kiR-vene: Preventing Alcohol and Other Drug Use and Violence Among Latino Youth

Sponsor
Boston College (Other)
Overall Status
Recruiting
CT.gov ID
NCT05240313
Collaborator
(none)
80
1
3
11
7.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: kiR venezolano
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Preventing Alcohol and Other Drug Use and Violence Among Latino Youth
Actual Study Start Date :
Jan 31, 2022
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Alcohol and other drug use [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.

  2. Interpersonal Aggression [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
11 Years to 14 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Raices Venezolanas Doral Florida United States 33122

Sponsors and Collaborators

  • Boston College

Investigators

  • Principal Investigator: Christopher P Salas-Wright, PhD, Boston College

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Christopher Salas-Wright, Professor, Boston College
ClinicalTrials.gov Identifier:
NCT05240313
Other Study ID Numbers:
  • AA026645
First Posted:
Feb 15, 2022
Last Update Posted:
Feb 15, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Christopher Salas-Wright, Professor, Boston College
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 15, 2022