Sexual ViolenceNCT03207386
Preventing Sexual Violence Through a Comprehensive, Peer-led Initiative
A study testing Youth VIP in people with Sexual Violence, run by University of New Hampshire at 1 site in United States.
Trial summary
The purpose of this multiple baseline study is to evaluate the effectiveness of a comprehensive youth-led sexual violence (SV) prevention program, Youth Voices in Prevention (Youth VIP). The prevention program builds on youth-adult partnerships among middle and high school students in Rapid City, South Dakota. Read more about this study
- Who is it for?
- Ages 12 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Sexual Violence
- What is being tested?
- Youth VIP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,647 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2017to 1 Jul 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Must be able to complete online survey independently
- Must be a student in the Rapid City community.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Hampshire
Durham, New Hampshire, 03824
About this study
Official title: Preventing Sexual Violence Through a Comprehensive, Peer-led Initiative: A Process and Outcome Evaluation
The purpose of this multiple baseline study is to evaluate the effectiveness of a comprehensive youth-led sexual violence (SV) prevention program, Youth Voices in Prevention (Youth VIP). The prevention program builds on youth-adult partnerships among middle and high school students in Rapid City, South Dakota. Consenting students will take part in a youth summit where they will be trained as popular opinion leaders to spread SV prevention messages among middle and high school youth and parents. Following the summit, youth will work in small groups focused on different aspects of evidence-based prevention strategies including bystander intervention, social marketing messaging, parent education, norms change, and social emotional learning. Multiple research methods will be used to examine implementation process and cost. In addition, consenting students will take six surveys across three years including several surveys before programming begins, and several to document Youth VIP outcomes after prevention programming takes place. Survey data from a demographically similar community will be used to assess changes over time among youth in Rapid City, SD. All phases of the project will be implemented with collaboration from a Research Programming Advisory Board of community members and professionals from Rapid City, SD.
Read the detailed description
Sexual violence (SV) impacts adolescents at rates higher than most other age demographics. Although it is a critical public health issue for youth, there are few prevention initiatives that lead to reductions in SV. There is increasing recognition that SV prevention efforts may be most effective if youth are central to the development and implementation of such efforts. Problematically, there are no rigorously evaluated youth-led SV prevention efforts, and researchers also know little about the process by which youth create prevention initiatives. Teen UP (TU) is a youth-led initiative in Rapid City, SD that focuses on addressing a variety of public health issues, including awareness about SV. This "homegrown" initiative is well integrated in the community and is the ideal platform on which additional multi-level, evidence-based SV prevention strategies can be added. Researchers and SV prevention specialists at the University of New Hampshire, in partnership with Rape Prevention Education-funded agencies in South Dakota (SD) (i.e., Network Against Family Violence and Sexual Assault [The Network] and Working Against Violence Inc. [WAVI]), will work together along with a number of community stakeholders (e.g., educators, peers, elders) and expert consultants to enhance TU to include additional SV prevention strategies, a project titled Youth Voices in Prevention (Youth VIP). Although the plan for the programming enhancement will be refined based on feedback from the Research and Programming Advisory Board (RPAB) and data collected during the refinement and planning phase of the project, the current plan is to convene a youth summit where high school youth will be trained as popular opinion leaders to diffuse SV prevention messages in addition to youth joining a formal working group specific to a SV prevention strategy that also aligns with youth's career aspirations. A mixed method approach will be used to measure implementation processes, fidelity, and costs over time, and to assess the impact of Youth VIP on rates of sexual violence perpetration among middle and high school students, as well as the secondary outcomes of sexual violence victimization, dating violence and bullying victimization and perpetration, depression, and suicidality. Collaboration with the community of students, parents, and professionals in Rapid City will be promoted by establishing a Research Programming Advisory Board (RPAB) that will meet monthly during the project.
