Clinical trial NCT05521906: Evaluation of PRYSHM for LGBTQIA2S+ Youth
Official title: Development and Pilot Evaluation of an Online Intervention to Prevent Dating Violence and Problem Drinking in Sexual Minority Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dating Violence
Alcohol Drinking
Lead sponsor: University of Nebraska Lincoln
Sponsor class: OTHER
Collaborators: name: University of Houston
name: University of Colorado, Colorado Springs
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2022-08-30
Enrollment: 314
Sex: ALL
Minimum age (years): 15
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: SGMY (N=300) are randomly assigned to a treatment (n=200) or wait-list (n=100) control condition.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Intimate Partner Violence Perpetration at Week 21
timeFrame: Week 21
measure: Intimate Partner Violence Victimization at Week 21
timeFrame: Week 21
measure: Alcohol Use at Week 21
timeFrame: Week 21
measure: Sexual and Gender Minority Specific Intimate Partner Violence Perpetration at Week 21
timeFrame: Week 21
measure: Sexual and Gender Minority Specific Intimate Partner Violence Victimization at Week 21
timeFrame: Week 21
measure: Drinking Intentions at Week 21
timeFrame: Week 21
measure: Willingness to Drink at Week 21
timeFrame: Week 21
Secondary outcomes:
measure: Experience of Negative Consequences as a Result of Alcohol Use at Week 21
timeFrame: Week 21
measure: Depressive Symptoms at Week 21
timeFrame: Week 21
measure: Drug Use at Week 21
timeFrame: Week 21
measure: Sexual Risk-Taking as Measured by the Sexual Risk Survey at Week 21
timeFrame: Week 21
Other outcomes:
measure: Identity Concealment Behaviors as Measured by the Outness Inventory for Sexual Orientation Family Subscale at Week 21
timeFrame: Week 21
measure: Experiences of Internalized Homonegativity at Week 21
timeFrame: Week 21
measure: Sense of LGBTQIA2S+ Community at Week 21
timeFrame: Week 21
measure: Emotional Regulation and Coping at Week 21
timeFrame: Week 21
measure: Conflict Resolution Skills as Measured by the Communication Skills Test at Week 21
timeFrame: Week 21
measure: Sexual Refusal Skills at Week 21
timeFrame: Week 21
measure: Bystander Behavior at Week 21
timeFrame: Week 21
measure: Accurate Perceptions of Dating Violence at Week 21
timeFrame: Week 21
measure: Protective Behavioral Strategies as Measured by the Alcohol Reduction Strategies- Current Confidence Questionnaire (ARS-CC) at Week 21
timeFrame: Week 21
measure: Hope for the Future as Measured by the Feelings About Being LGBTQIA2S+ at Week 21
timeFrame: Week 21
measure: Drinking Motives at Week 21
timeFrame: Week 21
measure: Drinking Refusal Skills at Week 21
timeFrame: Week 21
measure: Alcohol Use Bystander Behavior at Week 21
timeFrame: Week 21
measure: Accurate Perceptions of Alcohol Use at Week 21
timeFrame: Week 21
measure: Ethnic Identity at Week 21
timeFrame: Week 21
measure: Identity Concealment Behaviors as Measured by the Outness Inventory for Sexual Orientation World Subscale at Week 21
timeFrame: Week 21
measure: Identity Concealment Behaviors as Measured by the Outness Inventory for Gender Identity Family Subscale at Week 21
timeFrame: Week 21
measure: Identity Concealment Behaviors as Measured by the Outness Inventory for Gender Identity World Subscale at Week 21
timeFrame: Week 21
Locations:
city: Lincoln
country: United States
facility: University of Nebraska (Lincoln)
state: Nebraska
Study officials:
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