LGBTQ-affirmative Cognitive Behavioral Group Therapy for Youth: A Pilot Study
Phase: NA
Conditions: Anxiety Disorders, Depression, LGBTQ
Sponsor: Yale University

Protocol Number 2000030664 
 
10/01/2021 (Version #3) 
 
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LGBTQ-affirmative cognitive behavioral 
group therapy for youth: A pilot study 
 Protocol Number 
2000030664 
  
Protocol Version 
10/01/2021 
 Version #3 
 
Clinical Trials Registration Number (if applicable): NCT05408858 
 
Confidentiality Statement: 
 
 
 

Protocol Number 2000030664 
 
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Synopsis 
Purpose 
Lesbian, gay, bisexual, transgender, and queer (LGBTQ) youth experience more mental 
health problems than their heterosexual and cisgender peers. The purpose of the 
proposed mixed-methods study is to assess the feasibility, acceptability, and need for 
refinement of LGBTQ-affirmative cognitive therapy (also known as EQuIP) for youth aged 
12-17 years in New York, New Jersey, and Connecticut. This study will be the first to 
adapt this supportive intervention for youth, and the first to deliver it in a virtual group 
format. Qualitatively, we will conduct structured post-intervention interviews to assess the 
feasibility, acceptability, and refinement of the intervention in this population. 
Quantitatively, we will assess the feasibility and acceptability of the supportive intervention 
by examining changes from pre- to post-intervention in youth’s mental health symptoms, 
minority stress reactions, and emotional regulation and coping processes. 
Objectives 
The primary objective of this study is to assess the feasibility, acceptability, and need for 
refinement of an LGBTQ-affirmative supportive therapy adapted for youth. 
The secondary objective of this study is to investigate whether youth’s mental health 
symptoms, minority stress reactions, and emotional regulation and coping difficulties 
reduce over the course of the intervention. 
Study Population 
The study population will consist of LGBTQ youth between the ages of 12-17 years who 
meet DSM-5 criteria for an internalizing disorder (e.g., anxiety, depression, adjustment), 
live in New York, New Jersey, or Connecticut, are fluent in English, and have access to an 
Internet-enabled electronic device that allows for video-conferencing. This population was 
selected due to the need for additional mental health services as described above. 
Number of Participants 
20 participants will be enrolled in the study. Participants will be assigned to one of two 
groups of approximately 10 participants each. 
Study Design 
This is an open trial pilot intervention study that involves: interviews, online surveys, 
online group video-conferencing intervention sessions, audio-recording of intervention 
sessions. The intervention will consist of 10 weekly 90-minute group supportive therapy 
sessions conducted via Zoom. Study outcomes will be both quantitative (surveys) and 
qualitative (interviews) in nature.  
Study Duration 

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The entire study, including data analysis, is expected to last from August 2021 until 
August 2022. Participation for the subjects will begin in August 2021 (i.e., recruitment, 
pre-intervention assessment). Participants in the first group will begin the 10-week 
intervention in September-November 2021 and complete their post-intervention 
assessment in December 2021-January 2022. Participants in the second group will begin 
the 10-week intervention in February 2022 and complete their post-intervention 
assessment in May 2021-June 2022. Data analysis is expected to continue through 
August 2022. 
Outcome Variables 
Primary Objective: 
• 
Acceptability:  
o Main outcome: Client Satisfaction Questionnaire-8 (CSQ-8) 
o Supportive variables: Treatment Expectations, Top Problems Assessment, 
Top Problems Tracking Form, Acceptability of Session Questionnaire, 
AFFIRM Acceptability Survey, Exit Interview-Acceptability of program 
format, delivery, and content 
• 
Feasibility:  
o Main outcome: Session Attendance 
o Supportive variables: Homework Compliance Scale, Feasibility of Session 
Questionnaire, Feasibility of Program Questionnaire, Exit Interview-
Program feasibility 
• 
Need for refinement:  
o Main outcome: Exit interview 
o Supportive variables: Session Refinement Questions, Program Refinement 
Questions 
Secondary Objective: 
• 
Mental health:  
o Main outcome: Revised Children's Anxiety and Depression Scale (RCADS) 
o Supportive variables:  Depressive Symptom Index - Suicidality Subscale 
(DSI-SS), Strengths and Difficulties Questionnaire (SDQ), WHO-5 Well-
Being Index 
• 
Minority stress reactions:  
o Main outcome: Gender Minority Stress and Resilience Scale for 
Adolescents (GMSR-A) — Internalized Trans/Homophobia subscale 
o Supportive/related variables: Rest of GMSR-A, Child Perceived 
Discrimination Questionnaire (CPDQ), Outness Inventory (OI), Lesbian, 
Gay, Bisexual Affiliate Stigma Measure (LGB-ASM), Parental 
Rejection/Acceptance of LGBTQ child  
• 
Emotion regulation & coping:  
o Main outcome: Children's Emotion Management Scales (CEMS) 

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o Supportive variables: Emotion Regulation Questionnaire (ERQ-CA), Child 
Avoidance Measure (CAMS/CAMP), Children's Automatic Thoughts Scale 
- N/P version (CATS), Coping with Sexual Orientation-Related Minority 
Stress, Multidimensional Scale of Perceived Social Support (MSPSS) 
Locations/Facilities 
The study is housed within the Yale School of Public Health’s Pachankis lab, located at 
220 E. 23rd Street, New York, NY 10010. All study procedures will be conducted online. 
All assessments will be completed by phone, Zoom, or on Qualtrics. The intervention will 
be delivered online via Zoom, as will exit interviews. 
 
Abbreviations 
Abbreviation  
Explanation 
LGBTQ 
Lesbian, Gay, Bisexual, Transgender, and 
Queer 
CBT 
Cognitive-Behavioral Therapy 
EQuIP 
Empowering Queer Identities in 
Psychotherapy (name used to refer to 
LGBTQ-affirmative psychotherapy in 
recruitment flyers, with participants, etc.) 
DSM-5 
Diagnostic and Statistical Manual of Mental 
Disorders, 5th edition 
 
 

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Glossary of Terms 
Glossary 
Explanation 
Cognitive-Behavioral Therapy (CBT) 
A short term, structured, problem-solving 
form of evidence-based psychotherapy 
based on a framework focused on the 
relationship between thoughts, feelings, and 
behaviors. 
 
Stigma (also called minority stress) 
The unique and chronic negative 
experiences that LGBTQ individuals 
experience because of the inferior social 
status that social structures, institutions, 
policies, and social interactions 
communicate about individuals who do not 
identify as heterosexual and/or cisgender. 
Minority stress reactions 
The negative effects of anti-LGBTQ stigma 
on LGBTQ individuals’ wellbeing, including 
their cognitive, emotional, and behavioral 
wellbeing. Examples of minority stress 
reactions include internalized stigma (i.e., 
believing the anti-LGBTQ messages one 
hears), rejection sensitivity (i.e., heightened 
perception of rejection as a result of anti-
LGBTQ stigma), and identity concealment 
(i.e., concealing one’s LGBTQ identity due 
to fears of anti-LGBTQ backlash). 
EQuIP 
Empowering Queer Identities in 
Psychotherapy (name used to refer to 
LGBTQ-affirmative psychotherapy in 
recruitment flyers, with participants, etc.) 
 
 

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Table of Contents 
Synopsis .................................................................................................................................. 2 
Purpose ................................................................................................................................ 2 
Objectives ............................................................................................................................ 2 
Study Population .................................................................................................................. 2 
Number of Participants ......................................................................................................... 2 
Study Design ........................................................................................................................ 2 
Study Duration ..................................................................................................................... 2 
Outcome Variables ............................................................................................................... 3 
Locations/Facilities ............................................................................................................... 4 
Abbreviations ........................................................................................................................... 4 
Glossary of Terms ................................................................................................................... 5 
Protocol Revision History ......................................................................................................... 9 
1 
Background .................................................................................................................... 10 
1.1 
Background ............................................................................................................ 10 
1.2 
Prior Experience (if applicable) .............................................................................. 13 
2 
Rationale/Significance .................................................................................................... 15 
2.1 
Rationale and Study Significance .......................................................................... 15 
2.2 
Risks ...................................................................................................................... 15 
2.3 
Anticipated Benefits ............................................................................................... 18 
3 
Study Purpose and Objectives ....................................................................................... 19 
3.1 
Purpose .................................................................................................................. 19 
3.2 
Hypothesis ............................................................................................................. 19 
3.3 
Objectives .............................................................................................................. 19 
4 
Study Design .................................................................................................................. 20 
4.1 
Study Duration ....................................................................................................... 23 
4.2 
Outcome Variables/Endpoints ................................................................................ 23 
4.2.1 
Primary Outcome Variables/Endpoints .............................................................. 24 
4.2.2 
Secondary and Exploratory Outcome Variables/Endpoints (if applicable) ......... 26 
5 
Study Participants ........................................................................................................... 38 
5.1 
Study Population .................................................................................................... 38 

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5.2 
Number of Participants ........................................................................................... 38 
5.3 
Eligibility Criteria ..................................................................................................... 38 
5.4 
Recruitment Procedures ........................................................................................ 39 
5.5 
Consent/Assent Procedures/HIPAA Authorization ................................................. 40 
6 
Study Methods/Procedures ............................................................................................ 44 
6.1 
Study Procedures ................................................................................................... 44 
6.1.1 
Data Collection ................................................................................................... 50 
6.2 
Method of Assignment/Randomization (if applicable) ............................................ 51 
6.3 
Adverse Events Definition and Reporting .............................................................. 51 
6.4 
Reaction Management ........................................................................................... 52 
6.5 
Withdrawal Procedures .......................................................................................... 52 
6.6 
Locations/Facilities ................................................................................................. 52 
7 
Statistical Design ............................................................................................................ 53 
7.1 
Sample Size Considerations .................................................................................. 53 
7.2 
Planned Analyses .................................................................................................. 53 
7.2.1 
Secondary Objective Analyses (if applicable) .................................................... 53 
7.2.2 
Analysis of Subject Characteristics (if applicable) .............................................. 54 
7.2.3 
Interim Analysis (if applicable) ........................................................................... 54 
7.3 
Data Relevance ...................................................................................................... 54 
7.4 
Data Coding ........................................................................................................... 54 
7.5 
Data Analysis Tools ............................................................................................... 55 
7.6 
Data Monitoring ...................................................................................................... 55 
7.7 
Handling of Missing Data ....................................................................................... 55 
8 
Data/Specimen Handling and Record Keeping .............................................................. 56 
8.1 
Subject Data Confidentiality ................................................................................... 56 
8.2 
Data Quality Assurance ......................................................................................... 57 
8.3 
Data or Specimen Storage/Security ....................................................................... 57 
8.4 
Study Records ........................................................................................................ 58 
8.5 
Access to Source ................................................................................................... 58 
8.6 
Retention of Records ............................................................................................. 59 
8.7 
Data and Safety Monitoring Plan ........................................................................... 59 

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9 
Study Considerations ..................................................................................................... 60 
9.1 
Institutional Review Board (IRB) Review ............................................................... 60 
9.2 
Research Personnel Training ................................................................................. 60 
9.3 
Study Monitoring .................................................................................................... 60 
9.4 
Unanticipated Problems and Protocol Deviations .................................................. 61 
9.5 
Study Discontinuation ............................................................................................ 61 
9.6 
Study Completion ................................................................................................... 62 
9.7 
Conflict of Interest Management Plan .................................................................... 62 
9.8 
Funding Source ...................................................................................................... 62 
9.9 
Publication Plan ..................................................................................................... 62 
10 
Appendices ................................................................................................................ 63 
11 
List of Tables .............................................................................................................. 64 
 
 
 
 

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Protocol Revision History 
 
Version 
Date 
Summary of Substantial Changes 
October 1, 
2021 
Changes composition of groups to be based on time of recruitment, rather 
than based on age, in order to facilitate timely completion of study 
procedures; Extends study timeframe to allow for second group in spring 
2022; Removes exclusion criterion related to current mental health 
treatment — that is, eligible participants can be in supportive treatment (but 
not cognitive behavioral therapy) concurrent with their participation in the 
study. 
August 3, 
2021 
Addresses IRB requested revisions related to: Zoom sessions as supportive 
vs. treatment; recruitment; inclusion criteria; language related to 
confidentiality/privacy; provision of earbuds; use of HIPAA compliant Zoom 
platform; use of pseudonyms in Zoom sessions; use of Secure File Transfer. 
 
 
 
 
 
 
 
 

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1 Background 
1.1 
Background 
Lesbian, gay, bisexual, transgender, and queer (LGBTQ) youth experience mental health 
challenges, including anxiety, depression, and suicide attempts, at a higher rate than their 
heterosexual and cisgender peers (Russell & Fish, 2016). For example, LGBTQ youth are 
two to three times more likely to report a history of suicidality, relative to their heterosexual 
and cisgender peers (Marshal et al., 2011; Reisner et al., 2015). This phenomenon has been 
explained through the lens of minority stress theory, which states that stigma related to 
LGBTQ identity (e.g., discrimination, rejection) elicits minority stress reactions (e.g., 
concealment of LGBTQ identity, internalized stigma, rejection sensitivity) which then 
combines with general life stress to increase an individual’s risk of mental illness (Meyer, 
2003). Numerous studies have supported the use of this framework in understanding the 
development and maintenance of excess mental health concerns in LGBTQ youth (Baams 
et al., 2015; Goldbach et al., 2014; Goldbach & Gibbs, 2017; Paceley et al., 2017). However, 
to date, only one intervention for older LGBTQ adolescents (aged 15-18) has been 
developed that attempts to directly reduce youth’s maladaptive minority stress reactions, and 
this intervention has yet to be rigorously tested using a randomized controlled trial (Craig & 
Austin, 2016). Importantly, no minority stress-focused interventions exist for younger LGBTQ 
adolescents (e.g., ages 12-14). 
To date, the only minority stress reaction-focussed mental health intervention to have 
been tested in a randomized controlled trial with LGBTQ people is LGBTQ-affirmative 
cognitive behavioral therapy (CBT), developed over the past seven years by our team with 
support from the Yale Fund for Lesbian and Gay Studies, the David R. Kessler ’55 Resource 
Fund for LGBTQ Mental Health Research at Yale, and the National Institute of Mental 
Health. CBT is an evidence-based psychotherapy that focusses on helping clients 
understand links between their thoughts, emotions, and behaviors, and it has been shown to 
be effective at treating a wide range of mental health problems in children, adolescents, and 
adults, including anxiety and depression (Beck & Beck, 2011). LGBTQ-affirmative CBT 
builds upon a CBT base (Barlow et al., 2018) by adding minority stress reaction-specific 
education and examples to the intervention in an effort to target the underlying cognitive, 
affective, and behavioral pathways through which minority stress reactions impair LGBTQ 
young adults’ health. It is a skills-building intervention designed to reduce maladaptive 
minority stress reactions. This is achieved through the administration of nine modules that 
focus on motivational enhancement, psychoeducation regarding the nature and emotional 
impact of minority stress, tracking emotional experiences, mindful awareness and minority 
stress, cognitive flexibility, countering emotional behaviors, behavioral skills training, emotion 
exposures, and relapse prevention (Burton et al., 2019).  
 
Results from two randomized controlled trials of LGBTQ-affirmative CBT with gay 
and bisexual men and sexual minority women demonstrate that this intervention is effective 
in reducing symptoms of depression and anxiety in young adults, as well as reductions in 

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alcohol use and HIV-transmission-risk behavior in young men (Pachankis et al., 2015, 2020). 
Moreover, these studies showed that maladaptive minority stress reactions, like internalized 
stigma and rejection sensitivity, as well as emotion dysregulation, decreased across the 
course of LGBTQ-affirmative CBT. Thus, there is evidence that the intervention achieves its 
goal of addressing underlying minority stress reactions that contribute to mental health 
problems.  
 
