An interventional study of Connect Program and Communities Mobilizing for Change and Action (CMCA) in Opioid Abuse, sponsored by Emory University. Completed at 1 site in United States. Open to participants aged 15 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-03-05.
Sponsored by Emory University · Not applicable, Interventional, and Prevention
The target population is students attending high schools in small rural towns in the 14 counties that partially or fully fall within the Cherokee Nation reservation. Following recruitment of 20 school-based clusters, clusters are allocated to either the intervention condition or delayed-intervention control condition using constrained randomization. Constrained randomization helps to ensure balanced cluster sizes as well as similar levels of risk between the intervention and control at baseline. Study participants include all 10th grade students enrolled in the participating study high schools and students will be followed into the first year after their expected graduation.
The national public health opioid crisis has disproportionately burdened rural White populations, and disproportionately burdened American Indian populations. Therefore, the Cherokee Nation (CN) and Emory University public health scientists have designed an opioid prevention trial to be conducted in at-risk rural communities in the CN (in northeast Oklahoma) with primarily White and American Indian adolescents and young adults. The goal of this study is to implement and evaluate a theory-based, integrated multi-level community intervention designed to prevent the onset and escalation of opioid and other drug misuse. The researchers propose a cluster randomized trial building directly on the success of their most recent previous trial, which demonstrated that the intervention effectively reduced alcohol and other drug use among American Indian and other youth living within the CN. Two distinct intervention approaches-community organizing as implemented in the established Communities Mobilizing for Change and Action (CMCA) intervention protocol, and universal school-based brief intervention and referral as implemented in the established Connect intervention protocol -will be expanded and integrated to further enhance effects in preventing and reducing opioid misuse. The CMCA and Connect interventions were originally designed to target adolescent alcohol use but nevertheless showed significant beneficial effects on use of other drugs, including prescription drug misuse. The proposed study will: (1) further improve the design of the interventions with increased focus on opioids, (2) test the expanded, integrated versions in a cluster randomized trial, and (3) design and test new systems for sustained implementation within existing structures of the Cherokee Nation. Building upon the extant prevention science evidence, this study will respond to a gap in evidence concerning opioid misuse prevention among at-risk adolescents transitioning to young adulthood among American Indian and other rural youth.
1,411 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
This study's enrollment of 919 is above the median of 63 across 1,123 interventional studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →Emory University is the lead sponsor of 1,386 studies on the registry; 236 are open to participants now.
Of its 229 completed or terminated interventional studies of FDA-regulated products, 174 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria:
Inclusion criteria for high schools:
Exclusion criteria for high schools:
Students in schools assigned to the preventive intervention study condition will take part in the Connect school-based prevention program and the community-level Communities Mobilizing for Change and Action (CMCA) intervention.
Behavioral: Connect Program · Behavioral: Communities Mobilizing for Change and Action (CMCA)
Students in schools assigned to the control group will not receive the Connect and CMCA interventions. Schools in the control group will receive usual school and community prevention and will be offered the trial's programs after the end of this three-year study.
The Connect program includes school-based screening, brief intervention and referral, and will be treated as part of the participating schools' prevention programs. A computer-based screening and brief intervention will be 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 will be 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) will involve educating and organizing of adult volunteers and consent will be assumed by their participation. Trainings and tools will be 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.
Number of Days of Alcohol Use
The number of days of alcohol use in the past 30 days is compared between study arms.
Time frame: 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)
Number of Days of Heavy Alcohol Use
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.
Time frame: 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)
Number of Days of Marijuana Use
The number of days of marijuana use in the past 30 days is compared between study arms.
Time frame: 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)
Number of Days of Opioid Misuse
The number of days of opioid drug misuse use in the past 30 days is compared between study arms.
Time frame: 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)
Social Support From Parent/Caregiver
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.
Time frame: 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)
Social Support From Friend
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.
Time frame: 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)
Social Support From Teacher
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.