All students in grades 7 through 10 in the fall of 2017 will be invited to participate in two baseline and four follow-up surveys that will be given in school. Surveys will take place in fall and spring of each of three school years, and the cohort enrolled in fall of 2017 will be followed over time. Recruitment of students and parents is being done in close collaboration with the Rapid City Area School District. The investigators anticipate enrolling 2,000 students.
Qualitative data includes Photovoice interviews (a technique where students take pictures of their community and describe how those pictures relate to violence in their community), interviews of students who attended programming, and interviews with key adult stakeholders. We will identify common themes in this data using content analysis, then code the interviews for these themes. We will present both the frequency that these themes emerged and key exemplary quotes. We will use a variety of methods to analyze the quantitative data. First, we will examine change in outcomes over time as a function of exposure to programming. Second, using social network analysis, we will examine change in outcomes as a function of the programming exposure of one's close friends. Third, we will use pooled cross-sectional analyses to compare students in the same grade levels over time as the program is implemented (e.g., compare this year's eight graders to last years' eighth graders). Fourth, we will use multilevel modeling to examine trajectories and changes in the cohorts (e.g., compare growth in this year's eight graders to last years' eighth graders) who are nested within schools. We will examine outcomes in these ways for primary outcome (sexual violence perpetration and victimization), intermediary outcomes (e.g., social norms), and secondary outcomes (e.g., suicidal thoughts).
- Conditions
- Sexual Violence
- Being tested
- Youth VIP
- Keywords
- Sexual Violence, Prevention, Mixed-Methods, Outcome Evaluation, Process Evaluation, Adolescence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Youth VIPBehavioural
Youth VIP involves youth in partnerships with adults to adapt evidence based sexual violence prevention strategies for the local community environment. Youth VIP includes a three day intensive youth summit for prevention training and ongoing youth-adult prevention working groups.
| Study group | Role | What they receive |
|---|---|---|
| Youth VIP | Experimental | Youth VIP is a youth-led set of prevention strategies. Youth and their adult mentors are trained in evidence based sexual assault primary prevention strategies at a three day youth summit. The summit is followed by participation in working groups in which youth and their adult mentors will adapt best practices for sexual assault prevention to the Rapid City community and diffuse these strategies through both their own social networks and more formally in work in Rapid City middle and high schools. Receives: Behavioral: Youth VIP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reporting Any Form of Sexual Violence Perpetration
We used several measures to assess for a wide range of interpersonal violence victimization perpetration experiences during the past six months, all with response options 1 = yes or 0 = no. Outcome counts indicate number of participants who reported yes to any form of sexual violence perpetration. We used mirror items to assess for both victimization and perpetration experiences. Three items assessing sexual assault were drawn from Cook-Craig et al.'s (2014) measure that assessed for sexual coercion, physically-forced sex, and incapacitated sex. Five items from the YRBS were used to assess physically forced sexual contact, sexual dating violence, physical dating violence, bullying on school property, and electronic bullying (Centers for Disease Control and Prevention, 2014). We used three items from the American Association of University Women (2001) to assess homophobic teasing, sexual harassment, and sexual rumors. Lastly, two items assessed homophobic bullying and racial bullying.
Measured: 6 months
Secondary outcomes (1)
Number of Participants Reporting Any Form of Sexual Violence Victimization
We used several measures to assess for a wide range of interpersonal violence victimization perpetration experiences during the past six months, all with response options 1 = yes or 0 = no. Outcome counts indicate number of participants who reported yes to any form of sexual violence victimization. We used mirror items to assess for both victimization and perpetration experiences. Three items assessing sexual assault were drawn from Cook-Craig et al.'s (2014) measure that assessed for sexual coercion, physically-forced sex, and incapacitated sex. Five items from the YRBS were used to assess physically forced sexual contact, sexual dating violence, physical dating violence, bullying on school property, and electronic bullying (Centers for Disease Control and Prevention, 2014). We used three items from the American Association of University Women (2001) to assess homophobic teasing, sexual harassment, and sexual rumors. Lastly, two items assessed homophobic bullying and racial bullying.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start27 Feb 2017
- Primary completion1 Jul 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Sexual 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
- Not applicable
- Intervention model
- Sequential
- Model description
- Multiple baseline survey design across three years including two baseline surveys prior to prevention programming and rollout of doses of programming across two years.
