CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 919 enrolled
Drug / intervention
Connect Program +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04839978
NCT04839978N/ACompleted

Community Randomized Trial in the Cherokee Nation: Connect and CMCA for Preventing Drug Misuse Among Older Adolescents

Emory University·interventional·Posted Apr 9, 2021·Updated Mar 5, 2026

In Brief

A clinical study evaluating Connect Program and Communities Mobilizing for Change and Action (CMCA) for Opioid Abuse. Completed, enrolled 919 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpioid Abuse
CountriesUnited States

Timeline

N/ACompletedFinished
20222023202420252026
First PostedApr 9, 2021
Enrollment StartSep 29, 2021
Primary CompletionMay 17, 2024
Study CompletionDec 31, 2024
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 5.2 years ago

Interventions

Connect Programbehavioral

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.

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.