Trial Outcomes & Findings for Community Trial in the Cherokee Nation (NCT NCT04839978)
NCT ID: NCT04839978
Last Updated: 2025-06-19
Results Overview
The number of days of alcohol use in the past 30 days is compared between study arms.
COMPLETED
NA
919 participants
Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)
2025-06-19
Participant Flow
A total of 919 participants were enrolled from 20 high schools in the Cherokee Nation Reservation, in Tahlequah, Oklahoma, USA. Participant enrollment began on September 29, 2021 (the day of the Baseline survey) and the assessment at the end of high school (spring of 12th grade) occurred on May 17, 2024. The final study assessment for the 6-months post-graduation time point occurred on December 31, 2024.
Unit of analysis: high schools
Participant milestones
| Measure |
Preventive Intervention
Students in schools assigned to the preventive intervention study condition taking part in the Connect school-based prevention program and the community-level Communities Mobilizing for Change and Action (CMCA) intervention.
The Connect program includes school-based screening, brief intervention and referral, and was treated as part of the participating schools' prevention programs. A computer-based screening and brief intervention was supported by Cherokee Nation Behavioral Health (CNBH) supervised Connect coaches universally, to reduce potential stigma associated with speaking to a Connect coach and to reinforce drug free norms among all students. Follow-up of moderate to high-risk youth was conducted by a Connect Coach through Zoom, other electronic communication, or in-person visits, with referral to Cherokee Nation or community services if deemed necessary.
The community-level intervention Communities Mobilizing for Change and Action (CMCA) involved educating and organizing of adult volunteers and consent was assumed by their participation. Trainings and tools were provided, including Family Action Kits, to support local families, community organizations and citizens, including information on national and local opioid and other drug use, evidence-based policies, programs and practices, and how to motivate and create family and local action for drug prevention.
|
Control Group
Students in schools assigned to the control group did not receive the Connect and CMCA interventions. Schools in the control group received usual school and community prevention and were offered the trial's programs after the end of this three-year study.
|
|---|---|---|
|
Overall Study
STARTED
|
465 10
|
454 10
|
|
Overall Study
COMPLETED
|
330 10
|
307 10
|
|
Overall Study
NOT COMPLETED
|
135 0
|
147 0
|
Reasons for withdrawal
| Measure |
Preventive Intervention
Students in schools assigned to the preventive intervention study condition taking part in the Connect school-based prevention program and the community-level Communities Mobilizing for Change and Action (CMCA) intervention.
The Connect program includes school-based screening, brief intervention and referral, and was treated as part of the participating schools' prevention programs. A computer-based screening and brief intervention was supported by Cherokee Nation Behavioral Health (CNBH) supervised Connect coaches universally, to reduce potential stigma associated with speaking to a Connect coach and to reinforce drug free norms among all students. Follow-up of moderate to high-risk youth was conducted by a Connect Coach through Zoom, other electronic communication, or in-person visits, with referral to Cherokee Nation or community services if deemed necessary.
The community-level intervention Communities Mobilizing for Change and Action (CMCA) involved educating and organizing of adult volunteers and consent was assumed by their participation. Trainings and tools were provided, including Family Action Kits, to support local families, community organizations and citizens, including information on national and local opioid and other drug use, evidence-based policies, programs and practices, and how to motivate and create family and local action for drug prevention.
|
Control Group
Students in schools assigned to the control group did not receive the Connect and CMCA interventions. Schools in the control group received usual school and community prevention and were offered the trial's programs after the end of this three-year study.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
135
|
147
|
Baseline Characteristics
Community Trial in the Cherokee Nation
Baseline characteristics by cohort
| Measure |
Preventive Intervention
n=465 Participants
Students in schools assigned to the preventive intervention study condition taking part in the Connect school-based prevention program and the community-level Communities Mobilizing for Change and Action (CMCA) intervention.
|
Control Group
n=454 Participants
Students in schools assigned to the control group did not receive the Connect and CMCA interventions. Schools in the control group received usual school and community prevention and were offered the trial's programs after the end of this three-year study.
