Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2026-01-02 @ 1:18 PM
Study NCT ID:
NCT05080335
Status:
COMPLETED
Last Update Posted:
2022-05-04
First Post:
2021-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transgender Health: an Educational RCT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Participants will not be aware of which of the four arms they will be assigned to'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'RCT of three different education / training approaches'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-28', 'studyFirstSubmitDate': '2021-09-22', 'studyFirstSubmitQcDate': '2021-10-04', 'lastUpdatePostDateStruct': {'date': '2022-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'SOCIAL TOLERANCE Item 1 (SOC_01)', 'timeFrame': 'Before / after viewing videos (within 60 minutes), and after 30 days.', 'description': 'Response to the stem:\n\nTransgender people should have the opportunity to undergo operations to change their anatomy.\n\nScoring on a 6-point Likert scale ranging from 1 ("Strongly disagree") to 6 ("Strongly agree"), resulting in a score ranging from 1 to 6 with higher numbers representing better comfort and contact related to transgender individuals.'}, {'measure': 'SOCIAL TOLERANCE Item 2 (SOC_02)', 'timeFrame': 'Before / after viewing videos (within 60 minutes), and after 30 days.', 'description': 'Response to the stem:\n\nTransgender people should be accepted completely into our society.\n\nScoring on a 6-point Likert scale ranging from 1 ("Strongly disagree") to 6 ("Strongly agree"), resulting in a score ranging from 1 to 6 with higher numbers representing better comfort and contact related to transgender individuals.'}, {'measure': 'SOCIAL TOLERANCE Item 3 (SOC_03)', 'timeFrame': 'Before / after viewing videos (within 60 minutes), and after 30 days.', 'description': 'Response to the stem:\n\nTransgender people should have the opportunity to change their name.\n\nScoring on a 6-point Likert scale ranging from 1 ("Strongly disagree") to 6 ("Strongly agree"), resulting in a score ranging from 1 to 6 with higher numbers representing better comfort and contact related to transgender individuals.'}, {'measure': 'SOCIAL TOLERANCE Item 4 (SOC_04)', 'timeFrame': 'Before / after viewing videos (within 60 minutes), and after 30 days.', 'description': 'Response to the stem:\n\nOrganizations that promote transgender rights are necessary.\n\nScoring on a 6-point Likert scale ranging from 1 ("Strongly disagree") to 6 ("Strongly agree"), resulting in a score ranging from 1 to 6 with higher numbers representing better comfort and contact related to transgender individuals.'}, {'measure': 'SOCIAL TOLERANCE Item 5 (SOC_05)', 'timeFrame': 'Before / after viewing videos (within 60 minutes), and after 30 days.', 'description': 'Response to the stem:\n\nIt should be illegal for people to have their genitalia surgically altered. (R)\n\nScoring on a 6-point Likert REVERSED scale ranging from 1 ("Strongly agree") to 6 ("Strongly disagree"), resulting in a score ranging from 1 to 6 with higher numbers representing better comfort and contact related to transgender individuals.'}, {'measure': 'SOCIAL TOLERANCE Item 6 (SOC_06)', 'timeFrame': 'Before / after viewing videos (within 60 minutes), and after 30 days.', 'description': 'Response to the stem:\n\nBeing transgender is a sin. (R)\n\nScoring on a 6-point Likert REVERSED scale ranging from 1 ("Strongly agree") to 6 ("Strongly disagree"), resulting in a score ranging from 1 to 6 with higher numbers representing better comfort and contact related to transgender individuals.'}, {'measure': 'SOCIAL TOLERANCE Item 7 (SOC_07)', 'timeFrame': 'Before / after viewing videos (within 60 minutes), and after 30 days.', 'description': 'Response to the stem:\n\nTransgender people are a worthwhile part of our society.\n\nScoring on a 6-point Likert scale ranging from 1 ("Strongly disagree") to 6 ("Strongly agree"), resulting in a score ranging from 1 to 6 with higher numbers representing better comfort and contact related to transgender individuals.'