What is less clear, however, is whether this intervention could effectively address 
minority stress reactions and associated emotional problems in adolescents, as studies to 
date have focused on LGBTQ young adults aged 18 and over. Adolescence represents an 
important developmental period for intervention, particularly among LGBTQ individuals. 
Research shows that LGBTQ adolescents today come out at younger ages than previous 
generations (Calzo et al., 2011), which has been linked to their high rates of peer 
victimization (Russell et al., 2014) and family rejection (Newcomb et al., 2019). Critically, 
these painful experiences occur at an age when adolescents’ brains are still developing and 
thus they do not yet have the cognitive coping abilities that may help buffer LGBTQ adults 
against the negative minority stress reactions (Russell & Fish, 2019). In addition, numerous 
mental health conditions (e.g., anxiety, mood disorders) have an average onset during or 
immediately after adolescence (Kessler & Wang, 2008). Moreover, in episodic disorders like 
major depression and bipolar disorder, an individual’s risk of more episodes increases with 
each subsequent episode (Kessing et al., 2004). Thus, it is critical that vulnerable 
populations like LGBTQ youth receive effective mental health interventions early in order to 
mitigate both current distress and the continuation (and potential worsening) of symptoms 
into young adulthood. 
The purpose of this proposed mixed-methods study is to assess the feasibility, 
acceptability, and need for refinement of LGBTQ-affirmative cognitive behavior therapy for 
youth aged 12-17 years in the United States. Importantly, this study proposes to examine 
LGBTQ-affirmative CBT as a supportive intervention, rather than an individualized treatment, 
as the anticipated settings in which this program would be implemented are not treatment 
settings but rather community centers, which tend to provide supportive counseling. Thus, in 
contrast to treatment in which individual case conceptualizations would be developed for 
each participant, in this study, participants will all be provided with the same supportive 
information about minority stress and coping with stigma, with no individual case 
conceptualization. In addition, parents will only be provided supportive information with 
suggestions about how to support their child, rather than targeted treatment advice tailored 
to their specific child. 
References: 
Baams, L., Grossman, A. H., & Russell, S. T. (2015). Minority stress and mechanisms of risk for 
depression and suicidal ideation among lesbian, gay, and bisexual youth. Developmental 
Psychology, 51(5), 688–696. https://doi.org/10.1037/a0038994 
Barlow, D. H., Farchione, T. J., Sauer-Zavala, S., Murray Latin, H., Ellard, K. K., Bullis, J. R., Bentley, 
K. H., Boettcher, H. T., & Cassiello-Robbins, C. (2018). Unified protocol for transdiagnostic 
treatment of emotional disorders: Therapist guide (Second edition). Oxford University Press. 

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Beck, J. S., & Beck, J. S. (2011). Cognitive behavior therapy: Basics and beyond (2nd ed). Guilford 
Press. 
Burton, C. L., Wang, K., & Pachankis, J. E. (2019). Psychotherapy for the spectrum of sexual minority 
stress: Application and technique of the ESTEEM treatment model. Cognitive and Behavioral 
Practice, 26(2), 285–299. https://doi.org/10.1016/j.cbpra.2017.05.001 
Calzo, J. P., Antonucci, T. C., Mays, V. M., & Cochran, S. D. (2011). Retrospective recall of sexual 
orientation identity development among gay, lesbian, and bisexual adults. Developmental 
Psychology, 47(6), 1658–1673. https://doi.org/10.1037/a0025508 
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. https://doi.org/10.1016/j.childyouth.2016.02.022 
Goldbach, J. T., & Gibbs, J. J. (2017). A developmentally informed adaptation of minority stress for 
sexual minority adolescents. Journal of Adolescence, 55, 36–50. 
https://doi.org/10.1016/j.adolescence.2016.12.007 
Goldbach, J. T., Tanner-Smith, E. E., Bagwell, M., & Dunlap, S. (2014). Minority stress and substance 
use in sexual minority adolescents: A meta-analysis. Prevention Science, 15(3), 350–363. 
https://doi.org/10.1007/s11121-013-0393-7 
Kessing, L. V., Hansen, M. G., Andersen, P. K., & Angst, J. (2004). The predictive effect of episodes 
on the risk of recurrence in depressive and bipolar disorders—A life-long perspective. Acta 
Psychiatrica Scandinavica, 109(5), 339–344. https://doi.org/10.1046/j.1600-
0447.2003.00266.x 
Kessler, R. C., & Wang, P. S. (2008). The descriptive epidemiology of commonly occurring mental 
disorders in the United States. Annual Review of Public Health, 29(1), 115–129. 
https://doi.org/10.1146/annurev.publhealth.29.020907.090847 
Marshal, M. P., Dietz, L. J., Friedman, M. S., Stall, R., Smith, H. A., McGinley, J., Thoma, B. C., 
Murray, P. J., D’Augelli, A. R., & Brent, D. A. (2011). Suicidality and depression disparities 
between sexual minority and heterosexual youth: A meta-analytic review. The Journal of 
Adolescent Health: Official Publication of the Society for Adolescent Medicine, 49(2), 115–
123. https://doi.org/10.1016/j.jadohealth.2011.02.005 
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–
697. https://doi.org/10.1037/0033-2909.129.5.674 
Newcomb, M. E., LaSala, M. C., Bouris, A., Mustanski, B., Prado, G., Schrager, S. M., & Huebner, D. 
M. (2019). The influence of families on LGBTQ youth health: A call to action for innovation in 
research and intervention development. LGBT Health, 6(4), 139–145. 
https://doi.org/10.1089/lgbt.2018.0157 
Paceley, M. S., Goffnett, J., & Gandy-Guedes, M. (2017). Impact of victimization, community climate, 
and community size on the mental health of sexual and gender minority youth. Journal of 
Community Psychology, 658–671. https://doi.org/10.1002/jcop.21885 
Pachankis, J. E., Hatzenbuehler, M. L., Jonathon, H., Safren, S. A., & Parsons, J. T. (2015). LGB-
affirmative cognitive-behavioral therapy for young adult gay and bisexual men: A randomized 

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controlled trial of a transdiagnostic minority stress approach. Journal of Consulting and 
Clinical Psychology, 83(5), 875–889. 
Pachankis, J. E., McConocha, E. M., Clark, K. A., Wang, K., Behari, K., Fetzner, B. K., Brisbin, C. D., 
Scheer, J. R., & Lehavot, K. (2020). A transdiagnostic minority stress intervention for gender 
diverse sexual minority women’s depression, anxiety, and unhealthy alcohol use: A 
randomized controlled trial. Journal of Consulting and Clinical Psychology, 88(7), 613–630. 
https://doi.org/10.1037/ccp0000508 
Reisner, S. L., Vetters, R., Leclerc, M., Zaslow, S., Wolfrum, S., Shumer, D., & Mimiaga, M. J. (2015). 
Mental health of transgender youth in care at an adolescent urban community health center: 
A matched retrospective cohort study. Journal of Adolescent Health, 56(3), 274–279. 
https://doi.org/10.1016/j.jadohealth.2014.10.264 
Russell, S. T., & Fish, J. N. (2016). Mental health in lesbian, gay, bisexual, and transgender (LGBT) 
youth. Annual Review of Clinical Psychology, 12(1), 465–487. 
https://doi.org/10.1146/annurev-clinpsy-021815-093153 
Russell, S. T., & Fish, J. N. (2019). Sexual minority youth, social change, and health: A 
developmental collision. Research in Human Development, 16(1), 5–20. 
https://doi.org/10.1080/15427609.2018.1537772 
Russell, S. T., Toomey, R. B., Ryan, C., & Diaz, R. M. (2014). Being out at school: The implications 
for school victimization and young adult adjustment. American Journal of Orthopsychiatry, 
84(6), 635–643. https://doi.org/10.1037/ort0000037 
1.2 
Prior Experience (if applicable)  
LGBTQ-affirmative CBT has been previously developed and tested by the current 
research team. In the pilot testing of the intervention among a sample of gay and bisexual 
men (Pachankis et al., 2015), the intervention significantly reduced depressive, alcohol use 
problems, sexual compulsivity, and past-90-day condomless sex with casual partners, as 
well as improved condom use self-efficacy. The intervention yielded moderate and 
marginally significant improvements compared to a waitlist group in anxiety symptoms and 
past-90-day heavy drinking. Effects were generally maintained at follow-up. The research 
team has also tested LGBTQ-affirmative CBT among gender diverse, sexual minority 
women (see IRB protocol: 2000020997; Pachankis, McConocha, et al., 2020). Compared to 
waitlist, participants experienced significantly reduced depression and anxiety symptoms, 
and marginally reduced alcohol use. 
Since these studies, the research team has been in the process of testing the efficacy 
of the intervention among gay and bisexual men in an RCT against community mental health 
intervention and voluntary testing and counselling for HIV (see IRB protocol: 1509016430), 
as well as for an online platform (see IRB protocol: 2000025803).  
References: 
 
Pachankis, J. E., Hatzenbuehler, M. L., Rendina, H. J., Safren, S. A., & Parsons, J. T. (2015). LGB-
affirmative cognitive-behavioral therapy for young adult gay and bisexual men: A randomized 
controlled trial of a transdiagnostic minority stress approach. Journal of consulting and clinical 
psychology, 83(5), 875. 

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Pachankis, J. E., McConocha, E. M., Clark, K. A., Wang, K., Behari, K., Fetzner, B. K., ... & Lehavot, 
K. (2020). A transdiagnostic minority stress intervention for gender diverse sexual minority 
women’s depression, anxiety, and unhealthy alcohol use: A randomized controlled 
trial. Journal of Consulting and Clinical Psychology, 88(7), 613. 
 
 

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2 Rationale/Significance 
2.1 
Rationale and Study Significance  
LGBTQ youth experience more mental health problems than their heterosexual and 
cisgender peers. This phenomenon has been linked to LGBTQ youth’s experiences with 
stigma (e.g., discrimination on the basis of sexual orientation and/or gender identity) and 
associated minority stress reactions. However, to date, no interventions for LGBTQ youth as 
young as 12 years of age exist that are designed to specifically address these unique forms 
of stress. Further, the one group-based intervention for LGBTQ adolescents (aged 15-18) 
that exists, has not been delivered remotely via video conference, limiting the accessibility of 
this intervention to this vulnerable population. 
This study will be the first to adapt the LGBTQ-affirmative CBT intervention developed 
by our team for youth, and the first to deliver it in a virtual group format. By focusing the 
present investigation on assessing the feasibility, acceptability, and need for refinement of 
this intervention, we plan to improve the developmental appropriateness of the intervention 
for 12-17 year-olds, in anticipation of a larger future efficacy trial. 
 
2.2 
Risks 
The study participants are at minimal risk of harm as a result of participation in the proposed 
research study. Risks to potential study participants will be mitigated from the first contact 
with participants, as described in detail in the recruitment and informed consent section 
below. Although unlikely, one risk of the proposed study is that participants will experience 
emotional discomfort as a result of completing the assessments or the intervention. Breach 
of participants' confidentiality presents another possible risk. Breach of confidentiality can 
also occur if participants in this group-based intervention disclose information about other 
participants to outside parties. The research team's strategies to protect against these risks 
are described below.  
Recruitment and Informed Consent: The research team has conducted a number of studies 
involving young LGBTQ people, which have involved asking participants to complete 
potentially sensitive interviews and self-report measures. Thus, we have extensive protocols 
in place for all aspects of the study. All team members will complete IRB (re)certification as 
required. All team members will receive training in issues pertinent to research among 
LGBTQ people prior to any contact with participants or data. No identifying information is 
collected prior to the moment at which a participant provides informed consent.  
Participants will be recruited into the study through online advertisements. The online 
advertisements will direct parents/legal guardians of potential youth participants to an online 
screening survey, where parents/legal guardians will be prompted to provide consent for 
answering screener questions, as well as permission for their child to participate in the 
screening process. At the end of the parent’s screening survey, they will be prompted to 
enter an email address to which a link to the youth screening survey will be sent. Youth 

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participants will then be prompted to provide active assent for answering the screening 
questions. 
If determined eligible for the study, research team members will email both parent/guardian 
and child a copy of the full consent, assent, and parental permission forms and schedule a 
call to discuss the study. During the call, a study team member will review key points of the 
study and participation requirements with the youth participant and their parent/caregiver, 
and clarify any questions the pair may have. The team member will ensure that the 
participant and their parent understand the risks associated with the disclosure of 
information that could indicate imminent threat to self or others. Verification of 
comprehension of informed consent will be accomplished by asking participants and parents 
to recall central points in the consent process; points of confusion will be clarified. Once 
participants and parents have fully understood the requirements of the study, they will be 
asked to verbally consent and assent to participation during the call, and then to sign the 
consent and assent forms electronically. A youth’s parent or parent/caregiver must provide 
parental permission for their child to participate and the youth must assent to participate in 
order for the youth to be enrolled in the study. Study team members will be instructed to 
contact the PI, Dr. John Pachankis, or lead postdoctoral associate, Dr. Ilana Seager van 
Dyk, if they are unsure about any participant's capacity to consent. Participants will again 
see the consent form at the beginning of the pre-intervention assessment survey and again 
before their first group therapy session.  
There is a potential risk that engagement in this study could inadvertently reveal youth’s 
sexual orientation and/or gender identity to their parent or parent/caregiver, by virtue of the 
need for parental permission for the youth to participate. In order to mitigate this risk, only 
youth who indicate that their parent is aware of their LGBTQ status and that they are 
comfortable with their parent knowing that they are participating in this study will be eligible. 
All of the study recruitment materials make it clear to potential participants that 
parent/guardian consent will be required, in order to ensure that all potential participants are 
fully aware of this in advance, and can thus choose whether or not to participate accordingly. 
For parents/guardians who express concern about their child’s sexual orientation/gender 
identity to study staff, a resource list will be provided that lists helpful books, websites, and 
support groups. 
Protection Against Emotional Discomfort.  It is possible that participants may experience 
emotional discomfort in responding to assessments, or while discussing challenging 
experiences in intervention sessions. While every possible step will be taken to minimize 
such risk, consent documentation will make it clear that if participants have any concerns 
about any aspect of the study they may refuse to continue with the study at any time, without 
penalty. In addition, we will remind participants during the course of their assessments that 
they can refuse to answer any questions and may discontinue participation at any time. 
Research team members will receive training from a licensed clinical psychologist in 
appropriate response practices in instances of participant distress. This training will address 
the appropriate handling of imminent threats and provision of referrals to free counseling 
services in less imminent clinical situations.  

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During the course of the study, there is possibility that participants may report suicidality, 
homicidality, emotional distress, violent/aggressive or disruptive behavior, intoxication, 
and/or suspected abuse or maltreatment. Our lab’s clinical protocol has successfully guided 
reporting of such instances in our other online-based clinical trials (see IRB #2000025803 
and #2000029433). Our Clinical Protocol, attached to this application, will guide this training 
and its implementation during instances of participant distress. 
Protection Against Breach of Confidentiality. The primary potential risk to participants is 
breach of confidentiality. Breaches of confidentiality will occur if a participant reports a clear 
intention to harm themselves or another person. Health care professionals are required by 
state law to report suspected cases of abuse or neglect.  Breach of confidentiality can also 
occur if participants in this group-based intervention disclose information about participants 
to outside parties. Participants will agree in their signed consent forms that any information 
shared during group sessions may not be discussed outside of the intervention. During the 
consent process, we will indicate that youth will be able to pick a username that they will be 
known by during the Zoom sessions. This can be any name they want, including their 
affirmed first name (last names will not be allowed, nor will any other names that clearly 
identify the youth; e.g., phone number or address). The goal of using a username is to 
protect their privacy, so youth will be informed that using their legal name introduces some 
risk to their confidentiality. Youth will be kept in the Zoom waiting room until their study 
username is displayed. Youth will be reminded of their study username by email a few days 
before the first session, and will be provided instructions about how to change their 
username. Moreover, participants will be reminded at the beginning of each session to keep 
all information shared during the group intervention sessions private; that is, the session 
therapist will ask all group members to not disclose any other participant’s information 
outside of the group setting. Participants will also be told, however, that this protection 
cannot be guaranteed by the group leader. Participants will be notified on the consent form 
and at the start of each session that by participating in the study they acknowledge the risk 
that other participants will become aware of any information they disclose during the group 
intervention sessions and might disclose such information to others outside of the study. The 
likelihood that any additional breaches of confidentiality would occur is minimal, as steps will 
be taken to guard against this risk. All study team members will undergo rigorous training in 
maintaining participants’ confidentiality and will be in possession of valid Collaborative 
Institutional Training Initiative (CITI) certificates. Further, immediately upon providing 
consent, all participants will be assigned an identification number. Only one database will 
contain participant information with a link to identification numbers and no data will be stored 
on this file. This database will be stored on Yale’s HIPAA-compliant Secure Box server and 
will be password protected. This information will not be stored with any participant data and 
no other identifying information will appear on any form. All contact with participants will be 
made by counselors and research staff under explicit guidelines to preserve confidentiality 
when telephoning, emailing, or mailing information to participants.  
 

