Dating ViolencePRYSHMNCT05521906

Evaluation of PRYSHM for LGBTQIA2S+ Youth

A study testing Promoting Resilient Youth with Strong Hearts and Minds (PRYSHM) in people with Dating Violence and Alcohol Drinking, run by University of Nebraska Lincoln at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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… Read more about this study

Who is it for?: Ages 15 to 18 years
Conditions the study is for: Dating Violence, Alcohol Drinking
What is being tested?: Promoting Resilient Youth with Strong Hearts and Minds (PRYSHM)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 314 participants
Where: 1 siteUnited States
Study dates: 21 Sep 2022to 7 Dec 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 15 to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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,)

Who cannot join

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.

Show all 9Show fewer

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).

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Nebraska (Lincoln)
Lincoln, Nebraska, 68583-0858

Other trials in United States

About this study

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

Read the 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.

Conditions: Dating Violence, Alcohol Drinking
Being tested: Promoting Resilient Youth with Strong Hearts and Minds (PRYSHM)
Medical subject headings: Alcohol Drinking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Promoting Resilient Youth with Strong Hearts and Minds (PRYSHM)Behavioural
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..

Study groups in NCT05521906
Study group	Role	What they receive
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. Receives: Behavioral: Promoting Resilient Youth with Strong Hearts and Minds (PRYSHM)
Control	No intervention	Check-ins/provision of resources

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Week 21

Secondary outcomes (4)

Experience of Negative Consequences as a Result of Alcohol Use at 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.
Measured: Week 21
Depressive Symptoms at 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.
Measured: Week 21
Drug Use at 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.
Measured: Week 21
Sexual Risk-Taking as Measured by the Sexual Risk Survey at 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.
Measured: Week 21

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Sep 20227 Dec 2023

First posted30 Aug 2022
Study start21 Sep 2022
Primary completion23 Aug 2023
Study completion7 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (17)Papers the sponsor has linked to this study.
Other trials for Dating ViolenceStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: SGMY (N=300) are randomly assigned to a treatment (n=200) or wait-list (n=100) control condition.
Masking: None (open label)
Enrolment: 314 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05521906
Sponsor's protocol ID: 21985IRB
Other IDs: R34AA028401
Acronym: PRYSHM
Status last verified: Mar 2025
First submitted: 24 Aug 2022
Last updated: 18 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: IPD (using pseudoGUIDS) will be uploaded into the NIAAA data repository consistent with NIAAA policy for studies funded by NIAAA. The data in the NIAAA data archive are catalogued and made available to the general research community after a two year embargo period following the end date of the research award.

Publications

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. 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.
PubMed 26668180
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.
PubMed 25730143
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.
PubMed 20584573
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.
PubMed 24633850
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.
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.
PubMed 23233160
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.
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.
PubMed 20099941
Lin Y, J., Israel T. Development and validation of a psychological sense of LGBT community scale. Journal of Community Psychology. 2012;40(5):14.
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.
PubMed 23861097
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.
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.
PubMed 26037814
Growing up LGBT in America: NCOD report. Human Rights Campaignn.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Development and Pilot Evaluation of an Online Intervention to Prevent Dating Violence and Problem Drinking in Sexual Minority Youth
ClinicalTrials.gov ID: NCT05521906
Acronym / sponsor ID: PRYSHM / 21985IRB
Conditions: Dating Violence, Alcohol Drinking
Study type: Interventional
Recruitment status: Completed
Enrolment: 314 participants (actual)
Lead sponsor: University of Nebraska LincolnUniversity, hospital or other
Collaborators: University of Houston, University of Colorado, Colorado Springs, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study start: 21 Sep 2022 (actual)
Primary completion: 23 Aug 2023 (actual)
Study completion: 7 Dec 2023 (actual)
First posted: 30 Aug 2022 (actual)
Results: Posted 18 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: SGMY (N=300) are randomly assigned to a treatment (n=200) or wait-list (n=100) control condition.

