Evaluation of PRYSHM for LGBTQIA2S+ Youth

Not Applicable

Completed

Conditions: Dating Violence
Alcohol Drinking

Interventions: Behavioral: Promoting Resilient Youth with Strong Hearts and Minds (PRYSHM)

Registration Number: NCT05521906

Lead Sponsor: University of Nebraska Lincoln

Brief 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.

Detailed 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 & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 314

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).

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Condition	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 nine, one hour sessions co-facilitated by 2 LGBTQ+ adults.

Primary Outcome Measures

Name	Time	Method
Intimate Partner Violence Perpetration at Week 21	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 three months (at Week 21). The total score was created by summing the items. The range is 0 to 476. Higher scores represent more intimate partner violence perpetration.
Intimate Partner Violence Victimization at Week 21	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 three months (at Baseline, Week 21). The total score was created by summing the items. The range is 0 to 105. Higher scores represent more intimate partner violence victimization.
Alcohol Use at Week 21	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 on a scale of "0" to "40+". recoded the response scale using the mid-point of each response option (recoded values: 0 = 0, 1 = 1, 2 = 2, 3 = 3, 4 = 4, 5 = 5, 6 = 7.5, 7 = 14.5, 8 = 29.5, 9 = 40. Mean scores were then calculated. The range is 0 to 9. Higher scores represent more alcohol use.
Sexual and Gender Minority Specific Intimate Partner Violence Perpetration at Week 21	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 three months (Week 21). The total score was created by summing the items. The range is 0 to 5. Higher scores represent more sexual and gender minority specific intimate partner violence perpetration.
Sexual and Gender Minority Specific Intimate Partner Violence Victimization at Week 21	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 and/or gender minority victimizes dating violence. Participants rate how frequently they engaged in specific behaviors from 0 to 100 times over the past three months (Week 21). The total score was created by summing the items. The range is 0 to 16. Higher scores represent more sexual and gender minority specific intimate partner violence victimization.
Drinking Intentions at Week 21	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 three months (Week 21) on a scale of 0 to 4 ("definitely will" to "definitely won't") on one item. The range is 0 to 4. Higher scores represent more drinking intentions.
Willingness to Drink at Week 21	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 0 to 3 ("not at all" to "very willing") given a specific scenario. The mean score was created. The range is 0 to 3. Higher scores represent more willingness to drink

Secondary Outcome Measures

Name	Time	Method
Experience of Negative Consequences as a Result of Alcohol Use at Week 21	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 three months (Week 21) with a "yes" or "no" answer. The number of "yes" responses provides an indication of the severity of alcohol-related consequences. The total score was created by summing the items. The range is 0 to 24. Higher scores represent higher levels of problems and consequences from alcohol use.
Depressive Symptoms at Week 21	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. Higher scores indicate higher depressive symptomology.
Drug Use at Week 21	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 three months (Week 21) with either 1) yes or 0) no. The range is 0 to 1. A score of 1 indicates the use of drugs and therefore is considered a worse outcome.
Sexual Risk-Taking as Measured by the Sexual Risk Survey at Week 21	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 three months (week 21) on a scale of "0" to "30+". A composite score was created by recoding each item (0, 1, and 2 or more) and then creating a sum. The range is 0 to 8. Higher scores indicate higher levels of sexual risk.