NCT05240313

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2022

Completed
10 days until next milestone

Study Start

First participant enrolled

January 31, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 15, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

April 24, 2025

Completed
Last Updated

April 24, 2025

Status Verified

April 1, 2025

Enrollment Period

1.5 years

First QC Date

January 21, 2022

Results QC Date

December 19, 2024

Last Update Submit

April 22, 2025

Conditions

Keywords

LatinoAdolescentImmigrant

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (3)

keepin' it REAL (kiR)

EXPERIMENTAL

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

kiR + aggression

EXPERIMENTAL

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

Behavioral: kiR venezolano

Stress Management

ACTIVE COMPARATOR

A single session focused on stress management skills.

Behavioral: kiR venezolano

Interventions

kiR venezolanoBEHAVIORAL

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

Stress Managementkeepin' it REAL (kiR)kiR + aggression

Eligibility Criteria

Age11 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Born in Venezuela
  • Residing in U.S.
  • Within age range

You may not qualify if:

  • Participants will be excluded if they are otherwise cognitively unable to successfully engage in the intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Raices Venezolanas

Doral, Florida, 33122, United States

Location

MeSH Terms

Conditions

Alcohol Drinking

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Results Point of Contact

Title
Christopher Salas-Wright
Organization
Boston College

Study Officials

  • Christopher P Salas-Wright, PhD

    Boston College

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 21, 2022

First Posted

February 15, 2022

Study Start

January 31, 2022

Primary Completion

July 31, 2023

Study Completion

August 1, 2023

Last Updated

April 24, 2025

Results First Posted

April 24, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations