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

Primary Purpose

Alcohol Drinking, Violence in Adolescence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
kiR venezolano
Sponsored by
Boston College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol Drinking focused on measuring Latino, Adolescent, Immigrant

Eligibility Criteria

11 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Raices Venezolanas

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

keepin' it REAL (kiR)

kiR + aggression

Stress Management

Arm Description

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.

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

A single session focused on stress management skills.

Outcomes

Primary Outcome Measures

Alcohol and other drug use
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.
Interpersonal Aggression
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.

Secondary Outcome Measures

Full Information

First Posted
January 21, 2022
Last Updated
August 16, 2023
Sponsor
Boston College
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1. Study Identification

Unique Protocol Identification Number
NCT05240313
Brief Title
Preventing Alcohol and Other Drug Use and Violence Among Latino Youth
Acronym
kiR-vene
Official Title
Preventing Alcohol and Other Drug Use and Violence Among Latino Youth
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
January 31, 2022 (Actual)
Primary Completion Date
July 31, 2023 (Actual)
Study Completion Date
August 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston College

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking, Violence in Adolescence
Keywords
Latino, Adolescent, Immigrant

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
keepin' it REAL (kiR)
Arm Type
Experimental
Arm Description
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.
Arm Title
kiR + aggression
Arm Type
Experimental
Arm Description
The standard keepin' it REAL intervention, adapted for an online format, plus content on interpersonal aggression
Arm Title
Stress Management
Arm Type
Active Comparator
Arm Description
A single session focused on stress management skills.
Intervention Type
Behavioral
Intervention Name(s)
kiR venezolano
Intervention Description
A multi-week intervention focused on drug refusal skills and self-regulation.
Primary Outcome Measure Information:
Title
Alcohol and other drug use
Description
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.
Time Frame
3 months
Title
Interpersonal Aggression
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher P Salas-Wright, PhD
Organizational Affiliation
Boston College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Raices Venezolanas
City
Doral
State/Province
Florida
ZIP/Postal Code
33122
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Preventing Alcohol and Other Drug Use and Violence Among Latino Youth

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