- Masking
- None (open label)
- Enrolment
- 2,647 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Hampshire
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Katie Edwards, University of New Hampshire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03207386
- Sponsor's protocol ID
- UNH-03-6594&6603-01
- Status last verified
- Nov 2021
- First submitted
- 29 Jun 2017
- Last updated
- 12 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Kann L, Kinchen S, Shanklin SL, Flint KH, Kawkins J, Harris WA, Lowry R, Olsen EO, McManus T, Chyen D, Whittle L, Taylor E, Demissie Z, Brener N, Thornton J, Moore J, Zaza S; Centers for Disease Control and Prevention (CDC). Youth risk behavior surveillance--United States, 2013. MMWR Suppl. 2014 Jun 13;63(4):1-168.
PubMed 24918634Cook-Craig PG, Coker AL, Clear ER, Garcia LS, Bush HM, Brancato CJ, Williams CM, Fisher BS. Challenge and opportunity in evaluating a diffusion-based active bystanding prevention program: Green Dot in high schools. Violence Against Women. 2014 Oct;20(10):1179-202. doi: 10.1177/1077801214551288. Epub 2014 Sep 24.
PubMed 25255794American Association of University Women. (2001) Hostile Hallways: Bullying, Teasing, and Sexual Harassment in School, American Journal of Health Education, 32:5, 307-309, DOI: 10.1080/19325037.2001.10603488
Edwards KM, Banyard VL, Waterman EA, Mitchell KJ, Jones LM, Kollar LMM, Hopfauf S, Simon B. Evaluating the Impact of a Youth-Led Sexual Violence Prevention Program: Youth Leadership Retreat Outcomes. Prev Sci. 2022 Nov;23(8):1379-1393. doi: 10.1007/s11121-022-01343-x. Epub 2022 Mar 18.
PubMed 35303249
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Sexual Violence Through a Comprehensive, Peer-led Initiative: A Process and Outcome Evaluation
- ClinicalTrials.gov ID
- NCT03207386
- Acronym / sponsor ID
- UNH-03-6594&6603-01
- Conditions
- Sexual Violence
- Keywords
- Sexual Violence, Prevention, Mixed-Methods, Outcome Evaluation, Process Evaluation, Adolescence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,647 participants (actual)
- Lead sponsor
- University of New HampshireUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 27 Feb 2017 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 2 Jul 2017 (actual)
- Results
- Posted 3 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this multiple baseline study is to evaluate the effectiveness of a comprehensive youth-led sexual violence (SV) prevention program, Youth Voices in Prevention (Youth VIP). The prevention program builds on youth-adult partnerships among middle and high school students in Rapid City, South Dakota. Consenting students will take part in a youth summit where they will be trained as popular opinion leaders to spread SV prevention messages among middle and high school youth and parents. Following the summit, youth will work in small groups focused on different aspects of evidence-based prevention strategies including bystander intervention, social marketing messaging, parent education, norms change, and social emotional learning. Multiple research methods will be used to examine implementation process and cost. In addition, consenting students will take six surveys across three years including several surveys before programming begins, and several to document Youth VIP outcomes after prevention programming takes place. Survey data from a demographically similar community will be used to assess changes over time among youth in Rapid City, SD. All phases of the project will be implemented with collaboration from a Research Programming Advisory Board of community members and professionals from Rapid City, SD.
