perception of burden (either in using the web app or completion 
of the study surveys), which can easily be addressed by withdrawing from the study or discontinuing use 
of the web app at any time. 
Psychological distress is a potential risk to participants during the completion of the surveys and 
engagement with the experimental content. We will provide participants with contact information for the 
following crisis hotlines if they experience psychological distress related to participation in the study: 
● 
Trevor Project Lifeline 
● 
Trevor Chat/Trevor Text 
● 
Trans Lifeline 
● 
Crisis Text Line 
● 
National Suicide Prevention Line 
 
All hotlines are available 24 hours a day, 7 days a week.  
Unintended disclosure is also a potential risk. Data will be protected by extensive confidentiality 
procedures as described below. Data will be collected confidentially; this will be fully described in the 
informed consent. We have extensive data procedures already in place to ensure security of the data and 
information provided by participants: 
● 
Data will be encrypted at all times, from the point of entry into Qualtrics to the point of backup and 
to analysis. Data will be encrypted using standardized software (e.g., 256-bit, PGP). 
● 
Data will be de-identified and linked by the Study ID to minimize risk of inadvertent disclosure. 
● 
Data will never be released to non-study staff. 
● 
All electronic data sharing will be done only on the secure server. 
Study staff will be trained on confidentiality standards, which will include the following points: 
● 
Always maintain anonymity of the participant data. 
● 
Questionnaires are to be linked using the Study ID number. 
● 
Protect the electronic security of all databases. 
● 
Computers that can access electronic data should be physically secured and should be 
password-protected 
● 
Only authorized persons are to have access to electronic databases. 
Privacy and confidentiality concerns: Participants’ confidentiality (names, email addresses, phone 
numbers) will be protected, but the possibility remains that their information could be lost or stolen or 
confidentiality could be breached. 
Participants will be reminded at the beginning of each survey to consider their surroundings and the 
privacy of their device and internet connection. All communication between study staff and participants 
will not include sensitive information that may reveal their participation in a study about SGM or answers 
to any of the questions answered in the surveys. There is a possibility that participation in this research 
study could be disclosed in the following ways: 
1. If someone besides the participant sees the control website or experimental web app 
2. If someone besides the participant sees an email, text message, or direct message via social 
media sent from the study team and follows a link to the website/web app or a study survey 

The risk of disclosure of participation in a research study through receiving study related emails, text 
messages, direct messages via social media, interacting with the online surveys, or with the intervention 
on a participant’s device will be minimized in the following ways: 
1. Participants must enter a password to first gain access to the website or web app 
2. After 10 minutes of inactivity, the website will automatically redirect to www.google.com 
3. Emails, text messages, and direct messages via social media that include links to study surveys 
will not contain any reference to the nature of the survey or study 
4. Participants will be encouraged to delete any text messages received as part of the study to 
protect them from an unauthorized individual viewing the messages, and to interact with the study 
application when in private (e.g., turn on screen lock, complete surveys when alone). Participants 
will be notified of these risks in the consent process. 
 
2. Benefits: 
Participants will be asked about sensitive information, yet adequate protections for internet data collection 
are in place for this study. The main benefit of the proposed study to society is the development of a 
potentially feasible and acceptable web app that impacts key psychosocial outcomes among SGMY ages 
13-19, such as coping self-efficacy and symptoms of anxiety and depression. Participants in the 
experimental condition may experience improvements in their adaptive cognitive and behavioral coping 
skills, psychosocial wellbeing, symptoms of depression and anxiety, and greater life satisfaction. Potential 
benefits for the research far outweigh the risks for the participants. Others will benefit because the study 
will result in increased knowledge about tools that may help SGMY affirm their identities and cope with 
minority stress. Therefore, the risk/benefit ratio is favorable. 
 
3. Subject Privacy: 
All study activities occur over the internet, with specific precautions taken to support participants’ privacy. 
To minimize the risk of participants feeling uncomfortable about answering personal questions, we will 
use self-completed online surveys. Participants will input the answer to the question themselves. This 
format also allows participants to choose where and when they are comfortable completing study 
questionnaires.   
 
 
4. Subject Confidentiality: 
To minimize risks to confidentiality, we will secure study data with all appropriate physical, electronic, and 
operational protections. Data will be stored in a physically secure environment. All data files will have 
encryption and strong password protection. Any identifiable data will be stored on University of 
Pennsylvania’s secure servers or on fully encrypted laptops.  
  
