Trial Outcomes & Findings for Substance Use Prevention Campaign for American Indian Youth (NCT NCT03051633)
NCT ID: NCT03051633
Last Updated: 2020-08-03
Results Overview
The number of students who self-reported initiated alcohol for the first time during the study period
COMPLETED
NA
528 participants
18 months
2020-08-03
Participant Flow
Participant milestones
| Measure |
Be Under Your Own Influence Intervention
School-based anti-substance use communications campaign
Be Under Your Own Influence: School based anti-drug use communications campaign
|
Control
Assessment only
|
|---|---|---|
|
Overall Study
STARTED
|
342
|
186
|
|
Overall Study
COMPLETED
|
249
|
179
|
|
Overall Study
NOT COMPLETED
|
93
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Age not reported by respondent.
Baseline characteristics by cohort
| Measure |
Be Under Your Own Influence Intervention
n=342 Participants
School-based anti-substance use communications campaign
Be Under Your Own Influence: School based anti-drug use communications campaign
|
Control
n=186 Participants
Assessment only
|
Total
n=528 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
342 Participants
n=342 Participants
|
186 Participants
n=186 Participants
|
528 Participants
n=528 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=342 Participants
|
0 Participants
n=186 Participants
|
0 Participants
n=528 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=342 Participants
|
0 Participants
n=186 Participants
|
0 Participants
n=528 Participants
|
|
Age, Continuous
|
12.5 Years
STANDARD_DEVIATION .57 • n=248 Participants • Age not reported by respondent.
|
12.5 Years
STANDARD_DEVIATION .65 • n=164 Participants • Age not reported by respondent.
|
12.5 Years
STANDARD_DEVIATION .59 • n=412 Participants • Age not reported by respondent.
|
|
Sex: Female, Male
Female
|
188 Participants
n=339 Participants • Sex data was not given by the respondent.
|
91 Participants
n=186 Participants • Sex data was not given by the respondent.
|
279 Participants
n=525 Participants • Sex data was not given by the respondent.
|
|
Sex: Female, Male
Male
|
151 Participants
n=339 Participants • Sex data was not given by the respondent.
|
95 Participants
n=186 Participants • Sex data was not given by the respondent.
|
246 Participants
n=525 Participants • Sex data was not given by the respondent.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=342 Participants
|
47 Participants
n=186 Participants
|
65 Participants
n=528 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
324 Participants
n=342 Participants
|
139 Participants
n=186 Participants
|
463 Participants
n=528 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=342 Participants
|
0 Participants
n=186 Participants
|
0 Participants
n=528 Participants
|
|
Race/Ethnicity, Customized
American Indian
|
321 Participants
n=342 Participants
|
176 Participants
n=186 Participants
|
497 Participants
n=528 Participants
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: BUYOI efficacy was tested in a five-year study with two cohorts of middle school students, and five middle schools recruited from the Northern Plains and Southwest regions of the United States, representing a recent sample of American Indian adolescents (grades 7th-8th, age at first assessment = 12.5 years).
The number of students who self-reported initiated alcohol for the first time during the study period
Outcome measures
| Measure |
Be Under Your Own Influence Intervention
n=342 Participants
School-based anti-substance use communications campaign
Be Under Your Own Influence: School based anti-drug use communications campaign
|
Control
n=186 Participants
Assessment only
|
|---|---|---|
|
Alcohol Initiation
|
160 Participants
|
109 Participants
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: BUYOI efficacy was tested in a five-year study with two cohorts of middle school students, and five middle schools recruited from the Northern Plains and Southwest regions of the United States, representing a recent sample of American Indian adolescents (grades 7th-8th, age at first assessment = 12.5 years).
Number of participants self-reporting first-time alcohol intoxication initiation during the study period.
Outcome measures
| Measure |
Be Under Your Own Influence Intervention
n=342 Participants
School-based anti-substance use communications campaign
Be Under Your Own Influence: School based anti-drug use communications campaign
|
Control
n=186 Participants
Assessment only
|
|---|---|---|
|
Alcohol Intoxication Initiation
|
90 Participants
|
62 Participants
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: BUYOI efficacy was tested in a five-year study with two cohorts of middle school students, and five middle schools recruited from the Northern Plains and Southwest regions of the United States, representing a recent sample of American Indian adolescents (grades 7th-8th, age at first assessment = 12.5 years).
Number of participants who self-reported first-time marijuana use initiation during the study period
Outcome measures
| Measure |
Be Under Your Own Influence Intervention
n=342 Participants
School-based anti-substance use communications campaign
Be Under Your Own Influence: School based anti-drug use communications campaign
|
Control
n=186 Participants
Assessment only
|
|---|---|---|
|
Marijuana Initiation
|
183 Participants
|
97 Participants
|
Adverse Events
Be Under Your Own Influence Intervention
Control
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