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: Completed
• Conditions: Alcohol Drinking; Violence in Adolescence
• Intervention / Treatment: Behavioral: kiR venezolano

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: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Doral, Florida, United States, 33122
      • Raices Venezolanas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 14 years (Child)
• Accepts Healthy Volunteers: Yes

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: Parallel Assignment
• Masking: Single

Number of Arms

3

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.	Behavioral: kiR venezolano; 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	Behavioral: kiR venezolano; A multi-week intervention focused on drug refusal skills and self-regulation.
Active Comparator: Stress Management; A single session focused on stress management skills.	Behavioral: kiR venezolano; 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
Number of Participants With No Alcohol Use	We used one survey item from the self-report measure of substance use in prevention research scale, which asks youth how many alcoholic beverages they have consumed in the previous 30 days. Response options include none, only sips, all or part of one drink, 2 to 4 drinks, five to ten drinks, eleven to twenty drinks, and more than twenty drinks. No alcohol use ("none") during the study was considered a better outcome. There are no subscales or computed scores.	3 months
Number of Participants With No Engagement in Interpersonal Aggression	We used a composite scale of six items from the Revised Olweus Bully/Victim Questionnaire. The scale items measure the frequency of bullying activities, including making fun of, excluding, hitting, spreading rumors, threatening, and hurting others. Each item's responses include "almost never or never" (coded as 0), "weekly" (coded as 1), "several times per week" (coded as 2), and "daily" (coded as 3). Report of no bullying ("almost never or never") throughout the study was considered a better outcome.	3 months

Collaborators and Investigators

• Sponsor: Boston College
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Christopher P Salas-Wright, PhD, Boston College

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2022
• Primary Completion (Actual): July 31, 2023
• Study Completion (Actual): August 1, 2023

Study Registration Dates

• First Submitted: January 21, 2022
• First Submitted That Met QC Criteria: February 4, 2022
• First Posted (Actual): February 15, 2022

Study Record Updates

• Last Update Posted (Actual): April 24, 2025
• Last Update Submitted That Met QC Criteria: April 22, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Adolescent; Latino; Immigrant
• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking
• Other Study ID Numbers: 5110411; 5K01AA026645-05 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No