Community Randomized Trial in the Cherokee Nation: Connect and CMCA for Preventing Drug Misuse Among Older Adolescents
Phase: NA
Conditions: Opioid Abuse
Sponsor: Emory University

Community Randomized Trial in the Cherokee Nation: CONNECT and CMCA for 
Preventing Drug Misuse among Older Adolescents 
                                               NCT04839978 
                                            February 15, 2024 
Community Randomized Trial in the Cherokee Nation: CONNECT and CMCA for 
Preventing Drug Misuse among Older Adolescents 
                                               NCT04839978 
                                            February 15, 2024 
Community Randomized Trial in the Cherokee Nation: CONNECT and CMCA for 
Preventing Drug Misuse among Older Adolescents 
                                              NCT04839978 
                                           February 15, 2024 

Community Randomized Trial in the Cherokee Nation  
PIs: Komro, Livingston, Skinner 
Trial Phase 
02-15 2024 
 
 
 
1 
Community Randomized Trial in the Cherokee Nation: 
CONNECT and CMCA for Preventing Drug Misuse among Older Adolescents 
 
Trial Phase 
9/01/2020 – 8/31/2024 
 
NIDA 1UH3DA050234 
 
Emory University PIs: Kelli A. Komro and Melvin D. Livingston, III 
Cherokee Nation PI: Juli Skinner 
 
Emory University Co-Investigators 
Alexander Wagenaar 
 
Study sites: 
Cherokee Nation 
Emory University 
 
 

Community Randomized Trial in the Cherokee Nation  
PIs: Komro, Livingston, Skinner 
Trial Phase 
02-15 2024 
 
 
 
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Proposal for Research Protocol for Trial Phase 
 
I.  
Overview/Introduction 
 
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 white and American Indian adolescents 
and young adults. Our goal 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. 
We propose a community randomized trial building directly on the success of our most recent previous 
trial, which demonstrated that our 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 our established CMCA intervention protocol, and universal 
school-based brief intervention and referral as implemented in our 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 also 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 community 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, our 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. Our previous trial, conducted in partnership 
with the Cherokee Nation, ended with youth attaining age 18; the proposed new trial will additionally 
advance the science regarding strategies to engage young adults as they transition beyond high 
school.  
 
II.  
Methods and Study Population 
 
Sample 
Sixteen to twenty-four high schools and surrounding towns within the 14-county Cherokee Nation 
reservation in northeast Oklahoma will be purposively selected based on school and community 
characteristics (e.g., size of high school, distance between towns, existing prevention program), 
stratified by risk profile, and randomly assigned to study condition: (1) preventive intervention or (2) 
delay-program control. In-person meetings will be conducted with project leadership and school 
leadership (school district superintendents and high school principals). PIs will present study details 
and invite the school leadership to participate in the study and to sign a cooperative agreement form. If 
the high school within a selected town refuses to participate, a replacement town will be selected from 
within risk strata. Given our recruitment history, we anticipate a very high participation rate—our recent 
prevention research project with the Cherokee Nation resulted in a 100% school participation rate. 
 
Prevention Program Overview 

Community Randomized Trial in the Cherokee Nation  
PIs: Komro, Livingston, Skinner 
Trial Phase 
02-15 2024 
 
 
 