Detailed description
Sexual violence (SV) impacts adolescents at rates higher than most other age demographics. Although it is a critical public health issue for youth, there are few prevention initiatives that lead to reductions in SV. There is increasing recognition that SV prevention efforts may be most effective if youth are central to the development and implementation of such efforts. Problematically, there are no rigorously evaluated youth-led SV prevention efforts, and researchers also know little about the process by which youth create prevention initiatives. Teen UP (TU) is a youth-led initiative in Rapid City, SD that focuses on addressing a variety of public health issues, including awareness about SV. This "homegrown" initiative is well integrated in the community and is the ideal platform on which additional multi-level, evidence-based SV prevention strategies can be added. Researchers and SV prevention specialists at the University of New Hampshire, in partnership with Rape Prevention Education-funded agencies in South Dakota (SD) (i.e., Network Against Family Violence and Sexual Assault [The Network] and Working Against Violence Inc. [WAVI]), will work together along with a number of community stakeholders (e.g., educators, peers, elders) and expert consultants to enhance TU to include additional SV prevention strategies, a project titled Youth Voices in Prevention (Youth VIP). Although the plan for the programming enhancement will be refined based on feedback from the Research and Programming Advisory Board (RPAB) and data collected during the refinement and planning phase of the project, the current plan is to convene a youth summit where high school youth will be trained as popular opinion leaders to diffuse SV prevention messages in addition to youth joining a formal working group specific to a SV prevention strategy that also aligns with youth's career aspirations. A mixed method approach will be used to measure implementation processes, fidelity, and costs over time, and to assess the impact of Youth VIP on rates of sexual violence perpetration among middle and high school students, as well as the secondary outcomes of sexual violence victimization, dating violence and bullying victimization and perpetration, depression, and suicidality. Collaboration with the community of students, parents, and professionals in Rapid City will be promoted by establishing a Research Programming Advisory Board (RPAB) that will meet monthly during the project.
All students in grades 7 through 10 in the fall of 2017 will be invited to participate in two baseline and four follow-up surveys that will be given in school. Surveys will take place in fall and spring of each of three school years, and the cohort enrolled in fall of 2017 will be followed over time. Recruitment of students and parents is being done in close collaboration with the Rapid City Area School District. The investigators anticipate enrolling 2,000 students.
Qualitative data includes Photovoice interviews (a technique where students take pictures of their community and describe how those pictures relate to violence in their community), interviews of students who attended programming, and interviews with key adult stakeholders. We will identify common themes in this data using content analysis, then code the interviews for these themes. We will present both the frequency that these themes emerged and key exemplary quotes. We will use a variety of methods to analyze the quantitative data. First, we will examine change in outcomes over time as a function of exposure to programming. Second, using social network analysis, we will examine change in outcomes as a function of the programming exposure of one's close friends. Third, we will use pooled cross-sectional analyses to compare students in the same grade levels over time as the program is implemented (e.g., compare this year's eight graders to last years' eighth graders). Fourth, we will use multilevel modeling to examine trajectories and changes in the cohorts (e.g., compare growth in this year's eight graders to last years' eighth graders) who are nested within schools. We will examine outcomes in these ways for primary outcome (sexual violence perpetration and victimization), intermediary outcomes (e.g., social norms), and secondary outcomes (e.g., suicidal thoughts).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multiple baseline survey design across three years including two baseline surveys prior to prevention programming and rollout of doses of programming across two years.
| Arm | Type | Receives |
|---|---|---|
| Youth VIP | Experimental | Behavioral: Youth VIPYouth VIP is a youth-led set of prevention strategies. Youth and their adult mentors are trained in evidence based sexual assault primary prevention strategies at a three day youth summit. The summit is followed by participation in working groups in which youth and their adult mentors will adapt best practices for sexual assault prevention to the Rapid City community and diffuse these strategies through both their own social networks and more formally in work in Rapid City middle and high schools. |
Who may qualify
- Ages
- 12 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Must be able to complete online survey independently
- Must be a student in the Rapid City community.
