Sexual Assault Resistance Program for Preventing Victimization

(IDEA3 Trial)

Recruiting at 3 trial locations

Overseen By Charlene Y Senn, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

1920 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this randomized trial is to test whether the Internet-Delivered Enhanced Assess, Acknowledge, Act (IDEA3) sexual assault resistance education intervention reduces sexual violence victimization in undergraduate women. Participants in the intervention group will be asked to attend four three-hour group sessions of a sexual assault resistance program called IDEA3 with a partner, as well as fill out a number of surveys. Participants in the control group will be asked to attend a one-hour consent workshop with a partner and fill out surveys. Researchers will compare sexual assault victimization between the groups in the one year following the intervention.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the Sexual Assault Resistance Program for Preventing Victimization treatment?

Research suggests that using electronic formats for informed consent, like those in the Consent Workshop, can improve understanding and retention of information compared to traditional paper methods. This could enhance participants' comprehension and engagement in the Sexual Assault Resistance Program. ^{1 2 3 4 5}

Is the Sexual Assault Resistance Program safe for participants?

The Sexual Assault Resistance Program, including its Enhanced Assess, Acknowledge, Act (EAAA) version, has been shown to be safe for participants, with no significant emotional disturbance reported. Participants found the program acceptable and beneficial, with improvements in risk detection and self-defense skills. ^{6 7 8 9 10}

How is the Consent Workshop, IDEA3 Sexual Assault Resistance Intervention treatment different from other treatments for preventing sexual assault victimization?

The Consent Workshop, IDEA3 Sexual Assault Resistance Intervention is unique because it combines online and in-person components to teach women strategies to recognize and resist sexual assault, focusing on empowerment and self-defense. Unlike other programs, it has shown long-lasting effects in reducing sexual assault incidents and improving risk detection and self-efficacy over a two-year period. ^{6 7 9 11 12}

Research Team

Sarah Peitzmeier, PhD

Principal Investigator

University of Michigan

Charlene Senn, PhD

Principal Investigator

University of Windsor

Eligibility Criteria

This trial is for female-identifying university students in their 1st or 2nd year, aged between 17-24. Participants must be able to attend scheduled group sessions and willing to be paired with another student.

Inclusion Criteria

I am open and able to be paired with another student.

I identify as female.

I am a 1st or 2nd-year university student at one of the specified locations.

Exclusion Criteria

Not applicable.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants in the intervention group attend four 3-hour group sessions of the IDEA3 program over Zoom, spread over two to four weeks.

2-4 weeks

4 sessions (virtual)

Control

Participants in the control group attend a one-hour consent workshop over Zoom.

1 session

1 session (virtual)

Follow-up

Participants are monitored for outcomes related to sexual assault victimization and self-defense strategies at multiple time points.

12 months

Follow-up assessments at 1-week, 6-months, and 12-months post-intervention

Treatment Details

Interventions

• Consent Workshop
• IDEA3 Sexual Assault Resistance Intervention

Trial Overview The study tests the IDEA3 sexual assault resistance program versus a one-hour consent workshop. The intervention includes four three-hour sessions plus surveys, while the control involves just the workshop and surveys.

Participant Groups

Group I: IDEA3 sexual assault resistance intervention Experimental Treatment 1 Intervention

IDEA3 curriculum will be delivered by pairs of trained facilitators over Zoom to reach up to 8 pairs of female-identified university students in four, 3-hour units. The four units will be spread over two to four weeks' time.

Group II: Consent workshop Active Control 1 Intervention

Randomized participants who do not receive the intervention will receive one 60-minute session consisting of an internet delivered (Zoom) consent workshop.

