Support Programs for Sexual Violence and Alcohol Abuse Prevention

(CARE Trial)

Overseen By Rachel Gartner, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Non-student interfacing, Not in RAISE

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to enhance how college health and counseling centers support transgender and gender-diverse (TGD) students, who face higher risks of sexual violence and alcohol misuse. The study tests a training program for college health providers to better understand and address the needs of TGD students. It compares two approaches: one with general trauma support training and the other adding focused modules on gender-affirming care (Centering Gender Affirming Resources in Higher Education, or CARE). Counselors or nurses who regularly see undergraduate students in health or counseling appointments are well-suited for this trial. As an unphased trial, this study provides a unique opportunity to improve support systems for TGD students in college settings.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this training program is safe for college health center providers?

Research has shown that the CARE program focuses on supporting transgender and gender-diverse (TGD) students in colleges. These students often face higher risks of sexual violence and risky drinking. The program trains college health center staff to better understand and assist these students.

Although specific studies on the safety of the CARE program are lacking, it is a training and educational initiative, which suggests it is generally safe. Such programs typically include learning activities and practice improvements, which are safe and non-invasive. No reports of negative effects exist, as the program does not involve medication or physical procedures. This makes it a low-risk option for potential participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial involving the GIFTSS training and CARE learning modules because it combines trauma support with gender-affirming resources, addressing both sexual violence and the unique needs of gender-diverse students. Unlike typical prevention programs that may not consider gender diversity, this approach integrates specialized modules, ensuring that college health staff are better equipped to support all students inclusively. By focusing on both trauma-informed care and gender affirmation, the trial aims to create a more supportive and responsive environment for students facing these challenges.

What evidence suggests that this trial's treatments could be effective for reducing alcohol use and sexual violence among trans and gender diverse students?

Studies have shown that transgender and gender diverse (TGD) college students experience more sexual violence than their cisgender peers. The CARE training program in this trial aims to address this by helping healthcare providers better understand and support TGD individuals. Research suggests that training healthcare professionals in LGBTQ+ issues leads to better outcomes for these communities. While some methods to prevent sexual violence require more evidence, CARE's focus on inclusivity and education shows promise. Early signs indicate that this training could make college health centers more welcoming and supportive for TGD students, potentially reducing alcohol abuse and sexual violence. Participants in this trial may receive GIFTSS training alone or GIFTSS training combined with CARE learning modules, which include trans learning modules to support implementation with gender diverse service users. ^{1 2 6 7 8}

Who Is on the Research Team?

Elizabeth Miller, PhD

Principal Investigator

Principal Investigator

Are You a Good Fit for This Trial?

This trial is for trans and gender diverse (TGD) college students who are at higher risk of sexual violence and hazardous drinking. It aims to improve the support they receive from college health and counseling centers.

Inclusion Criteria

Those who are seeing undergraduate students at health and counseling appointments as a provider

Providers may include counselors, clinicians, nurses, health educators, medical assistants, social workers, advocates, and administrators

Exclusion Criteria

A college health or counseling center provider not participating in the RAISE study

A college health or counseling center provider that does not interface with students

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training

College health and counseling center providers undergo CARE training to improve knowledge and attitudes about TGD individuals and use of trans-inclusive practices.

Immediate completion

Asynchronous e-learning

Follow-up

Providers' knowledge, attitudes, and use of TGD-inclusive practices are assessed.

4-6 months

What Are the Treatments Tested in This Trial?

Interventions

• Centering Gender Affirming Resources in Higher Education (CARE)

Trial Overview The CARE project tests a training program for college health providers to enhance their understanding, confidence, and practices related to TGD student care. The effectiveness of this training in making campus resources more inclusive will be evaluated.

How Is the Trial Designed?

Group I: GIFTSS Training and Centering gender Affirming Resources in higher Education (CARE) Learning Modules Experimental Treatment 2 Interventions

Training for college health center clinicians and staff in implementation of GIFTSS combined with CARE's trans learning modules to support implementation with gender diverse service users.