|
Total
n=919 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
15.5 years
STANDARD_DEVIATION 0.6 • n=93 Participants
|
15.6 years
STANDARD_DEVIATION 0.7 • n=4 Participants
|
15.5 years
STANDARD_DEVIATION 0.7 • n=27 Participants
|
|
Sex/Gender, Customized
Female
|
230 Participants
n=93 Participants
|
214 Participants
n=4 Participants
|
444 Participants
n=27 Participants
|
|
Sex/Gender, Customized
Male
|
215 Participants
n=93 Participants
|
222 Participants
n=4 Participants
|
437 Participants
n=27 Participants
|
|
Sex/Gender, Customized
Decline to answer
|
20 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
35 Participants
n=27 Participants
|
|
Sex/Gender, Customized
Missing
|
0 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
American Indian Only
|
130 Participants
n=93 Participants
|
136 Participants
n=4 Participants
|
266 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White Only
|
174 Participants
n=93 Participants
|
149 Participants
n=4 Participants
|
323 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
American Indian and White
|
102 Participants
n=93 Participants
|
103 Participants
n=4 Participants
|
205 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other
|
55 Participants
n=93 Participants
|
61 Participants
n=4 Participants
|
116 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Missing
|
4 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
465 Participants
n=93 Participants
|
454 Participants
n=4 Participants
|
919 Participants
n=27 Participants
|
|
Participants reporting alcohol use in past 30 days
Alcohol use reported
|
74 Participants
n=93 Participants
|
92 Participants
n=4 Participants
|
166 Participants
n=27 Participants
|
|
Participants reporting alcohol use in past 30 days
Missing response
|
5 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Participants reporting heavy alcohol use in past 30 days
Heavy alcohol use reported
|
43 Participants
n=93 Participants
|
52 Participants
n=4 Participants
|
95 Participants
n=27 Participants
|
|
Participants reporting heavy alcohol use in past 30 days
Missing response
|
4 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Participants reporting marijuana use in past 30 days
Marijuana use reported
|
68 Participants
n=93 Participants
|
68 Participants
n=4 Participants
|
136 Participants
n=27 Participants
|
|
Participants reporting marijuana use in past 30 days
Missing response
|
7 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Participants reporting prescription opioid misuse in past 30 days
Prescription opioid misuse reported
|
21 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
38 Participants
n=27 Participants
|
|
Participants reporting prescription opioid misuse in past 30 days
Missing response
|
12 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)Population: The analysis population includes participants who completed the baseline survey as the overall number of participants analyzed. The least squares means are calculated adjusting for repeated measures with responses from all participants in the baseline population. The number of participants at each time point represents the students who completed subsequent surveys at the indicated time points. Some survey items were left unanswered by students.
The number of days of alcohol use in the past 30 days is compared between study arms.
Outcome measures
| Measure |
Preventive Intervention
n=465 Participants
Students in schools assigned to the preventive intervention study condition taking part in the Connect school-based prevention program and the community-level Communities Mobilizing for Change and Action (CMCA) intervention.
|
Control Group
n=454 Participants
Students in schools assigned to the control group did not receive the Connect and CMCA interventions. Schools in the control group received usual school and community prevention and were offered the trial's programs after the end of this three-year study.
|
|---|---|---|
|
Number of Days of Alcohol Use
Baseline (Fall of 10th Grade) to Spring of 10th Grade
|
0.71 days
Standard Error 0.17
|
0.58 days
Standard Error 0.14
|
|
Number of Days of Alcohol Use
Baseline (Fall of 10th Grade) to Fall of 11th Grade
|
0.70 days
Standard Error 0.16
|
0.70 days
Standard Error 0.16
|
|
Number of Days of Alcohol Use
Baseline (Fall of 10th Grade) to Spring of 11th Grade
|
0.69 days
Standard Error 0.15
|
0.84 days
Standard Error 0.18
|
|
Number of Days of Alcohol Use
Baseline (Fall of 10th Grade) to Fall of 12th Grade
|
0.68 days
Standard Error 0.16
|
1.01 days
Standard Error 0.22
|
|
Number of Days of Alcohol Use
Baseline (Fall of 10th Grade) to Spring of 12th Grade
|
0.66 days
Standard Error 0.17
|
1.21 days
Standard Error 0.28
|
PRIMARY outcome
Timeframe: Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)Population: The analysis population includes participants who completed the baseline survey as the overall number of participants analyzed. The least squares means are calculated adjusting for repeated measures with responses from all participants in the baseline population. The number of participants at each time point represents the students who completed subsequent surveys at the indicated time points. Some survey items were left unanswered by students.
The number of days of heavy alcohol use in the past 30 days is compared between study arms. Heavy alcohol use is defined as having at least four (among young women) or five (among young men) alcoholic drinks within a couple of hours.
Outcome measures
| Measure |
Preventive Intervention
n=465 Participants
Students in schools assigned to the preventive intervention study condition taking part in the Connect school-based prevention program and the community-level Communities Mobilizing for Change and Action (CMCA) intervention.
|
Control Group
n=454 Participants
Students in schools assigned to the control group did not receive the Connect and CMCA interventions. Schools in the control group received usual school and community prevention and were offered the trial's programs after the end of this three-year study.
|
|---|---|---|
|
Number of Days of Heavy Alcohol Use
Baseline (Fall of 10th Grade) to Spring of 10th Grade
|
0.51 days
Standard Error 0.11
|
0.30 days
Standard Error 0.07
|
|
Number of Days of Heavy Alcohol Use
Baseline (Fall of 10th Grade) to Fall of 11th Grade
|
0.50 days
Standard Error 0.10
|
0.40 days
Standard Error 0.09
|
|
Number of Days of Heavy Alcohol Use
Baseline (Fall of 10th Grade) to Spring of 11th Grade
|
0.48 days
Standard Error 0.10
|
0.52 days
Standard Error 0.11
|
|
Number of Days of Heavy Alcohol Use
Baseline (Fall of 10th Grade) to Fall of 12th Grade
|
0.47 days
Standard Error 0.10
|
0.68 days
Standard Error 0.14
|
|
Number of Days of Heavy Alcohol Use
Baseline (Fall of 10th Grade) to Spring of 12th Grade
|
0.46 days
Standard Error 0.11
|
0.90 days
Standard Error 0.20
|
PRIMARY outcome
Timeframe: Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)Population: The analysis population includes participants who completed the baseline survey as the overall number of participants analyzed. The least squares means are calculated adjusting for repeated measures with responses from all participants in the baseline population. The number of participants at each time point represents the students who completed subsequent surveys at the indicated time points. Some survey items were left unanswered by students.