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School district superintendents and high school principals will be asked to sign cooperative agreement 
forms to participate in the study. As with our previous school-based projects, school-based screening, 
brief intervention and referral (CONNECT program), conducted by Cherokee Nation Behavioral Health 
counselors, will be treated as part of the participating schools’ prevention programs. According to 
Oklahoma State statute (Stat. tit. 63 § 2602. Right of self-consent) a minor may consent to services for 
the prevention, diagnosis and treatment of drug and substance or alcohol abuse treatment. In addition, 
the Oklahoma Department of Public Health trains school nurses to provide health education and 
counseling to help prevent tobacco use, alcohol use, substance abuse, and other health related issues. 
The CONNECT school-based prevention program is consistent with the laws and standards of practice 
in Oklahoma. Cherokee Nation Behavioral Health (CNBH) youth services provides a central hub 
connecting youth and their families to programs, resources and services. The CNBH CONNECT 
coaches will introduce and support the CONNECT program. Each semester, a computer-based 
CONNECT screening and brief intervention will be implemented universally, to reduce potential stigma 
and to reinforce drug-free norms among all students. Universal screening avoids contributing to 
harmful, negative stereotypes likely to result from singling out students. The computer-based universal 
screening and brief intervention will be supported by either one or two Connect Coaches. As originally 
planned, 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 Computerized Intervention Authoring System (CIAS), an NIH-funded non-commercial research 
resource that allows development of interactive and tailored digital health interventions, will be used to 
develop the computer-based screening and brief intervention. The CIAS system was previously used to 
develop and test a computer-based alcohol and marijuana brief intervention with motivational 
interviewing (CBI) for school-based health centers and was found to be as effective as a nurse 
practitioner-delivered brief intervention (NBI) (Gryczynski et al., 2021; R01DA036604, PI Gryczynski). 
There were no significant differences between NBI and CBI on any outcomes, including marijuana use, 
marijuana-specific problems, alcohol use, binge drinking, alcohol-specific problems. Gryczynki has 
given us full access and permission to adapt the program for our needs, facilitating rapid development 
of an effective computerized version of screening and brief intervention. Students will be given a 
personal CONNECT ID number to access the computer-based brief intervention on a project computer, 
which will be set up in a private location with the schools. No personal identifying information will be 
entered into the computer or brief intervention program. A flow chart showing the implementation 
details is below. This process allows all collected CONNECT screening data to be stored in a 
deidentified manner. The school personnel will not be able to access any data entered into the CIAS 
system.  We will work with each school to troubleshoot any implementation/logistic problems 
throughout the intervention period. 

Community Randomized Trial in the Cherokee Nation  
PIs: Komro, Livingston, Skinner 
Trial Phase 
02-15 2024 
 
 
 
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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. We will 
provide trainings and tools, 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. 
 
The intervention will be further enhanced by including Cherokee Nation award-winning multi-media 
suicide prevention strategies adapted for drug use prevention. 
 
The evaluation of the prevention programs will be accomplished through self-report surveys of a cohort 
of high school students followed over three years, from grade 10 (ages 15-17) to the year following high 
school graduation (ages 18-20). A pilot survey will be administered in the study schools using all 
approved protocols in grade 9. The main outcome analysis will include baseline (fall of 10th grade) 
through spring of 12
th grade surveys. A secondary outcome analysis will include the six-month follow-up 
survey conducted six months post on-time high school graduation. 
 
Recruitment Procedures 
All 10th grade students enrolled in the participating study high schools will be eligible to participate in 
the study. As a universal preventive intervention, and given the need for a community-wide 
representative sample, there are no exclusionary criteria. Beginning in 10th grade, a cohort of high 
school students will be asked to participate in a brief, 20-30-minute, web-based survey on health 
behaviors two times per year. The survey will be administered using REDCap or Qualtrics on cellular-
connected project tablets and implemented during homeroom, a class period, lunch period, or at 
Sealed envelopes 
are created for 
each student in 
the intervention 
cohort. The 
envelope will be 
labeled with the 
students name. 
Inside the 
envelope will be a 
CONNECT ID.
Connect 
Coach 
delivers 
sealed 
envelopes to 
each school 
monthly 
Weekly a 
Connect 
Coach sends a 
list of student 
names to the 
school to pull 
at any point 
during the 
week
School pulls 
student and 
hands them 
their 
envelope
Student uses 
the computer 
privately and 
completes 
CIAS 
CONNECT
Students who 
need a follow 
up will be put 
into next 
months 
envelope pile

Community Randomized Trial in the Cherokee Nation  
PIs: Komro, Livingston, Skinner 
Trial Phase 
02-15 2024 
 
 
 
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another time convenient to each school and participant. All data will be encrypted as soon as it is 
entered and transmitted to a central server at Emory University. No school personnel will be involved in 
any survey administration tasks, avoiding any potential risks and biases that could accrue from the 
involvement of school personnel in survey administration. 
 