Group II: Giving Information for Trauma Support and Safety (GIFTSS) Training Active Control 1 Intervention

Training for college health center clinicians and staff in implementation of GIFTSS

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Opportunity Fund

Collaborator

Published Research Related to This Trial

A brief intervention aimed at educating college health center staff about sexual violence led to increased self-efficacy in harm reduction strategies among students, indicating that training can empower students to better manage risks associated with sexual violence.

Students who received the intervention were significantly more likely to disclose experiences of sexual violence during their health visits, suggesting that effective training can improve communication and support for affected individuals, although it did not lead to increased use of related services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cluster Randomized Trial of a College Health Center Sexual Violence Intervention. Miller, E., Jones, KA., McCauley, HL., et al.[2021]

A study of 754 undergraduate students found that sexual and gender minority (SGM) students with higher difficulties in emotion regulation tend to drink more alcohol, which is linked to greater severity of sexual assault victimization.

In contrast, cisgender, heterosexual students and SGM students with lower emotion regulation difficulties did not show this association, highlighting the need for targeted interventions to support SGM students in managing alcohol use and emotional challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emotion Regulation Difficulties Moderate the Association Between Typical Drinking and Sexual Assault Victimization Among Sexual and Gender Minority University Students. Kirwan, M., Leone, RM., Davis, KC., et al.[2023]

Transgender college students engage in higher-risk drinking behaviors compared to their cisgender peers, consuming alcohol more frequently and in greater quantities, which leads to a higher incidence of alcohol-related blackouts (36% vs. 25%).

The motivations for drinking among transgender students often include stress reduction, social anxiety, and self-esteem issues, indicating a need for targeted support and intervention strategies to address their unique challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alcohol-Related Blackouts, Negative Alcohol-Related Consequences, and Motivations for Drinking Reported by Newly Matriculating Transgender College Students. Tupler, LA., Zapp, D., DeJong, W., et al.[2022]

In a study of 242,624 college students, it was found that alcohol use and its associated harms varied significantly among different gender identities, with transgender individuals reporting higher odds of experiencing negative consequences like suicidal ideation when drinking.

Cisgender men experienced more injuries and legal troubles while drinking, whereas transgender women and nonbinary individuals reported lower instances of regret and unprotected sex, highlighting the need for tailored, gender-inclusive prevention strategies for alcohol-related harms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heavy drinking and drinking harms for cisgender and transgender college students. Dermody, SS., Lamb, KM., Kerr, DCR.[2022]

Transgender college students experience significantly higher rates of victimization, including various forms of violence, compared to their male and female peers, with data from a large study of 82,538 students.

Specifically, transgender students had the highest odds of experiencing severe sexual victimization, such as attempted sexual penetration and sexual abuse, highlighting the urgent need for targeted violence prevention programs in college environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Intersection of Gender Identity and Violence: Victimization Experienced by Transgender College Students. Griner, SB., Vamos, CA., Thompson, EL., et al.[2021]

Undergraduate students, particularly women, experience higher rates of campus sexual violence (CSV) compared to graduate/professional students and men, highlighting a significant risk factor in this population.

CSV is linked to increased alcohol use among undergraduates and poorer mental health outcomes for both undergraduates and graduate/professional students, suggesting a need for targeted prevention and intervention strategies in universities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Campus Sexual Violence, Gender, and Mental Health in Diverse Undergraduate/Graduate Students. Gómez, JM.[2022]

Gender and sexual minority (GSM) students are significantly more likely to experience sexual violence, with predictions showing they are 2.6 to 3 times more likely than cisgender heterosexual (CH) male students, and they may experience 74% more incidents of sexual violence over their college careers.

GSM students who experience sexual violence are at a higher risk for mental health issues, including PTSD and severe depression, compared to CH male students, highlighting the need for targeted support and interventions in higher education settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sexual Violence Among Gender and Sexual Minority College Students: The Risk and Extent of Victimization and Related Health and Educational Outcomes. Kammer-Kerwick, M., Wang, A., McClain, T., et al.[2021]

In a study of 462 trans and non-binary individuals, higher levels of reported discrimination were linked to increased risk of alcohol dependence and greater alcohol-related harms, highlighting the impact of social factors on drinking behaviors.

