Preventing Sexual Violence Through a Comprehensive, Peer-led Initiative

November 10, 2021 updated by: Katie Edwards, University of New Hampshire

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2647

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • New Hampshire
      • Durham, New Hampshire, United States, 03824
        • University of New Hampshire

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years to 90 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must be able to complete online survey independently
  • Must be a student in the Rapid City community.

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: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Youth VIP
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.
Behavioral: Youth VIP
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants Reporting Any Form of Sexual Violence Victimization
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 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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of New Hampshire

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Centers for Disease Control and Prevention

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 27, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 29, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 2, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UNH-03-6594&6603-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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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