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2.3 
Anticipated Benefits 
The disproportionate mental health burden experienced by LGBTQ young people is a clear 
public health concern. All participants in the present study will be exposed to information 
about how stressful LGBTQ-specific experiences (e.g., discrimination, coming out) are 
associated with mental health difficulties. We anticipate that participants will acquire 
knowledge and skills and will receive support needed to improve their capacity for managing 
emotional distress like anxiety and/or depression.  
Benefits to society in general are also anticipated through the dissemination of intervention 
findings. Results will better inform mental health professionals’ efforts to provide effective, 
tailored interventions with LGBTQ youth. Further, study findings could inform local and 
national public health agencies about potentially effective outreach and prevention strategies 
that can be delivered to LGBTQ youth who experience stress-sensitive mental health 
disorders, such as depression and anxiety. This project will also lay the groundwork for 
larger future studies examining the efficacy of this intervention with LGBTQ youth.  In sum, 
the potential benefits outweigh the potential risks to subjects, which are minimal. 

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3 Study Purpose and Objectives 
3.1 
Purpose 
LGBTQ youth experience more mental health problems than their heterosexual and 
cisgender peers. The purpose of the proposed mixed-methods study is to assess the 
feasibility, acceptability, and need for refinement of LGBTQ-affirmative cognitive behavior 
therapy for youth aged 12-17 years in New York, New Jersey, and Connecticut. This study 
will be the first to adapt the randomized controlled trial tested LGBTQ-affirmative CBT 
intervention for youth, and the first to deliver it in a virtual group format. Qualitatively, we will 
conduct structured post-intervention interviews to assess the feasibility, acceptability, and 
refinement of the intervention in this population. Quantitatively, we will assess the feasibility 
and acceptability of the intervention through analysis of indices like number of sessions 
attended, number of homework assignments completed, weekly satisfaction ratings, and a 
post-intervention feedback survey. We will also examine changes from pre- to post-
intervention in youth’s mental health symptoms, minority stress reactions, and emotional 
regulation and coping difficulties. These pilot data will be used to estimate the sample sizes 
needed for a future, larger trial of this intervention, as well as areas in which the intervention 
could be refined. 
3.2 
Hypothesis 
We predict that LGBTQ-affirmative cognitive behavioral therapy for youth will be acceptable 
and feasible (as measured by both qualitative and quantitative data) to both youth and their 
parents/guardians. Further, we anticipate that youth will exhibit increases in adaptive coping 
and decreases in anxiety and depression symptoms, and maladaptive minority stress 
reactions from pre- to post-intervention (although we do not necessarily expect statistically 
significant changes from pre- to post-assessment given the small sample size). 
3.3 
Objectives 
The primary objective of this study is to assess the feasibility, acceptability, and need for 
refinement of an LGBTQ-affirmative cognitive behavioral therapy adapted for youth. 
The secondary objective of this study is to investigate whether youth’s mental health 
symptoms, minority stress reactions, and emotional regulation and coping difficulties 
decrease over the course of the intervention. 
 
 

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4 Study Design 
This mixed methods prospective study is designed to assess the feasibility, acceptability, 
and need for refinement of LGBTQ-affirmative cognitive behavior therapy for youth aged 12-
17 years in New York, New Jersey, and Connecticut. To achieve this goal, two 10-week 
LGBTQ-affirmative CBT groups with LGBTQ youth will be conducted. 
The study population will consist of participants with internalizing disorders of mild to 
moderate severity who identify as LGBTQ, are 12-17 years of age, are fluent in English, and 
who live in New York, New Jersey, or Connecticut. Parents/legal guardians of these youth 
will also participate in screening, pre-intervention and post-intervention assessments. 
First, participants and their parents will complete an online screening survey, followed by a 
semi-structured diagnostic interview (K-SADS) with a trained clinical psychology 
postdoctoral fellow, to assess their eligibility for the study. Additional details about the 
recruitment process are provided in 5.4. Once eligible, participants will undergo the informed 
consent process for the study with trained study staff via Zoom or phone with the youth and 
their parent/caregiver (described in 5.5). Next, youth and their parent/caregiver will complete 
the pre-intervention survey within 2 weeks of the first intervention session. This consists of a 
number of measures to assess constructs relevant to the primary and secondary objectives 
of the study (see 4.2 for full list of measures). Youth will then be assigned to one of two 
intervention groups based on the timing of their enrollment (i.e., participants who enroll in fall 
2021 will be assigned to the first group, participants who enroll in winter/spring 2022 will be 
assigned to second group). 
The intervention itself will consist of 10 weekly, 90-minute group sessions, delivered 
remotely via Zoom. The intervention will be delivered by Dr. Seager van Dyk, who has 
experience counseling LGBTQ teenagers and who has received training in the intervention 
from the PI (who developed LGBTQ-affirmative CBT), with support from the study team. 
Intervention sessions and associated home practice will cover the following topics (additional 
details are provided in the Session Outlines document uploaded in IRES):  
• 
Building and keeping motivation 
• 
Introduction to LGBTQ-related stress 
• 
Getting to know your emotions  
• 
Introduction to emotional behaviors and behavioral experiments 
• 
Awareness of physical sensations and introduction to flexible thinking 
• 
Being flexible in your thinking 
• 
Awareness of emotional experiences 
• 
Assertiveness 
• 
Situational exposures 
• 
Reviewing accomplishments and looking ahead  
Participants will be taught intervention content through a range of teaching modalities 
including use of the Zoom whiteboard feature, videos, interactive activities, worksheets, and 

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group discussion. All sessions will be audio-recorded for supervision purposes, and audio 
recordings will be saved in a secure Yale Box folder. 
Following each intervention session, participants will be sent a brief survey to evaluate the 
acceptability, feasibility, and need for refinement of each intervention session. Participants 
will also complete brief mental health measures each week to address the study’s secondary 
objective. Participants will be asked to submit an electronic copy (e.g., PDF, photo) of any 
completed home practice assignments to the study team via Yale’s Secure File Transfer, in 
order to evaluate the acceptability of these assignments. Study staff will de-identify all home 
practice materials before saving them in a secure Yale Box folder with the participant’s study 
ID number. 
Post-intervention assessment measures will be sent to youth participants and their 
parent/caregiver immediately following the last intervention session, and will be available for 
three weeks (see 4.2 for full list of measures). After the post-intervention assessment is 
complete, youth will be invited to complete an exit interview via Zoom/phone to assess the 
feasibility, acceptability, and refinement. 
 
 
 

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Study Flow Diagram 
 
 

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4.1 
Study Duration 
The entire study, including data analysis, is expected to last from August 2021 until August 
2022. Participation for the subjects will begin in August 2021 (i.e., recruitment, pre-
intervention assessment). Participants in the first group will begin the 10-week intervention in 
September-November 2021 and complete their post-intervention assessment in December 
2021-January 2022. Participants in the second group will begin the 10-week intervention in 
February 2022 and complete their post-intervention assessment in May 2021-June 2022. 
Data analysis is expected to continue through August 2022. 
4.2 
Outcome Variables/Endpoints 
The following are the outcome variables and associated measures that will be administered 
at each time point (i.e., screening, pre-intervention, weekly assessments, and post-
intervention) in the study: 
* = Main outcome variable; all others are supportive variables 
Screening:  
• 
Mental health: Revised Children's Anxiety and Depression Scale (RCADS)*, Kiddie 
Schedule for Affective Disorders and Schizophrenia (K-SADS), Depressive Symptom 
Index - Suicidality Subscale (DSI-SS), Youth Psychosis At-Risk Questionnaire - Brief 
(YPARQ-B), Brief Child Mania Rating Scale - Parent Version (CMRS-P), Child & 
Adolescent Intellectual Disability Screening Questionnaire (CAIDS-Q) 
Pre-intervention: 
• 
Acceptability: Treatment Expectations 
• 
Mental health: Revised Children's Anxiety and Depression Scale (RCADS)*, 
Depressive Symptom Index - Suicidality Subscale (DSI-SS), Strengths and 
Difficulties Questionnaire (SDQ), WHO-5 Well-Being Index, CRAFFT 2.1, Autism 
Quotient-10 (AQ-10) 
• 
Minority stress reactions: Gender Minority Stress and Resilience Scale for 
Adolescents (GMSR-A)*, Outness Inventory (OI)  
• 
Stigma exposure: Gender Minority Stress and Resilience Scale for Adolescents 
(GMSR-A), Child Perceived Discrimination Questionnaire (CPDQ), Lesbian, Gay, 
Bisexual Affiliate Stigma Measure (LGB-ASM), Parental Rejection/Acceptance of 
LGBTQ child 
• 
Emotion regulation & coping: Children's Emotion Management Scales (CEMS)*, 
Emotion Regulation Questionnaire (ERQ-CA), Child Avoidance Measure 
(CAMS/CAMP), Children's Automatic Thoughts Scale - N/P version (CATS), Coping 
with Sexual Orientation-Related Minority Stress 
Weekly: 

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• 
Acceptability: Top Problems Assessment (Session 1 only), Top Problems Tracking 
Form, Client Satisfaction Questionnaire-8 (Session 5 only)*, Acceptability of Session 
Questionnaire 
• 
Feasibility: Session Attendance*, Homework Compliance Scale, Feasibility of 
Session Questionnaire 
• 
Need for refinement: Session Refinement Questions 
• 
Mental health: Revised Children's Anxiety and Depression Scale (RCADS-Short 
form)*, Depressive Symptom Index - Suicidality Subscale (DSI-SS) 
Post-intervention: 
• 
Acceptability: Top Problems Tracking Form, Client Satisfaction Questionnaire-8 
(CSQ-8)*, AFFIRM Acceptability Survey, Exit Interview-Acceptability of program 
format, delivery, and content 
• 
Feasibility: Feasibility of Program Questionnaire, Exit Interview-Program feasibility 
• 
Need for refinement: Program Refinement Questions, Exit Interview-Program need 
for refinement* 
• 
Mental health: Revised Children's Anxiety and Depression Scale (RCADS)*, 
Depressive Symptom Index - Suicidality Subscale (DSI-SS), Strengths and 
Difficulties Questionnaire (SDQ), WHO-5 Well-Being Index, CRAFFT 2.1 
• 
Minority stress reactions: Gender Minority Stress and Resilience Scale for 
Adolescents (GMSR-A)*, Outness Inventory (OI)  
• 
Stigma exposure: Gender Minority Stress and Resilience Scale for Adolescents 
(GMSR-A), Child Perceived Discrimination Questionnaire (CPDQ), Lesbian, Gay, 
Bisexual Affiliate Stigma Measure (LGB-ASM), Parental Rejection/Acceptance of 
LGBTQ child 
• 
Emotion regulation & coping: Children's Emotion Management Scales (CEMS)*, 
Emotion Regulation Questionnaire (ERQ-CA), Child Avoidance Measure 
(CAMS/CAMP), Children's Automatic Thoughts Scale - N/P version (CATS), Coping 
with Sexual Orientation-Related Minority Stress, Multidimensional Scale of Perceived 
Social Support (MSPSS) 
See Sections 4.2.1 and 4.2.2. for further explanations of each measure. 
 
4.2.1 Primary Outcome Variables/Endpoints 
Acceptability: 
• 
Client Satisfaction Questionnaire-8 (CSQ-8). The CSQ-8 (Larsen et al., 1979) is a 
well-validated, 8-item self-report questionnaire designed to assess patient/client 
satisfaction with services received. Both the adolescent self-report and the parent 
report of child services versions of the CSQ-8 will be used in this study. Items are 
scored on a 4-point scale, where higher scores indicate more satisfaction. The CSQ-
8 has demonstrated excellent internal consistency in prior studies (a = 0.93; Larsen 
et al., 1979). 

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Feasibility: 
• 
Session Attendance. Session attendance will be tracked by the study therapist(s) 
each week to examine the feasibility of weekly sessions. 
Need for refinement: 
• 
Exit Interview. The need to refine the intervention will also be assessed qualitatively 
during a post-intervention exit interview with each youth participant. Questions will 
probe participants’ suggestions for improving the intervention, as well as the parts of 
the intervention that they felt most helpful, among other topics. 
Mental health: 
• 
Revised Children's Anxiety and Depression Scale (RCADS). The RCADS (Chorpita 
et al., 2000; Ebesutani et al., 2010) is a 47-item questionnaire assessing symptoms 
of depression and anxiety in youth aged 6-18 years. Both the parent-report and the 
child self-report versions of this scale will be used in this study. In addition to a Total 
Internalizing Scale and a Total Anxiety Scale, the RCADS includes six subscales: 
separation anxiety disorder (SAD), social phobia (SP), generalized anxiety disorder 
(GAD), panic disorder (PD), obsessive compulsive disorder (OCD), and major 
depressive disorder (MDD). Items are rated on a 4-point Likert-scale from 0 (“never”) 
to 3 (“always”). Previous studies have showed the RCADS has good internal 
consistency (as = 0.73-0.82; Chorpita et al., 2000). 
Minority stress reactions: 
• 
Gender Minority Stress and Resilience Measure for Adolescents (GMSR-A). The 
GMSR-A (Hidalgo et al., 2019) is a 59-item youth-report questionnaire that assesses 
experiences of both distal (discrimination, rejection, victimization, non-affirmation) 
and proximal minority stress (internalized transphobia, negative expectations for the 
future, and non-disclosure of gender identity/history), as well as resilience (pride, 
community connectedness) among gender minority adolescents aged 12-18 years. 
Three subscales (discrimination, rejection, victimization) are rated using a count 
(yes/no) of items, while the remaining six subscales are scored using a 5-point scale, 
where 0 = Strongly Disagree and 4 = Strongly Agree. Prior research demonstrated 
good internal consistency for the GMSR-A and its subscales (as = 0.80-0.95; Hidalgo 
et al., 2019). For the purposes of this study, the wording of items will be modified 
slightly to apply to both sexual and gender minority youth (e.g., “I have been rejected 
at school or work because of my gender identity or expression” was changed to “I 
have been rejected at school or work because of my LGBTQ identity”). The primary 
outcome related to minority stress reactions for this study will be the Internalized 
trans/homophobia subscale of this questionnaire. 
Emotion regulation & coping:  
• 
Children's Emotion Management Scales (CEMS). The CEMS (Zeman et al., 2001; 
Zeman et al., 2010) is a 33-item measure assessing youth’s responses to 

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experiences of sadness (12 items), anger (11 items), and worry (10 items). Within 
each emotion scale, there are three subscales, including: inhibition, dysregulation, 
and regulation coping. Both the parent-report and the youth self-report versions of 
this scale will be used in this study. Participants are asked to indicate the degree to 
which each item applies to them using a 3-point scale, where 1 = Hardly ever, 2 = 
Sometimes, and 3 = Often. The CEMS has been validated for use with youth aged 7-
17 years and prior studies show that its subscales have adequate internal 
consistency (as = 0.62-0.77; Zeman et al., 2001; Zeman et al., 2010). 
4.2.2 Secondary and Exploratory Outcome Variables/Endpoints (if applicable) 
Acceptability: 
• 
Treatment Expectations. The Treatment Expectations measure (Lewin et al., 2011) is 
a single-item measure of participants’ confidence that the treatment they are about to 
receive will help them with their problems. Participants rate the question “how sure 
are you that doing this treatment will help you with your problems (including your 
anxiety and/or depression)?” on a 7-point scale, where 1 = Not sure at all and 7 = 
Extremely sure. This scale was adapted from Lewin et al. (2011), who used the scale 
in a sample of youth aged 8-17 years. The single item format is consistent with prior 
treatment expectations work (e.g., Borkovec & Nau, 1972; Vogel et al., 2006) 
• 
Top Problems Assessment / Top Problems Tracking Form. The Top Problems 
assessment (Weisz et al., 2011) is an idiographic measure used to identify and track 
child- and parent-reported target problems for psychological treatment over time. 
Youth are asked to identify the three main problems that they are experiencing in 
their life at the beginning of treatment, along with a behaviorally specific goal for 
addressing each of the identified problems. Then, throughout the course of 
treatment, youth provide weekly ratings of each problem’s severity on a Likert-type 
scale from 0 to 8, where 0 = total problem remission and 8 = extreme problem 
severity. The Top Problems assessment has been used in prior trials of the Unified 
Protocols for the Treatment of Emotional Disorders in Children and Adolescents (one 
of the treatments upon which the current intervention is based) (Milgram et al., 2021). 
For the purposes of this study, only child-reported target problems will be identified 
and tracked as parents will not be actively involved in the weekly intervention 
sessions. 
• 
Acceptability of Session Questionnaire. The Acceptability of Session Questionnaire 
(Heck, 2015) is a 10-item adolescent self-report questionnaire that will be used in this 
study to assess the acceptability of each intervention session. This scale was 
originally developed to assess a minority stress-informed mental health promotion 
program for LGBTQ high school students (Heck, 2015). For this study, five additional 
items were added to assess the acceptability of intervention components that are 
unique to this intervention (e.g., home practice tasks, group member support). The 
Heck (2015) study did not report psychometric properties of the scale. 

