Evaluation of PRYSHM for LGBTQIA2S+ Youth

Alcohol Drinking Clinical Trial

— PRYSHM  

Official title:

Development and Pilot Evaluation of an Online Intervention to Prevent Dating Violence and Problem Drinking in Sexual Minority Youth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05521906
• Other study ID #: 21985IRB
• Status: Completed
• Phase: N/A
• Start date: September 21, 2022
• Est. completion date: December 7, 2023

Study information

• Verified date: March 2024
• Source: University of Nebraska Lincoln
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The overarching goal of the proposed project is to develop an innovative, online synchronous DV and AU prevention curriculum created specifically for SGMY (ages 15 to 18); conduct a pilot randomized controlled trial to assess its feasibility and acceptability of the intervention and study procedures; identify preliminary outcomes of the intervention; and ensure that the intervention is working equally well for SGMY of color.

Description:

Alcohol use (AU) is strongly associated with dating violence (DV), and both DV and AU occur at alarmingly high rates among youth. Sexual and gender minority youth (SGMY) are no exception. Research suggests that DV and AU affects SGMY at rates significantly higher than cisgender heterosexual youth. This increased risk can be explained by experiences of minority stress, specifically distal stressors (e.g., discrimination experienced as a result of one's SOGIE [sexual orientation and gender identity and expression] status) and proximal stressors, including identity concealment (hiding one's SOGIE from others), and internalized homo/bi/transphobia (e.g., feeling ashamed of one's sexual orientation/gender identity, wishing one was not LGBTQ+). Whereas minority stress increases the risk for DV and AU, having a sense of community (e.g., sense of belonging, emotional connectedness) with other SGMY reduces the risk for DV and AU.

Prevention programming that targets proximal minority stressors and sense of community, in conjunction with evidence-based DV and AU prevention programming components (e.g., bystander intervention, refusal skills, correcting misperceptions of social norms, protective behavioral strategies), could reduce rates of DV and AU among SGMY. Also, because minority stress and sense of community are risk factors in the etiological pathways to other problematic health behaviors (e.g., sexual risk-taking), reducing minority stress, and increasing a sense of community among SGMY presumably may decrease other risk behaviors (e.g., drug use) and depressive symptoms. To date, however, no such programming exists for SGMY. In fact, DV and AU prevention programming has been widely criticized for lacking inclusive information for, as well as representations of, SGMY and universal DV programs do not work for SGMY. Further, although not specific to SGMY, universal DV programs do not work for youth of color, and SGMY of color experience the highest rates of DV and AU, underscoring the urgency for which DV and AU prevention programs for multiply minoritized SGMY, including those in hard to reach areas (e.g., rural communities), are needed.

Following a Stage 1A and 1B model, the proposed project seeks to develop and evaluate via a randomized controlled pilot study an online DV and AU prevention initiative for SGMY (15 to 18 years old), entitled Promoting Resilient Youth with Strong Hearts and Minds (PRYSHM). The PRYSHM program is theoretically grounded, follows best practices for effective health behavior prevention, and includes eight one hour sessions co-facilitated by two LGBTQIA2S+ adults. Use of synchronous online delivery via web-based teleconference was selected for PRYSHM given that a notable portion of SGMY are not out and thus may not have the opportunity to participate in an in-person program. This could be especially true for youth living in rural and remote areas of the U.S. where rates of minority stress are highest and sense of community is lowest (of note, the vast majority of youth in rural areas own smartphones). Also, research suggests that more than half of SGMY (both out and not-out youth) are members of an online LGBTQIA2S+ community, further underscoring the probable utility, scalability, and cost-effectiveness of online delivery of the PRYSHM.

Specific Aims of this R34 intervention development grant are as follows:

Aim 1: Development Phase: Finalize and refine PRYSHM materials through key informant feedback (i.e., SGMY advisory board, experts in the field) (Aim 1a) and conduct an open pilot trial with ten dating SGMY (Aim 1b).

Aim 2: Pilot Evaluation Phase: Recruit 300 dating SGMY via social media and other online advertisements and randomly assign them to a wait-list control condition (n = 100) or PRYSHM condition (n = 200) (Aim 2a). Assess acceptability and feasibility of the program and research procedures via post-session surveys, program observations, and online exit interviews with a subsample of youth (n = 20 or until saturation is achieved) (Aim 2b). Pre-, immediate, and 3-month posttests will be used to assess the acceptability of the study procedures (e.g., compliance with surveys) and generate initial data on the efficacy of PRYSHM in reducing DV and AU (Aim 2c). Exploratory analyses will examine mediators (e.g., sense of community, ethnic/racial cultural identity) and moderators (e.g., demographics [race/ethnicity, gender identity, dosage]) of treatment effects. Guided by intersectional literature that suggests not using comparative methods and sample size limitations, we will examine the treatment effects within groups of SGMY of color to determine promise of efficacy (Aim 2d).

