跳至主要内容
临床试验/NCT05240313
NCT05240313已完成不适用

Preventing Alcohol and Other Drug Use and Violence Among Latino Youth

Boston College2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2022年1月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
2
主要终点
Number of Participants With No Alcohol Use

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
11 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Number of Participants With No Alcohol Use

时间窗: 3 months

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.

Number of Participants With No Engagement in Interpersonal Aggression

时间窗: 3 months

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christopher Salas-Wright

Professor

Boston College

研究点 (2)

Loading locations...

相似试验