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• 
AFFIRM Acceptability Survey. The AFFIRM Acceptability Survey (Craig & Austin, 
2016) is a 17-item youth-report questionnaire originally designed to assess the 
acceptability of the CBT-based AFFIRM intervention with LGBTQ young people. 
Items were slightly modified for this study to omit the word “AFFIRM” and replace it 
with “this intervention.” Items address topics like intervention usefulness, relevance to 
participants’ lives, and overall satisfaction, and are rated on a 4-point scale, where 1 
= Strongly Disagree and 4 = Strongly Agree. The Craig & Austin (2016) study did not 
report psychometric properties of the scale. 
• 
Exit Interview. The acceptability of the intervention will also be assessed qualitatively 
during a post-intervention exit interview with each youth participant. Questions will 
address the acceptability of the intervention format, delivery modality, and the 
content. 
Feasibility: 
• 
Homework Compliance Scale. The Homework Compliance Scale (Primakoff, 
Epstein, & Covi, 1986) is a single-item rating scale that asks therapists to assess the 
degree to which a client completed assigned cognitive therapy homework. A 6-point 
scale is employed, where 1 = the patient did not attempt the assigned homework and 
6 = the patient did more of the assigned homework than was requested. In this study, 
therapist(s) will review homework with participants at the beginning of each session, 
and participants will also be asked to submit their homework assignment 
electronically to facilitate scoring. Therapists will provide a homework compliance 
score for each participant every session. 
• 
Feasibility of Session Questionnaire. This is a novel 5-item measure that assesses 
barriers to intervention engagement that youth may encounter, including difficulty 
accessing a device for the session, finding a private place from which to attend the 
session, technical difficulties, and homework incompletion. Participants will be asked 
to complete these questions after each session, and will rate items using a 
dichotomous yes/no response. 
• 
Feasibility of Program Questionnaire. This is a novel 4-item measure that is designed 
to assess parent/caregiver barriers to intervention engagement. This scale will be 
administered to parents/caregivers during the post-intervention assessment to 
capture feasibility of the intervention as a whole. Due to the broader scope of these 
questions (full intervention) relative to the youth items (individual sessions), items will 
be rated on a 4-point scale, where 1 = Disagree/Never and 4 = Agree/Always.  
• 
Exit Interview. The feasibility of the intervention will also be assessed qualitatively 
during a post-intervention exit interview with each youth participant. Questions will 
address the feasibility of session attendance (e.g., acquisition of an electronic 
device), session length, and home practice exercises, among other topics.  
Need for refinement: 

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• 
Session Refinement Questions. This is a novel 3-item measure that asks youth 
participants to describe their most favorite and least favorite aspects of a given 
intervention session, and to provide suggestions for ways to improve the session so 
that it is more helpful for LGBTQ youth. Youth participants will be asked to complete 
these questions after each session, and data will be analyzed qualitatively at the end 
of the intervention. 
• 
Program Refinement Questions. This is a novel 11-item measure for 
parents/caregivers that has two goals. First, parents/caregivers are asked to provide 
feedback on the parent/caregiver handouts that they receive electronically after each 
intervention session. Second, parents/caregivers are asked several questions that 
assess interest in a potential parent/caregiver group for future iterations of the 
intervention. In prior studies with the Unified Protocol for Adolescents, a parent group 
has been a component of the intervention model (Ehrenreich-May et al., 2017). 
However, since no studies have examined intervention preferences among parents 
of LGBTQ youth, parents’ answers to these questions will guide the study team as 
we seek to develop a parent group in the future. 
• 
Exit Interview. The need to refine the intervention will also be assessed qualitatively 
during a post-intervention exit interview with each youth participant. Questions will 
probe participants’ suggestions for improving the intervention, as well as the parts of 
the intervention that they felt most helpful, among other topics. 
Mental health: 
• 
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS). The KSADS 
(Kaufman et al., 1997, 2016) is a well-validated semi-structured diagnostic interview 
designed to identify DSM-5 mental disorders in youth. It has demonstrated excellent 
test-retest reliability in prior work (κ¬=0.77-1.00; Kaufman et al., 1997). The KSADS 
will be used in this study to determine whether youth are eligible for the study 
(inclusion: meet criteria for a DSM-5 internalizing disorder; exclusion: meet criteria for 
psychotic or bipolar spectrum diagnosis, active suicidality and/or homicidality, 
significant cognitive impairment, significant developmental or behavior disorder (if 
impairing youth’s ability to participate in group therapy) 
• 
Depressive Symptom Index - Suicidality Subscale (DSI-SS). The DSI-SS (Joiner, 
Pfaff, & Acres, 2002; Metalsky & Joiner, 1997) is a 4-item self-report questionnaire 
that assesses the frequency and intensity of suicidality in the past two weeks. Items 
are scored on a 0-3 scale, where higher scores indicate more suicidal thoughts and 
impulses. Previous studies with the DSI-SS have revealed strong internal 
consistency (a = 0.90; Joiner, Pfaff, & Acres, 2002). 
• 
Strengths and Difficulties Questionnaire (SDQ). The SDQ (Goodman, 1997; 
Goodman et al., 1998) is a 25-item questionnaire that assesses a broad range of 
psychological attributes of youth aged 3-17 years. Both the parent-report and the 
adolescent self-report versions of this scale will be used in this study. The measure 

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consists of five, five-item subscales measuring emotional difficulties, conduct 
problems, hyperactivity/inattention, peer relationship problems, and prosocial 
behavior. Participants are asked to rate whether each item is not true, somewhat 
true, or certainly true for them over the past six months. Previous studies with the 
SDQ have revealed good internal consistency (a = 0.73; Goodman, 2001). 
• 
WHO-5 Well-Being Index (WHO-5). The WHO-5 (Psychiatric Research Unit, 1998) is 
a brief, 5-item self-report questionnaire that measures subjective well-being. It is 
derived from longer, 10- and 28-item versions of the same scale (Bech et al., 1996). 
Participants are asked to rate how well each of the items applies to them over the 
past 14 days on a scale from 0 = none of the time to 5  = all of the time. It has been 
widely used and deemed valid in a range of countries and contexts (Topp et al., 
2015), and in youth as young as 9 years. The WHO-5 has demonstrated good 
internal consistency in adolescent samples (a = 0.82; de Wit et al., 2007). 
• 
CRAFFT 2.1. The CRAFFT 2.1 (The Center for Adolescent Behavioral Health 
Research, 2020) is a 9-item youth-report screening tool for risky substance use in 12-
21 year olds. Participants are asked to report on the frequency (# of days) of alcohol, 
marijuana, and other substance use in the past year, as well as high-risk behaviors 
(e.g., riding in a car driven by someone under the influence, use of substances to 
relax). Prior research indicates that the CRAFFT has good sensitivity in identifying 
both alcohol (0.79) and drug use (0.86) in adolescents (The Center for Adolescent 
Behavioral Health Research, 2020), and good predictive validity (Shenoi et al., 2019). 
• 
Youth Psychosis At-Risk Questionnaire - Brief (YPARQ-B). The YPARQ-B (Ord et 
al., 2004) is a 28-item youth-report questionnaire that assesses psychotic symptoms 
in adolescents as young as 12. It is an abbreviated version of the original 92-item 
scale by the same name (Ord et al., 2004). Participants are asked to indicate 
whether each item applies to them (“yes”) or not (“no”), or if they are “undecided.” 
The YPARQ-B has shown strong internal consistency in prior studies (a = 0.94; 
Fonseca-Pedrero et al., 2017), and high sensitivity (1.00) and specificity (0.80) (Kline 
et al., 2015). In this project, the YPARQ-B will be used to determine eligibility. 
Potential participants will be deemed ineligible if their score is 13 or above. 
• 
Brief Child Mania Rating Scale - Parent Version (CMRS-P). The brief CMRS-P 
(Henry et al., 2008) is a 10-item parent-report questionnaire that assesses manic 
symptoms in youth aged 9-17 years. It is an abbreviated version of the original 21-
item scale by the same name (Pavuluri et al., 2006). The brief CMRS-P has shown 
excellent internal consistency (a = 0.91), and strong sensitivity and specificity for 
differentiating mania from ADHD (0.84 and 0.92 respectively) and from healthy 
controls (0.90 and 0.96 respectively) (Henry et al., 2008). In this project, the CMRS-P 
will be used to determine eligibility. Potential participants will be deemed ineligible if 
their score is 10 or above.  
• 
Child & Adolescent Intellectual Disability Screening Questionnaire (CAIDS-Q). The 
CAIDS-Q (McKenzie et al., 2012) is a 7-item, parent-report questionnaire that 

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30 
screens for intellectual disability and related adaptive functioning difficulties in youth 
aged 8-18. Participants are asked to indicate whether each item (e.g., “can the 
child/adolescent read?”) applies to their child (“yes”) or not (“no”). Prior studies have 
demonstrated strong internal consistency of the CAIDS-Q (a = 0.88), and high 
sensitivity (0.96) and specificity (0.85) for differentiating intellectual disability from 
healthy controls (McKenzie et al., 2012). In this project, the CAIDS-Q will be used to 
determine eligibility. Potential participants will be deemed ineligible if their score is 64 
or above. 
• 
Autism Quotient-10 (AQ-10). The AQ-10 (Allison et al., 2012) is brief, 10-item 
screening tool for assessing symptoms of autism spectrum disorders (ASD). In this 
study, we will use the adolescent version of the scale, which asks parents to rate the 
degree to which each item applies to their teenager on a 4-point scale from Definitely 
Agree to Definitely Disagree. Prior studies with this scale have demonstrated good 
internal consistency (a = 0.89) and high sensitivity (0.93) and specificity (0.95) when 
differentiating between youth with ASD and healthy controls (cut point = 6) (Allison et 
al., 2012). In this study, the AQ-10 will be used to help characterize the sample, 
especially given the documented increased frequency of ASD traits in gender diverse 
youth (Warrier et al., 2020). We do not anticipate changes in these traits over the 
course of the trial, and thus will only administer this questionnaire at pre-intervention. 
Minority stress reactions: 
• 
Gender Minority Stress and Resilience Measure for Adolescents (GMSR-A). The 
GMSR-A (Hidalgo et al., 2019) is a 59-item youth-report questionnaire that assesses 
experiences of both distal (discrimination, rejection, victimization, non-affirmation) 
and proximal minority stress (internalized transphobia, negative expectations for the 
future, and non-disclosure of gender identity/history), as well as resilience (pride, 
community connectedness) among gender minority adolescents aged 12-18 years. 
Three subscales (discrimination, rejection, victimization) are rated using a count 
(yes/no) of items, while the remaining six subscales are scored using a 5-point scale, 
where 0 = Strongly Disagree and 4 = Strongly Agree. Prior research demonstrated 
good internal consistency for the GMSR-A and its subscales (as = 0.80-0.95; Hidalgo 
et al., 2019). For the purposes of this study, the wording of items will be modified 
slightly to apply to both sexual and gender minority youth (e.g., “I have been rejected 
at school or work because of my gender identity or expression” was changed to “I 
have been rejected at school or work because of my LGBTQ identity”). Pertinent 
subscales include: internalized transphobia, negative expectations for the future, and 
non-disclosure of gender identity/history, resilience, and community connectedness. 
• 
Outness Inventory (OI). The OI (Mohr & Fassinger, 2000) is an 11-item self-report 
measure that assesses the extent to which sexual minority individuals are open 
about their sexual orientation with various people in their lives (e.g., family, friends, 
strangers). For this study, the wording of the item anchors were modified slightly to 
apply to LGBTQ identity more broadly. In addition, two items related to the school 

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environment (school peers, teachers) were added, given the age of the sample. 
Items are rated on a 7-point scale, where 1 = person definitely does NOT know about 
my LGBTQ identity and 7 = person definitely knows about my LGBTQ identity and it 
is openly talked about. Prior studies have shown strong internal consistency for the 
OI total score (a = 0.94), as well as subscales pertaining to family (a = 0.91), world 
(a = 0.91), and religion (a = 0.96) (Wilkerson et al., 2016). 
Stigma exposure: 
• 
GMSR-A (as described in minority stress reactions section). Pertinent subscales 
include: discrimination, rejection, victimization, non-affirmation. 
• 
Child Perceived Discrimination Questionnaire (CPDQ). The CPDQ (LaFont et al., 
2018) is a 16-item youth-report scale designed to measure youth experiences of 
discrimination as perpetrated by their peers (8 items) and by adults (8 items). Items 
are rated for their frequency of occurrence using a 5-point scale, where 1 = Never 
and 5 = Very Often. The instructions for this scale were modified slightly for this study 
to pertain specifically to discrimination that youth perceive to be related to their 
LGBTQ identity. Prior investigations have shown the CPDQ has strong internal 
consistency (as = 0.90-0.92). 
• 
Lesbian, Gay, Bisexual Affiliate Stigma Measure (LGB-ASM). The LGB-ASM 
(Robinson, 2014) is a 17-item self-report measure that assesses stigma experiences 
of individuals who are affiliated (e.g., friends, family) with LGBTQ people. In addition 
to a total score, the LGB-ASM includes subscales measuring public 
discrimination/rejection-related affiliate stigma, vicarious affiliate stigma, and public 
shame affiliate stigma. Items are scored on a 6-point scale from 1 = Strongly 
Disagree to 6 = Strongly Agree. Prior studies demonstrate good internal consistency 
for the total scale (a = 0.87) and the subscales (as = 0.84-0.89) (Robinson, 2014). 
For this study, the wording of each item was slightly modified to pertain to parents’ 
feelings on behalf of their LGBTQ child. 
• 
Parental Rejection/Acceptance of LGBTQ Child. The Parental Rejection/Acceptance 
of LGBTQ Child scale (Pachankis et al., 2018) is a brief, 4-item scale that assesses 
LGBTQ individuals’ perceived parental rejection and acceptance. Participants are 
asked to rate the degree to which their mother (or closest female guardian) and their 
father (or closest male guardian) is accepting of their sexual orientation and gender 
identity, using a 6-point scale where 1 = completely accepting and 6 = completely 
rejecting. For the purposes of this study, matching items were created for parents to 
self-report their degree of acceptance of their LGBTQ child. 
Emotion regulation & coping:  
• 
Emotion Regulation Questionnaire for Children and Adolescents (ERQ-CA). The 
ERQ-CA (Gross & John, 2003; Gullone & Taffe, 2012) is a 10-item youth-report 
questionnaire assessing the use of emotion regulation strategies in youth aged 9-18. 
The scale is comprised of two subscales: cognitive reappraisal (6 items), and 

