- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05240313
Preventing Alcohol and Other Drug Use and Violence Among Latino Youth (kiR-vene)
There are currently no interventions aimed at preventing both alcohol and other drug (AOD) use and interpersonal violence that have been adapted for Latino adolescents. This study hypothesizes that a cultural adaptation of a validated AOD use prevention program (Keepin' it REAL) that also integrates violence prevention content will both amplify the AOD use effects of that intervention for Latino adolescents and lead to reductions in youth violence.
The purpose of this study is to conduct a pilot-test randomized controlled trial (RCT) of a youth AOD use prevention intervention that has been adapted to integrate interpersonal violence content and has been culturally adapted for a specific Latino population (Venezuelan migrant youth). The goals of the pilot test are to determine feasibility, acceptability, and preliminary effects of the intervention for future testing.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The intervention will be an adaptation of Keepin' it REAL (KiR). KiR is a 10-week intervention for early adolescents that is considered a model evidence-based AOD use prevention program by SAMHSA. It based on communications theory and the importance of aligning cultural values with AOD outcomes. Weekly sessions focus on teaching youth communications strategies to enhance their ability to navigate situations where substance use may be present. It incorporates a student workbook, videos, and in-session discussions and exercises. We will be adapting the intervention for an online platform so that it can be delivered virtually. We will also be integrated interpersonal aggression content to expand the logic and program theory of KIR to apply to situations in which violence may arise. The goal is to both delay initiation of AOD use/aggressive behaviors and change the youth's norms around the appropriateness of AOD use and interpersonal aggression. The intervention will delivered for the pilot study by members of the research team (PI and/or GRAs). The intervention materials will be translated into Spanish by a research team member who is a native speaker of Spanish and checked for accuracy by other members of team. Adaptations will be made in consultation with a community advisory board that consists of Venezuelan migrants to check for cultural fit, language appropriateness, and overall concordance with the target population. All members of the research team are either fluent or proficient in Spanish.
A three-armed RCT design will be used. In addition to a control group that will receive an abbreviated, one-session workshop, one group will receive a version of the intervention that has been adapted for Venezuelan youths and the other will receive a version of the intervention that has been adapted for Venezuelan youths and includes interpersonal violence content. The purpose of this design is to determine the effectiveness of the the culturally adaption of KiR for the original intended outcome (reduced AOD use) and the separate effect of integrating interpersonal violence content on reducing aggressive behaviors.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Christopher P Salas-Wright, PhD
- Phone Number: 617-552-1295
- Email: wrightcu@bc.edu
Study Locations
-
-
Florida
-
Doral, Florida, United States, 33122
- Raices Venezolanas
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Born in Venezuela
- Residing in U.S.
- Within age range
Exclusion Criteria:
- Substance use and/or engagement in interpersonal aggression will not be considered for purposes of inclusion/exclusion, unless the participant is intoxicated to the point of being unable to successfully complete a survey or participate in the intervention.
- Participants will be excluded if they are otherwise cognitively unable to successfully engage in the intervention
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: keepin' it REAL (kiR)
The standard keepin' it REAL intervention, adapted for an online format.
This includes 10 one-hour small group sessions focused on helping youth to develop drug refusal skills and improve decision making, risk assessment, and emotion regulation.
Additionally, short videos highlight various aspects of the program (refuse, explain, avoid, leave).
All materials are available in Spanish and English.
|
A multi-week intervention focused on drug refusal skills and self-regulation.
|
Experimental: kiR + aggression
The standard keepin' it REAL intervention, adapted for an online format, plus content on interpersonal aggression
|
A multi-week intervention focused on drug refusal skills and self-regulation.
|
Active Comparator: Stress Management
A single session focused on stress management skills.
|
A multi-week intervention focused on drug refusal skills and self-regulation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Alcohol and other drug use
Time Frame: 3 months
|
Measured via Graham et al.'s (1984) Project SMART Questionnaire as seen in the Journal of Drug Education.
Items will be examined both individually and as a composite scale.
This measure was developed and tested with 7th graders in the United States and has been found to have strong psychometric properties.
|
3 months
|
Interpersonal Aggression
Time Frame: 3 months
|
Physical and Non-Physical Aggression items were adapted from the Revised Olweus Bully/Victim Questionnaire (BVQ) (Olweus, 1996).
The BVQ is the most widely used bullying self-report survey in the world and includes multiple items related to in-person and online interpersonal aggression.
Items will be examined individually and as a composite scale.
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christopher P Salas-Wright, PhD, Boston College
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AA026645
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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