Tennessee Youth Prepared for Success- Be in Charge Intervention
Phase: NA
Conditions: Adolescent Behavior, Adolescent Problem Behavior, Risk Reduction
Sponsor: Centerstone Research Institute

 
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STUDY TITLE: 
TYPS: Tennessee Youth Prepared for Success 
 
PRINCIPAL INVESTIGATOR: 
Name: Jordan Nelon, Ph.D. 
Department: Centerstone Research Institute  
 
VERSION DATE: 
07/06/2023 
 
RELATED STUDIES:  
N/A 
 
Check any applicable boxes in the table below – you will be asked for 
further detail on these topics later in the protocol form: 
 
Indicate Vulnerable 
Population(s) to be Enrolled 
☒ Children  
☐ Cognitively Impaired Adults   
☐ Pregnant Women (IF the research activities will affect    
the pregnancy or the fetus) 
☐ Prisoners (or other detained/paroled individuals)  
 
International Research 
(check this box if you will 
collect data from 
individuals located outside 
the United States) 
 
 
☐ 
Research involving external 
collaborators (some 
research activities will be 
carried out by individuals 
not employed by 
Northwestern or NU 
affiliates) 
 
 
 
☐ 
 
Research has U.S. Federal 
government funding via 
direct award or a sub-award 
(e.g., NIH, NSF, other 
federal agencies or 
departments) 
 
☒ 
 
 
 
 

 
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1.0 
Purpose and rationale of the study: 
The principal objective of Tennessee Youth Prepared for Success is to pilot, implement, 
and test innovative adolescent pregnancy prevention strategies using a randomized 
controlled trial (RCT) to effectively educate youth on both abstinence and contraception 
with the goal of reducing youth pregnancies, births, and STIs/HIV/AIDS. Tennessee Youth 
Prepared for Success will address Adulthood Preparation Subjects (APS) to promote 
youths’ successful and healthy transition to adulthood; include a Positive Youth 
Development (PYD) approach to engage youth and provide positive influences and skill 
building opportunities; and implement activities/interventions within a trauma-informed 
approach to account for the mental health needs of those who have experienced 
maltreatment, abuse, or violence.The project’s goals and principal and subordinate 
objectives align with the PREIS program’s goals/objectives and purpose, including (1) 
targeting high-risk youth to prevent pregnancy and STIs, including HIV/AIDS; (2) 
rigorously evaluating interventions using an RCT; (3) manualizing/packaging curriculum; 
and (4) disseminating lessons learned, best practices, and relevant findings. Tennessee 
Youth Prepared for Success will serve 1,200 youth ages 14-19 in 9 primarily rural counties 
in East/Middle/West Tennessee, targeting high-risk/vulnerable youth, including rural 
youth, those residing in counties with high teen birth rates, and/or hard-to-reach youth (e.g., 
systems-involved). 
 
Tennessee Youth Prepared for Success will implement evidence-based curricula the 
promising curricula Be In Charge (BIC) for the treatment group, while the control group 
will receive the Adolescent Health Curriculum. BIC is an abstinence-based sexual health 
education program developed by Centerstone prevention staff in 2014 to increase a youth’s 
sexual health knowledge and skills for responsible decision-making. It is built upon the 
idea of building healthy relationship skills and information to help inform responsible 
choices regarding sexual experiences, and it has been refined since that time with input 
from key stakeholders from similar target populations/geographic areas (e.g., youth, 
parents, school personnel). The 7 units of curriculum fit in with the theory of planned 
behavior where the educational components of the BiC intervention are designed to impact 
knowledge, attitudes, norms, and perceived control over sexual health related outcomes 
(i.e., sexual intercourse and contraception usage), ultimately influencing intention and 
behavior. The curricula is trauma-informed and integrate a PYD approach through creation 
of safe environments, engagement of youth through creative activities, and facilitation of 
progressive skill-building. Tennessee Youth Prepared for Success will be guided by the 
Sexuality Information and Education Council of the United States Guidelines for 
Comprehensive Sexuality Education, which assists sexual health educators in delivering 
comprehensive, age/culturally/developmentally- appropriate and medically accurate 
messages. Adulthood Preparation Subjects (APS) will be directed by ACF’s Adult 
Preparation Subjects Resource Guide. 
 
Primary research questions include: (1) Do behavioral intentions to delay sexual initiation 
vary from pre-test to 1-year follow up? To what extent does this pattern vary based on 
assigned treatment condition?; (2) What is the relationship between assigned treatment 
condition and pregnancy rates reported at 1-year follow up?; (3) How does likelihood of 

 
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abstinence and contraception use change following delivery of the intervention? To what 
extent does this vary based on assigned treatment condition? A series of secondary research 
questions seek to understand outcomes related to implementation, theoretical constructs 
associated with behavior, and life skill changes. The secondary questions include: (1) To 
what degree were facilitators/educators able to implement the intervention/BiC with 
fidelity?; and (2) How do sexual health knowledge (e.g., HIV/STIs, teen pregnancy), 
healthy relationship skills, healthy life skills, attitudes/values about adolescent 
development, and parent-child communication change over time for Tennessee Youth 
Prepared for Success participants? How does this effect vary by mode of intervention (i.e., 
Be In Charge vs. Adolescent Health Curriculum)? The proposed evaluation study seeks to 
establish the efficacy of a teen pregnancy prevention program tailored to the specific needs 
of Tennessee Youth Prepared for Success’ population subgroups (e.g., rural youth), thus 
supporting efforts to address health disparities in teenage pregnancies. 
 