All 10th grade students in all participating high schools will be recruited. Participating schools will 
provide the researchers with a list of the most current home addresses and telephone numbers for all 
students in the participating high schools. Parent consent letters will be sent home by Emory University 
and the Cherokee Nation, describing the study and its importance and providing a toll-free and local 
telephone number that parents/guardians can call with questions or concerns. In-person visits will be 
made when requested or if the parent is unavailable via phone. Parents will be asked to respond by 
returning an addressed postage-paid postcard or calling Cherokee Nation Behavioral Health using toll-
free telephone numbers, if they refuse permission for their son or daughter to participate. Also, each 
adolescent/young adult participant will be given the opportunity to decide not to participate, and may 
withdraw their participation at any time. Students will be provided $5 for each biannual survey 
implemented within schools. For the six-month follow-up survey, planned for Fall 2024, administered 
outside of school, a $50 electronic Visa or gift card will be provided. A number of steps will be taken to 
maximize participation and retention rates. The fact that the intervention and assessments proposed in 
this application will be endorsed by the Cherokee Nation and school leadership at the participating high 
schools will help maximize participation rates. Youth will receive reminders and compensation for their 
time. For youth who are missing from school during survey administrations, tactics to reach them for 
follow-up surveys may include emailing and texting to ask how they are, update social media, email, 
phone and other contact information, and reminding them about an upcoming survey. We will use 
procedures for tracking and follow-up surveys as we implemented in a long-term follow-up of a cohort 
of youth in Chicago, including secure internet and in-person survey administration options. Although 
some attrition is anticipated, a substantial proportion of the students recruited at baseline are expected 
to be retained in the study. In our previous prevention trial in the Cherokee Nation, we maintained over 
80% participation across the three-year study. 
Our recruitment and retention protocol requires careful planning and treating school leadership, parents 
and study participants with respect and courtesy. Our previous trials demonstrate this has worked 
well—we have consistently been able to recruit a substantial percentage of the sample and have 
experienced few refusals. As with all field studies, recruiting students and parents/guardians in this 
fashion necessarily introduces potential selection bias because those who participate may be 
systematically different from those who decline. However, maintaining a respectable baseline 
participation rate, conducting descriptive analyses to determine whether the final sample is 
representative of the school demographically and to ensure comparability on relevant characteristics 
between communities, and weighting to adjust for nonresponse helps offset the effects of selection 
bias. Also, bias will be somewhat further reduced by providing financial incentives and maintaining 
direct contact with schools, parents and students. 
 
Measures 
The Youth Experiences Survey is attached. It will be used to collect data from youth participants to 
assess substance use and related risks/harms, perceived availability of opioids and other drugs, 
knowledge and perceptions of consequences, values and beliefs about substance use, social 
normative beliefs around substance use, social skills and social support.   
 
Each participant will be asked to complete a Contact Information Form during the final school-based 
survey in Spring 2024. The contact form will be a scannable paper form, separate from the tablet-based 
student survey, and students will be provided $5. The form asks about contact information to help us 

Community Randomized Trial in the Cherokee Nation  
PIs: Komro, Livingston, Skinner 
Trial Phase 
02-15 2024 
 
 
 
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maintain contact and reach participants for the follow-up survey. We will ask youth to provide phone 
numbers, email address, and home address. The Contact Information Form is attached. Mid-summer 
we will contact participants via text, call, or email to ask for confirmation of contact information. A $10 
electronic Visa or gift card will be provided for confirming contact information. 
 
III.  Risk/Benefits    
 
The data-gathering requirements and intervention activities of the proposed research pose no more 
than minimal risk to participants. The surveys will be designed to be of limited distress, although a 
student may be uncomfortable answering certain questions. The surveys are short—average 
completion time is expected to be 20-30 minutes. Participants will be reminded at the beginning of the 
survey that they are free to skip any questions or to stop the survey at any time. Our confidence in 
terms of the measures to be used is based on many years of experience in using these surveys. 
Moreover, students have reported a high level of comfort with the surveys and assessments in the past. 
Although rare, there is a possibility for the surveys to produce some stress or frustration, which will be 
carefully monitored. Thus, at most, participants may find these assessments boring, annoying, or 
frustrating. 
 
There is potential for significant direct benefits of this project to participating adolescents and young 
adults; the evidence-based interventions are expected to improve several outcomes under study, such 
as preventing the onset and escalation of drug use and related risks/harms. The control sites will be 
offered the intervention materials at the end of the study, as well as the opportunity for teacher and staff 
trainings provided Cherokee Nation Behavioral Health during the active study phased (e.g., bullying 
prevention training).  
 
