Evaluation of Values in Perspective (VIP) Program

• Sponsor: University of Miami (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT04879342
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 6.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Risk Behavior	Behavioral: VIP Program	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Evaluation of Values in Perspective (VIP) Program
• Actual Study Start Date: May 15, 2021
• Anticipated Primary Completion Date: May 15, 2023
• Anticipated Study Completion Date: May 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: VIP Program Group Participants in this group will receive a 26 week course on risk reduction strategies.	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.

Outcome Measures

Primary Outcome Measures

1. SRAE Scores - Middle School [Up to 26 weeks]

   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.

2. SRAE Scores - High School [Up to 26 weeks]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Miami	Coral Gables	Florida	United States	33146

Sponsors and Collaborators

• University of Miami

Investigators

• Principal Investigator: Guerda Nicolas, University of Miami

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Marie Guerda Nicolas, Professor, University of Miami
• ClinicalTrials.gov Identifier: NCT04879342
• Other Study ID Numbers: 20201386
• First Posted: May 10, 2021
• Last Update Posted: Jun 6, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jun 6, 2022