- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06058455
An Evaluation of an Online Sexual Assault Resistance Program (IDEA3) (IDEA3)
A Randomized Controlled Trial of the Efficacy of IDEA3 - An Evidence-based Sexual Assault Resistance Intervention for Undergraduate Women Adapted for Internet Delivery
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sarah M Peitzmeier, PhD
- Phone Number: (734) 764-4176
- Email: speitzme@umich.edu
Study Contact Backup
- Name: Charlene Y Senn, PhD
- Phone Number: 2255 519-253-3000
- Email: csenn@uwindsor.ca
Study Locations
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Ontario
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Guelph, Ontario, Canada, N1G 2W1
- Recruiting
- University of Guelph
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Contact:
- Paula Barata, PhD
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Principal Investigator:
- Paula Barata, PhD
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Windsor, Ontario, Canada, N9B 3P4
- Recruiting
- University of Windsor
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Contact:
- Charlene Senn, PhD
- Email: csenn@uwindsor.ca
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Principal Investigator:
- Charlene Senn, PhD
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-
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Michigan
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Ann Arbor, Michigan, United States, 48109
- Recruiting
- University of Michigan
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Contact:
- Sarah Peitzmeier, PhD
- Email: speitzme@umich.edu
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Principal Investigator:
- Sarah Peitzmeier, PhD
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Nebraska
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Lincoln, Nebraska, United States, 68588
- Recruiting
- University of Nebraska - Lincoln
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Contact:
- Katie Edwards, PhD
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Principal Investigator:
- Katie Edwards, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 1st- and 2nd-year university students at one of the 4 sites
- female-identifying students
- students between ages of 17-24
- able to attend one of the scheduled program groups
- able and willing to be matched with another eligible student
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: IDEA3 sexual assault resistance 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.
|
Internet-delivered EAAA (IDEA3), adapted from an in-person sexual assault resistance education intervention: Enhanced Assess, Acknowledge, Act (EAAA) intervention that was found in a randomized trial to reduce sexual assault victimization by about 50% at follow-up.
IDEA3 designed for female identifying university students and focuses on resisting sexual assault committed by males in 4, 3-hour units: 1-ASSESS builds ability to detect risk with male acquaintances and develop risk reduction strategies.
2-ACKNOWLEDGE explores overcoming emotional barriers preventing women from acknowledging risk and employing effective resistance strategies with males.
3-ACT shows effectiveness of resistance strategies and teaches verbal and physical self-defense in common situations.
4-RELATIONSHIPS & SEXUALITY adapts the Our Whole Lives curriculum to increase women's comfort in talking about sex/sexuality and identify sexual values/desires.
|
Active Comparator: Consent workshop
Randomized participants who do not receive the intervention will receive one 60-minute session consisting of an internet delivered (Zoom) consent workshop.
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Participant pairs assigned to the control arm will receive a 60-minute session consisting of a 60-min interactive, virtual consent workshop.
The workshop will include information on a) what consent is, including the idea that consent is about bodily autonomy and applies to interactions beyond sex, b) how to give and ask for consent, and c) examples of what it looks like to ask for and give/not give consent.
This presentation will be given by a well-trained Research Assistant.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Completed rape
Time Frame: Baseline, 1-week post-intervention, 6-months and 12-months after randomization
|
The Sexual Experiences Survey Short Form Victimization (SES-SFV) will be used to measure the primary sexual assault outcomes.
Completed rape will have occurred when a participant indicates she has had at least one experience of threatened, forced, or drugged completed (not attempted) sexual activity (oral, anal, or vaginal intercourse - answered 'once' or more to any of 9 questions (2c, 2d, 2e, 3c, 3d, 3e, 4c, 4d, or 4e) in the period between the baseline measurement and the 12-month survey measurement.
|
Baseline, 1-week post-intervention, 6-months and 12-months after randomization
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Attempted rape
Time Frame: Baseline, 1-week post-intervention, 6-months and 12-months after randomization
|
The SES-SFV will also be used to measure secondary sexual assault outcomes: Attempted rape will have occurred when a participant indicates she has had at least one experience of threatened, forced, or drugged attempted (not completed) sexual activity (oral, anal, or vaginal intercourse - answered 'once' or more to any of 9 questions (5c, 5d, 5e, 6c, 6d, 6e, 7c, 7d, or 7e) in the period between the baseline and the 12-month survey.