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expressive suppression (4 items). Items are rated on 5-point scale, where 1 = 
Strongly Disagree and 5 = Strongly Agree. Prior studies with youth demonstrate good 
internal consistency for the cognitive reappraisal subscale (a = 0.83) and adequate 
internal consistency for the expressive suppression subscale (a = 0.75) (Gullone & 
Taffe, 2012). 
• 
Child Avoidance Measure - Self Report (CAMS) and Parent Report (CAMP). The 
CAMS/CAMP (Whiteside et al., 2013) is an 8-item youth- and parent-report scale that 
assesses behavioral avoidance related to anxiety and worry in youth aged 9-18. Both 
the parent-report and the youth self-report versions of this scale will be used in this 
study. Participants are asked to rate the frequency with which they (or their child) 
engage in each behavioral avoidance strategy using a 4-point scale, where 0 = 
Almost Never and 3 = Almost Always. Prior studies demonstrate good internal 
consistency for both the youth self-report (a = 0.86-0.89) and the parent-report (a = 
0.90-0.91) versions of the scale (Whiteside et al., 2013). 
• 
Children's Automatic Thoughts Scale - Negative/Positive version (CATS). The CATS-
N/P (Schniering & Rapee, 2002; Hogendoorn et al., 2010) is a 50-item youth-report 
scale that assesses negative and positive self-statements in youth aged 8-18 years. 
The CATS-N/P is an extension of the original 40-item CATS (Schniering & Rapee, 
2002) that solely assessed negative thoughts. The CATS-N/P has five subscales: 
automatic thoughts related to physical threat, social threat, personal failure, and 
hostility, and positive automatic thoughts. Items are rated for their frequency on a 5-
point scale, where 0 = Not at all and 4 = All the time. Prior studies demonstrate 
excellent internal consistency for the total negative thoughts score (a = 0.94-0.95), 
physical threat subscale (a = 0.84-0.85), social threat subscale (a = 0.89-0.92), 
personal failure subscale (a = 0.87-0.92), hostility subscale (a = 0.83-0.85), and 
positive thoughts score (a = 0.86) (Schniering & Rapee, 2002; Hogendoorn et al., 
2010). 
• 
Coping with Sexual Orientation-Related Minority Stress. The Coping with Sexual 
Orientation-Related Minority Stress scale (Toomey et al., 2018) is a 10-item youth 
self-report questionnaire designed to assess sexual minority adolescents’ strategies 
for coping with minority stress. The scale consists of three subscales: LGBT-specific 
coping (3 items), alternative seeking (3 items), and cognitive strategies (4 items). 
Although this scale was not initially created for use with gender minority youth, all 
items are written to be inclusive (i.e., use of “LGBT”) and capture coping strategies 
that gender minorities may also use in the face of gender-related minority stress 
(e.g., “looking for services for LGBT youth,” “imagining a better future for yourself”). 
Items are scored on a 5-point scale, where 0 = Never and 4 = Very Often. Prior 
studies demonstrate that the three subscales have good internal consistency (aLGBT 
coping = 0.82; aalternative-seeking = 0.79; acognitive strategies = 0.78; Toomey et al., 2018). 
• 
Multidimensional Scale of Perceived Social Support (MSPSS). The MSPSS (Zimet et 
al., 1988; Canty-Mitchell & Zimet, 2000) is a 12-item self-report scale that measures 

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perceived social support from family, friends, and significant others. Originally an 
adult scale, the MSPSS has been successfully adapted for use with adolescents 
(Canty-Mitchell & Zimet, 2000). Participants are asked to rate how much they agree 
with each statement using a 7-point scale, where 1 = Very Strongly Disagree and 7 = 
Very Strongly Agree. Previous studies have found strong internal consistency for the 
MSPSS total score (a = 0.93), as well as the family (a = 0.91), friends (a = 0.89), and 
significant other (a = 0.91) subscales (Canty-Mitchell & Zimet, 2000).  
Other: 
In addition to the above measures, we will collect several measures to better characterize 
our sample and their current context.  
• 
Demographics: Both youth and parent/caregiver will be asked demographic 
questions about factors like age, sex, gender, sexual orientation, race, ethnicity, 
family income, employment, family structure, living situation, education, religion, and 
other related constructs. 
• 
Gender Unicorn: Youth will be asked to rate their gender identity, gender expression, 
sex assigned at birth, physical attraction, and emotional attraction using the Gender 
Unicorn worksheet (see Measure Packet). Each scale will be rated from 0-10. 
• 
General Parent-Child Relationship Characteristics. As parents/caregivers will be 
provided with parent/caregiver handouts throughout the intervention, we wanted to 
better characterize our youth participants’ contact with their parent/caregivers as part 
of this study. This novel 14-item measure assesses parents’ frequency of contact 
with their child, sense of connection with their child, as well as their experience of 
their child’s LGBTQ identity. All items will be administered to parents/caregivers at 
pre-intervention, but only Q6 (which assesses the degree to which the parent views 
the child’s LGBTQ identity as real and valid) will be readministered at the post-
intervention timepoint.  
• 
Family Assessment Device (FAD) — General Functioning Subscale. To characterize 
the youth’s family environment, both youth and parent/caregiver will be asked to 
complete the general functioning FAD subscale (Epstein et al., 1983; Byles et al., 
1988). The subscale includes 12 items that all assess aspects of adaptive and 
maladaptive family functioning. Items are scored on a 4-point scale from 1 = Strongly 
Agree to 4 = Strongly Disagree. Prior studies with this measure have demonstrated 
good internal consistency (a = 0.86; Byles et al., 1988). 
 
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https://doi.org/10.1207/s15327752jpa5201_2 
 
 
 

Protocol Number 2000030664 
 
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38 
5 Study Participants 
5.1 
Study Population 
The study population will consist of participants with internalizing disorders of mild to 
moderate severity who identify as LGBTQ, are 12-17 years of age, are fluent in English, and 
who live in New York, New Jersey, or Connecticut. Parents/legal guardians of these youth 
will also participate in pre-intervention and post-intervention assessments. 
This intervention, and the treatments on which this intervention is based, was developed for 
the treatment of internalizing disorders, and thus eligible participants must meet criteria for 
anxiety, depression, or another internalizing disorder. Participants with severe internalizing 
disorders will be provided with referral information and excluded due to safety concerns and 
the need for more intensive intervention services. 
This age group was selected due to the lack of interventions that have been adapted and 
tested for LGBTQ youth in adolescence, particularly in the 12-14 years age group. Moreover, 
this is a period during which internalizing psychopathology may emerge, making youth in this 
age range important targets for intervention. 
These three US states were selected to allow for regional and geographic similarities 
between participants’ locations (and thus potentially increase group rapport), to facilitate 
logistical aspects of the study (e.g., same time zone for all participants), and to aid in risk 
mitigation as needed, given the clinical nature of the sample (i.e., team has greater 
familiarity with local emergency services in these states). This geographic restriction might 
limit the generalizability of this intervention to LGBTQ adolescents in other parts of the US 
and world; however, as the goal of this pilot is to examine the feasibility and acceptability of 
the intervention in a small sample of diverse LGBTQ youth, we believe that this geographic 
restriction allows for diversity in participants while also limiting logistical barriers and 
mitigating risk. 
 
5.2 
Number of Participants 
A total of 20 LGBTQ youth (aged 12-17 years) and their parents will be selected to 
participate in this study.  
Given the numerous inclusion criteria, we anticipate needing to screen up to 100 participants 
in order to reach our target enrollment. 
  
5.3 
Eligibility Criteria 
In order to be eligible for inclusion in the study, an individual must meet all of the following 
criteria:   
• 
12-17 years old 
• 
Self-identify as LGBTQ (any diverse sexual orientation and/or gender identity) 
• 
Live in New York, New Jersey, or Connecticut 
• 
Fluent in English 

Protocol Number 2000030664 
 
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39 
• 
Meet diagnostic criteria for a DSM-5 internalizing disorder (any depressive, anxiety, 
obsessive-compulsive, or adjustment disorder) 
• 
Have consistent, weekly access to an Internet-enabled electronic device that allows 
for video-conferencing 
• 
Availability to attend 10 weekly 90 minute intervention sessions in summer 2021 
• 
Access to a quiet, private place for intervention sessions 
• 
Provision of informed consent from parent/guardian and assent from the youth 
 
Any individual who meets any of the following criteria will be excluded from participation in 
this study:  
• 
Evidence of any psychotic or bipolar spectrum diagnosis  
• 
Active suicidality and/or homicidality (defined as active intent or concrete plan, as 
opposed to passive ideation) or psychiatric hospitalization within the past 6 months 
• 
Significant cognitive impairment (as determined by an intellectual disability screener 
[CAIDS-Q]) or significant developmental disorder (if impairing youth’s ability to 
participate in group therapy) 
• 
Significant behavior disorder (e.g., oppositional defiant disorder, conduct disorder) if 
impairing youth’s ability to participate in group therapy 
• 
Received any cognitive-behavioral therapy treatment in the past 12 months 
• 
Unstable psychotropic medications (defined as changes to antidepressant dosage in 
the past 3 months, or changes to a benzodiazepine dosage in the past month) 
 
The virtual group sessions will exclude non-English speaking participants due to the need for 
participants to understand both the group facilitator and each other. As existing research 
highlights transportation as a key barrier to accessing services for economically 
disadvantaged LGBTQ youth (Zullo, Seager van Dyk, et al., 2021), the virtual format of the 
sessions could make the study more accessible to these youth. However, as participants will 
require a video-conferencing capable electronic device in order to participant, some 
economically disadvantaged potential participants will be excluded. Future trials might 
consider the addition of video-enabled e-tablets for youth and families without access. 
 
5.4 
Recruitment Procedures  
Recruitment strategy: Potential participants will be identified through responses to study 
advertisements posted widely online. Advertisements will be shared through social media 
(e.g., Facebook, Instagram, Twitter), our lab’s website, online search engines (e.g., Google 
Ads), and emails to local LGBTQ-related organizations, clinics, and listservs (e.g., Yale 
Gender Clinic, Kaleidoscope). Advertisements will attempt to target both eligible LGBTQ 
youth and their parent/caregivers, and will include a link to a Qualtrics-hosted screening 
survey (separate links for youth and parent/caregivers), as well as basic information about 
the study design. Advertisements will refer to the intervention and study as “EQuIP 
(Empowering Queer Identities in Psychotherapy)” to 1) be consistent with previous studies 
of this intervention that also used this branding, and 2) aid potential participants in 
remembering the name of the study during the recruitment process. 
 
Screening: Once potential participants navigate to the screening survey on Qualtrics, they 
will view one of two screens.  
• 
If the potential participant is a youth, they will be notified that their parent or 
parent/caregiver must provide parental permission/consent in order for them to 
proceed. Youth will also be informed that during the consent process, their 
parent/caregiver will learn that this study is for LGBTQ youth, so that youth can 
make an informed decision about whether to share the link with their 

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40 
parent/caregiver (particularly if their parent does not know about their LGBTQ 
status). They will be instructed to share the link to the parent/caregiver screening 
survey with their parent/caregiver at this time if they would like to continue with the 
screening process. 
• 
If the potential participant is a parent/caregiver, they will be asked to confirm that 
they have the legal right to consent for their child’s participation in research studies 
and/or medical/psychological care. If the participant confirms, they will view an 
online consent form and parental permission form for the screening process (details 
provided in section 5.5).  
 
If the parent/caregiver provides informed consent and parental permission for the screening 
process, they will then be asked to provide information about their child to assess eligibility, 
including the child’s age, pertinent demographics, residency in New York, New Jersey, or 
Connecticut, availability to participate in study procedures, and mental health symptoms. If 
the parent/caregiver’s responses to screening questions suggest their child is NOT eligible 
for the study, they will be thanked for their time and the survey will discontinue. If the 
parent/caregiver’s responses to screening questions suggest their child may be eligible for 
the study, they will be asked to provide both their own contact information (name, email 
address, phone number, physical address), as well as contact information for their child. 
The parent/caregiver will be directed to a separate online survey to provide this contact 
information for themselves and their child. A link to the youth version of the screening 
survey will be subsequently emailed to the youth.  
 
When the youth navigates to the screening survey, they will view an assent form for the 
screening process (details provided in section 5.5). If youth provide informed assent, they 
will be asked to complete questions to assess eligibility, including their LGBTQ status, 
pertinent demographics, availability to participate in study procedures, and mental health 
symptoms. Once youth complete this survey, they will be informed that based on their 
survey responses either 1) they are ineligible for the study, or 2) they may be eligible for the 
study, pending a phone screen with a study team member. 
 
Study team members will review responses to the screening survey to identify potentially 
eligible participants. If a youth appears to meet study criteria (as documented in Section 
5.3), including mental health symptoms on the RCADS-P or -C with a T-score of 65 or more 
(suggesting they likely meet diagnostic criteria for a DSM-5 internalizing disorder), the study 
team member will reach out to the child and their parent (by phone and/or email) to 
schedule a one-hour call (Zoom or phone) for a brief diagnostic interview with Dr. Seager 
van Dyk (postdoctoral fellow).  
 
During the one-hour call, Dr. Seager van Dyk will administer relevant modules from the 
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS), in order to confirm 
the youth meets diagnostic criteria for a DSM-5 internalizing disorder. If the youth does not 
meet diagnostic criteria for a DSM-5 internalizing disorder, the youth and parent will be 
informed that they do not meet eligibility criteria for the study, provided with a list of LGBTQ 
resources (including mental health resources) for youth, and the call will be concluded. If 
the youth does meet diagnostic criteria for a relevant disorder, the study team member will 
spend the rest of the call conducting the consent/assent process (described in Section 5.5). 
 
5.5 
Consent/Assent Procedures/HIPAA Authorization 
Consent, assent, and parental permission will be obtained online via the secure Yale 
Qualtrics survey software. As such, a waiver of documentation of consent is planned for this 

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41 
study. The PI will be responsible for ensuring that online consent, assent, and parental 
permission has been obtained appropriately. 
 
Given the sensitivity associated with disclosing LGBTQ status to parents/caregivers, 
particularly among youth who rely on their parent/caregivers for basic necessities (e.g., 
shelter, clothing, food), as well as the high likelihood of some youth selectively disclosing 
their LGBTQ status to one parent/caregiver but not the other (as is developmentally 
appropriate), we will only require one parent/caregiver to provide parental permission for 
their child to participate in this study. However, if any parent/caregiver with the appropriate 
legal authority requests that the child be removed from the study, their wishes will be 
respected.  
 