Time frame: 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)
Social Support From Other Adult
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.
Time frame: 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)
Perceived Availability of Alcohol
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.
Time frame: 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)
Perceived Availability of Marijuana
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.
Time frame: 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)
Perceived Availability of Prescription Opioids
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.
Time frame: 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)
Social Normative Beliefs About Alcohol Use
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
Time frame: 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)
Social Normative Beliefs About Marijuana
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.
Time frame: 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)
Social Normative Beliefs About Prescription Opioids
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.
Time frame: 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)
Self-Efficacy
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.
Time frame: 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)
Normative Estimates of Peer Drug Use
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.
Time frame: 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)
Proportion of Participants With Alcohol Use 6 Months Post-Graduation
Model predicted proportion of participants with alcohol use in the past 30 days is compared between study arms. The Least Squares Mean values are limited to the 6-month post-graduation time point while adjusting for baseline use.
Time frame: 6 Months Post-Graduation
Proportion of Participants With Heavy Alcohol Use 6 Months Post-Graduation
Model predicted proportion of participants with 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. The Least Squares Mean values are limited to the 6-month post-graduation time point while adjusting for baseline use.
Time frame: 6 Months Post-Graduation
Proportion of Participants With Marijuana Use 6 Months Post-Graduation
Model predicted proportion of participants with marijuana use in the past 30 days is compared between study arms. The Least Squares Mean values are limited to the 6-month post-graduation time point while adjusting for baseline use.
Time frame: 6 Months Post-Graduation
Number of Participants With Opioid Drug Misuse 6 Months Post-Graduation
The number of participants reporting prescription opioid misuse in the past 30 days at the survey administered 6-month post-graduation.
Time frame: 6 Months Post-Graduation
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.
| Milestone | Preventive Intervention | Control Group |
|---|---|---|
| Started | 465 | 454 |
| Completed 6 months post-graduation assessment | 214 | 196 |
| Completed | 330 | 307 |
| Not completed | 135 | 147 |
| Withdrew: Lost to follow-up | 135 | 147 |
The number of days of alcohol use in the past 30 days is compared between study arms.
| days | Preventive Intervention | Control Group |
|---|---|---|
| Baseline (Fall of 10th Grade) to Spring of 10th Grade | 0.71 ± 0.17 | 0.58 ± 0.14 |
| Baseline (Fall of 10th Grade) to Fall of 11th Grade | 0.70 ± 0.16 | 0.70 ± 0.16 |
| Baseline (Fall of 10th Grade) to Spring of 11th Grade | 0.69 ± 0.15 | 0.84 ± 0.18 |
| Baseline (Fall of 10th Grade) to Fall of 12th Grade | 0.68 ± 0.16 | 1.01 ± 0.22 |
| Baseline (Fall of 10th Grade) to Spring of 12th Grade | 0.66 ± 0.17 | 1.21 ± 0.28 |
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.
| days | Preventive Intervention | Control Group |
|---|---|---|
| Baseline (Fall of 10th Grade) to Spring of 10th Grade | 0.51 ± 0.11 | 0.30 ± 0.07 |
| Baseline (Fall of 10th Grade) to Fall of 11th Grade | 0.50 ± 0.10 | 0.40 ± 0.09 |
| Baseline (Fall of 10th Grade) to Spring of 11th Grade | 0.48 ± 0.10 | 0.52 ± 0.11 |
| Baseline (Fall of 10th Grade) to Fall of 12th Grade | 0.47 ± 0.10 | 0.68 ± 0.14 |
| Baseline (Fall of 10th Grade) to Spring of 12th Grade | 0.46 ± 0.11 | 0.90 ± 0.20 |
The number of days of marijuana use in the past 30 days is compared between study arms.