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Baseline, 1-week post-intervention, 6-months and 12-months after randomization
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Other Forms of Sexual Assault
Time Frame: Baseline, 1-week post-intervention, 6-months and 12-months after randomization
|
The SES-SFV will also be used to measure other sexual assault outcomes: Non-penetrative forced sexual contact will have occurred when a participant indicates she has had at least one such experience of non-penetrative sexual contact by any perpetrator strategy - answered 'once' or more to any of 5 questions (1a, 1b, 1c, 1d, 1e). Completed sexual coercion will have occurred when a participant indicates she has had at least one experience of coerced (not forced) completed sexual activity (oral, anal, or vaginal intercourse - answered 'once' or more to any of 6 questions (2a, 2b, 3a, 3b, 4a, 4b). Attempted sexual coercion will have occurred when a participant indicates she has had at least one experience of coerced (not forced) attempted (not completed) sexual activity (oral, anal, or vaginal intercourse - answered 'once' or more to any of 6 questions (5a, 5b, 6a, 6b, 7a, 7b). |
Baseline, 1-week post-intervention, 6-months and 12-months after randomization
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-defense self-efficacy
Time Frame: Baseline, 1-week post-intervention, 6-months and 12-months after randomization
|
Measured with a questionnaire to assess changes from baseline in women's confidence that they could defend themselves if confronted with a sexual assault situation.
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Baseline, 1-week post-intervention, 6-months and 12-months after randomization
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Perception of personal risk
Time Frame: Baseline, 1-week post-intervention, 6-months and 12-months after randomization
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A single item will be used to measure women's perception of their personal risk of sexual assault by male acquaintances.
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Baseline, 1-week post-intervention, 6-months and 12-months after randomization
|
Detection of risk cues
Time Frame: 1-week post-intervention, 6-months and 12-months after randomization
|
Participants' ability to detect risk in hypothetical assault scenarios will be assessed at the first time point by a measure in which participants read a scenario and then complete a subscale assessing their perception of the situation.
At the other time points a measure will be used in which an acquaintance (6-mos) and stranger (12-mos) vignette unfolds line by line and the point at which participants indicate they would become uncomfortable and when they would leave the scenario are recorded.
Receiving the same scenario/vignette more than once invalidates the measures.
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1-week post-intervention, 6-months and 12-months after randomization
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Willingness to use Effective Self-Defense Strategies
Time Frame: 1-week post-intervention
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Using the same vignettes participants read to assess the Detection of Risk Cues outcome, the Direct Resistance scale of an untitled measure developed by Testa et al (2006) will be used to assess participants' willingness to use effective self-defense strategies at different points while reading a vignette of a sexual assault scenario.
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1-week post-intervention
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Rape Myth Acceptance
Time Frame: Baseline, 1-week post-intervention, 6-months and 12-months after randomization
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The Updated Illinois Rape Myth Acceptance scale will be used to assess respondents' belief in prejudicial and false ideas about rape.
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Baseline, 1-week post-intervention, 6-months and 12-months after randomization
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Belief in Female Precipitation of Rape
Time Frame: Baseline, 1-week post-intervention, 6-months and 12-months after randomization
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The female precipitation subscale of the Perceived Causes of Rape scale will be used to measure beliefs that women cause rape.
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Baseline, 1-week post-intervention, 6-months and 12-months after randomization
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Knowledge of and Willingness to Use Effective Self-Defense Strategies
Time Frame: 1-week post-intervention, 6-months and 12-months after randomization
|
An open-ended question will be used to measure participants' knowledge of and willingness to use of the most effective self-defense strategies at follow-ups.
Participants will respond to the question "If a man I knew (e.g., a date or acquaintance) tried to force me to have sex with him when I didn't want to, I would ..." Using a coding system, these responses will be scored by two independent coders (blinded to the randomization group) for the presence or absence of effective forceful physical resistance and forceful verbal resistance strategies and their frequencies (e.g., punch, kick, and bite are all examples of forceful physical resistance).