This project is highly significant as it: (1) addresses DV and AU and related deleterious health behaviors (critical U.S. public health problems) among multiply minoritized SGMY; (2) can reach SGMY in rural and remote regions of the U.S. who experience the highest rates of minority stress and lowest sense of community; and (3) tests a scalable prevention strategy with the potential for paramount public health impact. This study is innovative as it is the first to test the effects of a group-based, online synchronous DV and AU prevention program tailored explicitly for diverse SGMY.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 304
• Est. completion date: December 7, 2023
• Est. primary completion date: August 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 18 Years

Eligibility

Inclusion Criteria:

• Self-identify as LGBTQIA2S+ (sexual and/or gender minority), and/or report being unsure of their sexual orientation, and/or report experiencing romantic/sexual attraction to someone of the same sex assigned at birth.

• Age between 15 and 18 years.

• Ability to read and speak in English.

• Current residence in the United States.

• Consistent access to an electronic device (e.g., smartphone, tablet, computer) with high speed Internet access and/or Wi-Fi.

• Ability to attend 9 weekly, one hour online intervention sessions.

• Recent or currently in a dating/romantic/sexual relationship (past three months).

• Not at high risk for suicide (as defined by not endorsing a critical item on a past-month suicide screening measure [SBQ-R], and/or not be deemed at elevated risk for suicide on the basis of a clinical interview,)

Exclusion Criteria:

• Age under 15 or over 18 years.

• Identify as heterosexual and cisgender.

• Current enrollment as a full-time college student.

• Lack of English language proficiency (either written and/or spoken).

• Current residence outside of the U.S.

• No current or recent (in past three months) dating/romantic/sexual relationship.

• No consistent access to an electronic device (e.g., smartphone, tablet, computer) with high speed Internet or Wi-Fi.

• Inability to attend scheduled weekly one hour intervention sessions.

• Elevated risk of suicidality (reporting a past month suicide attempt or past month suicide threat with intent to die on the SBQ-R or determined to be at elevated current risk for suicidality based on a clinical interview).

Related Conditions & MeSH terms

• Alcohol Drinking
• Dating Violence

Intervention

Behavioral:
• Promoting Resilient Youth with Strong Hearts and Minds (PRYSHM)
The intervention focuses on psycho-education (provision of accurate information about LGBTQIA2S+ people, education about the effects of alcohol), fostering positive identity development for LGBTQIA2S+ youth (e.g., fostering pride in identity, exposure to positive adult role models), teaching of alcohol use and sexual refusal skills, correction of inaccurate social norms about alcohol use and dating violence, teaching assertive communication skills, teaching emotion coping skills, mindfulness and grounding skills, and teaching bystander intervention skills related to dating/sexual violence and alcohol use..

Locations

Country	Name	City	State
United States	University of Nebraska (Lincoln)	Lincoln	Nebraska

Sponsors (3)

Lead Sponsor	Collaborator
University of Nebraska Lincoln	University of Colorado, Colorado Springs, University of Houston

Country where clinical trial is conducted

United States, 

References & Publications (17)

Baiocco R, D'Alessio M, Laghi F. Binge drinking among gay, and lesbian youths: The role of internalized sexual stigma, self-disclosure, and individuals' sense of connectedness to the gay community. Addict Behav. 2010 Oct;35(10):896-9. doi: 10.1016/j.addbeh.2010.06.004. Epub 2010 Jun 11. — View Citation

Bennett S, Banyard VL, Edwards KM. The Impact of the Bystander's Relationship With the Victim and the Perpetrator on Intent to Help in Situations Involving Sexual Violence. J Interpers Violence. 2017 Mar;32(5):682-702. doi: 10.1177/0886260515586373. Epub 2016 Jul 11. — View Citation

Dank M, Lachman P, Zweig JM, Yahner J. Dating violence experiences of lesbian, gay, bisexual, and transgender youth. J Youth Adolesc. 2014 May;43(5):846-57. doi: 10.1007/s10964-013-9975-8. Epub 2013 Jul 17. — View Citation

Edwards KM, Banyard VL, Sessarego SN. Dating and sexual violence victimization and perpetration among high school youth: Incidence and correlates. Manuscript in preparation. 2017.