Screening: As previously described, potential participants will first complete an initial 
screening to determine their eligibility for the study. Before potential youth participants 
provide any information, they will be directed to send their parent/caregiver a link to a 
consent and parental permission form (hosted online via Qualtrics). Parents/caregivers will 
be first asked the following question: 
• 
Do you have the legal right to consent for your child’s participation in research 
studies and/or medical/psychological care? (i.e., parental rights, guardianship rights).  
o YES, I confirm I have the legal right to provide consent for my child. 
o NO, I do NOT have the legal right to provide consent for my child. 
If the parent/caregiver selects YES, they will view an online consent form and parental 
permission form for the screening process. Parents/caregivers will be informed on the 
consent and parental permission forms about all steps of the screening process (caregiver 
and youth questionnaires, as well as a phone or Zoom call to determine eligibility), as well as 
related risks and benefits. Parents/caregivers will be informed that participation in the 
screening process does not guarantee inclusion in the intervention study, and that they have 
the option to participate or decline participation in the study (see attachments on IRES for 
online consent form). Parents/caregivers will be informed that both youth and 
parent/caregiver participation is required during the screening process (i.e., if the 
parent/caregiver elects not to provide parental permission for their child to participate in the 
screening but consents for their own participation, the screening will not proceed because 
youth input is vital for determining eligibility). Parents/caregivers will be provided with the PI’s 
contact information and directed to call or email the PI if they have any questions or 
concerns. Parents/caregivers will be informed that participation is voluntary and that they 
may withdraw from the study at any time, without penalty. A copy of the informed consent 
document will be given to the parent/caregiver for their records. Parents/caregivers will be 
required to check two of the following boxes before moving on to the rest of the screening 
questions: 
o On the consent form screen: 
o YES. I have read the above information. The study has been explained to me. 
My questions have been answered. I VOLUNTARILY AGREE to be in this 
study. 
o NO. I do NOT agree to participate in this online study. 
o On the parental permission form screen: 
o YES. I have read the above information. The study has been explained to me. 
My questions have been answered. I VOLUNTARILY AGREE to provide 
permission for my child to be in this study. 
o NO. I do NOT agree to provide permission for my child to be in this study. 
 

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42 
If the parent/caregiver’s responses to screening questions suggest their child may be eligible 
for the study, they will be asked to provide both their own contact information (name, email 
address, phone number, physical address), as well as contact information for their child. The 
parent/caregiver will be directed to a separate online survey to provide this contact 
information for themselves and their child. A link to the youth version of the screening survey 
will be subsequently sent to the youth. Assent will be obtained. A written explanation will be 
provided in terms suited to the participant's comprehension of the purposes, procedures, 
and potential risks of the study and of their rights as research participants. Youth will be 
provided the same information as was given to parent/caregivers during the 
consent/parental permission process, using developmentally appropriate language.  
 
Intervention Study: As described above, if youth are determined during the screening 
process to be eligible for the study, study team members will obtain informed consent, 
assent, and parental permission during a call (Zoom or phone) with both the youth and 
parent/caregiver. The study team member will review the consent, assent, and permission 
forms with the youth, along with the main study components (e.g., assessment timepoints, 
format of the intervention, timing of the intervention sessions). Copies of the consent, assent, 
and permission forms will be provided electronically to the youth and parent during the 
meeting for them to review in detail.  
 
Potential participants will be informed on these forms that the youth will receive $30 for 
completing the pre-intervention survey, $5 for each weekly survey they complete after each 
intervention session (up to a total of 10 sessions = $50), $30 for completing the post-
intervention survey, and $30 for completing a post-intervention one-hour exit interview (total 
= $140). In addition, parent/caregivers will be informed that they will receive $30 for 
completing the parent/caregiver version of the pre-intervention survey, and $30 for 
completing the parent/caregiver version of the post-intervention survey (total = $60). All 
study payments will be in the form of e-mailed Amazon gift cards or Venmo payments. 
Venmo payments will be sent to participants from the private @Yale-Study account and will 
be accompanied with the text “Thank you for your participation.”  
 
Youth and parents/caregivers will be given the opportunity to ask questions, and risks and 
benefits of participation will be reviewed. They will be provided with the PI’s contact 
information and directed to call or email the PI if they have any questions or concerns. Youth 
and parent/caregivers will be informed that participation is voluntary and that they may 
withdraw from the study at any time, without prejudice. A copy of the informed consent 
document will be given to the participants for their records. 
 
Once potential participants have made a decision with regard to their participation in the 
study, they will be asked to provide verbal consent, assent, and parental permission to the 
study member conducting the consent process. The study member will document the date 
and time of consent, assent, and permission. In addition, youth and parent/caregiver will be 
provided with a link to a Qualtrics survey containing the consent, assent, and parental 
permission forms, where they will be asked to select from the following options: 

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43 
o On the consent and assent form screens: 
o YES. I have read the above information. The study has been explained to me. 
My questions have been answered. I VOLUNTARILY AGREE to be in this 
study. 
o NO. I do NOT agree to participate in this study. 
o On the parental permission form screen: 
o YES. I have read the above information. The study has been explained to me. 
My questions have been answered. I VOLUNTARILY AGREE to provide 
permission for my child to be in this study. 
o NO. I do NOT agree to provide permission for my child to be in this study. 
 
Upon providing consent/permission/assent for the study, participants will be asked if they 
have access to headphones/ear buds or the equivalent for use during the Zoom sessions. If 
not, the study team will mail headphones/ear buds to the participant to ensure that all 
participants have the ability to participate while maintaining both their confidentiality and that 
of the other participants. During the consent process, we will also indicate that youth will be 
able to pick a username that they will be known by during the Zoom sessions. This can be 
any name they want, including their affirmed first name (last names will not be allowed, nor 
will any other names that clearly identify the youth; e.g., phone number or address). The 
goal of using a username is to protect their privacy, so youth will be informed that using their 
legal name introduces some risk to their confidentiality. Youth will be kept in the Zoom 
waiting room until their study username is displayed. Youth will be reminded of their study 
username by email a few days before the first session, and will be provided instructions 
about how to change their username. 
 
Youth participants who reach the age of majority (18 years) during the course of the study: 
Participants must be 12-17 years of age to participate in the intervention phase of the study 
(see eligibility criteria). However, if participants turn 18 during the post-intervention 
assessment phase, they will be reconsented to the study using the appropriate consent form 
before assessments are completed. Specifically, a study team member will arrange a phone 
or Zoom call with the participant to review the consent form, provide copies of the consent 
form to the participant, and answer any questions the participant may have. As during the 
previous consent process, they will be asked to provide verbal consent (which the team 
member will document) as well as indicate their consent in an online version of the consent 
form (hosted on Qualtrics) using the options provided above. If the participant decides not to 
reconsent to the study, they will no longer be contacted for assessments. 
 

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6 Study Methods/Procedures 
6.1 
Study Procedures 
This mixed methods prospective study is designed to assess the feasibility, acceptability, 
and need for refinement of LGBTQ-affirmative cognitive behavior therapy for youth aged 12-
17 years in New York, New Jersey, and Connecticut. To achieve this goal, two 10-week 
LGBTQ-affirmative CBT groups with LGBTQ youth will be conducted (content of the 
intervention is described further in Section 4, Study Design). 
The study population will consist of participants with internalizing disorders of mild to 
moderate severity who identify as LGBTQ, are 12-17 years of age, are fluent in English, and 
who live in New York, New Jersey, or Connecticut. Parents/legal guardians of these youth 
will also participate in screening, pre-intervention and post-intervention assessments. 
Recruitment: Potential participants will be identified through responses to study 
advertisements posted widely online. Advertisements will be shared through social media 
(e.g., Facebook, Instagram, Twitter), our lab’s website, online search engines (e.g., Google 
Ads), and emails to local LGBTQ-related organizations, clinics, and listservs (e.g., Yale 
Gender Clinic, Kaleidoscope). Advertisements will attempt to target both eligible LGBTQ 
youth and their parent/caregivers, and will include a link to a Qualtrics-hosted screening 
survey (separate links for youth and parent/caregivers), as well as basic information about 
the study design. 
 
Screening: Once potential participants navigate to the screening survey on Qualtrics, they 
will view one of two screens.  
• 
If the potential participant is a youth, they will be notified that their parent or 
parent/caregiver must provide parental permission/consent in order for them to 
proceed. Youth will also be informed that during the consent process, their 
parent/caregiver will learn that this study is for LGBTQ youth, so that youth can 
make an informed decision about whether to share the link with their 
parent/caregiver (particularly if their parent does not know about their LGBTQ 
status). They will be instructed to share the link to the parent/caregiver screening 
survey with their parent/caregiver at this time if they would like to continue with the 
screening process. 
• 
If the potential participant is a parent/caregiver, they will be asked to confirm that 
they have the legal right to consent for their child’s participation in research studies 
and/or medical/psychological care. If the participant confirms, they will view an 
online consent form and parental permission form for the screening process (details 
provided in section 5.5).  
 
If the parent/caregiver provides informed consent and parental permission for the screening 
process, they will then be asked to provide information about their child to assess eligibility, 
including the child’s age, pertinent demographics, residency in New York, New Jersey, or 
Connecticut, availability to participate in study procedures, and mental health symptoms. If 
the parent/caregiver’s responses to screening questions suggest their child is NOT eligible 
for the study, they will be thanked for their time and the survey will discontinue. If the 
parent/caregiver’s responses to screening questions suggest their child may be eligible for 
the study, they will be asked to provide both their own contact information (name, email 
address, phone number, physical address), as well as contact information for their child. 
The parent/caregiver will be directed to a separate online survey to provide this contact 
information for themselves and their child. A link to the youth version of the screening 
survey will be subsequently sent to the youth.  

Protocol Number 2000030664 
 
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45 
 
When the youth navigates to the screening survey, they will view an assent form for the 
screening process (details provided in section 5.5). If youth provide informed assent, they 
will be asked to complete questions to assess eligibility, including their LGBTQ status, 
pertinent demographics, availability to participate in study procedures, and mental health 
symptoms. Once youth complete this survey, they will be informed that based on their 
survey responses either 1) they are ineligible for the study, or 2) they may be eligible for the 
study, pending a phone screen with a study team member. 
 
Study team members will review responses to the screening survey to identify potential 
participants. If a potential youth participant appears to meet study criteria (as documented 
in Section 5.3), including mental health symptoms on the RCADS-P or -C with a T-score of 
65 or more (suggesting they likely meet diagnostic criteria for a DSM-5 internalizing 
disorder), the study team member will reach out to the child and their parent (by phone 
and/or email) to schedule a one-hour call (Zoom or phone) for a brief diagnostic interview 
with Dr. Seager van Dyk (lead postdoctoral associate).  
 
During the one-hour call, Dr. Seager van Dyk will administer relevant modules from the 
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS), in order to confirm 
the youth meets diagnostic criteria for a DSM-5 internalizing disorder. If the youth does not 
meet diagnostic criteria for a DSM-5 internalizing disorder, the youth and parent will be 
informed that they do not meet eligibility criteria for the study, provided with a list of LGBTQ 
resources (including mental health resources) for youth, and the call will be concluded. If 
the youth does meet diagnostic criteria for a relevant disorder, the study team member will 
spend the rest of the call conducting the consent/assent process (described in Section 5.5). 
 
Pre-intervention assessment: Within two weeks of the first intervention session, youth and 
their parent/caregiver will be sent a link to the pre-intervention assessment survey via 
Qualtrics. This consists of a number of measures to assess constructs relevant to the 
primary and secondary objectives of the study (see 4.2 for full list of measures). Youth will 
then be assigned to one of two intervention groups based on the timing of their enrollment 
(i.e., participants who enroll in fall 2021 will be assigned to the first group, participants who 
enroll in winter/spring 2022 will be assigned to second group). 
 
Intervention: Each week for ten weeks, youth participants will attend a 90-minute group 
therapy session via Zoom. Participants will be taught intervention content (see Session 
Outlines document uploaded in IRES for more details) through a range of teaching 
modalities including use of the Zoom whiteboard feature, videos, interactive activities, 
worksheets, and group discussion. The intervention will be delivered by Dr. Seager van 
Dyk, who has experience counseling LGBTQ teenagers and who has received training in 
the intervention from the PI (who developed LGBTQ-affirmative CBT), with support from the 
study team. To ensure fidelity to the intervention model, Dr. Seager van Dyk will engage in 
clinical supervision with the PI throughout the course of the intervention, and any 
inadequate fidelity to the intervention model will be addressed during these supervision 
meetings. All sessions will be audio-recorded for supervision purposes, and audio 
recordings will be saved in a secure Yale Box folder. Due to the need for clinical 
supervision given the pilot nature of this intervention, audio recording will be a mandatory 
aspect of the study. Participants and their parent/caregiver will be informed of this 
requirement during the informed consent process. 
 

Protocol Number 2000030664 
 
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46 
Weekly assessments: Following each intervention session, youth participants will be sent a 
brief survey to evaluate the acceptability, feasibility, and need for refinement of each 
intervention session. Participants will also complete brief mental health measures each 
week to address the study’s secondary objective. Participants will be asked to submit an 
electronic copy (e.g., PDF, photo) of any completed home practice assignments to the 
study team via Yale’s Secure File Transfer, in order to evaluate the acceptability of these 
assignments. Study staff will de-identify all home practice materials before saving them in a 
secure Yale Box folder with the participant’s study ID number. For the first two weekly 
assessments, a study team member will call the youth participant to ensure that they 
understand all the survey questions and to ensure that responses via both modalities (i.e., 
phone, online survey) are consistent. 
 
Post-intervention assessment: Post-intervention assessment measures will be sent to youth 
participants and their parent/caregiver immediately following the last intervention session, 
and will be available for three weeks (see 4.2 for full list of measures). 
 
Exit interview: Once all other study tasks are complete, exit interviews will be conducted 
with youth via Zoom/phone to assess the feasibility, acceptability, and need for refinement 
of the intervention. See Measure Packet uploaded in IRES for exit interview content. 
Unscheduled visits: We do not anticipate any unscheduled intervention visits outside of the 
regularly scheduled group therapy sessions. However, in the event that participants indicate 
suicidality on any of the assessment surveys, the clinical protocol for our lab will be initiated 
(as described in 6.4), which requires a study team member to reach out to the participant via 
phone or Zoom to complete a safety assessment. In addition, if a youth participant does not 
show up to their scheduled visit, a study team member will contact the participant and/or 
their parent/legal guardian by phone/Zoom to assess barriers to attendance 
 
 
 
 
 

Protocol Number 2000030664 
 
08/03/2021 (Version 2) 
 
 
Visit Schedule 
C = Child 
P = Parent 
T = Therapist 
Screening surveys 
Day -14 to 0 
Diagnostic interview 
/ Consent Call 
Day 1 
Pre-intervention  
Day 14 ± 7 
Session 1 
Day 28 ± 7 
Session 2 
Day 35 ± 7 
Session 3 
Day 42 ± 7 
Session 4 
Day 49 ± 7 
Session 5 
Day 56 ± 7 
Session 6 
Day 63 ± 7 
Session 7 
Day 70 ± 7 
Session 8 
Day 77 ± 7 
Session 9 
Day 84 ± 7 
Session 10 
Day 91 ± 7 
Post-intervention  
Day 91 ± 21 
Exit interview 
Day 98 ± 42 
Consent / Assent / Permission  
C, P 
C, P 
 
 
 
 
 
 
 
 
 
 
 
 
 
Background Information 
     Demographics 
C, P 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
     Gender Unicorn 
 
 
C 
 
 
 
 
 
 
 
 
 
 
C 
 
     Parent-Child Relationship  
 
 
P 
 
 
 
 
 
 
 
 
 
 
P* 
 
     FAD 
 
 
C, P 
 
 
 
 
 
 
 
 
 
 
C, P 
 
Acceptability 
     Treatment Expectations 
 
 
C 
 
 
 
 
 
 
 
 
 
 
 
 
     Top Problems Assessed 
 
 
 
C 
 
 
 
 
 
 
 
 
 
 
 
     Top Problems Tracking  
 
 
 
 
C 
C 
C 
C 
C 
C 
C 
C 
C 
C 
 
     CSQ-8 
 
 
 
 
 
 
 
C 
 
 
 
 
 
C, P 
 
     Acceptability of session  
 
 
 
C 
C 
C 
C 
C 
C 
C 
C 
C 
C 
 
 
     AFFIRM Acceptability  
 
 
 