}, {'measure': 'COMFORT and CONTACT Item 8 (CC_08)', 'timeFrame': 'Before / after viewing videos (within 60 minutes), and after 30 days.', 'description': 'Response to the stem:\n\nI avoid interacting with people whose gender is unclear to me. (R)\n\nScoring on a 6-point Likert REVERSED scale ranging from 1 ("Strongly agree") to 6 ("Strongly disagree"), resulting in a score ranging from 1 to 6 with higher numbers representing better comfort and contact related to transgender individuals.'}, {'measure': 'COMFORT and CONTACT Item 9 (CC_09)', 'timeFrame': 'Before / after viewing videos (within 60 minutes), and after 30 days.', 'description': 'Response to the stem:\n\nPeople with both breasts and a penis make me uncomfortable. (R)\n\nScoring on a 6-point Likert REVERSED scale ranging from 1 ("Strongly agree") to 6 ("Strongly disagree"), resulting in a score ranging from 1 to 6 with higher numbers representing better comfort and contact related to transgender individuals.'}, {'measure': 'COMFORT and CONTACT Item 10 (CC_10)', 'timeFrame': 'Before / after viewing videos (within 60 minutes), and after 30 days.', 'description': 'Response to the stem:\n\nWhen I meet someone, it is important for me to be able to identify them as a man or a woman. (R)\n\nScoring on a 6-point Likert REVERSED scale ranging from 1 ("Strongly agree") to 6 ("Strongly disagree"), resulting in a score ranging from 1 to 6 with higher numbers representing better comfort and contact related to transgender individuals.'}, {'measure': 'COMFORT and CONTACT Item 11 (CC_11)', 'timeFrame': 'Before / after viewing videos (within 60 minutes), and after 30 days.', 'description': 'Response to the stem:\n\nI feel uncomfortable when I cannot tell if someone is a man or a woman. (R)\n\nScoring on a 6-point Likert REVERSED scale ranging from 1 ("Strongly agree") to 6 ("Strongly disagree"), resulting in a score ranging from 1 to 6 with higher numbers representing better comfort and contact related to transgender individuals.'}, {'measure': 'COMFORT and CONTACT Item 12 (CC_12)', 'timeFrame': 'Before / after viewing videos (within 60 minutes), and after 30 days.', 'description': 'Response to the stem:\n\nI would feel uncomfortable if a close family member were dating a transgender person. (R)\n\nScoring on a 6-point Likert REVERSED scale ranging from 1 ("Strongly agree") to 6 ("Strongly disagree"), resulting in a score ranging from 1 to 6 with higher numbers representing better comfort and contact related to transgender individuals.'}, {'measure': 'COMFORT and CONTACT Item 13 (CC_13)', 'timeFrame': 'Before / after viewing videos (within 60 minutes), and after 30 days.', 'description': 'Response to the stem:\n\nI would feel comfortable if I learned a friend is transgender.\n\nScoring on a 6-point Likert scale ranging from 1 ("Strongly disagree") to 6 ("Strongly agree"), resulting in a score ranging from 1 to 6 with higher numbers representing better comfort and contact related to transgender individuals.'}, {'measure': 'COMFORT and CONTACT Item 14 (CC_14)', 'timeFrame': 'Before / after viewing videos (within 60 minutes), and after 30 days.', 'description': 'Response to the stem:\n\nI would feel comfortable if I learned my neighbor is transgender.\n\nScoring on a 6-point Likert scale ranging from 1 ("Strongly disagree") to 6 ("Strongly agree"), resulting in a score ranging from 1 to 6 with higher numbers representing better comfort and contact related to transgender individuals.'}, {'measure': 'ACCEPTANCE Item 15 (ACC_15)', 'timeFrame': 'Before / after viewing videos (within 60 minutes), and after 30 days.', 'description': 'Response to the stem:\n\nA person with a vagina can be a man.\n\nScoring on a 6-point Likert scale ranging from 1 ("Strongly disagree") to 6 ("Strongly agree"), resulting in a score ranging from 1 to 6 with higher numbers representing better acceptance of the gender spectrum.'}, {'measure': 'ACCEPTANCE Item 16 (ACC_16)', 'timeFrame': 'Before / after viewing videos (within 60 minutes), and after 30 days.', 'description': 'Response to the stem:\n\nA person with a penis can be a woman.