Evaluation of PRYSHM for LGBTQIA2S+ Youth

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Dating Violence, Alcohol Drinking

Intervention / Treatment
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* Behavioral: Promoting Resilient Youth with Strong Hearts and Minds (PRYSHM)


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: SGMY (N=300) are randomly assigned to a treatment (n=200) or wait-list (n=100) control condition.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Condition<br>The PRYSHM program is theoretically grounded, follows best practices for effective health behavior prevention, and includes nine, one hour sessions co-facilitated by 2 LGBTQ+ adults. | Behavioral: Promoting Resilient Youth with Strong Hearts and Minds (PRYSHM)<br>* 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..<br>|
| No Intervention: Control<br>Check-ins/provision of resources | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 |