Edwards KM, Sylaska KM, Neal AM. Intimate partner violence among sexual minority populations: A critical review of the literature and agenda for future research. Psychology of Violence. 2015;5(2):112-121.

Edwards KM, Sylaska KM. The perpetration of intimate partner violence among LGBTQ college youth: the role of minority stress. J Youth Adolesc. 2013 Nov;42(11):1721-31. doi: 10.1007/s10964-012-9880-6. Epub 2012 Dec 12. — View Citation

Edwards KM. Incidence and Outcomes of Dating Violence Victimization Among High School Youth: The Role of Gender and Sexual Orientation. J Interpers Violence. 2018 May;33(9):1472-1490. doi: 10.1177/0886260515618943. Epub 2015 Dec 13. — View Citation

Eisenberg ME, Toumbourou JW, Catalano RF, Hemphill SA. Social norms in the development of adolescent substance use: a longitudinal analysis of the International Youth Development Study. J Youth Adolesc. 2014 Sep;43(9):1486-97. doi: 10.1007/s10964-014-0111-1. Epub 2014 Mar 15. — View Citation

GLSEN. The 2015 national school climate survey: Executive summary. GLSEN;2015.

Growing up LGBT in America: NCOD report. Human Rights Campaignn.

Kertzner RM, Meyer IH, Frost DM, Stirratt MJ. Social and psychological well-being in lesbians, gay men, and bisexuals: the effects of race, gender, age, and sexual identity. Am J Orthopsychiatry. 2009 Oct;79(4):500-10. doi: 10.1037/a0016848. — View Citation

Lenhart A. A majority of American teens report access to a computer, game console, smartphone and a tablet. Washington, DC: Pew Research Center. 2015.

Lewis RJ, Millentich RJ, Kelley ML, Woody A. Minority stress, substance use, and intimate partner violence among sexual minority women. Aggression and Violent Behavior. 2012;17:247-256.

Lin Y, J., Israel T. Development and validation of a psychological sense of LGBT community scale. Journal of Community Psychology. 2012;40(5):14.

Mason TB, Lewis RJ, Gargurevich M, Kelley ML. Minority stress and intimate partner violence perpetration among lesbians: Negative affect, hazardous drinking, and intrusiveness as mediators. Psychology of Sexual Orientation and Gender Diversity. 2016;3(2):236-246.

Noar SM, Pierce LB, Black HG. Can computer-mediated interventions change theortical mediators of safer sex? A meta-analysis. Human Communication Research. 2010;36:36.