| days | Preventive Intervention | Control Group |
|---|---|---|
| Baseline (Fall of 10th Grade) to Spring of 10th Grade | 1.53 ± 0.20 | 1.71 ± 0.22 |
| Baseline (Fall of 10th Grade) to Fall of 11th Grade | 1.50 ± 0.18 | 1.88 ± 0.21 |
| Baseline (Fall of 10th Grade) to Spring of 11th Grade | 1.46 ± 0.18 | 2.07 ± 0.23 |
| Baseline (Fall of 10th Grade) to Fall of 12th Grade | 1.44 ± 0.19 | 2.28 ± 0.27 |
| Baseline (Fall of 10th Grade) to Spring of 12th Grade | 1.41 ± 0.22 | 2.51 ± 0.35 |
The number of days of opioid drug misuse use in the past 30 days is compared between study arms.
| days | Preventive Intervention | Control Group |
|---|---|---|
| Baseline (Fall of 10th Grade) to Spring of 10th Grade | 0.24 ± 0.09 | 0.07 ± 0.04 |
| Baseline (Fall of 10th Grade) to Fall of 11th Grade | 0.19 ± 0.07 | 0.10 ± 0.04 |
| Baseline (Fall of 10th Grade) to Spring of 11th Grade | 0.15 ± 0.05 | 0.13 ± 0.05 |
| Baseline (Fall of 10th Grade) to Fall of 12th Grade | 0.12 ± 0.05 | 0.17 ± 0.07 |
| Baseline (Fall of 10th Grade) to Spring of 12th Grade | 0.10 ± 0.05 | 0.23 ± 0.10 |
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.
| score on a scale | Preventive Intervention | Control Group |
|---|---|---|
| Baseline (Fall of 10th Grade) to Spring of 10th Grade | 3.50 ± 0.03 | 3.45 ± 0.03 |
| Baseline (Fall of 10th Grade) to Fall of 11th Grade | 3.50 ± 0.03 | 3.47 ± 0.03 |
| Baseline (Fall of 10th Grade) to Spring of 11th Grade | 3.49 ± 0.02 | 3.48 ± 0.03 |
| Baseline (Fall of 10th Grade) to Fall of 12th Grade | 3.49 ± 0.03 | 3.50 ± 0.03 |
| Baseline (Fall of 10th Grade) to Spring of 12th Grade | 3.49 ± 0.03 | 3.51 ± 0.03 |
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.
| score on a scale | Preventive Intervention | Control Group |
|---|---|---|
| Baseline (Fall of 10th Grade) to Spring of 10th Grade | 3.43 ± 0.03 | 3.39 ± 0.03 |
| Baseline (Fall of 10th Grade) to Fall of 11th Grade | 3.43 ± 0.03 | 3.40 ± 0.03 |
| Baseline (Fall of 10th Grade) to Spring of 11th Grade | 3.44 ± 0.03 | 3.41 ± 0.03 |
| Baseline (Fall of 10th Grade) to Fall of 12th Grade | 3.44 ± 0.03 | 3.43 ± 0.03 |
| Baseline (Fall of 10th Grade) to Spring of 12th Grade | 3.44 ± 0.04 | 3.44 ± 0.04 |
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.
| score on a scale | Preventive Intervention | Control Group |
|---|---|---|
| Baseline (Fall of 10th Grade) to Spring of 10th Grade | 3.25 ± 0.03 | 3.19 ± 0.03 |
| Baseline (Fall of 10th Grade) to Fall of 11th Grade | 3.27 ± 0.03 | 3.22 ± 0.03 |
| Baseline (Fall of 10th Grade) to Spring of 11th Grade | 3.29 ± 0.03 | 3.25 ± 0.03 |
| Baseline (Fall of 10th Grade) to Fall of 12th Grade | 3.31 ± 0.03 | 3.28 ± 0.03 |
| Baseline (Fall of 10th Grade) to Spring of 12th Grade | 3.33 ± 0.04 | 3.31 ± 0.04 |
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.