In this randomized control, experimental study, participants will be randomly assigned to 
receive either BIC (i.e., treatment group) or the Adolescent Health Curriculum (i.e., 
control/comparison group). Through comparison of key program outcomes, this project 
seeks to establish that BIC is (1) more effective the Adolescent Health Curriculum in 
decreasing 
pregnancy 
rates, 
delaying 
sexual 
initiation, 
and 
increasing 
abstinence/contraception use and (2) implemented with a higher degree of fidelity, 
reflective of its tailoring to current medical accuracy standards and subpopulation needs. 
Classrooms/community groups will be matched at the organizational level to mitigate 
confounding variables (e.g., geographic area, age, demographics). 
 
 
2.0 
Enrollment Criteria (who can be in your study and who would not 
be eligible to participate in your study): 
Tennessee Youth Prepared for Success will serve 1,200 youth ages 14-19 in 9 Tennessee 
counties (Anderson, Benton, Carroll, Hardeman, Roane, Scott, Sevier, Trousdale, and Union) 
who are at high risk or vulnerable for adolescent pregnancy and STIs, including HIV/AIDs. 
Participants must: (1) be between the ages of 14-19; (2) have a signed consent form from 
a guardian, along with assent or consent forms from the youth, as appropriate based on age, 
unless deemed otherwise by the Institutional Review Board (IRB); (3) be free of 
debilitating intellectual, mental health, or cognitive impairment (i.e. psychosis, orientation 
to time/place, etc. based on screening at program entry); and (4) be willing to share their 
experiences with sexual health & wellbeing training. Targeted high risk/vulnerable 
populations include rural youth, youth residing in high teen birth rate areas, and/or hard-
to-reach youth (e.g., youth in foster care). The target population is expected to include 
youth in grades 9-12 and mirror youth area demographics: 53% male, 47% female, 89% 
white, 6% Black/African American, and 2% Hispanic/Latino individuals. 
 
 
3.0 
Sample Size: 

 
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Tennessee Youth Prepared for Success proposes to serve a total of 1,200 unduplicated high-
risk youth over the 5-year grant period (Y1: 180; Y2-Y4: 840, annually; Y5: 300). The 
project will study unduplicated high-risk youth in Phases I and II of the project, comprising 
600 total in the control group (i.e., Y1: 90; Y2-Y4: 420) and 600 total in the treatment 
group (i.e., Y1: 90; Y2-Y4: 420). In Year 5, the study will have concluded, and services 
will continue for the 300 youth, as identified above. Tennessee Youth Prepared for Success’ 
target population comprises 25,450+ youth ages 14-19 with 53% male and 47% female. To 
arrive at these numbers, Tennessee Youth Prepared for Success considered community 
need and access in the geographic area, Centerstone client/target area demographics, and 
anticipated project staff caseloads; Centerstone’s independent third-party evaluator, the 
Centerstone Research Institute, used a power analysis to determine appropriate sample size 
for the rigorous evaluation, including allowances for natural attrition across the 
longitudinal data collection period. Participant breakout by age group, race, and ethnicity 
will mirror target area demographics. 
 
The target population was selected due to the prevalence of environmental and behavioral 
risk factors that can make youth vulnerable to unintended pregnancy, STIs, and/or 
HIV/AIDS. An anticipated 48% (7,614) of area high school students will have had sexual 
intercourse (vs. 41% of students across the country). Of sexually active youth, an 
anticipated 41% (3,121) did not use a condom during their last sexual encounter, and 16% 
(1,218) are expected to have had 4+ sexual partners. Individual risk behaviors have resulted 
in poor sexual health outcomes for target population youth. Furthermore, the target 
population’s geographical/physical composition (i.e., 1 partially rural, 8 rural counties) 
poses unique challenges to youth sexual risk and protective factors. Rural locales impede 
access to safe-sex information and pregnancy prevention services because of distance, 
fewer EBP- trained health professionals, and cultural factors (e.g., religious beliefs, stigma 
about sexual behavior/ contraception). All 9 counties’ teen pregnancy rates meet or exceed 
that of the state (27.3/1,000). 
 
 
4.0 
Recruitment and Screening Methods: 
All program and evaluation staff are responsible for recruitment and enrollment through 
either direct engagement with the target population or indirectly through support roles such 
as staff training and data analysis and reporting. Tennessee Youth Prepared for Success 
program and evaluation staff will devote at least 50% of their effort on activities related to 
recruitment, enrollment, engagement, and retention of program participants to ensure a 
sample size with adequate statistical power. 
 
