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Primary Prevention of Sexual Violence Among College Students

Primary Purpose

Sexual Violence, Substance Use, Substance Abuse

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
LifeSkills Training for College
Sponsored by
National Health Promotion Associates, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sexual Violence

Eligibility Criteria

18 Years - 20 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • College students

Exclusion Criteria:

  • Significant cognitive impairment or severe learning disabilities, as screened by field staff at participating sites
  • Any previous experience with the intervention program will also exclude adolescents from participating

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    LifeSkills Training for College

    Treatment as Usual (Control)

    Arm Description

    All students who consent to participate in the proposed study will complete pre, post, six- and 12-month follow-up surveys. Those randomized to the intervention group (n=2000) will participate in the LST program adapted for college which consists of six 30-minute online sessions (content-specific instruction and skills building activities along with opportunities to apply newly acquired knowledge and practice new skills) and three 60-minute small groups sessions (facilitator-led sessions with fellow incoming students that complement the online modules).

    All students who consent to participate in the proposed study will complete pre, post, six- and 12-month follow-up surveys. Those randomized to the control group (n=2000) will not participate in LST but will receive the sexual violence and substance abuse educational content normally provided by their schools.

    Outcomes

    Primary Outcome Measures

    Sexual violence behaviors, norms, and attitudes at baseline
    The investigators will assess (via questionnaire) key study variables including behaviors, norms, attitudes, and knowledge regarding sexual violence and hypothesized risk and protective factors. These outcomes will be examined and compared in both the intervention group and the control group.
    Change in baseline sexual violence behaviors, norms, and attitudes at post-intervention
    The investigators will assess (via questionnaire) key study variables including behaviors, norms, attitudes, and knowledge regarding sexual violence and hypothesized risk and protective factors. These outcomes will be examined and compared in both the intervention group and the control group.
    Change in baseline sexual violence behaviors, norms, and attitudes at 6-months
    The investigators will assess (via questionnaire) key study variables including behaviors, norms, attitudes, and knowledge regarding sexual violence and hypothesized risk and protective factors. These outcomes will be examined and compared in both the intervention group and the control group.
    Change in baseline sexual violence behaviors, norms, and attitudes at 12-months
    The investigators will assess (via questionnaire) key study variables including behaviors, norms, attitudes, and knowledge regarding sexual violence and hypothesized risk and protective factors. These outcomes will be examined and compared in both the intervention group and the control group.

    Secondary Outcome Measures

    Substance use and abuse behaviors, norms, and attitudes at baseline
    The investigators will assess (via questionnaire) key study variables including behaviors, norms, attitudes, and knowledge regarding alcohol and drug abuse and hypothesized risk and protective factors. These outcomes will be examined and compared in both the intervention group and the control group.
    Change in baseline substance use and abuse behaviors, norms, and attitudes at post-intervention
    The investigators will assess (via questionnaire) key study variables including behaviors, norms, attitudes, and knowledge regarding alcohol and drug abuse and hypothesized risk and protective factors. These outcomes will be examined and compared in both the intervention group and the control group.
    Change in baseline substance use and abuse behaviors, norms, and attitudes at 6-months
    The investigators will assess (via questionnaire) key study variables including behaviors, norms, attitudes, and knowledge regarding alcohol and drug abuse and hypothesized risk and protective factors. These outcomes will be examined and compared in both the intervention group and the control group.
    Change in baseline substance use and abuse behaviors, norms, and attitudes at 12-months
    The investigators will assess (via questionnaire) key study variables including behaviors, norms, attitudes, and knowledge regarding alcohol and drug abuse and hypothesized risk and protective factors. These outcomes will be examined and compared in both the intervention group and the control group.

    Full Information

    First Posted
    January 24, 2017
    Last Updated
    February 24, 2020
    Sponsor
    National Health Promotion Associates, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03037866
    Brief Title
    Primary Prevention of Sexual Violence Among College Students
    Official Title
    Primary Prevention of Sexual Violence Among College Students
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2015 (Actual)
    Primary Completion Date
    June 2020 (Anticipated)
    Study Completion Date
    June 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    National Health Promotion Associates, Inc.