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 |
|---|---|---|
| Youth VIPYouth VIP involves youth in partnerships with adults to adapt evidence based sexual violence prevention strategies for the local community environment. Youth VIP includes a three day intensive youth summit for prevention training and ongoing youth-adult prevention working groups. | Behavioural | Youth VIP |
Primary outcome
Number of Participants Reporting Any Form of Sexual Violence Perpetration
Time frame: 6 months
We used several measures to assess for a wide range of interpersonal violence victimization perpetration experiences during the past six months, all with response options 1 = yes or 0 = no. Outcome counts indicate number of participants who reported yes to any form of sexual violence perpetration. We used mirror items to assess for both victimization and perpetration experiences. Three items assessing sexual assault were drawn from Cook-Craig et al.'s (2014) measure that assessed for sexual coercion, physically-forced sex, and incapacitated sex. Five items from the YRBS were used to assess physically forced sexual contact, sexual dating violence, physical dating violence, bullying on school property, and electronic bullying (Centers for Disease Control and Prevention, 2014). We used three items from the American Association of University Women (2001) to assess homophobic teasing, sexual harassment, and sexual rumors. Lastly, two items assessed homophobic bullying and racial bullying.
1 secondary outcome
Number of Participants Reporting Any Form of Sexual Violence Victimization
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24918634Kann L, Kinchen S, Shanklin SL, Flint KH, Kawkins J, Harris WA, Lowry R, Olsen EO, McManus T, Chyen D, Whittle L, Taylor E, Demissie Z, Brener N, Thornton J, Moore J, Zaza S; Centers for Disease Control and Prevention (CDC). Youth risk behavior surveillance--United States, 2013. MMWR Suppl. 2014 Jun 13;63(4):1-168.
- Background: PubMed 25255794Cook-Craig PG, Coker AL, Clear ER, Garcia LS, Bush HM, Brancato CJ, Williams CM, Fisher BS. Challenge and opportunity in evaluating a diffusion-based active bystanding prevention program: Green Dot in high schools. Violence Against Women. 2014 Oct;20(10):1179-202. doi: 10.1177/1077801214551288. Epub 2014 Sep 24.
- BackgroundAmerican Association of University Women. (2001) Hostile Hallways: Bullying, Teasing, and Sexual Harassment in School, American Journal of Health Education, 32:5, 307-309, DOI: 10.1080/19325037.2001.10603488
- Derived from this study: PubMed 35303249Edwards KM, Banyard VL, Waterman EA, Mitchell KJ, Jones LM, Kollar LMM, Hopfauf S, Simon B. Evaluating the Impact of a Youth-Led Sexual Violence Prevention Program: Youth Leadership Retreat Outcomes. Prev Sci. 2022 Nov;23(8):1379-1393. doi: 10.1007/s11121-022-01343-x. Epub 2022 Mar 18.
- Individual participant dataSharing planned: Yes
Related trials for Sexual Violence
Not yet recruiting
BEAR for Women Who Have Experienced Sexual Assault and Have Suicidal Thoughts
Sexual Assault and Rape, Suicidal Thoughts
RecruitingPhase 2
Study of Cross-Cutting E-Health Prevention Approaches
Alcohol Misuse Prevention, Sexual Violence Prevention
Enrolling by invitation
The Effectiveness of a Brief Early Intervention of Acute Stress Syndrome Stabilization Protocol for Victims of Sexual Violence (ASSYST-SV).
Acute Stress Symptoms, Sexual Violence
Recruiting
Centering Gender Affirming Resources in Higher Education
Sexual Violence, Drinking Heavy
Recruiting
SER Familia: A Family-Based Intervention Addressing Syndemic Conditions Among Latino Families
Substance Abuse, Intimate Partner Violence (IPV)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Youth VIP in people with Sexual Violence, run by University of New Hampshire 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 12 Nov 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?
Yes. Results are posted in the registry (first posted 3 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Reporting Any Form of Sexual Violence Perpetration (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03207386, which also lists 4 linked publications.
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 12 Nov 2021.