Evaluation of PRYSHM for LGBTQIA2S+ Youth

NCT05521906 | Completed Results DMC

• 2 other identifiers: 21985IRBR34AA028401
• Study Type: interventional
• Target: 314
• Locations: 1 country
• Sites: 1

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.

Conditions

Dating Violence; Alcohol Drinking

Outcome Measures

Primary Outcomes (7)

• Intimate Partner Violence Perpetration at 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.

  Week 21

• Intimate Partner Violence Victimization at 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.

  Week 21

• Alcohol Use at 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.

  Week 21

• Sexual and Gender Minority Specific Intimate Partner Violence Perpetration at 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.

  Week 21

• Sexual and Gender Minority Specific Intimate Partner Violence Victimization at 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.

  Week 21

• Drinking Intentions at 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.

  Week 21

• Willingness to Drink at 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

  Week 21

Secondary Outcomes (4)

• Experience of Negative Consequences as a Result of Alcohol Use at Week 21

  Week 21

• Depressive Symptoms at Week 21

  Week 21

• Drug Use at Week 21

  Week 21

• Sexual Risk-Taking as Measured by the Sexual Risk Survey at Week 21

  Week 21

Other Outcomes (18)

• Identity Concealment Behaviors as Measured by the Outness Inventory for Sexual Orientation Family Subscale at Week 21

  Week 21

• Experiences of Internalized Homonegativity at Week 21

  Week 21

• Sense of LGBTQIA2S+ Community at Week 21

  Week 21

Study Arms (2)

Treatment Condition

EXPERIMENTAL

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)

Control

NO INTERVENTION

Check-ins/provision of resources

Interventions

Promoting Resilient Youth with Strong Hearts and Minds (PRYSHM) BEHAVIORAL

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..

Treatment Condition

Eligibility Criteria

• Age: 15 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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,)

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Nebraska Lincoln: lead
• University of Houston: collaborator
• University of Colorado, Colorado Springs: collaborator
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

University of Nebraska (Lincoln)

Lincoln, Nebraska, 68583-0858, United States

Location

Related Publications (17)

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

  BACKGROUND

• 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.

  PMID: 26668180 BACKGROUND

• 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.

  PMID: 25730143 BACKGROUND

• 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.

  PMID: 20584573 BACKGROUND

• 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.

  PMID: 24633850 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 23233160 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 20099941 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 23861097 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 26037814 BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Alcohol Drinking

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Results Point of Contact

• Title: Katie M Edwards, PhD
• Organization: University of Nebraska-Lincoln, Department of Educational Psychology/Interpersonal Violence Research Laboratory

katie.edwards@unl.edu

402-472-2448

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: SGMY (N=300) are randomly assigned to a treatment (n=200) or wait-list (n=100) control condition.

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: August 30, 2022
• Study Start: September 21, 2022
• Primary Completion: August 23, 2023
• Study Completion: December 7, 2023
• Last Updated: April 18, 2025
• Results First Posted: April 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: IPD will be available after a 2 year embargo period from the award end date. IPD will be available within the NIAAA data archive in perpetuity.
• Access Criteria: To access to IPD from within the NIAAA data archive, researchers will need to receive authorization by completing the NDA Data Access Request (DAR) and satisfying several pre-requisites. DARs will be reviewed by a special committee at NIAAA to ensure that the researcher has made an adequate case for the responsible use of the data. Individuals seeking access to IPD must be associated with an NIH recognized institution with an FWA and must provide a research-related need to access the data.

Locations

US (1)