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This project is designed to address the urgent need for an effective primary prevention approach to the problem of sexual violence among college students. The project involves developing, feasibility testing, and testing for effectiveness an innovative new approach to the primary prevention of sexual violence, alcohol, and drug abuse among college students utilizing both online e-learning and small group facilitator-led intervention modalities. The intervention is an adaptation of the successful evidence-based substance abuse and violence prevention approach called Life Skills Training (LST). The adapted intervention is designed to address the relationship between sexual violence and substance abuse; positively change social norms surrounding alcohol/drug abuse and sexual violence; train bystanders to identify and appropriately respond to problematic situations; and build social, self-regulation, and relationship skills through interactive learning and behavioral rehearsal scenarios. At the conclusion of the study, the investigators expect to be able to widely disseminate and market a new evidence-based primary prevention intervention for sexual violence for use in a variety of higher educational settings.
    Detailed Description
    This proposal is designed to address the urgent need for an effective primary prevention approach to the problem of sexual violence among college students. It is estimated that 1 in every 5 college women has been sexually assaulted while in college. There is a dearth of primary prevention strategies that have demonstrated significant reductions in sexual violence in college students as part of a rigorously designed evaluation. Research shows that many victims of sexual assault are abused while drunk, under the influence of drugs, or otherwise incapacitated, and that incidents of sexual violence typically occur in college party settings where the victim knows the perpetrator and the perpetrator has been drinking or using drugs. In Phase I of this study, the investigators established the feasibility, relevance, and appeal of the new primary prevention program for sexual violence, alcohol, and drug abuse for incoming college students. The program is an adaptation of a successful evidence-based substance abuse and violence prevention approach called Life Skills Training (LST). The LST approach is designed to build personal self-management skills, social skills, and other life skills needed to reduce substance abuse and violence, increase resilience, and successfully navigate developmental tasks. In Phase I, the investigators developed the full scope and sequence of the program which outlines the learning objectives and activities of the of the online e-learning modules and small group facilitator-led sessions; developed relevant prototype materials to represent a subset of the full program; conducted formative research to establish the feasibility, relevance, and appeal of the intervention through a series of focus groups with college students and key informant interviews with college prevention staff; and recruited over 40 colleges and universities to participate in Phase II of the project. In Phase II, the investigators will fully develop the skills building curriculum materials and conduct a rigorous randomized controlled trial to examine the impact of the intervention. Forty colleges will be randomized into either an intervention group that will receive the new intervention or a treatment-as-usual control group that will receive the existing information on sexual violence provided at the school. At the end of a two-month intervention period, and at 6- and 12month follow-up assessments, the investigators will compare changes in behaviors, norms, attitudes, and knowledge regarding alcohol, drug abuse, and sexual violence. The ultimate intervention holds promise for wide dissemination as an evidence-based primary prevention approach for sexual violence to four-year colleges, community or junior colleges, universities, graduate and professional schools, for-profit schools, trade schools, and career and technical schools. Phase II Specific Aims Fully develop the sexual violence primary prevention skills building curriculum materials; Conduct a randomized controlled trial to examine the impact of the intervention; randomize 40 colleges into either an intervention group that will receive the new intervention or a treatment-as-usual control group that will receive the existing information on sexual violence provided at the school; Conduct an outcome evaluation by assessing changes in the two experimental conditions with regards to behaviors, norms, attitudes, and knowledge regarding alcohol, drug abuse, and sexual violence at the end of the two-month intervention period, and at 6- and 12-month follow-up assessments; Conduct a process evaluation to document and monitor all Phase II project activities; Disseminate research findings to the scientific and practice communities; Create a provider training mechanism to promote dissemination and sustainability of the intervention; Based on the commercialization plan, implement a marketing strategy for the new primary prevention program aimed at institutions of higher education across the country.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sexual Violence, Substance Use, Substance Abuse