 
 
 
 
 
 
 
 
 
 
C, P 
 
     Format/delivery/content 
C 
Feasibility 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
     Session Attendance 
T 
T 
T 
T 
T 
T 
T 
T 
T 
T 
     Homework Compliance  
 
 
 
T 
T 
T 
T 
T 
T 
T 
T 
T 
T 
 
 
     Feasibility of Session  
 
 
 
C 
C 
C 
C 
C 
C 
C 
C 
C 
C 
 
 
     Feasibility of Program  
 
 
 
 
 
 
 
 
 
 
 
 
 
P 
C 
Need for Refinement 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
     Session Refinement  
 
 
 
C 
C 
C 
C 
C 
C 
C 
C 
C 
C 
 
 

Protocol Number 2000030664 
 
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48 
     Program Refinement  
 
 
 
 
 
 
 
 
 
 
 
 
 
P 
C 
Mental Health 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
     KSADS  
C, P 
     RCADS - Long 
C, P 
 
C, P 
 
 
 
 
 
 
 
 
 
 
C, P 
 
     RCADS - Short 
C 
C 
C 
C 
C 
C 
C 
C 
C 
C 
     DSI-SS 
 
C 
C 
C 
C 
C 
C 
C 
C 
C 
C 
C 
C 
C 
 
     SDQ 
 
 
C, P 
 
 
 
 
 
 
 
 
 
 
C, P 
 
     WHO-5 Well-Being Index 
 
 
C 
 
 
 
 
 
 
 
 
 
 
C 
 
     CRAFFT 2.1 
C 
C 
     AQ-10 
 
 
P 
 
 
 
 
 
 
 
 
 
 
 
 
     YPARQ-B 
C 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
     CMRS-P 
P 
     CAIDS-Q 
P 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Minority Stress 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
     GMSR-A 
 
 
C 
 
 
 
 
 
 
 
 
 
 
C 
 
     CPDQ 
 
 
C 
 
 
 
 
 
 
 
 
 
 
C 
 
     Outness Inventory (OI) 
 
 
C 
 
 
 
 
 
 
 
 
 
 
C 
 
     LGB-ASM 
 
 
P 
 
 
 
 
 
 
 
 
 
 
P 
 
     Parent Rejection 
 
 
C, P 
 
 
 
 
 
 
 
 
 
 
C, P 
 
Emotional Regulation & Coping 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
     CEMS 
 
 
C, P 
 
 
 
 
 
 
 
 
 
 
C, P 
 
     ERQ-CA 
 
 
C 
 
 
 
 
 
 
 
 
 
 
C 
 
     CAMS/CAMP 
 
 
C, P 
 
 
 
 
 
 
 
 
 
 
C, P 
 
     CATS 
 
 
C 
 
 
 
 
 
 
 
 
 
 
C 
 
     Minority Stress Coping 
 
 
C 
 
 
 
 
 
 
 
 
 
 
C 
 
     MSPSS 
 
 
C 
 
 
 
 
 
 
 
 
 
 
C 
 
Note. *Question 6 only. Parent-Child Relationship = General Parent-Child Relationship Questions. FAD = Family Assessment Device — General Functioning 
subscale. CSQ-8 = Client Satisfaction Questionnaire-8. KSADS = Kiddie Schedule for Affective Disorders and Schizophrenia. RCADS = Revised Children's 
Anxiety and Depression Scale. DSI-SS = Depressive Symptom Index - Suicidality Subscale. SDQ = Strengths and Difficulties Questionnaire. AQ-10 = Autism 

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Quotient-10. YPARQ-B = Youth Psychosis At-Risk Questionnaire – Brief. CMRS-P = Brief Child Mania Rating Scale - Parent Version. CAIDS-Q = Child & 
Adolescent Intellectual Disability Screening Questionnaire. GMSR-A = Gender Minority Stress and Resilience measure – Adolescent. CPDQ = Child 
Perceived Discrimination Questionnaire. LGB-ASM = Lesbian, Gay, Bisexual Affiliate Stigma Measure. Parent Rejection = Parental Rejection/Acceptance of 
LGBTQ child. CEMS = Children's Emotion Management Scales. ERQ-CA = Emotion Regulation Questionnaire for Children and Adolescents. CAMS/CAMP = 
Child Avoidance Measure Self / Parent. CATS = Children's Automatic Thoughts Scale - N/P version. Minority Stress Coping = Coping with Sexual Orientation-
Related Minority Stress. MSPSS = Multidimensional Scale of Perceived Social Support. 
 
 
 
 
 
 
 
 

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6.1.1 Data Collection 
All survey-based data collection will occur online via the secure Yale Qualtrics survey 
software. Such data collection will begin with the initial online screening surveys, to be 
completed by both parent/caregiver and the potential youth participant. Specific details 
about the contents of the screening surveys are provided elsewhere in this document; 
briefly, questions pertaining to the inclusion and exclusion criteria for this study will be 
asked in order to determine eligibility for the study. In addition, identifiable contact 
information (including parent/caregiver and youth name, email address, physical address 
and phone number) will be collected in these screening surveys in order to facilitate 
contacting participants for the diagnostic interview stage of the screening process. If, after 
the parent/caregiver completes their screening survey, it is clear that their child will not be 
eligible for the study, no contact information will be requested, in order to maximize 
potential participant confidentiality.  
After participants have completed the screening surveys through Qualtrics, a study team 
member will reach out potentially eligible participants (by phone and/or email) to schedule a 
one-hour call (Zoom or phone) for a brief diagnostic interview with Dr. Seager van Dyk (lead 
postdoctoral associate). Dr. Seager van Dyk will administer relevant modules from the 
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS), in order to confirm 
the youth meets diagnostic criteria for a DSM-5 internalizing disorder. Administration of the 
K-SADS requires advanced training, which Dr. Seager van Dyk received from a doctoral-
level supervisor in a prior role. She has 6 years of experience administering the K-SADS to 
more than 100 youth and their families. Dr. Seager van Dyk will record the youth and parent 
responses to the interview questions on a separate PDF copy of the KSADS for each 
participant, which will be saved after the interview on a secure Yale Box folder. In addition, 
diagnostic findings of the KSADS will be recorded in a de-identified spreadsheet saved in a 
secure Yale Box folder. 
All participants will be given a unique code that will serve as their study ID for the duration 
of the study. The use of the unique code will permit linkage of the data being collected 
across time points in the study. A master link file will connect participant names, phone 
numbers, email addresses, and physical addresses to their study code number. The link file 
will be password protected and only accessible to the study team as required for study 
tasks (e.g., providing participants with intervention-related materials). All data collection 
materials will be stored on password-protected folders on Yale Secure Box that requires 
dual-factor authentication to access. 
Pre-intervention assessment measures will be sent to youth participants and their parents 
via Qualtrics within two weeks of the first intervention session.  
All intervention sessions will be audio-recorded for supervision purposes, and audio 
recordings will be saved in a secure Yale Box folder. De-identified transcripts will be 
created of the interview data (also saved on Box). 

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Weekly assessments will be sent via Qualtrics to youth immediately following each 
intervention session. In addition, the study therapist (Dr. Seager van Dyk) will complete a 
weekly post-intervention Qualtrics survey tracking each participant’s attendance and 
homework compliance for the previous week. Participants will be asked to submit an 
electronic copy (e.g., PDF, photo) of any completed home practice assignments to the 
study team via Yale’s Secure File Transfer, in order to evaluate the acceptability of these 
assignments. Study staff will de-identify all home practice materials before saving them in a 
secure Yale Box folder with the participant’s study ID number. In line with the clinical 
protocol, home practice assignments will be reviewed by the study team within 24 hours or 
the next business day to assess for any report of harm to self or others. 
Post-intervention assessment measures will be sent to youth participants and their parents 
immediately following the last intervention session, and will be available for three weeks. 
None of the measures in these surveys require licensure for their administration. All 
measures can be found in the “Measures Packet” uploaded with the study protocol. 
Exit-interviews will be conducted via Zoom following the completion of the last intervention 
session and the post-intervention assessment. Audio recordings of the exit-interviews will 
be saved in a secure Yale Box folder, and transcripts will be created of the interview data 
(also saved on Box). Following the verification of the transcripts, the original audio files of 
the interviews will be deleted, and the transcripts will be de-identified.  
The study participant's contact information will be securely stored for internal use during the 
study. At the end of the study, all records will continue to be kept in a secure location for 
three years. After three years, all identifiable records for the study will be destroyed. 
 
6.2 
Method of Assignment/Randomization (if applicable)  
Participants will be assigned to groups based on the timing of their enrollment (i.e., 
participants who enroll in fall 2021 will be assigned to the first group, participants who enroll 
in winter/spring 2022 will be assigned to second group). In the event that more participants 
screen eligible for the study than is needed, priority will be given to participants who 
represent a diverse cross-section of identity groups (e.g., diverse sexual orientation, gender 
identity, race, ethnicity).  
 
6.3 
Adverse Events Definition and Reporting 
Adverse event means any untoward medical occurrence associated with the use of an 
intervention in humans. An adverse event (AE) or suspected adverse reaction is considered 
"serious" if, in the view of either the investigator or sponsor, it results in any of the following 
outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of 
existing hospitalization, a persistent or significant incapacity or substantial disruption of the 
ability to conduct normal life functions. 
 

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This protocol presents minimal risks to the subjects and Unanticipated Problems Involving 
Risks to Subjects or Others (UPIRSOs), including adverse events, are not anticipated. In the 
unlikely event that such events occur, Reportable Events (which are events that are serious 
or life-threatening and unanticipated (or anticipated but occurring with a greater frequency 
than expected) and possibly, probably, or definitely related) or Unanticipated Problems 
Involving Risks to Subjects or Others that may require a temporary or permanent interruption 
of study activities will be reported immediately (if possible), followed by a written report within 
5 calendar days of the Principal Investigator becoming aware of the event to the IRB (using 
the appropriate forms from the website) and any appropriate funding and regulatory 
agencies. The investigator will apprise fellow investigators and study personnel of all 
UPIRSOs and adverse events that occur during the conduct of this research project (e.g., 
through regular study meetings, via email as they are reviewed by the principal investigator.)   
 
6.4 
Reaction Management 
Participants will be reminded that they can stop participation at any time, skip any question, 
or take a break if experiencing mild distress during the assessments or during the 
intervention sessions. In the unlikely event that a participant experiences considerable 
distress, the study team will initiate our lab’s clinical protocol, attached to this proposal, 
which provides concrete steps for team members to take if a participant expresses 
suicidality, homicidality, emotional distress, violent/aggressive or disruptive behavior, 
intoxication, and/or suspected abuse or maltreatment. Research team members will receive 
training in this protocol from Dr. John Pachankis, a licensed clinical psychologist. This 
training will address the appropriate handling of imminent threats/concerns and provision of 
referrals to free counseling services in less imminent clinical situations. Identified clinically 
trained study team members (e.g., Drs. Seager van Dyk, Soulliard, Pachankis) will be on call 
for emergency consultation.  
 
6.5 
Withdrawal Procedures 
Participants will be able to withdraw from the study at any point. The consent forms will 
clearly state the voluntary nature of the study and possibility of withdrawal at any point. 
Additionally, participants will have the option of having their data destroyed.  
 
6.6 
Locations/Facilities 
The intervention sessions, assessments, and online surveys will be completed from the 
participants’ personal electronic devices (e.g., phones, tablets, or computers). All 
intervention and assessment sessions will be conducted via the PI or postdoctoral 
researchers’ Yale-affiliated HIPAA compliant Zoom video-conferencing accounts and require 
a passcode to enter. All measures will be conducted utilizing the secure Yale Qualtrics 
online survey software. The project is housed within the PI’s lab, which is physically located 
at 220 East 23rd Street, New York, NY 10010. 
 

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7 Statistical Design 
7.1 
Sample Size Considerations 
This pilot study is powered to assess the feasibility, acceptability, and need for refinement of 
LGBTQ-affirmative cognitive behavioral therapy adapted for youth. As was determined in 
prior studies in our lab (e.g., ESTEEM-conneCT; see IRB #2000022422), two groups is the 
minimum possible number of groups needed to gain this information. In line with prior 
studies in the lab, as well as the PI’s and postdoctoral associate’s clinical experience 
delivering psychotherapy groups, 10 participants per group is an ideal number of group 
members to facilitate optimal learning and information exchange. 
Our primary analysis plan involves 1) analysis of qualitative interviews with participants to 
gather feedback necessary for future testing and implementation and 2) quantitative 
analyses appropriate for estimating effect sizes necessary to power future trials. We are 
recruiting 20 youth to participate in the pilot study to generate sufficient depth and breadth of 
qualitative data. Drawing from similar research in the field, we estimate that 20 participants 
will allow us to gather data until saturation is reached and no new data will be introduced 
through further interviews. The quantitative data gathered from the 20 participants and their 
parents/guardians at pre-intervention, after weekly intervention sessions (youth only), and 
post-intervention will provide preliminary data to guide a future trial with a larger sample 
population. 
 
7.2 
Planned Analyses 
For the primary study objective (assessing the feasibility, acceptability, and need for 
refinement of the intervention), all participants’ qualitative and quantitative data will be 
analyzed. Qualitative exit interview data will be analyzed using an inductive approach to 
identify factors that might have increased and decreased the feasibility and acceptability of 
the intervention, as well as identify parts of the intervention that need refinement. 
Quantitative data (see Visit Schedule for summary of all available data related to feasibility, 
acceptability, and need for refinement at each timepoint) will be examined descriptively (e.g., 
means, standard deviations, proportions where appropriate), both within participants (e.g., 
plots of each participant’s feasibility, acceptability, and need for refinement data over the 10 
weekly sessions) and across participants. We will also examine whether there are 
differences in responses by age in average acceptability, feasibility, and need for refinement 
of each session separately and the intervention as a whole (e.g., descriptives, t-tests). 
 
7.2.1 Secondary Objective Analyses (if applicable) 
For the secondary study objective (investigating whether youth’s mental health symptoms, 
minority stress reactions, and emotional regulation and coping difficulties reduce over the 
course of the intervention), all participants’ quantitative responses to questionnaires 
addressing these topics will be examined for change over time (e.g., paired-sample t-tests 

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comparing pre-intervention scores to post-intervention scores) in order to provide preliminary 
data to guide a future trial with a larger sample population. In addition, descriptive analyses 
will be run (e.g., means, standard deviations). 
 
7.2.2 Analysis of Subject Characteristics (if applicable) 
We will collect demographic data about youth participants and their parents, including age, 
ethnicity, sex assigned at birth, gender identity, sexual orientation, education level, 
marital/relationship status (for parents), and family income. A complete list of all 
demographic variables is presented in the attached measures packet. All subject 
characteristics will be reported descriptively utilizing means and standard deviations for 
continuous variables and proportions for categorical variables.   
 
7.2.3 Interim Analysis (if applicable) 
N/A 
 
7.3 
Data Relevance 
In this study our primary objective is to assess the feasibility, acceptability, and need for 
refinement of an LGBTQ-affirmative therapy adapted for youth. The data that we will collect 
in this study is highly relevant to our primary objective. We will measure youth-reported 
acceptability of each session’s content, format, and facilitation; youth-rated feasibility of 
weekly home practice components and delivery mechanism; youth-reported suggestions for 
intervention refinement each week; and parent-rated intervention acceptability, feasibility, 
and suggestions for refinement at the end of the intervention program. In addition to this self- 
and parent-report data, we will also obtain objective measures of intervention feasibility by 
tracking session attendance, home practice completion, and technical difficulties. Finally, in 
alignment with our secondary objective to assess whether youth’s mental health symptoms, 
minority stress reactions, and emotional regulation and coping difficulties reduce over the 
course of the intervention, youth and their parents will complete quantitative questionnaires 
related to these topics at both pre-intervention and post-intervention timepoints. All data 
collected as part of this study is highly relevant to our research questions.  
 
