Community Trial in the Cherokee Nation

Not Applicable

Completed

Conditions: Opioid Abuse

Interventions: Behavioral: Connect Program
Behavioral: Communities Mobilizing for Change and Action (CMCA)

Registration Number: NCT04839978

Lead Sponsor: Emory University

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 919

Inclusion Criteria

Tenth grade students enrolled in the participating high schools

Exclusion Criteria

unable to understand written or verbal English

Inclusion criteria for high schools:

Counties that partially or fully fall within the Cherokee Nation reservation
Town population of 3,000 or less
Class size between 30 to 100 students

Exclusion criteria for high schools:

Metropolitan and micropolitan cores (Rural-Urban Commuting Area codes of 1 and 4)
Existence of a community drug prevention coalition

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Preventive Intervention	Communities Mobilizing for Change and Action (CMCA)	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.
Preventive Intervention	Connect Program	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.

Primary Outcome Measures

Name	Time	Method
Number of Days of Alcohol Use	Baseline (fall of 10th grade) up to spring of 12th grade	The number of days of alcohol use in the past 30 days is compared between study arms.
Number of Days of Opioid Misuse	Baseline (fall of 10th grade) up to spring of 12th grade	The number of days of opioid drug misuse use in the past 30 days is compared between study arms.
Number of Days of Heavy Alcohol Use	Baseline (fall of 10th grade) up to spring of 12th grade	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.
Number of Days of Marijuana Use	Baseline (fall of 10th grade) up to spring of 12th grade	The number of days of marijuana use in the past 30 days is compared between study arms.

Secondary Outcome Measures

Name	Time	Method
Number of Days of Marijuana Use	6 Months Post-Graduation	The number of days of marijuana use in the past 30 days is compared between study arms.
Number of Days of Opioid Drug Misuse	6 Months Post-Graduation	The number of days of prescription opioid misuse in the past 30 days is compared between study arms.
Social Support From Teacher	Baseline (fall of 10th grade) up to spring of 12th grade	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.
Social Support From Other Adult	Baseline (fall of 10th grade) up to spring of 12th grade	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.
Perceived Availability of Alcohol	Baseline (fall of 10th grade) up to spring of 12th grade	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.
Perceived Availability of Marijuana	Baseline (fall of 10th grade) up to spring of 12th grade	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.
Perceived Availability of Prescription Opioids	Baseline (fall of 10th grade) up to spring of 12th grade	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.
Social Normative Beliefs About Alcohol Use	Baseline (fall of 10th grade) up to spring of 12th grade	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
Social Normative Beliefs About Marijuana	Baseline (fall of 10th grade) up to spring of 12th grade	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.
Social Normative Beliefs About Prescription Opioids	Baseline (fall of 10th grade) up to spring of 12th grade	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.
Self-Efficacy	Baseline (fall of 10th grade) up to spring of 12th grade	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.
Normative Estimates of Peer Drug Use	Baseline (fall of 10th grade) up to spring of 12th grade	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.
Number of Days of Alcohol Use	6 Months Post-Graduation	The number of days of alcohol use in the past 30 days is compared between study arms.
Social Support From Parent/Caregiver	Baseline (fall of 10th grade) up to spring of 12th grade	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.
Social Support From Friend	Baseline (fall of 10th grade) up to spring of 12th grade	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.
Number of Days of Heavy Alcohol Use	6 Months Post-Graduation	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.