We will collect email addresses so we can reimburse participants for their time (i.e., study incentives) and 
for internal auditing purposes. To ensure we have sent participants their incentives, we will keep the email 
addresses in a password-protected file on a password-protected secure server. In addition, we will use 
participant email, IP address, browser/operating system, and time taken to complete the surveys to flag 
potential fraudulent/suspicious entries.  
  
Survey and intervention data files will identify participants using study ID numbers, assigned by study 
staff, which will be unrelated to the participant’s name or email address. We will keep a file containing 

contact information (i.e., email) and IP addresses separate from survey data. This file will be password-
protected and stored within a restricted folder on a secure server. The reason for keeping this personal 
information is solely administrative (i.e., to ensure that we keep a record of incentive payments, and to 
verify that fraudulent data collection does not occur (e.g., individuals may seek to falsify information on 
the web survey in hopes of receiving an incentive more than once). 
  
Online surveys and eligibility screening will take place on an encrypted commercial survey website, 
Qualtrics. This site has been used by the investigators for numerous online surveys with SGMY with no 
data security breaches. Access to data will be on a role-based standard; only those study staff who 
require access to each type of data to complete their study-related roles will be allowed access. All study 
staff will be trained in security and confidentiality procedures, and will sign a confidentiality agreement 
before receiving access to any participant data. No participant names or other identifying information 
appear on data documents or in data files as the contact information will be stored separately. Only 
designated staff will have access to the data. 
  
All web survey data will be secured using SSL 256-bit encryption. SSL encryption is the standard for all 
web-based transactions that include any identifiable information, including names, addresses, and credit 
card numbers.  
 
Participant contact information (name, email address, and phone number) will be destroyed at the end of 
the study, and will never be associated with the study data collected.  
 
 
5. Protected Health Information 
The following PHI will be collected in this study: 
● 
First name 
● 
City, State, zip code, and equivalent geocodes 
● 
Birth month and year 
● 
Telephone numbers 
● 
Electronic mail addresses 
● 
Internet IP addresses 
  
6. Compensation: 
Participants will receive $30 for the baseline survey and $40 for completion of the follow-up survey. 
This compensation is small enough to avoid undue influence, yet sufficiently substantial to 
compensate for time and effort, and promote retention. 
 
All compensation and incentives will be paid as Amazon.comdigital gift cards. Payment for the 
baseline survey will be sent once participants have completed the survey and have registered for an 
account within their respective arm of the intervention. The incentive for the follow-up survey will be 
sent after the participant completes the associated survey.  
 
7. Data and Safety Monitoring: 
The Principal Investigator will provide oversight of all study procedures and quality assurance checks. 
The data safety and monitoring plan includes the following protocols:  

 
● 
Electronic files and records will be stored in a firewalled, encrypted server at the University; only 
research staff will have access to this directory. To ensure participants' safety as well as the 
data's validity and integrity, only staff with extensive experience in studies with SGMY youth will 
be hired. 
● 
All staff will have signed a confidentiality agreement. We have several mechanisms to ensure the 
security and integrity of the data. The intervention content, questionnaires, and personal 
information will be secured with role-based security that will provide different types of users with 
different access privileges.  
● 
Survey data and web app data will be located on unique servers. Survey data and web app data 
will be linked using a unique Study ID. 
● 
All study personnel will have completed the Human Subject Training established by the CITI 
program. In addition, in compliance with the NIH policy, University graduate students and staff will 
participate in at least 8 hours of mandatory case study and discussions regarding scientific 
integrity and human subjects. Any additional personnel who may join the project will complete this 
training before they handle any subject data.  
● 
All research staff will be trained to recognize and document any unusual events or circumstances 
that occur during the study. Staff will be trained to immediately report any adverse events to the 
Principal Investigator and the University IRB.  
● 
The Principal Investigator and Project Director will monitor staff closely. Staff deficient in any 
aspect of performance will be re-trained, closely monitored for proficiency, and if not adhering to 
established protocols and procedures, will be terminated.  
● 
The Principal Investigator will be responsible for dissemination of study findings through 
presentations and publications. The Principal Investigator will also be solely responsible for 
handling any requests from other investigators to examine the data collected during this study. 
 
