Risk BehaviorNCT04879342
Evaluation of Values in Perspective (VIP) Program
A study testing VIP Program in people with Risk Behavior, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Risk Behavior
- What is being tested?
- VIP Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 850 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2021to 15 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Risk Behavior
- Being tested
- VIP Program
- Medical subject headings
- Risk-Taking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIP ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| VIP Program Group | Experimental | Participants in this group will receive a 26 week course on risk reduction strategies. Receives: Behavioral: VIP Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start15 May 2021
- Primary completion15 May 2025
- Study completion15 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risk BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 850 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie Guerda Nicolas, University of Miami
- Investigators
- Guerda Nicolas, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04879342
- Sponsor's protocol ID
- 20201386
- Status last verified
- Jun 2025
- First submitted
- 4 May 2021
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Values in Perspective (VIP) Program
- ClinicalTrials.gov ID
- NCT04879342
- Acronym / sponsor ID
- 20201386
- Conditions
- Risk Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 850 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 15 May 2021 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 10 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VIP Program Group | Experimental | Behavioral: VIP ProgramParticipants in this group will receive a 26 week course on risk reduction strategies. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VIP ProgramThis 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. | Behavioural | VIP Program Group |
Primary outcome
SRAE Scores - Middle School
Time frame: 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.
SRAE Scores - High School
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guerda Nicolas principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VIP Program in people with Risk Behavior, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SRAE Scores - Middle School (time frame: Up to 26 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.