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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04879342
Other study ID # 20201386
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date May 15, 2021
Est. completion date May 15, 2025

Study information

Verified date May 2024
Source University of Miami
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to review and assess the usefulness of the Values in Perspective (VIP) program to avoid adolescent risky behaviors.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 150
Est. completion date May 15, 2025
Est. primary completion date May 15, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years to 17 Years
Eligibility Inclusion criteria 1. A youth residing in Miami-Dade County. 2. Must be in grades 6-12 and must be eligible for free and reduced lunch. 3. Must be able to speak and read English proficiently. Exclusion criteria 1. Does not reside in Miami-Dade County. 2. Does not comprehend, speak, or read English proficiently. 3. In elementary school. 4. In high-income household as evidenced by not qualifying for free and reduced lunch.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
VIP Program
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.

Locations

Country Name City State
United States University of Miami Coral Gables Florida

Sponsors (1)

Lead Sponsor Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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