The number of days of marijuana use in the past 30 days is compared between study arms.
Outcome measures
| Measure |
Preventive Intervention
n=465 Participants
Students in schools assigned to the preventive intervention study condition taking part in the Connect school-based prevention program and the community-level Communities Mobilizing for Change and Action (CMCA) intervention.
|
Control Group
n=454 Participants
Students in schools assigned to the control group did not receive the Connect and CMCA interventions. Schools in the control group received usual school and community prevention and were offered the trial's programs after the end of this three-year study.
|
|---|---|---|
|
Number of Days of Marijuana Use
Baseline (Fall of 10th Grade) to Spring of 10th Grade
|
1.53 days
Standard Error 0.20
|
1.71 days
Standard Error 0.22
|
|
Number of Days of Marijuana Use
Baseline (Fall of 10th Grade) to Fall of 11th Grade
|
1.50 days
Standard Error 0.18
|
1.88 days
Standard Error 0.21
|
|
Number of Days of Marijuana Use
Baseline (Fall of 10th Grade) to Spring of 11th Grade
|
1.46 days
Standard Error 0.18
|
2.07 days
Standard Error 0.23
|
|
Number of Days of Marijuana Use
Baseline (Fall of 10th Grade) to Fall of 12th Grade
|
1.44 days
Standard Error 0.19
|
2.28 days
Standard Error 0.27
|
|
Number of Days of Marijuana Use
Baseline (Fall of 10th Grade) to Spring of 12th Grade
|
1.41 days
Standard Error 0.22
|
2.51 days
Standard Error 0.35
|
PRIMARY outcome
Timeframe: Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)Population: The analysis population includes participants who completed the baseline survey as the overall number of participants analyzed. The least squares means are calculated adjusting for repeated measures with responses from all participants in the baseline population. The number of participants at each time point represents the students who completed subsequent surveys at the indicated time points. Some survey items were left unanswered by students.
The number of days of opioid drug misuse use in the past 30 days is compared between study arms.
Outcome measures
| Measure |
Preventive Intervention
n=465 Participants
Students in schools assigned to the preventive intervention study condition taking part in the Connect school-based prevention program and the community-level Communities Mobilizing for Change and Action (CMCA) intervention.
|
Control Group
n=454 Participants
Students in schools assigned to the control group did not receive the Connect and CMCA interventions. Schools in the control group received usual school and community prevention and were offered the trial's programs after the end of this three-year study.
|
|---|---|---|
|
Number of Days of Opioid Misuse
Baseline (Fall of 10th Grade) to Fall of 11th Grade
|
0.19 days
Standard Error 0.07
|
0.10 days
Standard Error 0.04
|
|
Number of Days of Opioid Misuse
Baseline (Fall of 10th Grade) to Spring of 10th Grade
|
0.24 days
Standard Error 0.09
|
0.07 days
Standard Error 0.04
|
|
Number of Days of Opioid Misuse
Baseline (Fall of 10th Grade) to Spring of 11th Grade
|
0.15 days
Standard Error 0.05
|
0.13 days
Standard Error 0.05
|
|
Number of Days of Opioid Misuse
Baseline (Fall of 10th Grade) to Fall of 12th Grade
|
0.12 days
Standard Error 0.05
|
0.17 days
Standard Error 0.07
|
|
Number of Days of Opioid Misuse
Baseline (Fall of 10th Grade) to Spring of 12th Grade
|
0.10 days
Standard Error 0.05
|
0.23 days
Standard Error 0.10
|
SECONDARY outcome
Timeframe: Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)Population: The analysis population includes participants who completed the baseline survey as the overall number of participants analyzed. The least squares means are calculated adjusting for repeated measures with responses from all participants in the baseline population. The number of participants at each time point represents the students who completed subsequent surveys at the indicated time points. Some survey items were left unanswered by students.
Social support from parents/caregivers is assessed with 6 items which are responded to on a 4-point scale where 1 = never and 4 = often. The total score is expressed as the mean across items and ranges from 1 to 4, with higher scores indicating greater support.
