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Centering Gender Affirming Resources in Higher Education

Inclusive Practices for Gender Minority College Students to Reduce Sexual Violence and Heavy Drinking

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06390332
Acronym
CARE
Enrollment
100
Registered
2024-04-30
Start date
2024-12-11
Completion date
2027-06-01
Last updated
2026-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drinking Heavy, Sexual Violence

Keywords

Transgender, Gender Minorities

Brief summary

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.

Detailed description

"Centering gender Affirming Resources in higher Education (CARE)" expands upon RAISE's (R01 AA023260) cluster-randomized controlled trial across 28+ college campuses that is evaluating harm reduction interventions to reduce risk for sexual violence (SV) among undergraduate college students receiving care from college health and counseling centers (CHCs). A previous study by this research team found that students identifying as transgender or gender diverse (TGD) report particularly high lifetime prevalence of SV that is associated with greater odds of binge drinking compared to students not exposed to SV. Compounding these vulnerabilities, TGD students face high rates of discrimination on university campuses that drive heavy alcohol use and SV inequities, and lead to distrust of potential support resources like CHCs. CARE enhances RAISE's intervention by employing community-partnered methodologies to develop a training for CHC providers designed specifically to increase their competence in addressing TGD students' health needs with a focus on alcohol use and SV. The training involves a brief e-learning (asynchronous) intervention aimed at improving providers' knowledge and attitudes about TGD individuals, skills in delivering competent and affirming care, and knowledge of and self-efficacy to use TGD-inclusive practices. This trial will assess the feasibility, acceptability, appropriateness, and usability of CARE's training intervention in 15 randomized CHC sites from the parent study (Aim 1). The study will examine CHC provider knowledge and attitudes about TGD individuals, and their knowledge, self-efficacy, and use of TGD-inclusive practices with follow-up at 4-6 months (Aim 2).

Interventions

BEHAVIORALGiving Information for Trauma Support and Safety (GIFTSS) Training

Training for college health center staff and clinicians on GIFTSS intervention which is a universal education and brief counseling to address sexual violence prevention and intervention.

BEHAVIORALCentering gender Affirming Resources in higher Education (CARE) Learning Modules

Training for college health center clinicians and staff on trans and gender diverse (TGD) affirming clinical practices in addition to sexual violence and alcohol abuse prevention that is inclusive of TGD service users

Sponsors

University of Pittsburgh
Lead SponsorOTHER
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH
Opportunity Fund
CollaboratorUNKNOWN

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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 that does not interface with students. * A college health or counseling center provider not participating in the RAISE study.

Design outcomes

Primary

MeasureTime frameDescription
Provider perception of intervention feasibilityImmediately after CARE training completionDomain: Provider-Perceived Feasibility Specific Measurement: Feasibility of Intervention Measure (FIM). Specific Metric: End value Method of Aggregation: Mean score, range 1-5 cutoff mean score \> 4, higher score indicates greater feasibility
Provider perception of intervention acceptabilityImmediately after CARE training completionDomain: Provider-Perceived Acceptability Specific Measurement: Acceptability of Intervention Measure (AIM) Specific Metric: End value Method of Aggregation: Mean score, range 1-5, cutoff mean score \> 4, higher score indicates greater acceptability
Provider perception of intervention appropriatenessImmediately after CARE training completionDomain: Provider-Perceived Appropriateness Specific Measurement: Intervention Appropriateness Measure (IAM) Specific Metric: End value Method of Aggregation: Mean score, range 1-5 , cutoff mean score \> 4, higher score indicates greater appropriateness
Provider perception of intervention usabilityImmediately after CARE training completionDomain: Provider-Perceived Usability Specific Measurement: System Usability Scale (SUS) Specific Metric: End value Method of Aggregation: Mean score, range 1-5 , cutoff mean score \> 4, higher score indicates greater usability

Secondary

MeasureTime frameDescription
Knowledge and attitudes about TGD individuals.Baseline- Before taking CARE trainingDomain: Assessing provider knowledge, attitudes, and beliefs about transgender people Specific Measurement: Transgender Knowledge, Attitudes, and Beliefs (T-KAB) scale Specific Metric: End value Method of Aggregation: Mean score, range 1 to 4, 4 indicating favorable attitudes and beliefs towards transgender people
Attitudes concerning transphobiaBaseline- Before taking CARE trainingDomain: Assessing provider's attitudes regarding transphobia Specific Measurement: Transphobia Scale Specific Metric: End value Method of Aggregation: Mean score, range 1 to 7, 7 indicating a lesser degree of transphobia
Human value of transgender peopleBaseline- Before taking CARE trainingDomain: Assessing how providers view the human value of transgender people Specific Measurement: Transgender Attitudes and Beliefs Scale (TABS) Specific Metric: End value Method of Aggregation: Mean score, range 1 to 7, 7 indicating trans and gender diverse people hold high human value
Use of TGD-inclusive practicesBaseline- Before taking CARE trainingDomain: Use of transgender and gender diverse-inclusive practices Specific Measurement: The Lesbian, Gay, Bisexual, and Transgender Development of Clinical Skills Scale (LGBT-DOCSS) Specific Metric: End value Method of Aggregation: Mean score, range 1 to 7, 7 indicating high preparedness and knowledge to work with transgender patients
Trans-Inclusivity in professional settingsBaseline- Before taking CARE trainingDomain: Assessing how trans-inclusive providers are in their practice Specific Measurement: The Trans-Inclusive Provider Scale (TIPS) Specific Metric: End value Method of Aggregation: Mean score, range 1 to 5, 5 indicating high trans-inclusivity in care practices)
Social desirabilityBaseline- Before taking CARE trainingDomain: Measure of social desirability Specific Measurement: Marlowe- Crowne Social Desirability Scale Specific Metric: End Value Method of Aggregation: True and false questions, summary score from 0 to 1
Self-Efficacy to use trans and gender affirming practicesBaseline- Before taking CARE trainingDomain: Self-efficacy to use trans and gender affirming practices Specific Measurement: Investigator Developed Specific Metric: End value Method of Aggregation: Mean score, range 1 to 5, 5 indicating greater self-efficacy to use trans-affirming practices

Countries

United States

Contacts

CONTACTRegina Futcher, MSW
futcherr2@upmc.edu757-272-3783
CONTACTRachel Gartner, PhD
rachelgart@pitt.edu412-624-7232
PRINCIPAL_INVESTIGATORElizabeth Miller, PhD

Principal Investigator

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 9, 2026