Consent Workshop is already approved in Canada, United States for the following indications:

Approved in Canada as Consent Workshop for:

• Sexual assault prevention education

Approved in United States as Consent Workshop for:

• Sexual assault prevention education

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

University of Windsor

Collaborator

Trials

14

Recruited

7,400+

University of Nebraska

Collaborator

Trials

563

Recruited

1,147,000+

University of Guelph

Collaborator

Trials

87

Recruited

15,100+

Tufts University

Collaborator

Trials

271

Recruited

595,000+

Findings from Research

The electronic informed consent (eIC) process was found to be user-friendly, with 83% of participants reporting it as easy to use, and it did not increase technology burden compared to traditional paper consent.

eIC significantly improved the completeness of consent documents, with no errors in 235 eIC consents compared to a 6.4% error rate in paper consents, while maintaining similar levels of comprehension and participant agency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digitalizing the Clinical Research Informed Consent Process: Assessing the Participant Experience in Comparison With Traditional Paper-Based Methods. Buckley, MT., O'Shea, MR., Kundu, S., et al.[2023]

Caregivers showed similar comprehension of study information when using an interactive multimedia web-based video consent process compared to a conventional in-person consent method, indicating that multimedia formats can effectively convey important information.

Retention of study information over 20 weeks was significantly better with the multimedia format for caregivers, suggesting that this method may enhance long-term understanding of consent details in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehension by Caregivers and Adolescents of Clinical Trial Information Delivered via Multimedia Video Versus Conventional Practice: Nonrandomized Controlled Trial. Blake, KV., Antal, H., Bunnell, HT., et al.[2023]

A scoping review of 69 studies on electronic consent (eConsent) in academic medical centers revealed that 81% addressed ethical, legal, and social issues, highlighting the importance of these factors in the adoption of eConsent.

The review found no dominant commercial eConsent vendor, indicating a significant opportunity for researchers and software developers to create effective eConsent solutions that improve user experience and scalability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Replacing Paper Informed Consent with Electronic Informed Consent for Research in Academic Medical Centers: A Scoping Review. Chen, C., Lee, PI., Pain, KJ., et al.[2020]

A study involving 126 patients undergoing hip surgery found that those who received written information scored significantly higher in recalling details from their consent interview (48% correct) compared to those who received only verbal information (38% correct).

The use of written information sheets not only improves patient recall of important details but also serves as a valuable medicolegal record of the consent process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Informed consent for total hip arthroplasty: does a written information sheet improve recall by patients? Langdon, IJ., Hardin, R., Learmonth, ID.[2015]

Only 44% of clinical researchers working with older adults or those at risk of cognitive impairment use validated assessments to evaluate participants' understanding of consent for clinical trials, despite their importance.

Barriers to using these assessments include lack of awareness and knowledge, uncertainty about administration, and perceived burdens, indicating a need for better education and support from Institutional Review Boards (IRBs) and study sponsors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceived barriers to assessing understanding and appreciation of informed consent in clinical trials: A mixed-method study. Solomon, ED., Mozersky, J., Baldwin, K., et al.[2022]

The Enhanced Assess, Acknowledge, Act (EAAA) program significantly improved first-year women university students' perception of personal risk, self-defense self-efficacy, and knowledge of resistance strategies, with these benefits lasting for up to 24 months after the intervention.

The program led to a substantial reduction in the incidence of sexual assault, with decreases of 30% to 64% in completed and attempted rape, attempted coercion, and nonconsensual sexual contact over the two-year follow-up period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Secondary and 2-Year Outcomes of a Sexual Assault Resistance Program for University Women. Senn, CY., Eliasziw, M., Hobden, KL., et al.[2019]

In a study of 445 university women who completed the Enhanced Assess, Acknowledge, Act (EAAA) sexual assault resistance program, 42% reported using at least one strategy from the program within two years, with many finding these strategies effective in preventing attacks.

The women employed various resistance strategies, such as avoiding dangerous situations and assertive communication, which helped them feel empowered and challenged traditional gender norms, countering the notion that such programs place the responsibility solely on women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"I Felt Powerful and Confident": Women's Use of What They Learned in Feminist Sexual Assault Resistance Education. Crann, SE., Senn, CY., Radtke, HL., et al.[2023]

The SAFE program, designed for 25 heavy drinking college men, effectively combines personalized feedback and group workshops to educate participants about alcohol use, consent, and bystander intervention, showing promise in preventing sexual assault.

