Trial Outcomes & Findings for Preventing Alcohol and Other Drug Use and Violence Among Latino Youth (NCT NCT05240313)
NCT ID: NCT05240313
Last Updated: 2025-04-24
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
34 participants
Primary outcome timeframe
3 months
Results posted on
2025-04-24
Participant Flow
Participant milestones
| Measure |
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.
kiR venezolano: A multi-week intervention focused on drug refusal skills and self-regulation.
|
kiR + Aggression
The standard keepin' it REAL intervention was adapted for an online format, and there was content on interpersonal aggression. There was a 5-week and a 10-week version.
kiR venezolano: A multi-week intervention focused on drug refusal skills and self-regulation.
|
Stress Management
A single session focused on stress management skills.
kiR venezolano: A multi-week intervention focused on drug refusal skills and self-regulation.
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
14
|
8
|
|
Overall Study
COMPLETED
|
9
|
9
|
8
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
There were three groups involved in the trial.
Baseline characteristics by cohort
| Measure |
Keepin' it REAL (kiR)
n=12 Participants
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.
kiR venezolano: A multi-week intervention focused on drug refusal skills and self-regulation.
|
kiR + Aggression
n=14 Participants
The standard keepin' it REAL intervention was adapted for an online format, and there was content on interpersonal aggression. There was a 5-week and a 10-week version.
kiR venezolano: A multi-week intervention focused on drug refusal skills and self-regulation.
|
Stress Management
n=8 Participants
A single session focused on stress management skills.
kiR venezolano: A multi-week intervention focused on drug refusal skills and self-regulation.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
12 Participants
n=39 Participants • There were three groups involved in the trial.
|
14 Participants
n=41 Participants • There were three groups involved in the trial.
|
8 Participants
n=35 Participants • There were three groups involved in the trial.
|
34 Participants
n=31 Participants • There were three groups involved in the trial.
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=39 Participants • There were three groups involved in the trial.
|
0 Participants
n=41 Participants • There were three groups involved in the trial.
|
0 Participants
n=35 Participants • There were three groups involved in the trial.
|
0 Participants
n=31 Participants • There were three groups involved in the trial.
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants • There were three groups involved in the trial.
|
0 Participants
n=41 Participants • There were three groups involved in the trial.
|
0 Participants
n=35 Participants • There were three groups involved in the trial.
|
0 Participants
n=31 Participants • There were three groups involved in the trial.
|
|
Sex: Female, Male
Female
|
6 Participants
n=39 Participants • We had three different arms in the trial.
|
5 Participants
n=41 Participants • We had three different arms in the trial.
|
6 Participants
n=35 Participants • We had three different arms in the trial.
|
17 Participants
n=31 Participants • We had three different arms in the trial.
|
|
Sex: Female, Male
Male
|
6 Participants
n=39 Participants • We had three different arms in the trial.
|
9 Participants
n=41 Participants • We had three different arms in the trial.
|
2 Participants
n=35 Participants • We had three different arms in the trial.
|
17 Participants
n=31 Participants • We had three different arms in the trial.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=39 Participants • Our trial had three arms.
|
14 Participants
n=41 Participants • Our trial had three arms.
|
8 Participants
n=35 Participants • Our trial had three arms.
|
34 Participants
n=31 Participants • Our trial had three arms.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=39 Participants • Our trial had three arms.
|
0 Participants
n=41 Participants • Our trial had three arms.
|
0 Participants
n=35 Participants • Our trial had three arms.
|
0 Participants
n=31 Participants • Our trial had three arms.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants • Our trial had three arms.
|
0 Participants
n=41 Participants • Our trial had three arms.
|
0 Participants
n=35 Participants • Our trial had three arms.
|
0 Participants
n=31 Participants • Our trial had three arms.
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Participants who completed the baseline and 3-month follow-up.
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.
Outcome measures
| Measure |
Keepin' it REAL (kiR)
n=3 Participants
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.
kiR venezolano: A multi-week intervention focused on drug refusal skills and self-regulation.
|
kiR + Aggression
n=1 Participants
The standard keepin' it REAL intervention was adapted for an online format, and there was content on interpersonal aggression. There was a 5-week and a 10-week version.
kiR venezolano: A multi-week intervention focused on drug refusal skills and self-regulation.
|
Stress Management
A single session focused on stress management skills.
kiR venezolano: A multi-week intervention focused on drug refusal skills and self-regulation.
|
|---|---|---|---|
|
Number of Participants With No Alcohol Use
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Participants who completed baseline and three month follow up.
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.
Outcome measures
| Measure |
Keepin' it REAL (kiR)
n=3 Participants
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.
kiR venezolano: A multi-week intervention focused on drug refusal skills and self-regulation.
|
kiR + Aggression
n=1 Participants
The standard keepin' it REAL intervention was adapted for an online format, and there was content on interpersonal aggression. There was a 5-week and a 10-week version.
kiR venezolano: A multi-week intervention focused on drug refusal skills and self-regulation.
|
Stress Management
A single session focused on stress management skills.
kiR venezolano: A multi-week intervention focused on drug refusal skills and self-regulation.
|
|---|---|---|---|
|
Number of Participants With No Engagement in Interpersonal Aggression
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Keepin' it REAL (kiR)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
kiR + Aggression
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Stress Management
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place