\n\nScoring on a 6-point Likert scale ranging from 1 ("Strongly disagree") to 6 ("Strongly agree"), resulting in a score ranging from 1 to 6 with higher numbers representing better acceptance of the gender spectrum.'}, {'measure': 'ACCEPTANCE Item 17 (ACC_17)', 'timeFrame': 'Before / after viewing videos (within 60 minutes), and after 30 days.', 'description': 'Response to the stem:\n\nFemale-to-male transgender people are real men.\n\nScoring on a 6-point Likert scale ranging from 1 ("Strongly disagree") to 6 ("Strongly agree"), resulting in a score ranging from 1 to 6 with higher numbers representing better acceptance of the gender spectrum.'}, {'measure': 'ACCEPTANCE Item 18 (ACC_18)', 'timeFrame': 'Before / after viewing videos (within 60 minutes), and after 30 days.', 'description': 'Response to the stem:\n\nMale-to-female transgender people are real women.\n\nScoring on a 6-point Likert scale ranging from 1 ("Strongly disagree") to 6 ("Strongly agree"), resulting in a score ranging from 1 to 6 with higher numbers representing better acceptance of the gender spectrum.'}, {'measure': 'ACCEPTANCE Item 19 (ACC_19)', 'timeFrame': 'Before / after viewing videos (within 60 minutes), and after 30 days.', 'description': 'Response to the stem:\n\nA person transitioning from female to male should be able to use a men\'s bathroom.\n\nScoring on a 6-point Likert scale ranging from 1 ("Strongly disagree") to 6 ("Strongly agree"), resulting in a score ranging from 1 to 6 with higher numbers representing better acceptance of the gender spectrum.'}, {'measure': 'ACCEPTANCE Item 20 (ACC_20)', 'timeFrame': 'Before / after viewing videos (within 60 minutes), and after 30 days.', 'description': 'Response to the stem:\n\nThere are only two genders: male and female.\n\nScoring on a 6-point Likert REVERSED scale ranging from 1 ("Strongly agree") to 6 ("Strongly disagree"), resulting in a score ranging from 1 to 6 with higher numbers representing better comfort and contact related to transgender individuals.'}, {'measure': 'ACCEPTANCE Item 21 (ACC_21)', 'timeFrame': 'Before / after viewing videos (within 60 minutes), and after 30 days.', 'description': 'Response to the stem:\n\nSex and gender are the same thing.\n\nScoring on a 6-point Likert REVERSED scale ranging from 1 ("Strongly agree") to 6 ("Strongly disagree"), resulting in a score ranging from 1 to 6 with higher numbers representing better comfort and contact related to transgender individuals.'}, {'measure': 'ACCEPTANCE Item 22 (ACC_22)', 'timeFrame': 'Before / after viewing videos (within 60 minutes), and after 30 days.', 'description': 'Response to the stem:\n\nA person transitioning from male to female should be able to use a women\'s bathroom.\n\nScoring on a 6-point Likert scale ranging from 1 ("Strongly disagree") to 6 ("Strongly agree"), resulting in a score ranging from 1 to 6 with higher numbers representing better acceptance of the gender spectrum.'}], 'primaryOutcomes': [{'measure': 'Change in T-KAB TOTAL score (TOT)', 'timeFrame': 'Before / after viewing videos (within 60 minutes), and after 30 days.', 'description': 'The T-KAB (Clark and Hughto, 2020) is a 22-item, 3-factor measure representing: acceptance of the gender spectrum (ACC), social tolerance (ST), and comfort and contact (CC) related to transgender people. The total score (TOT) is the sum of it three sub-scales.\n\nThe adjusted T-KAB It is scored on a 6-point Likert scale (instead of the 4-point original) ranging from 1 ("Strongly disagree") to 4 ("Strongly agree"). An even-number scale was utilized to ensure that participants choose either agreement or disagreement, and thus, a neutral option was not included in the scale.\n\nThis results in an item-level score ranging from 1 to 6, and an overall TOT range from 22 to 132, with higher numbers representing better outcomes.\n\nWe changed the wording and reverse-scoring of 6 items, which due to double-negative wording, proved confusing in pilot testing. This resulted in 9/22 reverse-scored items (R), from the original scale with 15/22 R\'s.'