Preliminary assessments indicate that the SAFE program is feasible and acceptable, with positive feedback on its content and delivery, suggesting it could be a valuable intervention for reducing sexual aggression in high-risk drinking environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sexual Assault Prevention for Heavy Drinking College Men: Development and Feasibility of an Integrated Approach. Orchowski, LM., Barnett, NP., Berkowitz, A., et al.[2020]

A pilot study involving 136 college women found that a computer-based risk reduction program was well-accepted and did not cause significant emotional distress, indicating its feasibility for this population.

Participants in the risk reduction program showed improved risk detection skills compared to those in the control group, suggesting preliminary efficacy in enhancing awareness and response to potential sexual victimization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Brief Computer-Based Sexual Assault Risk Reduction Program: A Feasibility, Acceptability, and Preliminary Efficacy Pilot Study. Newins, AR., White, SW.[2021]

An online curriculum aimed at educating health and social service providers about the psychological responses of women post-sexual assault was effective, with 175 participants showing significant improvements in knowledge and perceived competency after training.

The training resulted in a positive response from participants, indicating that it successfully enhanced understanding of the complex reactions and behaviors of survivors, which are often misunderstood by professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recognizing and Responding to the Commonly Misunderstood Reactions to Sexual Assault: Evaluation of an Online Curriculum. Mason, R., Du Mont, J., Lanthier, S., et al.[2021]

Only 36.2% of the 836 students invited attended the initial session of the intervention on responding to sexual assault and partner abuse disclosures, but a high retention rate of 83.1% attended the follow-up booster session.

Factors influencing attendance included being female, identifying as a sexual minority, having fewer prior negative reactions, and higher satisfaction with the initial session, while scheduling issues and discomfort with the topic were common reasons for not attending.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of uptake and retention in an intervention to improve social reactions to disclosures of sexual assault and partner abuse. Waterman, EA., Edwards, KM., Rodriguez, LM., et al.[2023]

Current sexual assault prevention programs on college campuses often operate in isolation, focusing separately on different groups (men, women, and bystanders), which limits their overall effectiveness.

A comprehensive and interconnected prevention approach that integrates various strategies for all students is necessary to enhance safety and reduce sexual assault risks on campuses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating Sexual Assault Resistance, Bystander, and Men's Social Norms Strategies to Prevent Sexual Violence on College Campuses: A Call to Action. Orchowski, LM., Edwards, KM., Hollander, JA., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Digitalizing the Clinical Research Informed Consent Process: Assessing the Participant Experience in Comparison With Traditional Paper-Based Methods. [2023]

2. Canada pubmed.ncbi.nlm.nih.gov

Comprehension by Caregivers and Adolescents of Clinical Trial Information Delivered via Multimedia Video Versus Conventional Practice: Nonrandomized Controlled Trial. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Replacing Paper Informed Consent with Electronic Informed Consent for Research in Academic Medical Centers: A Scoping Review. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Informed consent for total hip arthroplasty: does a written information sheet improve recall by patients? [2015]

5. England pubmed.ncbi.nlm.nih.gov

Perceived barriers to assessing understanding and appreciation of informed consent in clinical trials: A mixed-method study. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Secondary and 2-Year Outcomes of a Sexual Assault Resistance Program for University Women. [2019]

7. England pubmed.ncbi.nlm.nih.gov

"I Felt Powerful and Confident": Women's Use of What They Learned in Feminist Sexual Assault Resistance Education. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Sexual Assault Prevention for Heavy Drinking College Men: Development and Feasibility of an Integrated Approach. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

A Brief Computer-Based Sexual Assault Risk Reduction Program: A Feasibility, Acceptability, and Preliminary Efficacy Pilot Study. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Recognizing and Responding to the Commonly Misunderstood Reactions to Sexual Assault: Evaluation of an Online Curriculum. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Predictors of uptake and retention in an intervention to improve social reactions to disclosures of sexual assault and partner abuse. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Integrating Sexual Assault Resistance, Bystander, and Men's Social Norms Strategies to Prevent Sexual Violence on College Campuses: A Call to Action. [2021]