Outcome measures
| Measure |
Preventive Intervention
n=465 Participants
Students in schools assigned to the preventive intervention study condition taking part in the Connect school-based prevention program and the community-level Communities Mobilizing for Change and Action (CMCA) intervention.
|
Control Group
n=454 Participants
Students in schools assigned to the control group did not receive the Connect and CMCA interventions. Schools in the control group received usual school and community prevention and were offered the trial's programs after the end of this three-year study.
|
|---|---|---|
|
Social Support From Parent/Caregiver
Baseline (Fall of 10th Grade) to Spring of 10th Grade
|
3.50 score on a scale
Standard Error 0.03
|
3.45 score on a scale
Standard Error 0.03
|
|
Social Support From Parent/Caregiver
Baseline (Fall of 10th Grade) to Fall of 11th Grade
|
3.50 score on a scale
Standard Error 0.03
|
3.47 score on a scale
Standard Error 0.03
|
|
Social Support From Parent/Caregiver
Baseline (Fall of 10th Grade) to Spring of 11th Grade
|
3.49 score on a scale
Standard Error 0.02
|
3.48 score on a scale
Standard Error 0.03
|
|
Social Support From Parent/Caregiver
Baseline (Fall of 10th Grade) to Fall of 12th Grade
|
3.49 score on a scale
Standard Error 0.03
|
3.50 score on a scale
Standard Error 0.03
|
|
Social Support From Parent/Caregiver
Baseline (Fall of 10th Grade) to Spring of 12th Grade
|
3.49 score on a scale
Standard Error 0.03
|
3.51 score on a scale
Standard Error 0.03
|
SECONDARY outcome
Timeframe: Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)Population: The analysis population includes participants who completed the baseline survey as the overall number of participants analyzed. The least squares means are calculated adjusting for repeated measures with responses from all participants in the baseline population. The number of participants at each time point represents the students who completed subsequent surveys at the indicated time points. Some survey items were left unanswered by students.
Social support from a friend is assessed with 6 items, which are responded to on a 4-point scale where 1 = never and 4 = often. The total score is expressed as the mean across items and ranges from 1 to 4, with higher scores indicating greater support.
Outcome measures
| Measure |
Preventive Intervention
n=465 Participants
Students in schools assigned to the preventive intervention study condition taking part in the Connect school-based prevention program and the community-level Communities Mobilizing for Change and Action (CMCA) intervention.
|
Control Group
n=454 Participants
Students in schools assigned to the control group did not receive the Connect and CMCA interventions. Schools in the control group received usual school and community prevention and were offered the trial's programs after the end of this three-year study.
|
|---|---|---|
|
Social Support From Friend
Baseline (Fall of 10th Grade) to Spring of 10th Grade
|
3.43 score on a scale
Standard Error 0.03
|
3.39 score on a scale
Standard Error 0.03
|
|
Social Support From Friend
Baseline (Fall of 10th Grade) to Fall of 11th Grade
|
3.43 score on a scale
Standard Error 0.03
|
3.40 score on a scale
Standard Error 0.03
|
|
Social Support From Friend
Baseline (Fall of 10th Grade) to Spring of 11th Grade
|
3.44 score on a scale
Standard Error 0.03
|
3.41 score on a scale
Standard Error 0.03
|
|
Social Support From Friend
Baseline (Fall of 10th Grade) to Fall of 12th Grade
|
3.44 score on a scale
Standard Error 0.03
|
3.43 score on a scale
Standard Error 0.03
|
|
Social Support From Friend
Baseline (Fall of 10th Grade) to Spring of 12th Grade
|
3.44 score on a scale
Standard Error 0.04
|
3.44 score on a scale
Standard Error 0.04
|
SECONDARY outcome
Timeframe: Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)Population: The analysis population includes participants who completed the baseline survey as the overall number of participants analyzed. The least squares means are calculated adjusting for repeated measures with responses from all participants in the baseline population. The number of participants at each time point represents the students who completed subsequent surveys at the indicated time points. Some survey items were left unanswered by students.
Social support from a teacher is assessed with 6 items, which are responded to on a 4-point scale where 1 = never and 4 = often. The total score is expressed as the mean across items and ranges from 1 to 4, with higher scores indicating greater support.
Outcome measures
| Measure |
Preventive Intervention
n=465 Participants
Students in schools assigned to the preventive intervention study condition taking part in the Connect school-based prevention program and the community-level Communities Mobilizing for Change and Action (CMCA) intervention.
|
Control Group
n=454 Participants
Students in schools assigned to the control group did not receive the Connect and CMCA interventions. Schools in the control group received usual school and community prevention and were offered the trial's programs after the end of this three-year study.
|
|---|---|---|
|
Social Support From Teacher
Baseline (Fall of 10th Grade) to Spring of 10th Grade
|
3.25 score on a scale
Standard Error 0.03
|
3.19 score on a scale
Standard Error 0.03
|
|
Social Support From Teacher
Baseline (Fall of 10th Grade) to Fall of 11th Grade
|
3.27 score on a scale
Standard Error 0.03
|
3.22 score on a scale
Standard Error 0.03
|
|
Social Support From Teacher
Baseline (Fall of 10th Grade) to Spring of 11th Grade
|
3.29 score on a scale
Standard Error 0.03
|
3.25 score on a scale
Standard Error 0.03
|
|
Social Support From Teacher
Baseline (Fall of 10th Grade) to Fall of 12th Grade
|
3.31 score on a scale
Standard Error 0.03
|
3.28 score on a scale
Standard Error 0.03
|
|
Social Support From Teacher
Baseline (Fall of 10th Grade) to Spring of 12th Grade
|
3.33 score on a scale
Standard Error 0.04
|
3.31 score on a scale
Standard Error 0.04
|
SECONDARY outcome
Timeframe: Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)Population: The analysis population includes participants who completed the baseline survey as the overall number of participants analyzed. The least squares means are calculated adjusting for repeated measures with responses from all participants in the baseline population. The number of participants at each time point represents the students who completed subsequent surveys at the indicated time points. Some survey items were left unanswered by students.