}], 'secondaryOutcomes': [{'measure': 'Change in T-KAB ACCEPTANCE sub-scale (ACC)', 'timeFrame': 'Before / after viewing videos (within 60 minutes), and after 30 days.', 'description': 'The T-KAB ACCEPTANCE sub-scale (ACC) is an 8-item measure representing acceptance of the gender spectrum\n\nThe adjusted ACC is scored on a 6-point Likert scale ranging from 1 ("Strongly disagree") to 6 ("Strongly agree"). This adjustment resulted in an item-level score ranging from 1 to 6, and an overall TOT ranging from 8 to 48, with higher numbers representing better acceptance of the gender spectrum.\n\nOf note, all six items changed from double negative wording were part of the ACC sub-scale. As one example, we changed ACC item 1 from:\n\nA person with a vagina cannot can be a man. (R)\n\nto:\n\nA person with a vagina can can be a man.'}, {'measure': 'Change in T-KAB SOCIAL TOLERANCE sub-scale (ST)', 'timeFrame': 'Before / after viewing videos (within 60 minutes), and after 30 days.', 'description': 'The T-KAB SOCIAL TOLERANCE sub-scale (ST) is a 7-item measure representing social tolerance (ST) related to transgender people.\n\nThe adjusted ST is scored on a 6-point Likert scale ranging from 1 ("Strongly disagree") to 6 ("Strongly agree"). This adjustment resulted in an item-level score ranging from 1 to 6, and an overall TOT ranging from 7 to 42, with higher numbers representing better social tolerance related to transgender individuals.'}, {'measure': 'Change in T-KAB COMFORT AND CONTACT sub-scale (CC)', 'timeFrame': 'Before / after viewing videos (within 60 minutes), and after 30 days.', 'description': 'The T-KAB COMFORT AND CONTACT sub-scale (CC) is a 7-item measure representing social tolerance (ST) related to transgender people.\n\nThe adjusted ST is scored on a 6-point Likert scale ranging from 1 ("Strongly disagree") to 6 ("Strongly agree"). This adjustment resulted in an item-level score ranging from 1 to 6, and an overall TOT ranging from 7 to 42, with higher numbers representing better comfort and contact related to transgender individuals.'}, {'measure': 'Change in SOCIAL comfort level (SOC)', 'timeFrame': 'Before / after viewing videos (within 60 minutes), and after 30 days.', 'description': 'This item uses a slider ranging continuously from 0 ("Very uncomfortable") to 100 ("Very comfortable") in response to the question "How comfortable would you be interacting SOCIALLY with transgender individuals?") Higher numbers indicate higher comfort level.'}, {'measure': 'Change in PROFESSIONAL comfort level (PROF)', 'timeFrame': 'Before / after viewing videos (within 60 minutes), and after 30 days.', 'description': 'This item uses a slider ranging continuously from 0 ("Very uncomfortable") to 100 ("Very comfortable") in response to the question "How comfortable would you be interacting in a PROFESSIONAL or EDUCATIONAL setting with transgender individuals?") Higher numbers indicate higher comfort level.'}, {'measure': 'Change in FAMILIAL comfort level (FAM)', 'timeFrame': 'Before / after viewing videos (within 60 minutes), and after 30 days.', 'description': 'This item uses a slider ranging continuously from 0 ("Very uncomfortable") to 100 ("Very comfortable") in response to the question "How comfortable would you be interacting with a transgender individual in your FAMILY ") Higher numbers indicate higher comfort level.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Transgender', 'Health Attitude']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://doi.org/10.1007/s13178-019-00399-9', 'label': 'Clark, K.A., Hughto, J.M. Development and Psychometric Evaluation of the Transgender Knowledge, Attitudes, and Beliefs (T-KAB) Scale. Sex Res Soc Policy 17, 353-363 (2020).'}]}, 'descriptionModule': {'briefSummary': 'The investigators will conduct a randomized controlled trial (RCT) comparing two different educational approaches on the healthcare of transgender and gender expansive (TGE) youth. Finding best practices to educate healthcare providers and the community at large stand to make an impact on the mental health of TGE youth by helping them feel more welcome and better understood by the communities in which they live.