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

Trial Summary

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 data supports the effectiveness of the treatment Centering Gender Affirming Resources in Higher Education (CARE) for preventing sexual violence and alcohol abuse?

Research shows that sexual and gender minority students benefit from interventions targeting alcohol use and emotion regulation difficulties, which are components that CARE may address. Additionally, reducing discrimination and providing supportive social spaces can help decrease alcohol-related harms, suggesting that CARE's focus on gender-affirming resources could be effective. ^{1 2 3 4 5}

Is the treatment for sexual violence and alcohol abuse prevention safe for humans?

The research articles do not provide specific safety data for the treatment programs mentioned, such as CARE, but they highlight the need for gender-inclusive prevention efforts and the importance of addressing alcohol use and sexual violence among diverse student populations. ^{3 6 7 8 9}

How does the CARE treatment differ from other treatments for sexual violence and alcohol abuse prevention?

The CARE treatment is unique because it centers on gender-affirming resources in higher education, focusing on the specific needs of diverse gender identities, which is not typically addressed in standard prevention programs. This approach is particularly important for transgender and nonbinary students who face different patterns of alcohol use and related harms compared to cisgender students. ^{1 3 8 10 11}

What is the purpose of this trial?

Centering gender Affirming Resources in higher Education (CARE) project is nested within the parent study "Reducing Alcohol Involved Sexual violence in higher Education" (RAISE; R01 AA023260; NCT05185440). CARE is a pilot cluster-randomized trial that centers trans and gender diverse (TGD) students who are at elevated risk for SV and hazardous drinking. CARE tests a novel college health and counseling center (CHC) training program designed to improve provider knowledge about TGD individuals, increase their self-efficacy and use of trans-inclusive practices. This includes an evaluation of the feasibility, acceptability, appropriateness, and usability of CARE's training intervention for college health and counseling center providers. This research will produce the first rigorously evaluated TGD-focused CHC provider training which has the potential to increase the accessibility of CHC's for TGD university students- ultimately lowering rates of alcohol use and SV among this disproportionately impacted population.

Research Team

Elizabeth Miller, PhD

Principal Investigator

Principal Investigator

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

References

1. United States 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. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Alcohol-Related Blackouts, Negative Alcohol-Related Consequences, and Motivations for Drinking Reported by Newly Matriculating Transgender College Students. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Heavy drinking and drinking harms for cisgender and transgender college students. [2022]

4. United States 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. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Discrimination, gender dysphoria, drinking to cope, and alcohol harms in the UK trans and non-binary community. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

The Intersection of Gender Identity and Violence: Victimization Experienced by Transgender College Students. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

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

8. United States pubmed.ncbi.nlm.nih.gov

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

9. United States 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. [2021]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Cluster Randomized Trial of a College Health Center Sexual Violence Intervention. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Academic Safety Planning: Intervening to Improve the Educational Outcomes of Collegiate Survivors of Interpersonal Violence. [2022]