NCT04879342

Brief Summary

The primary purpose of this study is to evaluate the effectiveness and perceived usefulness of the Values in Perspective (VIP) program in reducing and preventing engagement in risky behaviors among youths. The VIP program is a structured, values-based intervention designed to promote self-awareness, ethical decision-making, and long-term goal setting in young people. This study aims to assess how participation in the program influences youths' attitudes, knowledge, and behaviors related to common adolescent risk factors such as substance use, unsafe sexual activity, and delinquency. The goal is to determine whether the VIP program can serve as a scalable and culturally relevant prevention strategy to promote positive youth development and reduce high-risk behaviors in middle and high school-aged youths.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
850

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 10, 2021

Completed
5 days until next milestone

Study Start

First participant enrolled

May 15, 2021

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2025

Completed
Last Updated

June 26, 2025

Status Verified

June 1, 2025

Enrollment Period

4 years

First QC Date

May 4, 2021

Last Update Submit

June 20, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • SRAE Scores - Middle School

    Sexual Risk Avoidance Education Program (SRAE) for middle school participants has a total score ranging from 0 to 170 with a higher score indicating higher risk behavior.

    Up to 26 weeks

  • SRAE Scores - High School

    Sexual Risk Avoidance Education Program (SRAE) for high school participants has a total score ranging from 0 to 190 with a higher score indicating higher risk behavior.

    Up to 26 weeks

Study Arms (1)

VIP Program Group

EXPERIMENTAL

Participants in this group will receive a 26 week course on risk reduction strategies.

Behavioral: VIP Program

Interventions

VIP ProgramBEHAVIORAL

This intervention will engage the participants with psychoeducational material once a week. This material will include didactic instruction as well as participant engagement in developmentally appropriate activities.

VIP Program Group

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • A youth residing in Miami-Dade County.
  • Must be in grades 6-12 and must be eligible for free and reduced lunch.
  • Must be able to speak and read English proficiently.

You may not qualify if:

  • Does not reside in Miami-Dade County.
  • Does not comprehend, speak, or read English proficiently.
  • In elementary school.
  • In high-income household as evidenced by not qualifying for free and reduced lunch.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Coral Gables, Florida, 33146, United States

Location

MeSH Terms

Conditions

Risk-Taking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Guerda Nicolas

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 4, 2021

First Posted

May 10, 2021

Study Start

May 15, 2021

Primary Completion

May 15, 2025

Study Completion

May 15, 2025

Last Updated

June 26, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations