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| ID | Type | Description | Link |
|---|---|---|---|
| UH3DA050234 | U.S. NIH Grant/Contract | View source | |
| UG3DA050234 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preventive Intervention | Experimental | 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. |
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| Control Group | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Connect Program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Days of Alcohol Use | The number of days of alcohol use in the past 30 days is compared between study arms. | 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. | 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. | 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. | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) |
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Inclusion Criteria:
Exclusion Criteria:
Inclusion criteria for high schools:
Exclusion criteria for high schools:
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| Name | Affiliation | Role |
|---|---|---|
| Kelli Komro, PhD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cherokee Nation Reservation | Tahlequah | Oklahoma | 74464 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40768695 | Derived | Komro KA, Livingston MD, Skinner JR, Livingston BJ, Kominsky TK, Jagtiani A, Barry CM, Wagenaar AC, Cooper HLF, Harmon M, Ivanich E, LaBounty H, Gassaway AN, Talavera-Brown SL. Primary Prevention of Drug Overdoses in Rural Low-Resource and Tribal Communities: A Cluster Randomized Trial. Am J Public Health. 2025 Sep;115(9):1508-1517. doi: 10.2105/AJPH.2025.308205. | |
| 39312248 | Derived | Jagtiani A, Livingston MD, Barry CM, Talavera-Brown S, LaBounty H, Skinner JR, Livingston BJ, Lincoln AN, Komro KA. Tribal Identity, Pain Interference, and Substance Use Among American Indian and Alaska Native Adolescents. JAMA Pediatr. 2024 Nov 1;178(11):1192-1198. doi: 10.1001/jamapediatrics.2024.3284. |
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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.
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Data will available for sharing following publication of the study findings.
It is the responsibility of any external party requesting access to project data to request in writing to the project PI the specific data requested, and to apply to the Cherokee Nation IRB for such access according to procedures promulgated by the Cherokee Nation. Further, any such access is conditional on meeting all requirements specified by the Cherokee Nation IRB. Persons interested in using the data should contact the PI listed on manuscripts and publications as a means of facilitating access to the data.
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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.
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Control Group |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Days of Alcohol Use | The number of days of alcohol use in the past 30 days is compared between study arms. | 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. | Posted | Least Squares Mean | Standard Error | days | 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) |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kelli Komro, PhD | Emory University | 404-727-8742 | kkomro@emory.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 15, 2024 | Apr 3, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 30, 2020 | Jul 10, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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Sixteen to 20 high schools and surrounding towns within the 14 counties that partially or fully fall within the Cherokee Nation reservation in northeast Oklahoma will be randomly assigned to receive the preventive interventions offered by this study or usual school and community prevention. A total of 800 to 1200 students are expected to enroll from the randomized sites.
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| Communities Mobilizing for Change and Action (CMCA) | Behavioral | 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. |
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 6 Months Post-Graduation |
| 35197100 | Derived | Komro KA, Kominsky TK, Skinner JR, Livingston MD, Livingston BJ, Avance K, Lincoln AN, Barry CM, Walker AL, Pettigrew DW, Merlo LJ, Cooper HLF, Wagenaar AC. Study protocol for a cluster randomized trial of a school, family, and community intervention for preventing drug misuse among older adolescents in the Cherokee Nation. Trials. 2022 Feb 23;23(1):175. doi: 10.1186/s13063-022-06096-0. |
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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Participants reporting alcohol use in past 30 days | Count of Participants | Participants |
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| Participants reporting heavy alcohol use in past 30 days | Count of Participants | Participants |
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| Participants reporting marijuana use in past 30 days | Count of Participants | Participants |
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| Participants reporting prescription opioid misuse in past 30 days | Count of Participants | Participants |
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| OG001 | 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. |
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| Primary | 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. | 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. | Posted | Least Squares Mean | Standard Error | days | 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) |
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| Primary | Number of Days of Marijuana Use | The number of days of marijuana use in the past 30 days is compared between study arms. | 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. | Posted | Least Squares Mean | Standard Error | days | 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) |
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| Primary | 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. | 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. | Posted | Least Squares Mean | Standard Error | days | 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) |
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| Secondary | 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. | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 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) |
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| Secondary | 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. | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 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) |
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| Secondary | 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. | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 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) |
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| Secondary | 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. | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 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) |
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| Secondary | 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. | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 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) |
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| Secondary | 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. | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 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) |
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| Secondary | 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. | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 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) |
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| Secondary | 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 | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 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) |
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| Secondary | 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. | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 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) |
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| Secondary | 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. | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 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) |