Vagi KJ, O'Malley Olsen E, Basile KC, Vivolo-Kantor AM. Teen Dating Violence (Physical and Sexual) Among US High School Students: Findings From the 2013 National Youth Risk Behavior Survey. JAMA Pediatr. 2015 May;169(5):474-82. doi: 10.1001/jamapediatrics.2014.3577. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from Baseline in Identity Concealment Behaviors as Measured by the Outness Inventory for Sexual Orientation and the Outness Inventory for Gender Identity at Week 9 and Week 21	The Outness Inventory for Sexual Orientation and the Outness Inventory for Gender Identity are two modified measures that determine to what extent an individual's social network knows about the sexual orientation and/or gender identity of the individual. Scores are analyzed as a sum of individuals and groups who are aware of the individual's sexual orientation and/or gender identity. Change = (Week 9 score - baseline score; Week 21 score - baseline score).	Baseline, Week 9, and Week 21
Other	Change from Baseline in Experiences of Internalized Homonegativity at Week 9 and Week 21	The Adapted Homonegativity Items constitute a validated self-report measure that assesses to what extent an individual experiences internalized homonegativity. Individuals are asked to indicate their agreement with specific statements representing internalized homonegativity on a scale from 1 (strongly disagree) to 4 (strongly agree). Responses are averaged to provide an indication of internalized homonegativity. Change = (Week 9 score - baseline score; Week 21 score - baseline score).	Baseline, Week 9, and Week 21
Other	Change from Baseline in Sense of LGBTQIA2S+ Community at Week 9 and Week 21	The Psychological Sense of LGBT Community is a validated, self-report measure that assesses the extent to which an individual feels they belong to and contribute to the LGBTQIA2S+ community. Participants rate how often they feel specific indicators of LGBTQIA25+ community on a scale from 1 (none) to 5 (a great deal). The measure provides two subscales: needs fulfillment and membership. Responses within each subscale are averaged to provide a score for that subscale. Change = (Week 9 score - baseline score; Week 21 score - baseline score).	Baseline, Week 9, and Week 21
Other	Change from Baseline in Emotional Regulation and Coping at Week 9 and Week 21	The Difficulties in Emotion Regulation Scale (DERS-16): Impulse Control Subscale assesses an individual's capacity for impulse control. Participants rate how often they feel out of control of their emotions when upset on a scale of 1 (almost never) to 5 (almost always). Responses are summed with higher scores reflecting greater levels of emotional dysregulation. Change = (Week 9- baseline; Week 21- baseline).	Baseline, Week 9, and Week 21
Other	Change from Baseline in Conflict Resolution Skills as Measured by the Communication Skills Test at Week 9 and Week 21	The Communication Skills Test: 10-Item Version (CST-10) is a validated, self-report measure which assesses how likely an individual is to utilize specific conflict resolution skills when experiencing conflict with a romantic partner. Participants are asked to rate how easy or difficult it would be to engage in specified de-escalation strategies on a scale of 1 (very difficult) to 4 (very easy). The scale is computed by creating a mean score from the item responses, including reverse-scored items. Change = (Week 9 score - baseline score; Week 21 score - baseline score).	Baseline, Week 9, and Week 21
Other	Change from Baseline in Sexual Refusal Skills at Week 9 and Week 21	The Sexual Communication Self-Efficacy Scale assesses capacity for refusal during intimate interactions. Participants rate how difficult it would be to refuse a sexual request on a scale of 1 (very difficult) to 4 (very easy). The measure provides two subscales: negative sexual messages, positive sexual messages. The respective subscale scores are calculated by taking the means of the subscale's items. Change = (Week 9- baseline; Week 21- baseline).	Baseline, Week 9, and Week 21
Other	Change from Baseline in Bystander Behavior at Week 9 and Week 21	Bringing in the Bystander Intervention Items assesses the capacity to intervene in instances of dating violence. Participants rate how likely they would be to intervene in a specific situation from "very unlikely" to "very likely". The measure provides two subscales: reactive and proactive. Subscale scores are calculated by summing item responses on the respective subscale. Change = (Week 9- baseline; Week 21- baseline).	Baseline, Week 9, and Week 21
Other	Change from Baseline in Accurate Perceptions of Dating Violence at Week 9 and Week 21	The Perceived Dating Violence Norms, adapted from the Measure of Adolescent Relationship Harassment and Abuse (MARSHA)-Perpetration scale, assesses an perceptions of dating violence within LGBTQIA2S+ teenage relationships. Participants indicate what percentage of LGBTQIA2S+ teenage relationships they believe experience specific scenarios related to abuse. The measure provides 6 subscales: social control, physical abuse, sexual abuse, isolation, cyber control, intimidation. Subscale scores are calculated by averaging item responses on the respective subscale. Change = (Week 9- baseline; Week 21- baseline).	Baseline, Week 9, and Week 21
