Centering Gender Affirming Resources in Higher Education

NCT06390332 | Recruiting

• 2 other identifiers: STUDY22040105R01AA023260-07W1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Sexual Violence; Drinking Heavy

Keywords

Transgender; Gender Minorities

Outcome Measures

Primary Outcomes (4)

• Provider perception of intervention feasibility

  Domain: 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

  Immediately after CARE training completion

• Provider perception of intervention acceptability

  Domain: 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

  Immediately after CARE training completion

• Provider perception of intervention appropriateness

  Domain: 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

  Immediately after CARE training completion

• Provider perception of intervention usability

  Domain: 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

  Immediately after CARE training completion

Secondary Outcomes (14)

• Knowledge and attitudes about TGD individuals.

  Baseline- Before taking CARE training

• Knowledge and attitudes about TGD individuals.

  At 6 months

• Attitudes concerning transphobia

  Baseline- Before taking CARE training

• Attitudes concerning transphobia

  At 6 months

• Human value of transgender people

  Baseline- Before taking CARE training

Study Arms (2)

Giving Information for Trauma Support and Safety (GIFTSS) Training

ACTIVE COMPARATOR

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

Behavioral: Giving Information for Trauma Support and Safety (GIFTSS) Training

GIFTSS Training and Centering gender Affirming Resources in higher Education (CARE) Learning Modules

EXPERIMENTAL

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.

Behavioral: Giving Information for Trauma Support and Safety (GIFTSS) Training; Behavioral: Centering gender Affirming Resources in higher Education (CARE) Learning Modules

Interventions

Giving Information for Trauma Support and Safety (GIFTSS) Training BEHAVIORAL

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.

GIFTSS Training and Centering gender Affirming Resources in higher Education (CARE) Learning Modules; Giving Information for Trauma Support and Safety (GIFTSS) Training

Centering gender Affirming Resources in higher Education (CARE) Learning Modules BEHAVIORAL

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

GIFTSS Training and Centering gender Affirming Resources in higher Education (CARE) Learning Modules

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator
• Opportunity Fund: collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

MeSH Terms

Interventions

Safety

Intervention Hierarchy (Ancestors)

Accident Prevention; Accidents; Public Health; Environment and Public Health

Study Officials

• Elizabeth Miller, PhD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Regina Futcher, MSW

CONTACT

757-272-3783; futcherr2@upmc.edu

Rachel Gartner, PhD

CONTACT

412-624-7232; rachelgart@pitt.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 30, 2024
• Study Start: December 11, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 12 months after end of study
• Access Criteria: data uploaded to NDA

Locations

US (1)