Social support from an adult, other than a parent/caregiver or teacher, is assessed with 6 items which are responded to on a 4-point scale where 1 = never and 4 = often. The total score is expressed as the mean across items and ranges from 1 to 4, with higher scores indicating greater support.
Outcome measures
| Measure |
Preventive Intervention
n=465 Participants
Students in schools assigned to the preventive intervention study condition taking part in the Connect school-based prevention program and the community-level Communities Mobilizing for Change and Action (CMCA) intervention.
|
Control Group
n=454 Participants
Students in schools assigned to the control group did not receive the Connect and CMCA interventions. Schools in the control group received usual school and community prevention and were offered the trial's programs after the end of this three-year study.
|
|---|---|---|
|
Social Support From Other Adult
Baseline (Fall of 10th Grade) to Spring of 10th Grade
|
3.05 score on a scale
Standard Error 0.05
|
3.06 score on a scale
Standard Error 0.05
|
|
Social Support From Other Adult
Baseline (Fall of 10th Grade) to Fall of 11th Grade
|
3.09 score on a scale
Standard Error 0.04
|
3.09 score on a scale
Standard Error 0.04
|
|
Social Support From Other Adult
Baseline (Fall of 10th Grade) to Spring of 11th Grade
|
3.14 score on a scale
Standard Error 0.04
|
3.11 score on a scale
Standard Error 0.04
|
|
Social Support From Other Adult
Baseline (Fall of 10th Grade) to Fall of 12th Grade
|
3.18 score on a scale
Standard Error 0.05
|
3.13 score on a scale
Standard Error 0.05
|
|
Social Support From Other Adult
Baseline (Fall of 10th Grade) to Spring of 12th Grade
|
3.22 score on a scale
Standard Error 0.05
|
3.15 score on a scale
Standard Error 0.05
|
SECONDARY outcome
Timeframe: Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)Population: The analysis population includes participants who completed the baseline survey as the overall number of participants analyzed. The least squares means are calculated adjusting for repeated measures with responses from all participants in the baseline population. The number of participants at each time point represents the students who completed subsequent surveys at the indicated time points. Some survey items were left unanswered by students.
Ease or difficulty in accessing alcohol is assessed with 4 items using a 4-point scale where 1 = very difficult to get and 4 = very easy to get. The total score is expressed as the mean across items and ranges from 1 to 4, with higher scores indicating greater ease of availability.
Outcome measures
| Measure |
Preventive Intervention
n=465 Participants
Students in schools assigned to the preventive intervention study condition taking part in the Connect school-based prevention program and the community-level Communities Mobilizing for Change and Action (CMCA) intervention.
|
Control Group
n=454 Participants
Students in schools assigned to the control group did not receive the Connect and CMCA interventions. Schools in the control group received usual school and community prevention and were offered the trial's programs after the end of this three-year study.
|
|---|---|---|
|
Perceived Availability of Alcohol
Baseline (Fall of 10th Grade) to Spring of 10th Grade
|
2.18 score on a scale
Standard Error 0.07
|
2.22 score on a scale
Standard Error 0.07
|
|
Perceived Availability of Alcohol
Baseline (Fall of 10th Grade) to Fall of 11th Grade
|
2.20 score on a scale
Standard Error 0.06
|
2.27 score on a scale
Standard Error 0.07
|
|
Perceived Availability of Alcohol
Baseline (Fall of 10th Grade) to Spring of 11th Grade
|
2.22 score on a scale
Standard Error 0.06
|
2.32 score on a scale
Standard Error 0.07
|
|
Perceived Availability of Alcohol
Baseline (Fall of 10th Grade) to Fall of 12th Grade
|
2.24 score on a scale
Standard Error 0.07
|
2.37 score on a scale
Standard Error 0.07
|
|
Perceived Availability of Alcohol
Baseline (Fall of 10th Grade) to Spring of 12th Grade
|
2.26 score on a scale
Standard Error 0.07
|
2.42 score on a scale
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)Population: The analysis population includes participants who completed the baseline survey as the overall number of participants analyzed. The least squares means are calculated adjusting for repeated measures with responses from all participants in the baseline population. The number of participants at each time point represents the students who completed subsequent surveys at the indicated time points. Some survey items were left unanswered by students.
Ease or difficulty in accessing marijuana is assessed with 5 items using a 4-point scale where 1 = very difficult to get and 4 = very easy to get. The total score is expressed as the mean across items and ranges from 1 to 4, with higher scores indicating greater ease of availability.