The minimal risk of a breach of confidentiality, plus possible discomfort that may accompany some 
behavioral change efforts, is easily outweighed by the likely benefits. 
 
IV.  Data Security/Monitoring 
 
Data collectors will be professional staff with training in Human Subjects Research. They will be 
thoroughly trained in the principles of the study and use of the survey methods. They will also be 
qualified to interact with adolescents, parents, and school administrators. Drs. Komro and Kominsky will 
coordinate and train on collection of survey data. An Evaluation Field Supervisor will oversee all field 
activities, including administration of assent forms, coordination with schools and teachers, and 
administration of assessments. The tracking and assessment databases will be linked by arbitrarily-
assigned study numbers (not school ID or other such numbers) to ensure identifying information is not 
contained in the assessment databases. Data collected for the study will be transmitted immediately via 
cellular-connected tablets using REDCap or Qualtrics to the Emory University server where checks will 
be run for data consistency and quality. It is important to note that the schools will not obtain or 
maintain any individual-level survey results and research staff will not retain any identifying information; 
thus there will be no way to link names with survey results. Processes are in place to generate de-
identified databases and statistical programs for analyses. 
 
Prior to any member of the research staff initiating contact with research participants, they will be 
trained in the following areas: 1) Protecting human study volunteers in research in accordance with 
Emory and Cherokee Nation IRB requirements; 2) Understanding the project grant (background, 
application, and aims); 3) Demonstrated understanding of data collection forms; 4) Understanding how 
all forms are filed, both electronic and material (i.e. exact location, computer drive, folders, and which 

Community Randomized Trial in the Cherokee Nation  
PIs: Komro, Livingston, Skinner 
Trial Phase 
02-15 2024 
 
 
 
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electronic files need to be password protected); 5) Understanding which type of events need to be 
reported and the process of reporting (e.g., emotional reports related to incidence of victimization or 
violence, adverse events reporting, active suicidal/homicidal ideation, releasing information, etc); and 6) 
Survey and follow-up protocols. Training tasks will be organized by a checklist which will be completed 
during orientation. Prevention of minor adverse events will include the following. Participants will be 
acclimated to the study in the school, which will be familiar to them. They will be given time to relax and 
ask questions. They will also be assured that, if at any time they experience any emotional discomfort, 
they may request a break or ask to be discontinued from the study. The investigators have been 
conducting both clinical and research work with adolescents for many years. If a student reveals any 
abusive experiences, the interviewer will be required to report it to the school or a local authority. The 
PIs, in consultation with the IRBs, will determine if they are mandated to report the incident to an 
appropriate professional or authority. 
 
Protections relevant to children. 
We believe that study participation of adolescents and young adults, ages 15-20, involves no more than 
minimal risk. All of the interventions to be provided have been shown in experimental trials to benefit 
adolescents. Most have beneficial effects on drug use. Participation in surveys poses, at most, minor 
risks of discomfort. 
 
Data Collection and Management Procedures. 
We will collect data from youth to assess risk and protective factors, substance use and related harms. 
Age ranges of the youth will be from 15 to 20. Students will complete a short (20-30-minute) survey 
each semester within their homeroom, selected class period, or lunch period or on their own time 
through electronic survey distribution and once again approximately six months following graduation to 
monitor influences and outcomes. When in-school survey administration is not feasible students will be 
asked to participate in a private location through an electronic survey link. On average, each student 
will provide approximately seven data points throughout the project. 
 
Data collectors will be professional staff with training in Human Subjects Research. They will be 
thoroughly trained in the principles of the study and use of the survey methods. They will also be 
qualified to interact with adolescents, parents, and school administrators. Drs. Komro and Kominsky will 
coordinate and train on collection of survey data. An Evaluation Field Supervisor, under the supervision 
of the PIs, will oversee all field activities, including administration of assent forms, coordination with 
schools and teachers, and administration of assessments. The tracking and assessment databases will 
be linked by arbitrarily-assigned study numbers (not school ID or other such numbers) to ensure 
identifying information is not contained in the assessment databases. Data collected for the study will 
be transmitted immediately via cellular-connected tablets using REDCap or Qualtrics to the Emory 
University server where checks will be run for data consistency and quality. It is important to note that 
the schools will not obtain or maintain any individual-level survey results and research staff will not 
retain any identifying information; thus there will be no way to link names with survey results. Processes 
are in place to generate de-identified databases and statistical programs for analyses. 
 
