Preventing Alcohol and Other Drug Use and Violence Among Latino Youth

NCT ID: NCT05240313

Last Updated: 2025-04-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-31

Study Completion Date

2023-08-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Alcohol Drinking Violence in Adolescence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

kiR venezolano

Intervention Type BEHAVIORAL

A multi-week intervention focused on drug refusal skills and self-regulation.

kiR + aggression

The standard keepin' it REAL intervention, adapted for an online format, plus content on interpersonal aggression

Group Type EXPERIMENTAL

kiR venezolano

Intervention Type BEHAVIORAL

A multi-week intervention focused on drug refusal skills and self-regulation.

Stress Management

A single session focused on stress management skills.

Group Type ACTIVE_COMPARATOR

kiR venezolano

Intervention Type BEHAVIORAL

A multi-week intervention focused on drug refusal skills and self-regulation.

Interventions

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kiR venezolano

A multi-week intervention focused on drug refusal skills and self-regulation.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

11 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

Boston College

OTHER

Sponsor Role lead

Responsible Party

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Christopher Salas-Wright

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christopher P Salas-Wright, PhD

Role: PRINCIPAL_INVESTIGATOR

Boston College

Locations

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Raices Venezolanas

Doral, Florida, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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5K01AA026645-05

Identifier Type: NIH

Identifier Source: secondary_id

View Link

5110411

Identifier Type: -

Identifier Source: org_study_id

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