Outcome measures
| Measure |
Preventive Intervention
n=465 Participants
Students in schools assigned to the preventive intervention study condition taking part in the Connect school-based prevention program and the community-level Communities Mobilizing for Change and Action (CMCA) intervention.
|
Control Group
n=454 Participants
Students in schools assigned to the control group did not receive the Connect and CMCA interventions. Schools in the control group received usual school and community prevention and were offered the trial's programs after the end of this three-year study.
|
|---|---|---|
|
Perceived Availability of Marijuana
Baseline (Fall of 10th Grade) to Spring of 10th Grade
|
2.04 score on a scale
Standard Error 0.07
|
2.10 score on a scale
Standard Error 0.07
|
|
Perceived Availability of Marijuana
Baseline (Fall of 10th Grade) to Fall of 11th Grade
|
2.06 score on a scale
Standard Error 0.07
|
2.14 score on a scale
Standard Error 0.07
|
|
Perceived Availability of Marijuana
Baseline (Fall of 10th Grade) to Spring of 11th Grade
|
2.08 score on a scale
Standard Error 0.07
|
2.18 score on a scale
Standard Error 0.07
|
|
Perceived Availability of Marijuana
Baseline (Fall of 10th Grade) to Fall of 12th Grade
|
2.10 score on a scale
Standard Error 0.07
|
2.23 score on a scale
Standard Error 0.07
|
|
Perceived Availability of Marijuana
Baseline (Fall of 10th Grade) to Spring of 12th Grade
|
2.12 score on a scale
Standard Error 0.07
|
2.27 score on a scale
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)Population: The analysis population includes participants who completed the baseline survey as the overall number of participants analyzed. The least squares means are calculated adjusting for repeated measures with responses from all participants in the baseline population. The number of participants at each time point represents the students who completed subsequent surveys at the indicated time points. Some survey items were left unanswered by students.
Ease or difficulty in accessing prescription opioids is assessed with 5 items using a 4-point scale where 1 = very difficult to get and 4 = very easy to get. The total score is expressed as the mean across items and ranges from 1 to 4, with higher scores indicating greater ease of availability.
Outcome measures
| Measure |
Preventive Intervention
n=465 Participants
Students in schools assigned to the preventive intervention study condition taking part in the Connect school-based prevention program and the community-level Communities Mobilizing for Change and Action (CMCA) intervention.
|
Control Group
n=454 Participants
Students in schools assigned to the control group did not receive the Connect and CMCA interventions. Schools in the control group received usual school and community prevention and were offered the trial's programs after the end of this three-year study.
|
|---|---|---|
|
Perceived Availability of Prescription Opioids
Baseline (Fall of 10th Grade) to Spring of 10th Grade
|
1.52 score on a scale
Standard Error 0.04
|
1.47 score on a scale
Standard Error 0.04
|
|
Perceived Availability of Prescription Opioids
Baseline (Fall of 10th Grade) to Fall of 11th Grade
|
1.51 score on a scale
Standard Error 0.03
|
1.49 score on a scale
Standard Error 0.03
|
|
Perceived Availability of Prescription Opioids
Baseline (Fall of 10th Grade) to Spring of 11th Grade
|
1.49 score on a scale
Standard Error 0.03
|
1.51 score on a scale
Standard Error 0.03
|
|
Perceived Availability of Prescription Opioids
Baseline (Fall of 10th Grade) to Fall of 12th Grade
|
1.48 score on a scale
Standard Error 0.03
|
1.53 score on a scale
Standard Error 0.04
|
|
Perceived Availability of Prescription Opioids
Baseline (Fall of 10th Grade) to Spring of 12th Grade
|
1.47 score on a scale
Standard Error 0.04
|
1.55 score on a scale
Standard Error 0.04
|
SECONDARY outcome
Timeframe: Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)Population: The analysis population includes participants who completed the baseline survey as the overall number of participants analyzed. The least squares means are calculated adjusting for repeated measures with responses from all participants in the baseline population. The number of participants at each time point represents the students who completed subsequent surveys at the indicated time points. Some survey items were left unanswered by students.
Participants are asked 4 items to assess if they think various social groups (parents, community adults, peers, self) disapprove of young people drinking alcohol. Responses are given as 1 = don't disapprove, 2 = disapprove, and 3 = strongly disapprove. The total score is expressed as the mean across items and ranges from 1 to 3, with higher scores indicating stronger disapproval
Outcome measures
| Measure |
Preventive Intervention
n=465 Participants
Students in schools assigned to the preventive intervention study condition taking part in the Connect school-based prevention program and the community-level Communities Mobilizing for Change and Action (CMCA) intervention.
|
Control Group
n=454 Participants
Students in schools assigned to the control group did not receive the Connect and CMCA interventions. Schools in the control group received usual school and community prevention and were offered the trial's programs after the end of this three-year study.