The deidentified data collected within the CIAS CONNECT system will reside on secure servers at 
Michigan State University. Only the PI, the research project manager and the CONNECT coaches will 
have access to the link list of CONNECT ID to participant name.  
 
Confidentiality 

Community Randomized Trial in the Cherokee Nation  
PIs: Komro, Livingston, Skinner 
Trial Phase 
02-15 2024 
 
 
 
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NIH’s Certificate of Confidentiality (CoC) policy automatically issues a CoC for any NIH-funded projects 
using identifiable, sensitive information. Further information is included in the Confidentiality Certificate 
section. 
 
V.  Data Analysis 
 
Throughout the study, age ranges of the students will be from 15 to 20. Students will complete a short 
(20-30-minute) survey each semester within their homeroom, selected class period, or lunch period or 
on their own time through electronic survey distribution and once again approximately six months 
following graduation to monitor influences and outcomes. When in-school survey administration is not 
feasible students will be asked to participate in a private location through an electronic survey link. On 
average, each student will provide approximately seven data points throughout the project, so we can 
analyze trends over time in the onset and escalation of risk and protective factors and drug use 
outcomes. 
 
We will analyze the effects of the CMCA and CONNECT interventions on proximal outcomes (e.g., 
perceived availability of drugs, social normative beliefs, social support, self-efficacy, and normative 
estimates of peer drug use) and on distal outcomes of opioid and other drug use (e.g., prescription 
opioids without a doctor telling you to take them, marijuana use, alcohol use). The trial consists of 
“doubly repeated” measures--repeated measures nested within each student, plus students are nested 
within schools. Any statistical analysis that ignores lack of independence due to nesting will be subject 
to inflated type-1 errors. To account for both the clustering effect of students nested within schools and 
repeated measures nested within student, intervention effects on proximal and drug use outcomes will 
be estimated with generalized linear mixed models. 
 
As part of our strategy to follow students into the first year after their expected graduation, we will 
employ extensive tracking procedures to maintain a high response rate across study waves. There may 
still exist students who miss survey administrations or who are lost to follow-up. As in our previous 
Cherokee Nation prevention trial, we will use multiple imputation to account for non-response over time 
and potential attrition. All available outcomes data will be used to impute missing outcome data from 
those with missing survey waves. 
 
VI.  Dissemination 
 
Sharing of the data generated by this project is key to the project, especially if the intervention is 
successful. We anticipate that we will present on the intervention and evaluation process in the second 
year and at least annually on data collected after the second year when sufficient baseline data are 
collected. Sharing of the findings will involve a primary paper describing the study outcomes and 
papers that describes the study design and intervention implementation details, as well as submitting to 
lead workshops on the intervention approaches at relevant national meetings and conferences. 
 
De-identified data for additional analyses will be available to outside individuals through contacting the 
PI and with approval of the Cherokee Nation Institutional Review Board. Access to data will not be 
possible until the publication and release of the main outcome papers. After this, we will institute a 
concept plan process where internal study staff first have the availability to write primary papers or give 
presentations on particular topics. If outside individuals then wish to analyze data, we will welcome this 
collaboration. Contact information for the PI will be listed on all manuscripts and publications as a 
means to access the data. We will abide by the Steering Committee’s data and resource policy, 

Community Randomized Trial in the Cherokee Nation  
PIs: Komro, Livingston, Skinner 
Trial Phase 
02-15 2024 
 
 
 
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consistent with the relevant NIH policies, laws and regulations and with approval from the Cherokee 
Nation Institutional Review Board. 
 
The current versions of the CMCA Handbook and CONNECT materials are available through the 
Emory Prevention Research Center’s website (http://web1.sph.emory.edu/eprc/research/cmca-
connect.html ). We plan to update this website and the materials as we expand the interventions to 
address substance use. 
 
Clinicaltrials.gov: We will ensure that clinical trial under the award are registered and results information 
is submitted to ClinicalTrials.gov as outlined in the policy and according to the specific timelines stated 
in the policy; informed consent documents for the clinical trial will include a specific statement relating 
to posting of clinical trial information at ClinicalTrials.gov; and Emory University has an internal policy in 
place and of Office of Research Compliance to ensure that clinical trials registration and results 
reporting occur in compliance with policy requirements. 
 