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| Secondary | 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. | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 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) |
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| Secondary | 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. | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 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) |
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| Secondary | 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. | This analysis includes participants who responded to this survey item in the 6 months post-graduation assessment. | Posted | Number | 95% Confidence Interval | proportion of participants | 6 Months Post-Graduation |
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| Secondary | 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. | This analysis includes participants who responded to this survey item in the 6 months post-graduation assessment. | Posted | Number | 95% Confidence Interval | proportion of participants | 6 Months Post-Graduation |
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| Secondary | 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. | This analysis includes participants who responded to this survey item in the 6 months post-graduation assessment. | Posted | Number | 95% Confidence Interval | proportion of participants | 6 Months Post-Graduation |
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| Secondary | 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. | This analysis includes participants who responded to this survey item in the 6 months post-graduation assessment. | Posted | Count of Participants | Participants | 6 Months Post-Graduation |
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| 0 |
| 465 |
| 0 |
| 465 |
| 0 |
| 465 |
| EG001 | 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. | 0 | 454 | 0 | 454 | 0 | 454 |
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| Baseline (Fall of 10th Grade) to Fall of 11th Grade |
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| Baseline (Fall of 10th Grade) to Spring of 11th Grade |
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| Baseline (Fall of 10th Grade) to Fall of 12th Grade |
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| Baseline (Fall of 10th Grade) to Spring of 12th Grade |
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| Baseline (Fall of 10th Grade) to Fall of 11th Grade |
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| Baseline (Fall of 10th Grade) to Spring of 11th Grade |
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| Baseline (Fall of 10th Grade) to Fall of 12th Grade |
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| Baseline (Fall of 10th Grade) to Spring of 12th Grade |
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| Baseline (Fall of 10th Grade) to Fall of 11th Grade |
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| Baseline (Fall of 10th Grade) to Spring of 11th Grade |
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| Baseline (Fall of 10th Grade) to Fall of 12th Grade |
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| Baseline (Fall of 10th Grade) to Spring of 12th Grade |
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| Baseline (Fall of 10th Grade) to Fall of 11th Grade |
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| Baseline (Fall of 10th Grade) to Spring of 11th Grade |
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| Baseline (Fall of 10th Grade) to Fall of 12th Grade |
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| Baseline (Fall of 10th Grade) to Spring of 12th Grade |
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| Baseline (Fall of 10th Grade) to Fall of 11th Grade |
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| Baseline (Fall of 10th Grade) to Spring of 11th Grade |
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| Baseline (Fall of 10th Grade) to Fall of 12th Grade |
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| Baseline (Fall of 10th Grade) to Spring of 12th Grade |
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| Baseline (Fall of 10th Grade) to Fall of 11th Grade |
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| Baseline (Fall of 10th Grade) to Spring of 11th Grade |
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| Baseline (Fall of 10th Grade) to Fall of 12th Grade |
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| Baseline (Fall of 10th Grade) to Spring of 12th Grade |
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| Baseline (Fall of 10th Grade) to Fall of 11th Grade |
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| Baseline (Fall of 10th Grade) to Spring of 11th Grade |
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| Baseline (Fall of 10th Grade) to Fall of 12th Grade |
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| Baseline (Fall of 10th Grade) to Spring of 12th Grade |
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| Baseline (Fall of 10th Grade) to Fall of 11th Grade |
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| Baseline (Fall of 10th Grade) to Spring of 11th Grade |
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| Baseline (Fall of 10th Grade) to Fall of 12th Grade |
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| Baseline (Fall of 10th Grade) to Spring of 12th Grade |
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| Baseline (Fall of 10th Grade) to Fall of 11th Grade |
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| Baseline (Fall of 10th Grade) to Spring of 11th Grade |
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| Baseline (Fall of 10th Grade) to Fall of 12th Grade |
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| Baseline (Fall of 10th Grade) to Spring of 12th Grade |
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| Baseline (Fall of 10th Grade) to Fall of 11th Grade |
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| Baseline (Fall of 10th Grade) to Spring of 11th Grade |
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| Baseline (Fall of 10th Grade) to Fall of 12th Grade |
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| Baseline (Fall of 10th Grade) to Spring of 12th Grade |
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| Baseline (Fall of 10th Grade) to Fall of 11th Grade |
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| Baseline (Fall of 10th Grade) to Spring of 11th Grade |
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| Baseline (Fall of 10th Grade) to Fall of 12th Grade |
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| Baseline (Fall of 10th Grade) to Spring of 12th Grade |
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| Baseline (Fall of 10th Grade) to Fall of 11th Grade |
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| Baseline (Fall of 10th Grade) to Spring of 11th Grade |
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| Baseline (Fall of 10th Grade) to Fall of 12th Grade |
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| Baseline (Fall of 10th Grade) to Spring of 12th Grade |
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| Baseline (Fall of 10th Grade) to Fall of 11th Grade |
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| Baseline (Fall of 10th Grade) to Spring of 11th Grade |
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| Baseline (Fall of 10th Grade) to Fall of 12th Grade |
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| Baseline (Fall of 10th Grade) to Spring of 12th Grade |
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| Baseline (Fall of 10th Grade) to Fall of 11th Grade |
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| Baseline (Fall of 10th Grade) to Spring of 11th Grade |
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| Baseline (Fall of 10th Grade) to Fall of 12th Grade |
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| Baseline (Fall of 10th Grade) to Spring of 12th Grade |
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| Baseline (Fall of 10th Grade) to Fall of 11th Grade |
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| Baseline (Fall of 10th Grade) to Spring of 11th Grade |
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| Baseline (Fall of 10th Grade) to Fall of 12th Grade |
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| Baseline (Fall of 10th Grade) to Spring of 12th Grade |
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