|
|---|---|---|
|
Social Normative Beliefs About Alcohol Use
Baseline (Fall of 10th Grade) to Spring of 10th Grade
|
2.11 score on a scale
Standard Error 0.03
|
2.03 score on a scale
Standard Error 0.03
|
|
Social Normative Beliefs About Alcohol Use
Baseline (Fall of 10th Grade) to Fall of 11th Grade
|
2.10 score on a scale
Standard Error 0.03
|
2.02 score on a scale
Standard Error 0.03
|
|
Social Normative Beliefs About Alcohol Use
Baseline (Fall of 10th Grade) to Spring of 11th Grade
|
2.10 score on a scale
Standard Error 0.03
|
2.01 score on a scale
Standard Error 0.03
|
|
Social Normative Beliefs About Alcohol Use
Baseline (Fall of 10th Grade) to Fall of 12th Grade
|
2.09 score on a scale
Standard Error 0.03
|
2.00 score on a scale
Standard Error 0.03
|
|
Social Normative Beliefs About Alcohol Use
Baseline (Fall of 10th Grade) to Spring of 12th Grade
|
2.08 score on a scale
Standard Error 0.03
|
1.99 score on a scale
Standard Error 0.03
|
SECONDARY outcome
Timeframe: Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)Population: The analysis population includes participants who completed the baseline survey as the overall number of participants analyzed. The least squares means are calculated adjusting for repeated measures with responses from all participants in the baseline population. The number of participants at each time point represents the students who completed subsequent surveys at the indicated time points. Some survey items were left unanswered by students.
Participants are asked 4 items to assess if they think various social groups (parents, community adults, peers, self) disapprove of young people using marijuana. Responses are given as 1 = don't disapprove, 2 = disapprove, and 3 = strongly disapprove. The total score is expressed as the mean across items and ranges from 1 to 3, with higher scores indicating stronger disapproval.
Outcome measures
| Measure |
Preventive Intervention
n=465 Participants
Students in schools assigned to the preventive intervention study condition taking part in the Connect school-based prevention program and the community-level Communities Mobilizing for Change and Action (CMCA) intervention.
|
Control Group
n=454 Participants
Students in schools assigned to the control group did not receive the Connect and CMCA interventions. Schools in the control group received usual school and community prevention and were offered the trial's programs after the end of this three-year study.
|
|---|---|---|
|
Social Normative Beliefs About Marijuana
Baseline (Fall of 10th Grade) to Spring of 10th Grade
|
2.16 score on a scale
Standard Error 0.03
|
2.08 score on a scale
Standard Error 0.03
|
|
Social Normative Beliefs About Marijuana
Baseline (Fall of 10th Grade) to Fall of 11th Grade
|
2.16 score on a scale
Standard Error 0.03
|
2.09 score on a scale
Standard Error 0.03
|
|
Social Normative Beliefs About Marijuana
Baseline (Fall of 10th Grade) to Spring of 11th Grade
|
2.16 score on a scale
Standard Error 0.03
|
2.09 score on a scale
Standard Error 0.03
|
|
Social Normative Beliefs About Marijuana
Baseline (Fall of 10th Grade) to Fall of 12th Grade
|
2.16 score on a scale
Standard Error 0.03
|
2.09 score on a scale
Standard Error 0.03
|
|
Social Normative Beliefs About Marijuana
Baseline (Fall of 10th Grade) to Spring of 12th Grade
|
2.15 score on a scale
Standard Error 0.04
|
2.10 score on a scale
Standard Error 0.04
|
SECONDARY outcome
Timeframe: Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)Population: The analysis population includes participants who completed the baseline survey as the overall number of participants analyzed. The least squares means are calculated adjusting for repeated measures with responses from all participants in the baseline population. The number of participants at each time point represents the students who completed subsequent surveys at the indicated time points. Some survey items were left unanswered by students.
Participants are asked 4 items to assess if they think various social groups (parents, community adults, peers, self) disapprove of young people missing prescription opioids. Responses are given as 1 = don't disapprove, 2 = disapprove, and 3 = strongly disapprove. The total score is expressed as the mean across items and ranges from 1 to 3, with higher scores indicating stronger disapproval.
Outcome measures
| Measure |
Preventive Intervention
n=465 Participants
Students in schools assigned to the preventive intervention study condition taking part in the Connect school-based prevention program and the community-level Communities Mobilizing for Change and Action (CMCA) intervention.
|
Control Group
n=454 Participants
Students in schools assigned to the control group did not receive the Connect and CMCA interventions. Schools in the control group received usual school and community prevention and were offered the trial's programs after the end of this three-year study.
|
|---|---|---|
|
Social Normative Beliefs About Prescription Opioids
Baseline (Fall of 10th Grade) to Spring of 10th Grade
|
2.54 score on a scale
Standard Error 0.03
|
2.46 score on a scale
Standard Error 0.03
|
|
Social Normative Beliefs About Prescription Opioids
Baseline (Fall of 10th Grade) to Fall of 11th Grade
|
2.55 score on a scale
Standard Error 0.02
|
2.49 score on a scale
Standard Error 0.02
|
|
Social Normative Beliefs About Prescription Opioids
Baseline (Fall of 10th Grade) to Spring of 11th Grade
|
2.56 score on a scale
Standard Error 0.02
|
2.51 score on a scale
Standard Error 0.02
|
|
Social Normative Beliefs About Prescription Opioids
Baseline (Fall of 10th Grade) to Fall of 12th Grade
|
2.57 score on a scale
Standard Error 0.03
|
2.54 score on a scale
Standard Error 0.03
|
|
Social Normative Beliefs About Prescription Opioids
Baseline (Fall of 10th Grade) to Spring of 12th Grade
|
2.58 score on a scale
Standard Error 0.03
|
2.56 score on a scale
Standard Error 0.03
|
SECONDARY outcome
Timeframe: Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)Population: The analysis population includes participants who completed the baseline survey as the overall number of participants analyzed. The least squares means are calculated adjusting for repeated measures with responses from all participants in the baseline population. The number of participants at each time point represents the students who completed subsequent surveys at the indicated time points. Some survey items were left unanswered by students.