At the conclusion of this project, all parents and students will be sent a letter summarizing the 
aggregate results of the study. No personal identifying information will be provided, rather a summary of 
the overall study results will be provided so that families will be informed about study findings. 
Additionally, a lay summary with findings will be submitted as part of the study closure with the 
Cherokee Nation IRB. Finally, as with the previous alcohol prevention trial every effort will be made to 
make presentations within the Cherokee Nation organizational structure and to the school 
administrations to help ensure that the results are adequately disseminated to the communities 
themselves in addition to scientific publications and presentations to broader scientific and prevention 
communities.  
 
Bibliography 
 
Dent, C.W., et al., Demographic, Psychosocial and Behavioral-Differences in Samples of Actively and 
Passively Consented Adolescents. Addictive Behaviors, 1993. 18(1): p. 51-56.  
 
Ellickson, P.L. and J.A. Hawes, An Assessment of Active Versus Passive Methods for Obtaining 
Parental Consent. Evaluation Review, 1989. 13(1): p. 45-55.  
 
Esbensen, F.A., et al., Differential attrition rates and active parental consent. Evaluation Review, 1999. 
23(3): p. 316-335. 
 
Gottfredson, G.D., E.M. Jones, and T.W. Gore, An assessment of a program to prevent problem 
behavior by development school capacity for guardianship. 1996, Ellicott City, MD: Gottfredson 
Associates, Inc  
 
Pokorny, S.B., et al., Do participation rates change when active consent procedures replace passive 
consent. Evaluation Review, 2001. 25(5): p. 567-580. 
 
 
 
 
 
 

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Trial Phase 
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Community Randomized Trial in the Cherokee Nation  
PIs: Komro, Livingston, Skinner 
Trial Phase 
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Informed Consent 
A series of mailings (1 introduction postcard, 1 informed consent letter, 1 reminder postcard) will be 
sent to parents/guardians of all 10th grade students in the participating schools. The letter sent to 
parents includes the information required for informed consent set forth in 45 CFR 46.116. Parents can 
refuse participation for their child by calling Dr. Kominsky (contact information provided) using a toll-free 
number or by mailing a pre-addressed postage-paid postcard. Students will provide assent to 
participate. Assent forms will be read aloud prior to the administration of each survey. Follow-up calls or 
in-person meetings will be made to parents who request more information or are otherwise 
unreachable. The consent and assent forms include a statement indicating that they may decline 
participation without any repercussions and may terminate participation in the surveys at any time. The 
form also states that participation in this study will in no way influence their school standing, grades, or 
evaluations, and for parents, that it will not affect their status in the school, with the Cherokee Nation, or 
any other standings. Methods to ensure confidentiality will also be explained. Any questions youth have 
will be answered. Only those who have been read assent forms and whose parents have not refused 
consent via the postcard or phone will be included in the study. Copies of the consent mailings and 
assent form are included in this submission. 
 
Waiver of Written Parental Consent 
In our previous prevention trial in the Cherokee Nation, which included the community (CMCA) and 
screening and brief intervention (CONNECT) prevention interventions and a youth survey as proposed 
here, we were granted a waiver of written parental consent. We understand in order to justify a waiver 
of written parental consent; the following four criteria must be met [45 CFR 46.116 (d)]: 
1. The research involves no more than minimal risk to the subjects; 
2. The waiver or alteration will not adversely affect the rights and welfare of the subjects; 
3. The research could not practicably be carried out without the waiver or alteration; and 
4. Whenever appropriate, the subjects will be provided with additional pertinent information after 
participation. 
We believe our procedures and study protocol fulfill these four criteria and the criteria outline in 45 CFR 
46.408. This has been confirmed by continued prior approval of these procedures by the University of 
Florida Institutional Review Board and Cherokee Nation Institutional Review Board in 2011 and Emory 
University’s Institutional Review Board in 2015. Our justification to waive the requirement of written 
parental consent is as follows: 
 