8. Investigator’s Risk/Benefit Assessment: 
No more than minimal risk: The risks to research participants enumerated above are reasonable in 
relation to the anticipated increase in knowledge about LGBTQ+ identity and adaptive cognitive and 
behavioral coping skills. Our study is expected to result in a benefit to society since it will provide a basis 
of knowledge on the efficacy of a web app for improving key psychosocial outcomes among SGMY, such 
as coping self-efficacy and symptoms of anxiety and depression. Thus, the unlikely risks entailed by 
participation in this study are offset by its potential benefits. 
 
  
INFORMED CONSENT: 
  
1. Consent Process: 
Informed consent will consist of an electronic document displayed to participants as a Qualtrics survey. 
The consent form is written in English and outlines the voluntary nature of the study, participant's freedom 
to discontinue the survey at any time, the nature of the study, study procedures, the kinds of information 
to be collected, the duration of the study, the principal investigator’s contact information, instructions to 
reach out with any questions that may arise during the study, approval to retain email addresses to send 
incentives, and the procedures to guarantee their confidentiality. Currently, our consent has a literacy 
level of 8th grade (tested with the Coleman Liau index), which we believe makes it accessible for all ages, 
including 13-19 year-olds.  
 

To encourage participants to read and understand the information provided in the Informed Consent, they 
will be asked after each consent form section to confirm they have read, understood, and agree to the 
terms before they can proceed to the next section. 
 
A waiver of written documentation of consent is being requested of the IRB. Finally, we recognize that 
consent is an ongoing process. Participants will have access to the consent form at all times, as a copy 
will be available in the web app. If a participant wishes to end their participation in the study, they are 
given instructions in the web app to contact the study staff via phone or email. 
  
2. Waiver of Informed Consent: 
This study will require assent from minor participants, but will not require consent from parents or 
guardians. The content of the website intervention involves sensitive information related to gender and 
sexuality. In addition, to participate, youth and young adults must identify as a sexual or gender minority, 
and some youth may not have yet disclosed this information to their parents or guardians. If the IRB 
required parental consent, it would bias the sample to include only participants whose parents know their 
true gender identity and sexual orientation.  
 
We will request that the UPenn IRB grant a waiver of parental consent to participate in this research study 
for youth participants who are 13 to 17 years of age. The research team has been granted waivers of 
parental permission for prior studies with sexual minority youth. Under 45 CFR 46.408 (c), an IRB has the 
authority to waive parental permission if it determines that “a research protocol is designed for conditions 
or a subject population for which parental or guardian permission is not a reasonable requirement to 
protect the subjects” and “an appropriate mechanism for protecting the children who will participate as 
research subjects is substituted” and “that the waiver is not inconsistent with Federal, State, or local law.”  
A waiver of parental permission for studies with lesbian, gay, bisexual, transgender, and queer (LGBTQ) 
youth that do not involve greater than minimal risk is a common practice among researchers working in 
the area of gay and lesbian health/mental health. This is done to avoid the selection biases operating in 
only recruiting youth whose parents are both aware of and comfortable with their sexual orientation. 
Commonly these youth have explored their sexual orientation without their parents’ knowledge as the 
youth struggle with issues of disclosure and its consequences within the social, religious, and economic 
context of their families. A requirement for parental permission in this type of study could not only affect a 
person’s willingness to participate, but could also potentially impact the ability of researchers to engage in 
this type of research with sexual minority youth. 
If the purpose of requiring parental permission as stated in CFR is to protect the minor subject, then 
requiring parental permission for youth in these circumstances is not a reasonable requirement. 
Additional privacy protections are provided in that all assessments, notes, reports, and other records will 
be identified by only a coded number to maintain participant confidentiality. These records and any forms 
that do contain identifying information will be kept in a password-protected file on a secure server. 
  
RESOURCES NECESSARY FOR HUMAN RESEARCH PROTECTION: 
Because the aim of the study is to test the effectiveness of a web app designed for teenagers and young 
adults, we will take every available step to minimize the risk of identifying/linking data being subpoenaed, 
stolen, or inadvertently released. First, all research staff members are required to complete ethical 
clearance certification regarding protection of human’s subjects through their IRB. Second, this study will 
have documented procedures to safeguard against the risk of the linking information being stolen by 

keeping such information in password-protected files on secure servers. Only essential study personnel 
who have completed CITI certification for human subjects research ethics training (http://citiprogram.org) 
will have access to participant data.