| score on a scale | Preventive Intervention | Control Group |
|---|---|---|
| Baseline (Fall of 10th Grade) to Spring of 10th Grade | 3.05 ± 0.05 | 3.06 ± 0.05 |
| Baseline (Fall of 10th Grade) to Fall of 11th Grade | 3.09 ± 0.04 | 3.09 ± 0.04 |
| Baseline (Fall of 10th Grade) to Spring of 11th Grade | 3.14 ± 0.04 | 3.11 ± 0.04 |
| Baseline (Fall of 10th Grade) to Fall of 12th Grade | 3.18 ± 0.05 | 3.13 ± 0.05 |
| Baseline (Fall of 10th Grade) to Spring of 12th Grade | 3.22 ± 0.05 | 3.15 ± 0.05 |
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.
| score on a scale | Preventive Intervention | Control Group |
|---|---|---|
| Baseline (Fall of 10th Grade) to Spring of 10th Grade | 2.18 ± 0.07 | 2.22 ± 0.07 |
| Baseline (Fall of 10th Grade) to Fall of 11th Grade | 2.20 ± 0.06 | 2.27 ± 0.07 |
| Baseline (Fall of 10th Grade) to Spring of 11th Grade | 2.22 ± 0.06 | 2.32 ± 0.07 |
| Baseline (Fall of 10th Grade) to Fall of 12th Grade | 2.24 ± 0.07 | 2.37 ± 0.07 |
| Baseline (Fall of 10th Grade) to Spring of 12th Grade | 2.26 ± 0.07 | 2.42 ± 0.07 |
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.
| score on a scale | Preventive Intervention | Control Group |
|---|---|---|
| Baseline (Fall of 10th Grade) to Spring of 10th Grade | 2.04 ± 0.07 | 2.10 ± 0.07 |
| Baseline (Fall of 10th Grade) to Fall of 11th Grade | 2.06 ± 0.07 | 2.14 ± 0.07 |
| Baseline (Fall of 10th Grade) to Spring of 11th Grade | 2.08 ± 0.07 | 2.18 ± 0.07 |
| Baseline (Fall of 10th Grade) to Fall of 12th Grade | 2.10 ± 0.07 | 2.23 ± 0.07 |
| Baseline (Fall of 10th Grade) to Spring of 12th Grade | 2.12 ± 0.07 | 2.27 ± 0.07 |
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.
| score on a scale | Preventive Intervention | Control Group |
|---|---|---|
| Baseline (Fall of 10th Grade) to Spring of 10th Grade | 1.52 ± 0.04 | 1.47 ± 0.04 |
| Baseline (Fall of 10th Grade) to Fall of 11th Grade | 1.51 ± 0.03 | 1.49 ± 0.03 |
| Baseline (Fall of 10th Grade) to Spring of 11th Grade | 1.49 ± 0.03 | 1.51 ± 0.03 |
| Baseline (Fall of 10th Grade) to Fall of 12th Grade | 1.48 ± 0.03 | 1.53 ± 0.04 |
| Baseline (Fall of 10th Grade) to Spring of 12th Grade | 1.47 ± 0.04 | 1.55 ± 0.04 |
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
| score on a scale | Preventive Intervention | Control Group |
|---|---|---|
| Baseline (Fall of 10th Grade) to Spring of 10th Grade | 2.11 ± 0.03 | 2.03 ± 0.03 |
| Baseline (Fall of 10th Grade) to Fall of 11th Grade | 2.10 ± 0.03 | 2.02 ± 0.03 |
| Baseline (Fall of 10th Grade) to Spring of 11th Grade | 2.10 ± 0.03 | 2.01 ± 0.03 |
| Baseline (Fall of 10th Grade) to Fall of 12th Grade | 2.09 ± 0.03 | 2.00 ± 0.03 |
| Baseline (Fall of 10th Grade) to Spring of 12th Grade | 2.08 ± 0.03 | 1.99 ± 0.03 |
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.