Other	Change from Baseline in Protective Behavioral Strategies as Measured by the Alcohol Reduction Strategies- Current Confidence Questionnaire (ARS-CC) at Week 9 and Week 21	The Alcohol Reduction Strategies- Current Confidence Questionnaire (ARS-CC) is a validated, self-report measure which assesses an individual's use of alcohol reduction strategies to prevent negative consequences associated with alcohol use. Participants are asked to rate how confident they are in their ability to utilize a given strategy on a scale of 1 (not at all confident) to 5 (completely confident). Responses are averaged to provide an overall score, with a higher average indicating a greater capacity to utilize alcohol reduction strategies. Change = (Week 9 score - baseline score; Week 21 score - baseline score).	Baseline, Week 9, and Week 21
Other	Change from Baseline in Hope for the Future as Measured by the Feelings about Being LGBTQIA2S+ at Week 9 and Week 21	The Feelings about Being LGBTQIA2S+ is a validated, self-report measure which assesses an individual's feelings toward the future as an LBGTQIA2S+ individual. Participants are asked to rate the likelihood of experiencing positive life outcomes as an LBGTQIA2S+ individual on a scale of 1 (definitely no) to 4 (definitely yes). Response items are averaged to provide an overall score, with higher scores indicating a more positive outlook. Change = (Week 9 score - baseline score; Week 21 score - baseline score).	Baseline, Week 9, and Week 21
Other	Baseline measure in Family Rejection	The Family Rejection: LGBT-Specific is a modified, self-report measured based on Ryan, et al. (2010) which assesses an individual's perception of family rejection based on their status as a member of the LBGTQIA2S+ community. Participants are asked to rate how often they experience specific negative interactions with family members on a scale of 0 (never) to 2 (often). Responses are dichotomized as either "occurring" or "not occurring", and items are summed, with a higher score indicating greater family rejection. We measure for a baseline score.	Baseline
Other	Change from Baseline in Drinking Motives at Week 9 and Week 21	The Drinking Motives Questionnaire- Revised (DMQ-R) assesses the extent to which a participant uses alcohol to cope with negative emotions. Participants indicate how often they experience a given motive for drinking on a scale of 1 (almost never/never) to 5 (almost always/always). Scale scores are calculated as the sum of the respective items, with higher scores indicating a greater likelihood that a participant uses alcohol to cope with negative emotions. Change = (Week 9- baseline; Week 21- baseline).	Baseline, Week 9, and Week 21
Other	Change from Baseline in Drinking Refusal Skills at Week 9 and Week 21	The Drinking Refusal Self-Efficacy Questionnaire- Shortened Adolescent Version (DRSEQ-SRA) assesses individual capacity to resist alcohol use. Given a scenario, participants rate their ability to refuse alcohol from "I am very sure I could NOT resist drinking" to "I am very sure I could resist drinking". Two subscales are provided: social pressure, emotional relief. Total and subscale scores are calculated by summing item responses on the total measure and respective subscales. Change = (Week 9- baseline; Week 21- baseline).	Baseline, Week 9, and Week 21
Other	Change from Baseline in Alcohol Use Bystander Behavior at Week 9 and Week 21	The Alcohol Use: Likelihood to Intervene assesses the capacity to intervene in situations of alcohol abuse and addiction. Participants are asked to rate how likely they would be to intervene in specific situations on a scale of 1 (very unlikely) to 4 (very likely). Responses across items are averaged to provide an overall score, with a higher score indicating a greater capacity to intervene. Change = (Week 9- baseline; Week 21- baseline).	Baseline, Week 9, and Week 21
Other	Change from Baseline in Accurate Perceptions of Alcohol Use at Week 9 and Week 21	The Drinking Norms Rating Form, adjusted to LGBTQIA2S+ populations, assesses an individual's perception of drinking behavior of LGBTQIA2S+ teens. Participants indicate what percentage of LGBTQIA2S+ teens they believe engage in specific drinking behaviors. Percentages are averaged to indicate perception. Change = (Week 9- baseline; Week 21- baseline).	Baseline, Week 9, and Week 21
Other	Change from Baseline in Ethnic Identity at Week 9 and Week 21	The Multi-Group Ethnic Identity Measure assesses adolescents' perceived affirmation and sense of belonging to their ethnic identity. Participants indicate how much they agree on a five point scale with each of 13 statements about their ethnic identity. Change = (Week 9- baseline; Week 21- baseline).	Baseline, Week 9, and Week 21
Primary	Change from Baseline in Intimate partner violence perpetration at Week 9 and Week 21	The Measure of Adolescent Relationship Harassment and Abuse (MARSHA): Perpetration Scale assesses how often an individual perpetrates dating violence. Participants rate how frequently they engaged in specific behaviors from 0 to 100 times over the past month (at Week 9) or past three months (at Baseline and Week 21). The following subscales are generated from the measure: social control, physical abuse, sexual abuse, isolation, cyber control, and intimidation. Change = (Week 9 score - baseline; Week 21- baseline).	Baseline, Week 9, and Week 21