(1) The research involves no more than minimal risk to the subjects. 
Risks posed by the survey are no more than minimal. The questions have been used with thousands of 
children since 1975, and are the same as those used in federal government surveys, such as those 
supported by CDC and NIDA. The survey does not probe psychologically (such as with the use of 
clinical psychological tools), nor does it ask questions about physical and sexual abuse. Youth, ages 
15-20, are not coerced into completing the survey. They are clearly told that they do not have to 
complete the survey if they do not want to and that they can skip any and all question(s) that they want 
to. To further protect the confidentiality of the subjects, NIH’s Certificate of Confidentiality (CoC) policy 
automatically issues a CoC for any NIH-funded projects using identifiable, sensitive information. We 
inform youth that their answers will remain confidential and that the Certificate of Confidentiality 
protects them. Responses are kept completely confidential. Study IDs are assigned to the surveys and 
identifying information is kept in separate, secure encrypted electronic files at Emory University. No one 
has access to any of those files except for trained study personnel. Only the PI and research 
coordinator has access to the link list of study ID to participant name. 
 
(2) The waiver or alteration will not adversely affect the rights and welfare of the subjects. 

Community Randomized Trial in the Cherokee Nation  
PIs: Komro, Livingston, Skinner 
Trial Phase 
02-15 2024 
 
 
 
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The letter sent to parents includes the information required for informed consent set forth in 45 CFR 
46.116. The information that will be sent to parents explains the research purposes and duration; 
describes the procedures to be followed; lays out reasonable foreseeable risks; describes the extent to 
which confidential data identifying the subject will be maintained; explains whom to contact for answers 
to questions about the research; states that participation is voluntary and can be discontinued at any 
time; and indicates that refusal involves no penalty or loss of benefits. The parents can refuse 
participation for their child by calling Dr. Kominsky at Cherokee Nation Behavioral Health a toll-free 
number or by sending in a pre-addressed, stamped postcard. In addition, youth are given an assent 
form. 
 
Youth participants also have the opportunity to easily refuse participation at any point in the survey 
process, including being able to skip any questions they choose. Hence these procedures meet 
national ethical and legal standards set forth in 45 CFR 46. The protocol has been carefully reviewed 
and approved by the IRB at the University of Florida and Cherokee Nation for the previous trial in the 
Cherokee Nation and is based on the protocol followed in our previous research over the past 25 years.  
 
(3) The research could not practicably be carried out without the waiver or alteration. 
A requirement to obtain written parental consent will significantly undermine the validity of the research 
study due to very low parental response rates among students most at risk for substance use, our key 
dependent variable (Dent et al., 1993; Ellickson & Hawes, 1989; Esbensen et al., 1999). In general, 
studies comparing various parental consent procedures suggest that requiring written consent can lead 
to biases on significant dependent variables that may adversely affect the generalizability of results of 
studies of adolescent drug use (Esbensen et al., 1999; Pokorny et al., 2001). It has been shown that 
requiring written parental consent threatens the scientific validity of research since only 28% to 43% of 
parents take the time to return signed consent forms, yet only about 3% of those actually withhold 
consent (Gottredson, Jones & Gore, 1996). When requiring written consent, Ellickson and Hawes 
concluded that nonresponse was considerably more likely to signify latent consent than a deliberate 
refusal. In addition, researchers who have used active consent have reported unacceptably low 
response rates and underrepresentation of important groups, including racial/ethnic minority youth 
(Dent et al., 1993; Ellickson & Hawes, 1989; Esbensen et al., 1999). Therefore, if written parental 
consent was required in the proposed study, we would only be surveying less than half of the students 
who participated in the prevention program, with obvious bias in who completes the survey. In a study 
comparing parent consent procedures, Ellickson and Hawes concluded that carefully designed 
procedures that do not require signatures from parents can inform parents while avoiding the large 
nonresponse rates and sample bias associated with requiring written consent. We will send a series of 
personal letters (postcard, consent letter, postcard reminder) to each parent. 
 
(4) Whenever appropriate, subjects will be provided with additional pertinent information after 
participation. 
At the conclusion of this project, all parents and students will be sent a letter summarizing the 
aggregate results of the study. No personal identifying information will be provided, rather a summary of 
the overall study results will be provided so that families will be informed about study findings. An 
example of the study findings brochure from our previous study is included in this packet. 
 
