ViolenceNCT03473067
Community Level Primary Prevention of Dating and Sexual Violence in Middle Schools
A study testing Social Norms Marketing Campaign and Capacity Building in people with Violence, run by Lifespan at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- Violence
- What is being tested?
- Social Norms Marketing Campaign and Capacity Building
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,344 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2017to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Rhode Island Hospital
Providence, Rhode Island, 02904
About this study
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.
Read the 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.
- Conditions
- Violence
- Being tested
- Social Norms Marketing Campaign, Capacity Building
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Norms Marketing CampaignBehavioural
Also called Your Voice Your Data
This poster based marketing campaign is designed to correct inaccurate perceptions of norms regarding violence.
Capacity BuildingOther
Schools will participate in teacher training and parent training.
| Study group | Role | What they receive |
|---|---|---|
| Social Norms Marketing | Experimental | This arm includes a social norms marketing campaign tailored to the school. Receives: Behavioral: Social Norms Marketing Campaign |
| Capacity Building | Active comparator | This arm includes a series of teacher training, and parent engagement meetings, with the goal of building capacity to address violence in the school. Receives: Other: Capacity Building |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual Violence Victimization
Rates of sexual violence victimization
Measured: Over 6 months
Dating Violence Victimization
Rates of dating violence victimization
Measured: Over 6 months
Sexual Violence Perpetration
Rates of sexual violence perpetration
Measured: Over 6 months
Dating Violence Perpetration
Rates of dating violence perpeptration
Measured: Over 6 months
Secondary outcomes (2)
Bystander Intervention
Rates of bystander intervention
Measured: Over 6 months
Attitudes Towards Violence
Attitudes towards violence scale
Measured: Change from baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study start1 Sep 2017
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ViolenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4,344 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lifespan
- Sponsor type
- University, hospital or other
- Collaborators
- Brown University
- Responsible party
- Principal investigator, Lindsay Orchowski Ph.D., Lifespan
- Investigators
- Lindsay M. Orchowski, Ph.D., Principal investigator, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03473067
- Sponsor's protocol ID
- 1U01CE002651
- Status last verified
- Feb 2021
- First submitted
- 28 Aug 2017
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Level Primary Prevention of Dating and Sexual Violence in Middle Schools
- ClinicalTrials.gov ID
- NCT03473067
- Acronym / sponsor ID
- 1U01CE002651
- Conditions
- Violence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,344 participants (actual)
- Lead sponsor
- LifespanUniversity, hospital or other
- Collaborators
- Brown University
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 22 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Social Norms Marketing | Experimental | Behavioral: Social Norms Marketing CampaignThis arm includes a social norms marketing campaign tailored to the school. |
| Capacity Building | Active comparator | Other: Capacity BuildingThis arm includes a series of teacher training, and parent engagement meetings, with the goal of building capacity to address violence in the school. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social Norms Marketing CampaignAlso: Your Voice Your DataThis poster based marketing campaign is designed to correct inaccurate perceptions of norms regarding violence. | Behavioural | Social Norms Marketing |
| Capacity BuildingSchools will participate in teacher training and parent training. | Other | Capacity Building |
Primary outcome
Sexual Violence Victimization
Time frame: Over 6 months
Rates of sexual violence victimization
Dating Violence Victimization
Time frame: Over 6 months
Rates of dating violence victimization
Sexual Violence Perpetration
Time frame: Over 6 months
Rates of sexual violence perpetration
Dating Violence Perpetration
Time frame: Over 6 months
Rates of dating violence perpeptration
2 secondary outcomes
Bystander Intervention
Time frame: Over 6 months
Attitudes Towards Violence
Time frame: Change from baseline to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lindsay M. Orchowski, Ph.D. principal investigator
Rhode Island Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social Norms Marketing Campaign and Capacity Building in people with Violence, run by Lifespan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual Violence Victimization (time frame: Over 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021.