Primary	Change from Baseline in Intimate partner violence victimization at Week 9 and Week 21	The Measure of Adolescent Relationship Harassment and Abuse (MARSHA): Victimization Scale assesses how often an individual experiences abusive behavior from a romantic partner. Participants indicate how often they have been the victim of abuse from 0 to 100 times in the past month (at Week 9) or past three months (at Baseline, Week 21). Scores generate the following subscales: privacy control, social control, physical abuse, sexual abuse, intimidation. Change = (Week 9- baseline; Week 21- baseline).	Baseline, Week 9, and Week 21
Primary	Change from Baseline in Alcohol Use at Week 9 and Week 21	The Alcohol Use Questionnaire is based on the Daily Drinking Questionnaire and assesses an individual's alcohol use. Participants indicate how often they have used/abused alcohol within their lifetime, over the past 3 months, and within 30 days on a scale of "0" to "40+". Change = (Week 9- baseline; Week 21- baseline)	Baseline, Week 9, and Week 21
Primary	Change from Baseline in Sexual and Gender Minority Specific Intimate Partner Violence Perpetration at Week 9 and Week 21	The Conflict Tactics Scale-Revised: Sexual and Gender Minority Specific Intimate Partner Violence Perpetration (CTS-2:IPV-Perpetration, SGM specific) assesses how often an individual identifying as a sexual and/or gender minority perpetrates dating violence. Participants rate how frequently they engaged in specific behaviors from 0 to 100 times over the past month (at Week 9) or past three months (at Baseline, Week 21). Change = (Week 9- baseline; Week 21- baseline).	Baseline, Week 9, and Week 21
Primary	Change from Baseline in Sexual and Gender Minority Specific Intimate Partner Violence Victimization at Week 9 and Week 21	The Conflict Tactics Scale-Revised: Sexual and Gender Minority Specific Intimate Partner Violence Victimization (CTS-2:IPV-Victimization, SGM specific) assesses how often an individual identifying as a sexual or gender minority experiences intimate partner violence. Participants rate how frequently they have experienced intimate partner violence from 0 to 100 times in the past month (at Week 9) or past three months (at Baseline, Week 21). Change = (Week 9- baseline; Week 21- baseline).	Baseline, Week 9, and Week 21
Primary	Change from Baseline in Drinking Intentions at Week 9 and Week 21	The Drinking Intentions Questionnaire is an instrument based on the Daily Drinking Questionnaire and assesses how likely an individual is to drink in the future. Participants to rate how likely they are to drink alcohol in the next month (Week 9) or three months (Baseline and Week 21) on a scale of "definitely will" to "definitely won't". Change = (Week 9- baseline; Week 21- baseline).	Baseline, Week 9, and Week 21
Primary	Change from Baseline in Willingness to Drink at Week 9 and Week 21	The Willingness to Drink Questionnaire assesses intensity of drinking behavior. Participants rate how likely they would be to drink at varying levels of intensity on a scale from "not at all" to "very willing" given a specific scenario. Change = (Week 9- baseline; Week 21- baseline).	Baseline, Week 9, and Week 21
Secondary	Change from Baseline in Experience of Negative Consequences as a Result of Alcohol Use at Week 9 and Week 21	The Brief Young Adult Alcohol Consequences Questionnaire is a validated, self-report instrument assessing the frequency with which an individual has experienced negative consequences as a result of drinking alcohol. Participants are asked to indicate if they have experienced a specific consequence of drinking alcohol in the past month (at Week 9) or past three months (at Baseline and Week 21) with a "yes" or "no" answer. The number of "yes" responses provides an indication of the severity of alcohol-related consequences. Change = (Week 9 score - baseline score; Week 21 score - baseline score).	Baseline, Week 9, and Week 21
Secondary	Change from Baseline in Depressive Symptoms at Week 9 and Week 21	The construct will be measured using 8 items from the Patient Health Questionnaire-9 Item (PHQ-9) which is a validated, self-report instrument assessing experience of symptoms associated with major depressive disorder. Participants are asked to measure how many days in the past two weeks they have experienced a symptom of depression on a scale of 0 (not at all) to 3 (nearly every day). The sum of all responses is used to indicate likelihood of major depressive disorder. Change = (Week 9 score - baseline score; Week 21 score - baseline score).	Baseline, Week 9, and Week 21
Secondary	Change from Baseline in Drug Use at Week 9 and Week 21	The construct will be measured using two questions from the Youth Risk Behavior Surveillance (YRBS) questionnaire that address drug use. Participants are asked to indicate if they have used specific drugs in the past month (at Week 9) or past three months (at Baseline, Week 21) with either 1) yes or 2) no. A dichotomous item will be made for the two items to indicate if the participant has engaged in drug use for a given timeframe. Change = (Week 9 score - baseline score, Week 21 score - baseline score).	Baseline, Week 9, and Week 21
Secondary	Change from Baseline in Sexual Risk-Taking as Measured by the Sexual Risk Survey at Week 9 and Week 21	The Sexual Risk Survey is a validated self-report measure assess how often an individual has engaged in risky sexual behavior. Participants indicate how often they have engaged in risky sexual behaviors in the past month (at week 9) or past three months (baseline, week 21) on a scale of "0" to "30+". Scores are analyzed at the item level. Change = (Week 9 score - baseline score; Week 21 score - baseline score).	Baseline, Week 9, and Week 21