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    4000 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    LifeSkills Training for College
    Arm Type
    Experimental
    Arm Description
    All students who consent to participate in the proposed study will complete pre, post, six- and 12-month follow-up surveys. Those randomized to the intervention group (n=2000) will participate in the LST program adapted for college which consists of six 30-minute online sessions (content-specific instruction and skills building activities along with opportunities to apply newly acquired knowledge and practice new skills) and three 60-minute small groups sessions (facilitator-led sessions with fellow incoming students that complement the online modules).
    Arm Title
    Treatment as Usual (Control)
    Arm Type
    No Intervention
    Arm Description
    All students who consent to participate in the proposed study will complete pre, post, six- and 12-month follow-up surveys. Those randomized to the control group (n=2000) will not participate in LST but will receive the sexual violence and substance abuse educational content normally provided by their schools.
    Intervention Type
    Behavioral
    Intervention Name(s)
    LifeSkills Training for College
    Other Intervention Name(s)
    LifeSkills Training, LST
    Intervention Description
    The intervention will consist of e-learning modules (self-guided) and small-group sessions (facilitator led). The intervention is designed for new college students and is aimed at providing tools and strategies to help them maximize opportunities and adeptly handle the challenges ahead. The intervention will teach them the knowledge and skills needed to stay safe from problems that are prevalent among new students on college campuses, such as alcohol and drug abuse and sexual violence.
    Primary Outcome Measure Information:
    Title
    Sexual violence behaviors, norms, and attitudes at baseline
    Description
    The investigators will assess (via questionnaire) key study variables including behaviors, norms, attitudes, and knowledge regarding sexual violence and hypothesized risk and protective factors. These outcomes will be examined and compared in both the intervention group and the control group.
    Time Frame
    Pre-test (prior to participating in the first session/module of the intervention)
    Title
    Change in baseline sexual violence behaviors, norms, and attitudes at post-intervention
    Description
    The investigators will assess (via questionnaire) key study variables including behaviors, norms, attitudes, and knowledge regarding sexual violence and hypothesized risk and protective factors. These outcomes will be examined and compared in both the intervention group and the control group.
    Time Frame
    Post-test (within 2 weeks of completing final session/module of the intervention)
    Title
    Change in baseline sexual violence behaviors, norms, and attitudes at 6-months
    Description
    The investigators will assess (via questionnaire) key study variables including behaviors, norms, attitudes, and knowledge regarding sexual violence and hypothesized risk and protective factors. These outcomes will be examined and compared in both the intervention group and the control group.
    Time Frame
    6-month followup (within 6-7 months of completing final session of intervention)
    Title
    Change in baseline sexual violence behaviors, norms, and attitudes at 12-months
    Description
    The investigators will assess (via questionnaire) key study variables including behaviors, norms, attitudes, and knowledge regarding sexual violence and hypothesized risk and protective factors. These outcomes will be examined and compared in both the intervention group and the control group.
    Time Frame
    12-month followup (within 12-13 months of completing final session of intervention)
    Secondary Outcome Measure Information:
    Title
    Substance use and abuse behaviors, norms, and attitudes at baseline
    Description
    The investigators will assess (via questionnaire) key study variables including behaviors, norms, attitudes, and knowledge regarding alcohol and drug abuse and hypothesized risk and protective factors. These outcomes will be examined and compared in both the intervention group and the control group.
    Time Frame
    Pre-test (prior to participating in the first session/module of the intervention)
    Title
    Change in baseline substance use and abuse behaviors, norms, and attitudes at post-intervention
    Description
    The investigators will assess (via questionnaire) key study variables including behaviors, norms, attitudes, and knowledge regarding alcohol and drug abuse and hypothesized risk and protective factors. These outcomes will be examined and compared in both the intervention group and the control group.
    Time Frame
    Post-test (within 2 weeks of completing final session/module of the intervention)
    Title
    Change in baseline substance use and abuse behaviors, norms, and attitudes at 6-months
    Description
    The investigators will assess (via questionnaire) key study variables including behaviors, norms, attitudes, and knowledge regarding alcohol and drug abuse and hypothesized risk and protective factors. These outcomes will be examined and compared in both the intervention group and the control group.
    Time Frame
    6-month followup (within 6-7 months of completing final session of intervention)
    Title
    Change in baseline substance use and abuse behaviors, norms, and attitudes at 12-months
    Description
    The investigators will assess (via questionnaire) key study variables including behaviors, norms, attitudes, and knowledge regarding alcohol and drug abuse and hypothesized risk and protective factors. These outcomes will be examined and compared in both the intervention group and the control group.
    Time Frame
    12-month followup (within 12-13 months of completing final session of intervention)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: College students Exclusion Criteria: Significant cognitive impairment or severe learning disabilities, as screened by field staff at participating sites Any previous experience with the intervention program will also exclude adolescents from participating
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kenneth W Griffin, PhD
    Organizational Affiliation
    National Health Promotion Associates, Inc.
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Primary Prevention of Sexual Violence Among College Students

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