7.4 
Data Coding 
Quantitative data will be scored based on each measure’s pre-specified ratings scale (see 
Measures packet on IRES). Outcomes utilized in statistical analyses will be continuous sum 
or mean scores, as applicable. 
Qualitative data from the exit interviews and feedback forms will be analyzed using an 
inductive approach. 
 

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7.5 
Data Analysis Tools 
Data will be managed and analyzed utilizing SPSS Statistics. 
 
7.6 
Data Monitoring 
The principal investigator is responsible for monitoring the data, assuring protocol 
compliance, and conducting safety reviews weekly during collection periods of pre-
intervention data, weekly intervention data, and post-intervention data. During the review 
process the principal investigator will evaluate whether the study should continue 
unchanged, require modification/amendment, or close to enrollment. 
 
7.7 
Handling of Missing Data 
Given the small sample size (N = 20), the use of qualitative data, and the primarily 
descriptive nature of these analyses, no imputation methods will be used to account for 
missing data. All available data will be analyzed, and no cases will be dropped. 
 
 

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8 Data/Specimen Handling and Record 
Keeping 
8.1 
Subject Data Confidentiality 
Participant confidentiality is strictly held in confidence by the participating investigators and 
their staff. Therefore, the study protocol, documentation, data, and all other information 
generated will be held in strict confidence. All research activities will be conducted in as 
private a setting as possible. Representatives of the IRB may inspect all documents and 
records required to be maintained by the investigator for the participants in this study. The 
study site will permit access to such records. 
To ensure confidentiality, participant names and contact information (e.g., email address, 
phone number, physical address), which will only be recorded during the initial online 
screener and on consent/assent forms, will be kept separate from all other data. All data will 
be collected via the secure Qualtrics survey server and via Zoom (for assessments and 
intervention sessions). Participants will be assigned a unique code number after consenting 
to the screening phase of the study, as well as a separate unique code after selection to 
enroll in the intervention phase of the study. The use of these unique codes will permit 
linkage of the data being collected across all time points in the study. A master link file will 
connect participants’ names and contact details to their study code number. The link file will 
be password-protected and only accessible to the PI and study team members. The link file 
will be stored separately from the rest of participants’ data in a separate Yale Secure Box 
folder. Upon collection of the study data, de-identified data will be stored on password-
protected folders on Yale Secure Box that requires dual-factor authentication to access. De-
identified survey data will be downloaded and organized in SPSS files and stored on 
password-protected computers by the study team.  
Breaches of confidentiality will occur if a participant reports a clear intention to harm 
themselves or another person. Health care professionals are required by state law to report 
suspected cases of abuse or neglect. Breach of confidentiality can also occur if participants 
in this group-based intervention disclose information about participants to outside parties. 
Participants will be informed during the consent process that any information shared during 
group sessions may be discussed outside of the intervention, although study staff will 
encourage participants to respect each other’s confidentiality. During the consent process, 
we will indicate that youth will be able to pick a username that they will be known by during 
the Zoom sessions. This can be any name they want, including their affirmed first name (last 
names will not be allowed, nor will any other names that clearly identify the youth; e.g., 
phone number or address). The goal of using a username is to protect their privacy, so youth 
will be informed that using their legal name introduces some risk to their confidentiality. 
Youth will be kept in the Zoom waiting room until their study username is displayed. Youth 
will be reminded of their study username by email a few days before the first session, and 
will be provided instructions about how to change their username. Moreover, participants will 
be reminded at the beginning of each session that all information shared in the intervention 

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setting is private and confidential. Participants will also be notified on the consent form and 
at the start of each session that by participating in the study they acknowledge the risk that 
other participants will become aware of any information they disclose during the group 
intervention sessions and might disclose such information to others outside of the study. 
The likelihood that any additional breaches of confidentiality would occur is minimal, as steps 
will be taken to guard against this risk. To protect participants’ confidentiality, all study 
therapists and research assistants (RAs) will undergo rigorous training in maintaining 
participants’ confidentiality and will be in possession of valid Collaborative Institutional 
Training Initiative (CITI) certificates. All contact with participants will be made by research 
staff under explicit guidelines to preserve confidentiality when telephoning, emailing, or 
mailing information to participants.  
The study participant's contact information will be securely stored for internal use during the 
study. At the end of the study, all records will continue to be kept in a secure location for 
three years. After three years, all identifiable records for the study will be destroyed. 
Study participant research data, which is for purposes of statistical analysis and scientific 
reporting, will be transmitted to and stored in a Yale Secure Box folder only accessible by 
research study team members. As previously noted, this will not include the participant's 
contact or identifying information. Rather, individual participants and their research data will 
be identified by a unique study identification number. The study data entry and study 
management systems used will be secured and password protected. At the end of the study, 
all study databases will be de-identified and archived in a Yale Secure Box folder. 
Taken together, these measures are anticipated to be highly effective in protecting the 
confidentiality of participants and have proven successful in other studies that the PI and 
their research team have implemented. 
 
8.2 
Data Quality Assurance 
All assessment measures for the online screening questionnaires, pre-intervention 
assessments, weekly surveys, and post-intervention assessment will be administered via the 
secure Qualtrics survey platform using contact list functions to accurately and consistently 
administer surveys to participants. Additionally, attention check questions will be placed 
throughout the surveys at each time point in order to better ensure participant attention when 
answer the survey questions. Dr. Seager van Dyk (who will be delivering the intervention) 
will follow intervention session outlines consistently, in order to facilitate comparisons across 
the two age groups of participants. Study research assistants will be trained to follow up with 
participants who miss all or part of an assessment to minimize missing data (although RAs 
will only provide up to two reminders, in order to avoid participants feeling pressured to 
complete the study tasks).  
 
8.3 
Data or Specimen Storage/Security 

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To ensure confidentiality, participant names and contact information (e.g., email address, 
phone number, physical address), which will only be recorded during the initial online 
screener and on consent/assent forms, will be kept separate from all other data. All data will 
be collected via the secure Qualtrics survey server and via Zoom (for assessments and 
intervention sessions). Participants will be assigned a unique study ID number after 
consenting to the screening phase of the study, as well as a separate unique study ID after 
selection to enroll in the intervention phase of the study. The use of these unique study ID 
numbers will permit linkage of the data being collected across all time points in the study. A 
master link file will connect participants’ names and contact details to their study code 
number. The link file will be password-protected and only accessible to the PI and study 
team members. The link file will be stored separately from the rest of participants’ data in a 
separate Yale Secure Box folder. Upon collection of the study data, de-identified data will be 
stored on password-protected folders on Yale Secure Box that requires dual-factor 
authentication to access. De-identified survey data will be downloaded and organized in 
SPSS files and stored on password-protected computers by the study team.  
In summary, we will keep four separate electronic and password-protected files.  
1. The first will be a database that contains participant names, all the contact information 
that they provide for scheduling the study appointments (including telephone number, 
email address, mailing address, and date of birth), and study ID number 
2. The second will contain all survey information.  
3. The third will track study payments.  
4. The fourth will contain study ID numbers from the screening survey and study ID 
numbers from the intervention study, so that we can link data from the different 
surveys. (“master link file”) 
Only the first database will contain participant names, while the others will only contain study 
ID numbers.  
 
8.4 
Study Records 
Study records will consist of responses from self- and parent-report surveys, study 
therapist(s) reports of participant attendance and homework completion, as well as audio-
recordings of intervention sessions. The PI will be responsible for maintaining the study 
documentation, which will be maintained on a Yale Secure Box folder.  
 
8.5 
Access to Source 
Source documents will consist of surveys and other study measures that will all be 
administered online via Qualtrics or Zoom. All source data will be electronic (i.e., no surveys 
with handwritten responses). Research data will only be accessible in a Yale Secure Box 
folder by members of the research team (all of whom will be appropriately trained in data 
management). Although there are currently no plans to transfer data to collaborators, such a 

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transfer would only include de-identifiable data/documents, and the transfer would occur 
using Yale’s secure file transfer service. 
 
8.6 
Retention of Records 
At the end of the study, all records will continue to be kept in a Yale Secure Box folder. After 
three years, all identifiable records for the study will be destroyed.  
 
8.7 
Data and Safety Monitoring Plan  
The principal investigator is responsible for monitoring the data, assuring protocol 
compliance, and conducting safety reviews weekly during collection periods of pre-
intervention data, weekly intervention data, and post-intervention data. During the review 
process the principal investigator will evaluate whether the study should continue 
unchanged, require modification/amendment, or close to enrollment. 
 
The principal investigator and the Institutional Review Board (IRB) have the authority to stop 
or suspend the study or require modifications. 
 
This protocol presents minimal risks to the subjects and Unanticipated Problems Involving 
Risks to Subjects or Others (UPIRSOs), including adverse events, are not anticipated. In the 
unlikely event that such events occur, Reportable Events (which are events that are serious 
or life-threatening and unanticipated (or anticipated but occurring with a greater frequency 
than expected) and possibly, probably, or definitely related) or Unanticipated Problems 
Involving Risks to Subjects or Others that may require a temporary or permanent interruption 
of study activities will be reported immediately (if possible), followed by a written report within 
5 calendar days of the Principal Investigator becoming aware of the event to the IRB (using 
the appropriate forms from the website) and any appropriate funding and regulatory 
agencies. The principal investigator will apprise fellow investigators and study personnel of 
all UPIRSOs and adverse events that occur during the conduct of this research project via 
email as they are reviewed. The protocol’s research monitor, Yale University, and decision-
making bodies will be informed of adverse events, such as loss of confidentiality, within 5 
days of the event becoming known to the principal investigator. 
 
 
 

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9 Study Considerations 
9.1 
Institutional Review Board (IRB) Review 
The protocol will be submitted to the IRB for review and approval. Approval of the protocol 
must be obtained before initiating any research activity. Any change to the protocol will 
require an approved IRB amendment before implementation. The IRB will have final 
determination whether informed consent and HIPAA authorization are required. Study 
closure will be submitted to the IRB after all research activities have been completed. Other 
study events (e.g. data breaches, protocol deviations) will be submitted per Yale policies. 
 
9.2 
Research Personnel Training 
Drs. Pachankis (PI, clinical psychologist) and Seager van Dyk (postdoctoral associate with a 
PhD in clinical psychology) will be primarily responsible for ensuring the scientific, clinical, 
and technical robustness of the intervention, including its adaptation for adolescents, 
translation to the remote format (i.e., Zoom), and its ongoing delivery. Dr. Seager van Dyk, 
with the aid of undergraduate research assistants, will be responsible for overseeing 
recruitment and selection of potential participants into the study. Dr. Seager van Dyk will 
provide undergraduate research assistants with live training on selection procedures, 
including how to obtain consent/assent from participants, and how to conduct phone screens 
with youth and their families. Dr. Seager van Dyk (who has extensive training in and years of 
experience using the KSADS diagnostic interview with adolescents and their families) will be 
responsible for completing the diagnostic interview portion of the screening process. Dr. 
Seager van Dyk, in consultation with Drs. Pachankis and Soulliard (postdoctoral associate 
with a PhD in clinical psychology), will be responsible for the preparation of session 
materials. Dr. Seager van Dyk, with the support of the study team, will deliver the 
intervention. Dr. Seager van Dyk, with the aid of undergraduate research assistants, will be 
responsible for online administration of the study measures, as well as the cleaning and 
organizing of the study data. Drs. Seager van Dyk and Layland (postdoctoral associate) will 
be primarily responsible for data analysis. Dr. Pachankis will be responsible as the PI for 
oversight of the previously mentioned responsibilities.  
All study team members (including undergraduate research assistants) will undergo rigorous 
training in responsible research conduct with human subjects (including maintaining 
participants’ confidentiality) and will be in possession of valid Collaborative Institutional 
Training Initiative (CITI) certificates. All clinical team members (e.g., Drs. Seager van Dyk, 
Soulliard) will undergo a comprehensive training in the lab’s clinical protocol by Dr. 
Pachankis, which outlines procedures for managing participants in distress, including those 
expressing symptoms of suicidality, homicidality, active distress, violence, and other possible 
clinical presentations. This clinical protocol has previously been approved by the Yale IRB, 
and is attached to this application. 
 
9.3 
Study Monitoring  

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The study will be monitored internally for accuracy and adherence to study protocols by 
study team members on a weekly basis.  
 
9.4 
Unanticipated Problems and Protocol Deviations 
A protocol deviation is any noncompliance with the protocol. The noncompliance may be 
either on the part of the participant, the investigator, or the study site staff. As a result of 
deviations, corrective actions are to be developed by the site and implemented promptly. 
 
It is the responsibility of the principal investigator to identify and report deviations within 5 
working days of identification of the protocol deviation. All deviations must be addressed in 
study source documents and the reviewing IRB per their policies. 
 
Unanticipated problems (UP) involving risks to participants or others include, in general, any 
incident, experience, or outcome that meets all of the following criteria: 
• 
Unexpected in terms of nature, severity, or frequency given (a) the research 
procedures that are described in the protocol-related documents, such as the 
Institutional Review Board (IRB)-approved research protocol and informed consent 
document; and (b) the characteristics of the participant population being studied; 
• 
Related or possibly related to participation in the research ("possibly related" means 
there is a reasonable possibility that the incident, experience, or outcome may have 
been caused by the procedures involved in the research); and 
• 
Suggests that the research places participants or others at a greater risk of harm 
(including physical, psychological, economic, or social harm) than was previously 
known or recognized. 
 
If the study team becomes aware of an unanticipated problem (e.g. data breach, protocol 
deviation), the event will be reported to the IRB by via email. 
 
The UP report will include the following information: 
• 
Protocol identifying information: protocol title and number, PI's name, and the IRB 
project number; 
• 
A detailed description of the event, incident, experience, or outcome; 
• 
An explanation of the basis for determining that the event, incident, experience, or 
outcome represents an UP; 
• 
A description of any changes to the protocol or other corrective actions that have 
been taken or are proposed in response to the UP. 
 
To satisfy the requirement for prompt reporting, UPs will be reported using the following 
timeline: 
• 
UPs will be reported to the IRB within 5 days of the investigator becoming aware of 
the event. 
 
9.5 
Study Discontinuation 

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The research team will discuss discontinuation of the study in the event that participants 
experience unanticipated adverse events (e.g., increased active suicidality) over the course 
of study completion. The IRB will be involved in such a discussion. 
 
9.6 
Study Completion 
Data collection for the study will end in late June 2022. Data analysis is expected to continue 
through August 2022. The study is anticipated to be completed upon the writing of a 
manuscript for publication by December 2022. At this time, the study team will notify the IRB 
that the study is complete. 
 
9.7 
Conflict of Interest Management Plan  
The independence of this study from any actual or perceived influence, such as by the 
pharmaceutical industry, is critical. Therefore, any actual conflict of interest of persons who 
have a role in the design, conduct, analysis, publication, or any aspect of this trial will be 
disclosed and managed. Furthermore, persons who have a perceived conflict of interest will 
be required to have such conflicts managed in a way that is appropriate to their participation 
in the trial. The study leadership in conjunction with the appropriate conflict of interest review 
committee has established policies and procedures for all study group members to disclose 
all conflicts of interest and will establish a mechanism for the management of all reported 
dualities of interest. 
 
All investigators will follow the applicable conflict of interest policies. 
 
9.8 
Funding Source 
The study is funded by Yale-administered gifts, including the David R. Kessler M.D. ’55 
Resource Fund for LGBTQ Mental Health Research at YSPH and the Yale Fund for LGBTQ 
Studies (FLAGS). 
 
9.9 
Publication Plan 
Upon the completion of data analysis by August 2022, the research team anticipates 
submitting a manuscript for publication (led by the study’s lead postdoctoral associate, Dr. 
Seager van Dyk) by December 2022. It will be the PI’s primary responsibility for publishing 
the study results.  
 

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10 Appendices 
Appendix # 
Title 
Section 
Topic 
 
 

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11 List of Tables