In summary, the risks posed by the prevention programs and survey are no more than minimal. Youth, 
their families, schools and communities have been exposed to these alcohol/drug prevention strategies 
that have been previously tested and found to reduce alcohol and other drug use among young people. 
Every effort is being made to reduce risk and protect the confidentiality of the subjects. A waiver of the 

Community Randomized Trial in the Cherokee Nation  
PIs: Komro, Livingston, Skinner 
Trial Phase 
02-15 2024 
 
 
 
13 
requirement for written parental consent is critical to avoid sample selection bias. The knowledge 
gained from this research relies on inclusion of a nonbiased sample of subjects. 
 
 

Community Randomized Trial in the Cherokee Nation  
PIs: Komro, Livingston, Skinner 
Trial Phase 
02-15 2024 
 
 
 
14 
Consent Mailings- Postcards 
 
 
 
 
 
 
 
Dear Parent/Guardian(s): 
 
You will be receiving an important letter regarding your high school 
student’s participation in a survey at school within the next week. This 
survey is part of a project in which Emory University and Cherokee 
Nation Behavioral Health will be working with your son or daughter’s 
high school. Please be on the look out for this important information! 
 
The letter will explain the project in detail but if you have any 
questions please contact Dr. Terrence Kominsky at 1-800-256-0671 
ext. 4984 or at his direct line at 918-207-4984. 
 
Thank you!      
   
   
   
 
           
    
     
        
 
 
 
Dear Parent/Guardian(s): 
 
This is a reminder concerning the letter you recently received about 
your high school student participating in a survey at school. Please 
return the postcard included with that letter if you DO NOT want your 
son or daughter to participate. 
 
If you have any questions or concerns please contact Dr. Terrence 
Kominsky at 1-800-256-0671 ext. 4984 or at his direct line at 918-207-
4984. 
 
 
Thank you!  
    
   
  
             
  
    
       
 

Community Randomized Trial in the Cherokee Nation  
PIs: Komro, Livingston, Skinner 
Trial Phase 
02-15 2024 
 
 
 
15 
 
 
Consent Postcard Text 
 
 
Return this card ONLY if you DO NOT want your child to participate in the Emory University and the 
Cherokee Nation Behavioral Health’s Youth Experiences Survey. 
 
Please fill out the following information:  
 
Child’s name (please print) _______________________________________________________ 
 
Address_______________________________________________________________________ 
 
City_____________________________  State _________________  Zip Code______________ 
 
Parent’s/Guardian’s name (please print)______________________________________________ 
 
If you have questions or concerns, contact Dr. Terrence Kominsky, free of charge, at 1-800-256-0671 
extension 4984 or at his direct line at 918-207-4984. Thank you!  
 
 
 
 
 

Community Randomized Trial in the Cherokee Nation  
PIs: Komro, Livingston, Skinner 
Trial Phase 
02-15 2024 
 
 
 
16 
 
Confidentiality Certificate 
NIH’s Certificate of Confidentiality (CoC) policy automatically issues a CoC for any NIH-funded projects 
using identifiable, sensitive information which includes this study. We inform youth that their answers 
will remain confidential and that the Certificate of Confidentiality protects them. Responses are kept 
completely confidential. Study IDs are assigned to the surveys and identifying information is kept in 
separate, secure encrypted electronic files at Emory University. No one has access to any of those files 
except for trained study personnel. Only the PI and research coordinator has access to the link list of 
study ID to participant name. 
 
 
 
 
 

Community Randomized Trial in the Cherokee Nation  
PIs: Komro, Livingston, Skinner 
Trial Phase 
02-15 2024 
 
 
 
17 
Contact Information Form 
 
We are excited to keep in touch with you and see how you are doing in about six months. We 
would like to send you a brief survey and you will be paid $50. Are you willing to provide us 
with information that will help us contact you? We will keep this information separate from your 
survey answers and completely confidential.  
 
We need the following information because it will help us contact you for a brief paid survey in 
the fall. Remember, we will keep this information separate from your survey answers and 
completely private. We will not share this information with anyone. 
 
OK to text you about the paid survey? 
 
What is your cell phone number? 
 
What is your home number? 
 
What is your personal email (not your school email)? 
 
What is your current address? 
Address: 
City: 
State: 
Zip code: 
 
 
THANK YOU!