Alcohol DrinkingkiR-veneNCT05240313
Preventing Alcohol and Other Drug Use and Violence Among Latino Youth
A study testing kiR venezolano in people with Alcohol Drinking and Violence in Adolescence, run by Boston College at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 11 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking, Violence in Adolescence
- What is being tested?
- kiR venezolano
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2022to 1 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Born in Venezuela
- Residing in U.S.
- Within age range
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Alcohol Drinking, Violence in Adolescence
- Being tested
- kiR venezolano
- Keywords
- Latino, Adolescent, Immigrant
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kiR venezolanoBehavioural
A multi-week intervention focused on drug refusal skills and self-regulation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: kiR venezolano |
| kiR + aggression | Experimental | The standard keepin' it REAL intervention, adapted for an online format, plus content on interpersonal aggression Receives: Behavioral: kiR venezolano |
| Stress Management | Active comparator | A single session focused on stress management skills. Receives: Behavioral: kiR venezolano |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start31 Jan 2022
- Primary completion31 Jul 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston College
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Christopher Salas-Wright, Boston College
- Investigators
- Christopher P Salas-Wright, PhD, Principal investigator, Boston College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05240313
- Sponsor's protocol ID
- 5110411
- Other IDs
- 5K01AA026645-05
- Acronym
- kiR-vene
- Status last verified
- Apr 2025
- First submitted
- 21 Jan 2022
- Last updated
- 24 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Alcohol and Other Drug Use and Violence Among Latino Youth
- ClinicalTrials.gov ID
- NCT05240313
- Acronym / sponsor ID
- kiR-vene / 5110411
- Conditions
- Alcohol Drinking, Violence in Adolescence
- Keywords
- Latino, Adolescent, Immigrant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Boston CollegeUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 31 Jan 2022 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 15 Feb 2022 (actual)
- Results
- Posted 24 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| keepin' it REAL (kiR) | Experimental | Behavioral: kiR venezolanoThe 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. |
| kiR + aggression | Experimental | Behavioral: kiR venezolanoThe standard keepin' it REAL intervention, adapted for an online format, plus content on interpersonal aggression |
| Stress Management | Active comparator | Behavioral: kiR venezolanoA single session focused on stress management skills. |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Born in Venezuela
- Residing in U.S.
- Within age range
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| kiR venezolanoA multi-week intervention focused on drug refusal skills and self-regulation. | Behavioural | Stress Management, keepin' it REAL (kiR), kiR + aggression |
Primary outcome
Number of Participants With No Alcohol Use
Time frame: 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
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher P Salas-Wright, PhD principal investigator
Boston College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing kiR venezolano in people with Alcohol Drinking and Violence in Adolescence, run by Boston College at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With No Alcohol Use (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.