| score on a scale | Preventive Intervention | Control Group |
|---|---|---|
| Baseline (Fall of 10th Grade) to Spring of 10th Grade | 2.16 ± 0.03 | 2.08 ± 0.03 |
| Baseline (Fall of 10th Grade) to Fall of 11th Grade | 2.16 ± 0.03 | 2.09 ± 0.03 |
| Baseline (Fall of 10th Grade) to Spring of 11th Grade | 2.16 ± 0.03 | 2.09 ± 0.03 |
| Baseline (Fall of 10th Grade) to Fall of 12th Grade | 2.16 ± 0.03 | 2.09 ± 0.03 |
| Baseline (Fall of 10th Grade) to Spring of 12th Grade | 2.15 ± 0.04 | 2.10 ± 0.04 |
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.
| score on a scale | Preventive Intervention | Control Group |
|---|---|---|
| Baseline (Fall of 10th Grade) to Spring of 10th Grade | 2.54 ± 0.03 | 2.46 ± 0.03 |
| Baseline (Fall of 10th Grade) to Fall of 11th Grade | 2.55 ± 0.02 | 2.49 ± 0.02 |
| Baseline (Fall of 10th Grade) to Spring of 11th Grade | 2.56 ± 0.02 | 2.51 ± 0.02 |
| Baseline (Fall of 10th Grade) to Fall of 12th Grade | 2.57 ± 0.03 | 2.54 ± 0.03 |
| Baseline (Fall of 10th Grade) to Spring of 12th Grade | 2.58 ± 0.03 | 2.56 ± 0.03 |
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.
| score on a scale | Preventive Intervention | Control Group |
|---|---|---|
| Baseline (Fall of 10th Grade) to Spring of 10th Grade | 1.59 ± 0.03 | 1.65 ± 0.03 |
| Baseline (Fall of 10th Grade) to Fall of 11th Grade | 1.58 ± 0.02 | 1.64 ± 0.03 |
| Baseline (Fall of 10th Grade) to Spring of 11th Grade | 1.57 ± 0.02 | 1.63 ± 0.02 |
| Baseline (Fall of 10th Grade) to Fall of 12th Grade | 1.55 ± 0.03 | 1.62 ± 0.03 |
| Baseline (Fall of 10th Grade) to Spring of 12th Grade | 1.54 ± 0.04 | 1.60 ± 0.04 |
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.
| score on a scale | Preventive Intervention | Control Group |
|---|---|---|
| Baseline (Fall of 10th Grade) to Spring of 10th Grade | 2.50 ± 0.06 | 2.51 ± 0.06 |
| Baseline (Fall of 10th Grade) to Fall of 11th Grade | 2.45 ± 0.06 | 2.52 ± 0.06 |
| Baseline (Fall of 10th Grade) to Spring of 11th Grade | 2.41 ± 0.06 | 2.52 ± 0.06 |
| Baseline (Fall of 10th Grade) to Fall of 12th Grade | 2.36 ± 0.06 | 2.52 ± 0.06 |
| Baseline (Fall of 10th Grade) to Spring of 12th Grade | 2.32 ± 0.07 | 2.52 ± 0.07 |
Model predicted proportion of participants with alcohol use in the past 30 days is compared between study arms. The Least Squares Mean values are limited to the 6-month post-graduation time point while adjusting for baseline use.
| proportion of participants | Preventive Intervention | Control Group |
|---|---|---|
| Proportion of Participants With Alcohol Use 6 Months Post-Graduation | 0.30 (0.23 to 0.37) | 0.47 (0.39 to 0.55) |
Model predicted proportion of participants with 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. The Least Squares Mean values are limited to the 6-month post-graduation time point while adjusting for baseline use.