Arm	Type	Receives
Treatment Condition	Experimental	Behavioral: 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.
Control	No intervention	–Check-ins/provision of resources

Who may qualify

Ages: 15 to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (9 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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..	Behavioural	Treatment Condition

Primary outcome

Intimate Partner Violence Perpetration at Week 21
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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

4 secondary outcomes

Experience of Negative Consequences as a Result of Alcohol Use at Week 21
Time frame: Week 21
Depressive Symptoms at Week 21
Time frame: Week 21
Drug Use at Week 21
Time frame: Week 21
Sexual Risk-Taking as Measured by the Sexual Risk Survey at Week 21
Time frame: Week 21

Results and safety

Results posted to the registry on 18 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention	213	204
Waitlist Control	101	100

Primary outcome: Intimate Partner Violence Perpetration at Week 21

Time frame: Week 21. Mean (Standard Deviation). Unit: score on a scale

Measure	Intervention n = 170	Waitlist Control n = 83
Value	5.79 (39.85)	4.46 (11.02)

Population analysed: This number reflects the final number of participants in Week 21; 61 participants lost to attrition throughout the study.

Primary outcome: Intimate Partner Violence Victimization at Week 21

Time frame: Week 21. Mean (Standard Deviation). Unit: units on a scale

Measure	Intervention n = 170	Waitlist Control n = 83
Value	5.57 (16.56)	6.83 (19.73)

Population analysed: This number reflects the final number of participants in Week 21; 61 participants lost to attrition throughout the study.

Primary outcome: Alcohol Use at Week 21

Time frame: Week 21. Mean (Standard Deviation). Unit: score on a scale

Measure	Intervention n = 170	Waitlist Control n = 83
Value	1.13 (2.58)	1.86 (4.37)

Population analysed: This number reflects the final number of participants in Week 21; 61 participants lost to attrition throughout the study.

Primary outcome: Sexual and Gender Minority Specific Intimate Partner Violence Perpetration at Week 21

Time frame: Week 21. Mean (Standard Deviation). Unit: units on a scale

Measure	Intervention n = 170	Waitlist Control n = 83
Value	0.04 (0.42)	0.10 (0.54)

Population analysed: This number reflects the final number of participants in Week 21; 61 participants lost to attrition throughout the study.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Data on adverse events were collected throughout the study from baseline (enrollment 1-2 weeks before programming), during intervention (9-week programming), post-program survey (within 3 weeks of program end), 3-month follow-up from baseline, and during waitlist control intervention programming (at month 12 (9-weeks of programming)).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment Condition	0 of 204 (0%)	6 of 204 (2.9%)	0 of 204
Waitlist Control	0 of 100 (0%)	0 of 100 (0%)	0 of 100
Waitlist Control: Treatment Condition	0 of 16 (0%)	0 of 16 (0%)	0 of 16

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
BackgroundEdwards KM, Banyard VL, Sessarego SN. Dating and sexual violence victimization and perpetration among high school youth: Incidence and correlates. Manuscript in preparation. 2017.
Background: PubMed 26668180Edwards 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.
Background: PubMed 25730143Vagi 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.
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BackgroundMason 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.
BackgroundEdwards 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: PubMed 23233160Edwards 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.
BackgroundLewis 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: PubMed 20099941Kertzner 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.
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Individual participant dataSharing planned: Yes. IPD (using pseudoGUIDS) will be uploaded into the NIAAA data repository consistent with NIAAA policy for studies funded by NIAAA. The data in the NIAAA data archive are catalogued and made available to the general research community after a two year embargo period following the end date of the research award.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Promoting Resilient Youth with Strong Hearts and Minds (PRYSHM) in people with Dating Violence and Alcohol Drinking, run by University of Nebraska Lincoln at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intimate Partner Violence Perpetration at Week 21 (time frame: Week 21). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05521906, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025.