- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03473067
Community Level Primary Prevention of Dating and Sexual Violence in Middle Schools
February 17, 2021 updated by: Lindsay Orchowski Ph.D., Lifespan
Dating and sexual violence are significant public health concerns occurring on a continuum of severity across the lifespan, with serious consequences to victims and society.
The present research advances the science of prevention by rigorously evaluating a comprehensive social norms marketing campaign to promote community-level change in dating and sexual violence in middle schools.
Partnership between researchers and a CDC Rape Prevention and Education Program (RPE) funded agency is a core feature of this work, and aims to build community capacity to implement and evaluate violence prevention efforts, and promote the subsequent uptake of social norms marketing campaigns as a strategy for reducing dating and sexual violence among youth.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
In a group cluster trial, a comprehensive, tailored, data-based social norms marketing campaign that addresses misperceptions of: 1) the acceptability of dating and sexual violence; 2) gender roles; 3) sexual activity; 4) sexual communication/consent; 5) support for victims; and 6) bystander intervention will be evaluated among middle schools.
Poster messaging will be paired with several systematic efforts to diffuse program content through the community, including a Lunch and Learn Teacher Training, Social Norms Video, Teacher Workbook, Parent Mailing, and Parent Information Session.
A member of the researcher-practitioner team, designated as a School Resource Provider, will oversee campaign implementation in partnership with a teacher champion.
The Resource Provider will also track campaign intensity, assess campaign credibility through intercept interviews with teachers and students, work with teachers to infuse messaging into classroom activities, and assist the teacher champion with addressing "kick-back" to the campaign.
Outcome assessments will be completed by teachers, administrators and students.
Towards the goal of exploring the role of other environmental factors as moderators of program effects, school administrators will assess their community readiness to develop and implement school dating and sexual violence prevention policy, in general, and social norms marketing, in particular.
A neighborhood scan will also be conducted to estimate the density of nearby outlets associated with gender-based personal violence.
Study Type
Interventional
Enrollment (Actual)
4344
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Rhode Island
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Providence, Rhode Island, United States, 02904
- Rhode Island Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Student at a middle school or teacher/administrator at a middle school
- Provide student assent and parental consent as specified in protocol or provide adult consent for study participation
Exclusion Criteria:
• None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Social Norms Marketing
This arm includes a social norms marketing campaign tailored to the school.
|
This poster based marketing campaign is designed to correct inaccurate perceptions of norms regarding violence.
Other Names:
|
Active Comparator: Capacity Building
This arm includes a series of teacher training, and parent engagement meetings, with the goal of building capacity to address violence in the school.
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Schools will participate in teacher training and parent training.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sexual Violence Victimization
Time Frame: Over 6 months
|
Rates of sexual violence victimization
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Over 6 months
|
Dating Violence Victimization
Time Frame: Over 6 months
|
Rates of dating violence victimization
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Over 6 months
|
Sexual Violence Perpetration
Time Frame: Over 6 months
|
Rates of sexual violence perpetration
|
Over 6 months
|
Dating Violence Perpetration
Time Frame: Over 6 months
|
Rates of dating violence perpeptration
|
Over 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bystander Intervention
Time Frame: Over 6 months
|
Rates of bystander intervention
|
Over 6 months
|
Attitudes Towards Violence
Time Frame: Change from baseline to 6 months
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Attitudes towards violence scale
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Change from baseline to 6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Teacher Engagement in Bystander Intervention
Time Frame: Over 6 months
|
Rates of bystander intervention behavior among teachers
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Over 6 months
|
Perceptions of Social Norms
Time Frame: Change from baseline to 6 months
|
A series of items were developed for the purpose of the present study to assess student perceptions of peer norms regarding dating and sexual violence.
Items are scored on a range of 0% - 100% to indicate the percent of peers within the school that would endorse each item.
Scores for each item will be examined individually.
Positive scores on this measure are indicated when respondents perceive a greater number of their peers would endorse healthy behavior.
|
Change from baseline to 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Lindsay M. Orchowski, Ph.D., Rhode Island Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2017
Primary Completion (Actual)
June 30, 2020
Study Completion (Actual)
June 30, 2020
Study Registration Dates
First Submitted
August 28, 2017
First Submitted That Met QC Criteria
March 21, 2018
First Posted (Actual)
March 22, 2018
Study Record Updates
Last Update Posted (Actual)
February 18, 2021
Last Update Submitted That Met QC Criteria
February 17, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 1U01CE002651 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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