Coping motives and drinking to manage dysphoria were significant predictors of alcohol dependence, suggesting that interventions aimed at reducing discrimination and providing supportive environments could help mitigate alcohol-related issues in this community.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Discrimination, gender dysphoria, drinking to cope, and alcohol harms in the UK trans and non-binary community. Davies, EL., Ezquerra-Romano, I., Thayne, B., et al.[2023]

A significant 29% of trans* and gender nonconforming (TGNC) college students report experiences of sexual violence, highlighting the need for targeted prevention efforts.

Interviews with 16 sexual violence prevention educators revealed that they face challenges in being gender inclusive, often navigating a spectrum from unawareness to active gender transformation in their educational practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Campus Sexual Violence Prevention Educators' Use of Gender in Their Work: A Critical Exploration. Marine, SB., Nicolazzo, Z.[2021]

Campus-based advocacy services for survivors of intimate partner violence (IPV) and sexual assault (SA) focus on unique student needs, including academic accommodations and safety planning, which are essential for enhancing their educational experience.

The study identified key components of 'academic safety planning' that can improve academic outcomes for survivors, potentially leading to better long-term personal safety and economic security.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Academic Safety Planning: Intervening to Improve the Educational Outcomes of Collegiate Survivors of Interpersonal Violence. Voth Schrag, RJ., Wood, LG., Hairston, D., et al.[2022]

Transgender individuals are significantly more likely to experience sexual violence while under the influence of alcohol compared to cisgender individuals, with 9.3% of transgender respondents reporting such experiences in the past year versus 4.2% of cisgender respondents.

Non-binary transgender participants and those assigned female at birth reported even higher rates of sexual victimization, highlighting the need for specialized support services that are sensitive to the unique experiences and needs of transgender individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing Transgender and Cisgender Experiences of Being Taken Advantage of Sexually While Under the Influence of Alcohol and/or Other Drugs. Connolly, D., Aldridge, A., Davies, E., et al.[2021]

Citations

1. withpower.com withpower.com/trial/phase-violence-sexual-4-2024-daeee

Support Programs for Sexual Violence and Alcohol Abuse ... ... Centering Gender Affirming Resources in Higher Education (CARE) will have tolerable side effects & efficacy for patients with Sexual Violence and Alcohol Abuse.

2. psycnet.apa.org psycnet.apa.org/record/2024-05958-001

“There's no safety in these systems”: Centering trans and ... Transgender and gender diverse (TGD) college students experience higher rates of sexual violence (SV) than their cisgender peers.

3. cce.upmc.com cce.upmc.com/163040-care-centering-gender-affirming-resources-through-education-module-3

CARE: Centering gender Affirming Resources through ... This training is developed to improve knowledge and attitudes about TGD individuals, increase self-efficacy and use of TGD-inclusive practices, ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2949732925000742

Systematic Review: Exploring the Effectiveness of Health ... This systematic review evaluates the effectiveness of LGBTQ+ competency training programs for healthcare professionals and examines their impact on LGBTQ+ ...

5. cdc.gov cdc.gov/violenceprevention/pdf/sv-prevention-resource_508.pdf

Sexual Violence Prevention Resource for Action Within this resource, some approaches do not yet have research evidence demonstrating impact on rates of SV victimization or perpetration but instead are ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11724704/

Improving School Environments for Preventing Sexual ... This qualitative study aimed to understand LGBTQ+ students' perspectives on how middle and high school environments can better prevent and address SV.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0190740924004389

“It changed me for the better”: Feasibility, acceptability, and ... The purpose of the current study was to describe and present implementation outcome data from an open pilot trial of the Promoting Resilient Youth with ...

8. researchgate.net researchgate.net/publication/373744268_There's_no_safety_in_these_systems_Centering_trans_and_gender_diverse_students'_campus_climate_experiences_to_prevent_sexual_violence

Centering Trans and Gender Diverse Students' Campus ... Transgender and gender diverse (TGD) students on university campuses experience high rates of sexual violence relative to their cisgender peers ...