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1-week post-intervention, 6-months and 12-months after randomization
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Acceptance of Sexualized Aggression
Time Frame: Baseline, 1-week post-intervention, 6-months and 12-months after randomization
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Increases or decreases in acceptance of sexualized aggression will be assessed as measured by the 15-item Acceptance of Sexualized Aggression scale.
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Baseline, 1-week post-intervention, 6-months and 12-months after randomization
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Sexual and Reproductive Empowerment Scale
Time Frame: Baseline, 1-week post-intervention, 6-months and 12-months after randomization
|
The Sexual and Reproductive Empowerment Scale assesses sexual and reproductive empowerment among adolescents and young adults.
Investigators will use 13 items from the four subscales of sexual safety; self-love; sense of future; and sexual pleasure.
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Baseline, 1-week post-intervention, 6-months and 12-months after randomization
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Self-Blame Following Sexual Assault
Time Frame: Baseline, 1-week post-intervention, 6-months and 12-months after randomization
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Behavioral self-blame subscale from the Rape Attribution Questionnaire will be used to assess the extent to which women who are sexually assaulted in the follow-up timeframe of the trial blame themselves for the incident(s).
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Baseline, 1-week post-intervention, 6-months and 12-months after randomization
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Charlene Y Senn, PhD, University of Windsor
- Principal Investigator: Sarah M Peitzmeier, PhD, University of Michigan
Publications and helpful links
General Publications
- Upadhyay UD, Danza PY, Neilands TB, Gipson JD, Brindis CD, Hindin MJ, Foster DG, Dworkin SL. Development and Validation of the Sexual and Reproductive Empowerment Scale for Adolescents and Young Adults. J Adolesc Health. 2021 Jan;68(1):86-94. doi: 10.1016/j.jadohealth.2020.05.031. Epub 2020 Jul 17.
- Testa M, Vanzile-Tamsen C, Livingston JA, Buddie AM. The role of women's alcohol consumption in managing sexual intimacy and sexual safety motives. J Stud Alcohol. 2006 Sep;67(5):665-74. doi: 10.15288/jsa.2006.67.665.
- Cowan, G., & Campbell, R. R. (1995). Rape causal attitudes among adolescents. Journal of Sex Research, 32(2), 145-153.
- Cowan, G., & Quinton, W. J. (1997). Cognitive style and attitudinal correlates of the perceived causes of rape scale. Psychology of Women Quarterly, 21(2), 227-245.
- Frazier PA. Perceived control and distress following sexual assault: a longitudinal test of a new model. J Pers Soc Psychol. 2003 Jun;84(6):1257-69. doi: 10.1037/0022-3514.84.6.1257.
- Gray, M. D., Lesser, D., Quinn, E., & Brounds, C. (1990). The effectiveness of personalizing acquaintance rape prevention: Programs on perception of vulnerability and on reducing risktaking behavior. Journal of College Student Development, 31, 217-220.
- Marx BP, Calhoun KS, Wilson AE, Meyerson LA. Sexual revictimization prevention: an outcome evaluation. J Consult Clin Psychol. 2001 Feb;69(1):25-32. doi: 10.1037//0022-006x.69.1.25.
- Messman-Moore, T. L., & Brown, A. L. (2006). Risk perception, rape and sexual revictimization: A prospective study of college women. Psychology of Women Quarterly, 30, 159-172. doi:10. 1111/j.1471-6402.2006.00279.x
- Payne, D. L., Lonsway, K. A., & Fitzgerald, L. F. (1999). Rape myth acceptance: Exploration of its structure and its measurement using the Illinois Rape Myth Acceptance Scale. Journal of Research in Personality, 33, 27-68.
- Senn, C. Y., Gee, S. S., & Thake, J. (2011). Emancipatory sexuality education and sexual assault resistance: Does the former enhance the latter?. Psychology of Women Quarterly, 35(1), 72-91.
- Papp, L. J. (2023). Sexualized aggression in college drinking settings: A four-year prospective cohort study of undergraduate women [Unpublished doctoral dissertation]. University of Michigan.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HUM00229565
- 23-063 (UWindsor REB (responsible REB))
- 183649 (Other Grant/Funding Number: CIHR)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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