Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2025-12-25 @ 7:26 PM
Study NCT ID:
NCT06390332
Status:
RECRUITING
Last Update Posted:
2025-08-27
First Post:
2024-04-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Centering Gender Affirming Resources in Higher Education
Sponsor:
Organization:
Raw JSON
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Specific Metric: End value Method of Aggregation: Mean score, range 1-5 cutoff mean score \\> 4, higher score indicates greater feasibility'}, {'measure': 'Provider perception of intervention acceptability', 'timeFrame': 'Immediately after CARE training completion', 'description': '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'}, {'measure': 'Provider perception of intervention appropriateness', 'timeFrame': 'Immediately after CARE training completion', 'description': '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'}, {'measure': 'Provider perception of intervention usability', 'timeFrame': 'Immediately after CARE training completion', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Knowledge and attitudes about TGD individuals.', 'timeFrame': 'Baseline- Before taking CARE training', 'description': 'Domain: 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'}, {'measure': 'Knowledge and attitudes about TGD individuals.', 'timeFrame': 'At 6 months', 'description': 'Domain: Assessing provider knowledge, attitudes, and beliefs about transgender people Specific Measurement: Transgender Knowledge, Attitudes, and Beliefs (T-KAB) scale Specific Metric: Change from baseline Method of Aggregation: Mean score, range 1 to 4, 4 indicating favorable attitudes and beliefs towards transgender people'}, {'measure': 'Attitudes concerning transphobia', 'timeFrame': 'Baseline- Before taking CARE training', 'description': "Domain: 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"}, {'measure': 'Attitudes concerning transphobia', 'timeFrame': 'At 6 months', 'description': "Domain: Assessing provider's attitudes regarding transphobia Specific Measurement: Transphobia Scale Specific Metric: Change from baseline Method of Aggregation: Mean score, range 1 to 7, 7 indicating a lesser degree of transphobia"}, {'measure': 'Human value of transgender people', 'timeFrame': 'Baseline- Before taking CARE training', 'description': 'Domain: 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'}, {'measure': 'Human value of transgender people', 'timeFrame': 'At 6 months', 'description': 'Domain: Assessing how providers view the human value of transgender people Specific Measurement: Transgender Attitudes and Beliefs Scale (TABS) Specific Metric: Change from Baseline Method of Aggregation: Mean score, range 1 to 7, 7 indicating trans and gender diverse people hold high human value'}, {'measure': 'Use of TGD-inclusive practices', 'timeFrame': 'Baseline- Before taking CARE training', 'description': 'Domain: 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'}, {'measure': 'Use of TGD-inclusive practices', 'timeFrame': 'At 6 months', 'description': 'Domain: 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: Change from baseline Method of Aggregation: Mean score, range 1 to 7, 7 indicating high preparedness and knowledge to work with transgender patients'}, {'measure': 'Trans-Inclusivity in professional settings', 'timeFrame': 'Baseline- Before taking CARE training', 'description': 'Domain: 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)'}, {'measure': 'Trans-Inclusivity in professional settings', 'timeFrame': 'At 6 months', 'description': 'Domain: Assessing how trans-inclusive providers are in their practice Specific Measurement: The Trans-Inclusive Provider Scale (TIPS) Specific Metric: Change from Baseline Method of Aggregation: Mean score, range 1 to 5, 5 indicating high trans-inclusivity in care practices'}, {'measure': 'Social desirability', 'timeFrame': 'Baseline- Before taking CARE training', 'description': 'Domain: 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'}, {'measure': 'Social desirability', 'timeFrame': 'At 6 months', 'description': 'Domain: Measure of social desirability Specific Measurement: Marlowe- Crowne Social Desirability Scale Specific Metric: Change from Baseline Method of Aggregation: True and false questions, summary score from 0 to 1'}, {'measure': 'Self-Efficacy to use trans and gender affirming practices', 'timeFrame': 'Baseline- Before taking CARE training', 'description': 'Domain: 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'}, {'measure': 'Self-Efficacy to use trans and gender affirming practices', 'timeFrame': 'At 6 months', 'description': 'Domain: Self-efficacy to use trans and gender affirming practices Specific Measurement: Investigator Developed Specific Metric: Change from baseline Method of Aggregation: Mean score, range 1 to 5, 5 indicating greater self-efficacy to use trans-affirming practices'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Transgender', 'Gender Minorities'], 'conditions': ['Sexual Violence', 'Drinking Heavy']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '"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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Those who are seeing undergraduate students at health and counseling appointments as a provider.\n* Providers may include counselors, clinicians, nurses, health educators, medical assistants, social workers, advocates, and administrators.\n\nExclusion Criteria:\n\n* A college health or counseling center provider that does not interface with students.\n* A college health or counseling center provider not participating in the RAISE study.'}, 'identificationModule': {'nctId': 'NCT06390332', 'acronym': 'CARE', 'briefTitle': 'Centering Gender Affirming Resources in Higher Education', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Inclusive Practices for Gender Minority College Students to Reduce Sexual Violence and Heavy Drinking', 'orgStudyIdInfo': {'id': 'STUDY22040105'}, 'secondaryIdInfos': [{'id': 'R01AA023260-07W1', 'link': 'https://reporter.nih.gov/quickSearch/R01AA023260-07W1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Giving Information for Trauma Support and Safety (GIFTSS) Training', 'description': 'Training for college health center clinicians and staff in implementation of GIFTSS', 'interventionNames': ['Behavioral: Giving Information for Trauma Support and Safety (GIFTSS) Training']}, {'type': 'EXPERIMENTAL', 'label': 'GIFTSS Training and Centering gender Affirming Resources in higher Education (CARE) Learning Modules', 'description': "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.", 'interventionNames': ['Behavioral: Giving Information for Trauma Support and Safety (GIFTSS) Training', 'Behavioral: Centering gender Affirming Resources in higher Education (CARE) Learning Modules']}], 'interventions': [{'name': 'Giving Information for Trauma Support and Safety (GIFTSS) Training', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['GIFTSS Training and Centering gender Affirming Resources in higher Education (CARE) Learning Modules', 'Giving Information for Trauma Support and Safety (GIFTSS) Training']}, {'name': 'Centering gender Affirming Resources in higher Education (CARE) Learning Modules', 'type': 'BEHAVIORAL', 'description': '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', 'armGroupLabels': ['GIFTSS Training and Centering gender Affirming Resources in higher Education (CARE) Learning Modules']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Elizabeth Miller, MD, PhD', 'role': 'CONTACT'}], 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'centralContacts': [{'name': 'Regina Futcher, MSW', 'role': 'CONTACT', 'email': 'futcherr2@upmc.edu', 'phone': '757-272-3783'}, {'name': 'Rachel Gartner, PhD', 'role': 'CONTACT', 'email': 'rachelgart@pitt.edu', 'phone': '412-624-7232'}], 'overallOfficials': [{'name': 'Elizabeth Miller, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Principal Investigator'}]}, 'ipdSharingStatementModule': {'url': 'http://nda.nih.gov/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': '12 months after end of study', 'ipdSharing': 'YES', 'accessCriteria': 'data uploaded to NDA'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}, {'name': 'Opportunity Fund', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Elizabeth Miller', 'investigatorAffiliation': 'University of Pittsburgh'}}}}