Self-efficacy is assessed with 3 items asking how easy or hard it would be for participants to ask for help or refuse alcohol or drugs. Responses given on a 4-point scale, where 1 = very easy and 4 = very hard. The total score is expressed as the mean across items and ranges from 1 to 4, with lower scores indicating increased self-efficacy.
Outcome measures
| Measure |
Preventive Intervention
n=465 Participants
Students in schools assigned to the preventive intervention study condition taking part in the Connect school-based prevention program and the community-level Communities Mobilizing for Change and Action (CMCA) intervention.
|
Control Group
n=454 Participants
Students in schools assigned to the control group did not receive the Connect and CMCA interventions. Schools in the control group received usual school and community prevention and were offered the trial's programs after the end of this three-year study.
|
|---|---|---|
|
Self-Efficacy
Baseline (Fall of 10th Grade) to Spring of 10th Grade
|
1.59 score on a scale
Standard Error 0.03
|
1.65 score on a scale
Standard Error 0.03
|
|
Self-Efficacy
Baseline (Fall of 10th Grade) to Fall of 11th Grade
|
1.58 score on a scale
Standard Error 0.02
|
1.64 score on a scale
Standard Error 0.03
|
|
Self-Efficacy
Baseline (Fall of 10th Grade) to Spring of 11th Grade
|
1.57 score on a scale
Standard Error 0.02
|
1.63 score on a scale
Standard Error 0.02
|
|
Self-Efficacy
Baseline (Fall of 10th Grade) to Fall of 12th Grade
|
1.55 score on a scale
Standard Error 0.03
|
1.62 score on a scale
Standard Error 0.03
|
|
Self-Efficacy
Baseline (Fall of 10th Grade) to Spring of 12th Grade
|
1.54 score on a scale
Standard Error 0.04
|
1.60 score on a scale
Standard Error 0.04
|
SECONDARY outcome
Timeframe: Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)Population: The analysis population includes participants who completed the baseline survey as the overall number of participants analyzed. The least squares means are calculated adjusting for repeated measures with responses from all participants in the baseline population. The number of participants at each time point represents the students who completed subsequent surveys at the indicated time points. Some survey items were left unanswered by students.
Normative estimates of peer drug use (alcohol, marijuana, prescription opioid misuse) are assessed with 3 items asking about how many of their peers in school used drugs in the past year. Possible responses are 1 = none or almost none, 2 = less than half, 3 = about half, 4 = more than half, and 5 = almost all or all. The total score is expressed as the mean across items and ranges from 1 to 5, with higher scores indicating higher normative estimates of peer drug use.
Outcome measures
| Measure |
Preventive Intervention
n=465 Participants
Students in schools assigned to the preventive intervention study condition taking part in the Connect school-based prevention program and the community-level Communities Mobilizing for Change and Action (CMCA) intervention.
|
Control Group
n=454 Participants
Students in schools assigned to the control group did not receive the Connect and CMCA interventions. Schools in the control group received usual school and community prevention and were offered the trial's programs after the end of this three-year study.
|
|---|---|---|
|
Normative Estimates of Peer Drug Use
Baseline (Fall of 10th Grade) to Spring of 10th Grade
|
2.50 score on a scale
Standard Error 0.06
|
2.51 score on a scale
Standard Error 0.06
|
|
Normative Estimates of Peer Drug Use
Baseline (Fall of 10th Grade) to Fall of 11th Grade
|
2.45 score on a scale
Standard Error 0.06
|
2.52 score on a scale
Standard Error 0.06
|
|
Normative Estimates of Peer Drug Use
Baseline (Fall of 10th Grade) to Spring of 11th Grade
|
2.41 score on a scale
Standard Error 0.06
|
2.52 score on a scale
Standard Error 0.06
|
|
Normative Estimates of Peer Drug Use
Baseline (Fall of 10th Grade) to Fall of 12th Grade
|
2.36 score on a scale
Standard Error 0.06
|
2.52 score on a scale
Standard Error 0.06
|
|
Normative Estimates of Peer Drug Use
Baseline (Fall of 10th Grade) to Spring of 12th Grade
|
2.32 score on a scale
Standard Error 0.07
|
2.52 score on a scale
Standard Error 0.07
|
SECONDARY outcome
Timeframe: 6 Months Post-GraduationThe number of days of alcohol use in the past 30 days is compared between study arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 Months Post-GraduationThe number of days of heavy alcohol use in the past 30 days is compared between study arms. Heavy alcohol use is defined as having at least four (among young women) or five (among young men) alcoholic drinks within a couple of hours.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 Months Post-GraduationThe number of days of marijuana use in the past 30 days is compared between study arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 Months Post-GraduationThe number of days of prescription opioid misuse in the past 30 days is compared between study arms.
Outcome measures
Outcome data not reported
Adverse Events
Preventive Intervention
Control Group
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