Clinical trial NCT05240313: Preventing Alcohol and Other Drug Use and Violence Among Latino Youth
Official title: Preventing Alcohol and Other Drug Use and Violence Among Latino Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Drinking
Violence in Adolescence
Keywords: Latino
Adolescent
Immigrant
Lead sponsor: Boston College
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2022-02-15
Enrollment: 34
Sex: ALL
Minimum age (years): 11
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With No Alcohol Use
timeFrame: 3 months
measure: Number of Participants With No Engagement in Interpersonal Aggression
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Doral
country: United States
facility: Raices Venezolanas
state: Florida
Study officials:
affiliation: Boston College
name: Christopher P Salas-Wright, PhD
role: PRINCIPAL_INVESTIGATOR
References: