Sexual Assault Resistance Program for Preventing Victimization

(IDEA3 Trial)

Recruiting at 4 trial locations

Overseen By Charlene Y Senn, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Maryland, College Park

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

Compensation: Varies

Number of Visits: 6

1920 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special online program, IDEA3 (Internet-Delivered Enhanced Assess, Acknowledge, Act Sexual Assault Resistance Intervention), can reduce sexual assault experiences among female university students. Participants will either join four online group sessions teaching resistance skills or attend a one-hour consent workshop. Researchers will compare the sexual assault experiences between these two groups over the following year. The trial seeks first- and second-year female university students willing to partner with another student and attend scheduled sessions. As an unphased trial, it offers participants the chance to contribute to important research that could lead to effective sexual assault prevention strategies.

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 prior data suggests that the IDEA3 sexual assault resistance intervention is safe?

Research has shown that the Internet-Delivered Enhanced Assess, Acknowledge, Act (IDEA3) program is well-received. This program significantly reduces incidents of sexual violence, including rape and attempted rape, among university women. Previous evaluations have not identified any major side effects or safety concerns. Participants often join group sessions led by trained facilitators, focusing on empowering them to resist potential assaults. Overall, this approach has proven effective without causing harm to participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to empower individuals in preventing sexual assault. Unlike traditional programs that may focus on awareness campaigns or reactive measures, the IDEA3 intervention is a proactive approach delivered over Zoom, making it accessible and scalable. It involves interactive sessions led by trained facilitators that equip participants with resistance strategies, potentially leading to more effective prevention of victimization. Additionally, the use of a virtual format allows for a flexible and comfortable learning environment that can reach a broader audience. This trial aims to find out if these new methods can significantly reduce the risk of sexual assault among university students.

What evidence suggests that the IDEA3 sexual assault resistance intervention is effective for preventing victimization?

Research has shown that the Enhanced Assess, Acknowledge, Act (EAAA) program, on which the IDEA3 intervention is based, effectively reduces sexual assault. Studies have found that this program can decrease the rates of rape and attempted rape by over 50% among participating women. In this trial, participants in the IDEA3 sexual assault resistance intervention arm will receive online sessions led by trained facilitators who teach skills to resist sexual violence. Randomized controlled trials have tested this program, making it the only one of its kind proven to reduce sexual assault on campus. These findings suggest that the IDEA3 intervention could effectively prevent sexual violence among undergraduate women. Meanwhile, participants in the consent workshop arm will receive a 60-minute internet-delivered session focusing on consent education. ^{1 2 3 6 7}

Who Is on the Research Team?

Sarah Peitzmeier, PhD

Principal Investigator

University of Maryland

Charlene Senn, PhD

Principal Investigator

University of Windsor

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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 Maryland, College Park

Lead Sponsor

Trials

163

Recruited

46,800+

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+

University of Michigan

Collaborator

Trials

1,891

Recruited

6,458,000+

University of Central Florida

Collaborator

Trials

101

Recruited

1,191,000+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12541260/

An Internet-Delivered Sexual Assault Resistance Intervention ... The Enhanced Assess, Acknowledge, Act (EAAA) SA resistance program is the only intervention proven in a randomized controlled trial (RCT) to ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06058455

An Evaluation of an Online Sexual Assault Resistance ... The Enhanced Assess, Acknowledge, Act (EAAA) sexual assault resistance program has been shown to substantially reduce rates of SV (50% for rape and attempted ...

3. injurycenter.umich.edu injurycenter.umich.edu/project/publish-47/

Adapting an evidence-based sexual assault prevention intervention ... EAAA is a 12-hour, peer facilitator-led, in-person intervention proven to reduce attempted or completed rape victimization by over 50% among female ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41055953/

Protocol for a Multisite Randomized Controlled Efficacy Trial Secondary aims will assess the impact of the Internet-Delivered EAAA (IDEA3) on other forms of SA (attempted rape, attempted and completed ...

5. ctv.veeva.com ctv.veeva.com/study/can-the-idea3-intervention-prevent-intimate-partner-violence-a-substudy-to-the-idea3-randomized-co

Can the IDEA3 Intervention Prevent Intimate Partner Violence?: A ... The Enhanced Assess, Acknowledge, Act (EAAA) program is the only intervention proven to reduce the one-year incidence of campus SA in a randomized controlled ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07218159

Can the IDEA3 Intervention Prevent Intimate Partner ... The Enhanced Assess, Acknowledge, Act (EAAA) program is the only intervention proven to reduce the one-year incidence of campus SA in a ...

7. injurycenter.umich.edu injurycenter.umich.edu/project/adapting-an-evidence-based-sexual-assault-prevention-intervention-for-women-undergraduates-for-online-delivery/

Adapting an evidence-based sexual assault prevention ... EAAA is a 12-hour, peer facilitator-led, in-person intervention proven to reduce attempted or completed rape victimization by over 50% among female ...