| proportion of participants | Preventive Intervention | Control Group |
|---|---|---|
| Proportion of Participants With Heavy Alcohol Use 6 Months Post-Graduation | 0.15 (0.10 to 0.21) | 0.25 (0.19 to 0.33) |
Model predicted proportion of participants with marijuana use in the past 30 days is compared between study arms. The Least Squares Mean values are limited to the 6-month post-graduation time point while adjusting for baseline use.
| proportion of participants | Preventive Intervention | Control Group |
|---|---|---|
| Proportion of Participants With Marijuana Use 6 Months Post-Graduation | 0.12 (0.08 to 0.19) | 0.20 (0.13 to 0.27) |
The number of participants reporting prescription opioid misuse in the past 30 days at the survey administered 6-month post-graduation.
| Participants | Preventive Intervention | Control Group |
|---|---|---|
| Number of Participants With Opioid Drug Misuse 6 Months Post-Graduation | 1 | 3 |
Collected over Information on adverse events was collected on days when the surveys were administered, during the period of time of survey administration. 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). Adverse events were not collected during the survey administered at 6-months post-graduation.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Preventive Intervention | 0/465 (0%) | 0/465 (0%) | 0/465 (0%) |
| Control Group | 0/454 (0%) | 0/454 (0%) | 0/454 (0%) |
| Age, Continuous(years) | Preventive Intervention | Control Group | Total |
|---|---|---|---|
| Mean | 15.5 ± 0.6 | 15.6 ± 0.7 | 15.5 ± 0.7 |
| Sex/Gender, Customized(Participants) | Preventive Intervention | Control Group | Total |
|---|---|---|---|
| Female | 230 | 214 | 444 |
| Male | 215 | 222 | 437 |
| Decline to answer | 20 | 15 | 35 |
| Missing | 0 | 3 | 3 |
| Race/Ethnicity, Customized(Participants) | Preventive Intervention | Control Group | Total |
|---|---|---|---|
| American Indian Only | 130 | 136 | 266 |
| White Only | 174 | 149 | 323 |
| American Indian and White | 102 | 103 | 205 |
| Other | 55 | 61 | 116 |
| Missing | 4 | 5 | 9 |
| Region of Enrollment(Participants) | Preventive Intervention | Control Group | Total |
|---|---|---|---|
| United States | 465 | 454 | 919 |
| Participants reporting alcohol use in past 30 days(Participants) | Preventive Intervention | Control Group | Total |
|---|---|---|---|
| Alcohol use reported | 74 | 92 | 166 |
| Missing response | 5 | 2 | 7 |
| Participants reporting heavy alcohol use in past 30 days(Participants) | Preventive Intervention | Control Group | Total |
|---|---|---|---|
| Heavy alcohol use reported | 43 | 52 | 95 |
| Missing response | 4 | 7 | 11 |
| Participants reporting marijuana use in past 30 days(Participants) | Preventive Intervention | Control Group | Total |
|---|---|---|---|
| Marijuana use reported | 68 | 68 | 136 |
| Missing response | 7 | 9 | 16 |
| Participants reporting prescription opioid misuse in past 30 days(Participants) | Preventive Intervention | Control Group | Total |
|---|---|---|---|
| Prescription opioid misuse reported | 21 | 17 | 38 |
| Missing response | 12 | 18 | 30 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Deidentified participant data will be available for sharing, provided all data requests are reviewed and approved by the Cherokee Nation Institutional Review Board (IRB). Data and associated documentation sharing requires a negotiated data-sharing agreement that provides for: 1) review and approval of the data request and study protocol by the Cherokee Nation IRB, 2) a commitment to using the data only for research purposes, 3) restrictions against attempting to identify study participants, 4) a commitment to securing the data using secure computer technology, 5) a commitment to destroying data after the specific requested analyses are completed, 6) agreement to submit all presentations and manuscripts to the appropriate tribal authorities for review and approval prior to public dissemination and publication, 7) reporting responsibilities to the Cherokee Nation, 8) restrictions on redistribution of the data to third parties, and 9) proper acknowledgement of the source of the data.
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Emory University