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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06171633
Other study ID # 66842
Secondary ID 1R01GM147063
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date March 6, 2024
Est. completion date June 2027

Study information

Verified date April 2024
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study targets three aims: Aim 1: focuses on PIs' and mentors' confidence in their ability to intervene on sexual harassment and their attitudes, perceptions, and knowledge (APK) about sexual harassment, civility, microaggressions, and unconscious bias. Aim 2: focuses on trainees' experiences of sexual harassment and microaggressions and civility, sense of belonging, well-being, productivity, and persistence in a research career. Aim 3: focuses on the culture and climate of the research learning environment.


Description:

Participants (PIs, mentors, and trainees), starting in year one, will be asked to complete a baseline survey (using the secure survey software Qualtrics) regardless of condition assignment. Then, for nine months, PIs, mentors, and mentees will receive virtual educational materials (presented using a Learning Management System) appropriate to the condition to which their program has been randomized. The initial post-survey for PIs and mentors will be integrated into the final module to evaluate short-term outcomes, encompassing attitudes, perceptions, and knowledge. Subsequently, the second post-survey will be administered one year later. Trainees will participate in three post-surveys: one immediately after, another one year later, and a final one two years later.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 2160
Est. completion date June 2027
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - PIs, Mentors and Trainees of T-32 Programs Exclusion Criteria: - People who are not PIs, Mentors and Trainees of T-32 Programs

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
E-STOP online educational program (treatment condition)
Participants access online video modules through an online learning platform. Program includes modules on civility and upstander interventions and education about sexual harassment, microaggressions, and implicit bias.
E-STOP online educational program (control condition)
Participants access online video modules through an online learning platform. Program includes authorship ethics only.

Locations

Country Name City State
United States Stanford University Stanford California

Sponsors (2)

Lead Sponsor Collaborator
Stanford University National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

References & Publications (7)

Fiellin LE, Hieftje KD, Pendergrass TM, Kyriakides TC, Duncan LR, Dziura JD, Sawyer BG, Mayes L, Crusto CA, Forsyth BW, Fiellin DA. Video Game Intervention for Sexual Risk Reduction in Minority Adolescents: Randomized Controlled Trial. J Med Internet Res. 2017 Sep 18;19(9):e314. doi: 10.2196/jmir.8148. — View Citation

Montanaro E, Fiellin LE, Fakhouri T, Kyriakides TC, Duncan LR. Using Videogame Apps to Assess Gains in Adolescents' Substance Use Knowledge: New Opportunities for Evaluating Intervention Exposure and Content Mastery. J Med Internet Res. 2015 Oct 28;17(10):e245. doi: 10.2196/jmir.4377. — View Citation

Mueller AS, Jenkins TM, Osborne M, Dayal A, O'Connor DM, Arora VM. Gender Differences in Attending Physicians' Feedback to Residents: A Qualitative Analysis. J Grad Med Educ. 2017 Oct;9(5):577-585. doi: 10.4300/JGME-D-17-00126.1. — View Citation

Salles A, Mueller CM, Cohen GL. Exploring the Relationship Between Stereotype Perception and Residents' Well-Being. J Am Coll Surg. 2016 Jan;222(1):52-8. doi: 10.1016/j.jamcollsurg.2015.10.004. Epub 2015 Oct 21. — View Citation

Sompayrac L, Danna KJ. An SV40 mutant oncoprotein has a nuclear location. Virology. 1989 Jul;171(1):267-70. doi: 10.1016/0042-6822(89)90536-9. — View Citation

Tenbrunsel AE, Rees MR, Diekmann KA. Sexual Harassment in Academia: Ethical Climates and Bounded Ethicality. Annu Rev Psychol. 2019 Jan 4;70:245-270. doi: 10.1146/annurev-psych-010418-102945. Epub 2018 Aug 29. — View Citation

Torres MB, Salles A, Cochran A. Recognizing and Reacting to Microaggressions in Medicine and Surgery. JAMA Surg. 2019 Sep 1;154(9):868-872. doi: 10.1001/jamasurg.2019.1648. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Confidence to Intervene on Sexual Harassment Scale Score Participants are asked to rate: "How confident are you in your ability to intervene when you hear about or witness sexual harassment?" Score range: 1 (not at all confident) to 5 (extremely confident). Survey at baseline, immediately post-intervention (9 months after baseline), and 1 year after the completion of the 9-month intervention
Secondary Persistence in research careers Participants are asked to rate: "How extensively do you expect to be involved in research during your medical career?" Score range 1 (not involved) to 5 (exclusively) baseline, immediately post-intervention (9 months after baseline), and 1 year after completion of the 9-month intervention.
Secondary Experiences of sexual harassment as measured by the short Sexual Experiences Questionnaire (SEQ-DoDs) The SEQ consists of 4 domains: gender harassment--sexist hostility (4 questions); gender harassment--sexual hostility (4 questions); unwanted sexual attention (4 questions); and sexual coercion (4 questions); the score for each question ranges from 1 (never) to 5 (many times); scores for questions within each domain are summed and divided by the number of questions, resulting in an average score range from 1 (never) to 5 (many times) for each domain. baseline, immediately post-intervention (9 months after baseline), and 1 year after completion of the 9-month intervention.
See also
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Not yet recruiting NCT06101056 - Code of Respect (X-CoRe): Trial of a Multi-level Sexual Assault and Sexual Harassment Prevention Intervention for Active Duty Airmen N/A
Completed NCT04716400 - Effectiveness Study of the Intervention "Stop Sexual Harassment" in Secondary School N/A
Completed NCT03521115 - Family Based Prevention of Alcohol and Risky Sex for Older Teens N/A

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