\n\nThe study aims are to evaluate two educational interventions: 1) The inclusion of a video clip component of two TGE youth (Video \\[V\\] vs No video \\[N\\]) into a one-hour didactic; and 2) The delivery of the same didactic content by a cis- \\[C\\] vs a trans-gender \\[TG\\] woman.', 'detailedDescription': "This will be a randomized control trial (RCT) of equal allotment to one of four parallel didactic conditions. The investigators will randomly assign participants to one of three teaching conditions: 1) Trans Video \\[TV\\]; 2) Cis Video \\[CV\\]; and 3) Cis No video \\[CN\\]. Participants will complete a baseline assessment (PRE) before the start of the same didactic content, but delivered in the three different ways described above. This design will help the investigators make comparisons across video use (yes/no), about type of presenter (trans/cis), and about the interaction of the two approaches. For the 'no video' condition (CN), the didactic will not include the videos until after completion of the POST assessment.\n\nThe study design will ensure that all participants will receive the exact same didactic content during whichever session they attend. All participants will then receive a follow up questionnaire two weeks later (2WK POST) to assess content retention."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* English-speaking\n* Living in the US\n* Ages GE 18\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT05080335', 'briefTitle': 'Transgender Health: an Educational RCT', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Transgender and Gender-expansive Youth: Randomized Controlled Trial of a Healthcare Didactic Enhanced by Simulated Patient Video Clips', 'orgStudyIdInfo': {'id': '2000028980_c'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'TRANS-gender female instructor, with videos (TV)', 'description': 'Didactic materials use embedded WITH short videos of transgender youth; lesson led by a TRANS-gender woman with extensive experience as an educator on transgender health', 'interventionNames': ['Other: Short videos']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CIS-gender female instructor, with videos (CV)', 'description': 'Didactic materials use embedded WITH short videos of transgender youth; lesson led by a CIS-gender woman with extensive experience as an educator on transgender health', 'interventionNames': ['Other: Short videos']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CIS-gender female, with NO videos (CN)', 'description': 'Didactic materials do NOT use short videos of transgender youth \\[until AFTER completion of the POST outcome measures\\]; lesson is led by a CIS-gender woman with extensive experience as an educator on transgender health', 'interventionNames': ['Other: Short videos']}, {'type': 'NO_INTERVENTION', 'label': 'No intervention control', 'description': 'Subjects randomized to this arm will complete the baseline assessment and the post assessment thirty days later, but just \\*before\\* receiving the intervention (TV).'}], 'interventions': [{'name': 'Short videos', 'type': 'OTHER', 'description': 'As an educational RCT, the didactic content will be the same across the four arms, but its deliver will vary by:\n\n1. TRANS- vs CIS-gender female instructors\n2. With or without short videos of transgender youth embedded into the didactic \\[TV or CV\\]; for the group with no embedded videos \\[NV\\], the same videos will be shown AFTER completion of the post measures)\n3. No-intervention control, in which TV will be delivered \\*after\\* collection of pre/post measures.', 'armGroupLabels': ['CIS-gender female instructor, with videos (CV)', 'CIS-gender female, with NO videos (CN)', 'TRANS-gender female instructor, with videos (TV)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale Child Center', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale Child Study Center', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Andres Martin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}