Tennessee Youth Prepared for Success staff have successfully managed a number of 
strategic partnerships, including those with county school systems, community-based 
organizations (e.g., Planend Parenthood), youth-serving groups, faith-based groups, 
youth/family resource centers, parks and recreation, local health departments, and 
community coalitions/action groups. Staff have fostered/maintained these relationships via 
frequent communications (e.g., personal visits, calls, and emails), sharing outcome data 
through reports, presentations, and collaborations. A formal strategy for ensuring effective 

 
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management and monitoring with partner organizations, such as county school systems, 
includes signed MOUs. Informal strategies include the use of e-letters; networking 
opportunities (e.g., conferences); on-site visits and meetings; focus groups and feedback  
sessions; and satisfaction  surveys. During implementation, the PD/PM will maintain 
ongoing contact with top leadership from schools and community partners to monitor 
project performance and ensure effective relationships. 
 
The Research Institute will further execute a selection of traditional and innovative, data- 
driven recruitment and tracking strategies appealing to the diversity of the target 
population. The RI utilizes Community Engagement (CE) Studios as a primary 
recruitment, enrollment, engagement, and retention strategy. The CE Studio is a 
consultative model allowing researchers to obtain meaningful, program-specific input from 
parents, community members, community leaders, students, and other key stakeholders. 
The CE Studio includes: (1) RI consultation with the PD; (2) creation of a unique panel of 
community experts who represent the Tennessee Youth Prepared for Success population 
of interest; (3) pre-meeting coaching for the PD; (4) orientation and preparation of the 
expert panel; (5) a face-to-face meeting where the PD makes a brief presentation and 
community experts provide project-specific feedback; (6) compensation of community 
experts; and (7) a post-meeting summary with additional feedback for the PD. The CE 
model is instrumental in bringing the community perspective to the forefront of the 
research conversation and has proven to be a particularly effective approach for engaging 
populations underrepresented in research, including racial and ethnic minorities, gender 
and sexual identity minorities, people in rural areas, and youth. 
 
In order to be eligible for receiving Tennessee Youth Prepared for Success services, 
organizations must: (1) be located in Tennessee Youth Prepared for Success’ service area 
and (2) sign a Tennessee Youth Prepared for Success MOU and, where applicable, have 
documented approval from the school board for program implementation and data 
collection. Tennessee Youth Prepared for Success has already secured third-party 
agreements (i.e., MOUs, LOCs) and Letters of Support from diverse state and local 
organizations rooted in the target population’s culture and experienced in healthcare, 
behavioral health, trauma-informed care, and other supportive services. Schools and other 
youth-serving community organizations will partner with Tennessee Youth Prepared for 
Success to provide both a safe space for the provision of prevention/education services as 
well as access to potential participants. 
 
Centerstone program staff will educate/train 1,200 youth, engage 2,500 parents and 
community members, and distribute sexual health information materials among 5,000 
community members. The RI will ensure a sample size of adequate statistical power by 
developing a REDCap locator form, participant tracking database, and MyCap. REDCap 
will be used to track stakeholder engagement including which stakeholder groups and 
when, where, why, and how they were engaged; their level of engagement; and how 
challenges to engagement were overcome. 
 
 

 
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5.0 
Research Locations: 
Tennessee Youth Prepared for Success will serve 1,200 youth ages 14-19 in Anderson, 
Benton, Carroll, Hardeman, Roane, Scott, Sevier, Trousdale, and Union counties in 
Tennessee, targeting high-risk/vulnerable youth, including rural youth, those residing in 
counties with high teen birth rates, and/or hard-to-reach youth (e.g., systems-involved). 
BiC will be offered in primarily rural areas, including schools and non-traditional settings 
(e.g., Boys and Girls Club, faith-based), with hard-to-reach populations (e.g., homeless 
youth, foster care), and in areas of high teen birth rates. The survey platform will be 
adminstered through an online source, (i.e., Qualtrics), to collect the questionnaires or 
through pencil and paper administration. 
 
 
6.0 
Multi-site Research (research that involves external collaborating 
institutions and individuals): 
N/A 
 
 
7.0 
International Research (where data collection will occur outside 
the United States and U.S. territories, including online activities) 
N/A 
 
 
8.0 
Procedures Involved: 
Please check the boxes for all applicable data collection procedures you plan to use: 
☒One-on-one interviews 
☒Focus Groups 
☒Questionnaires/surveys 
☐Analysis of secondary data (medical record data, educational records, government or 
private sector datasets, etc.) 
☐Ethnographic observation 
☐Physiological measurements (e.g., EEG, EKG, MRI) 
☐Biospecimen collection (saliva samples, blood draws, hair samples, etc.) 
☐Mobile applications/data collection devices (e.g., Fitbits, actigraphs, etc.) 
☐Behavioral decision making tasks (e.g., puzzles, interactive games, etc.) 
☐Physical activities such as walking and other forms of exercise 
☐Other procedures (briefly list types of procedures here if not covered by the check-boxes 
above): ______________________________________________ 
 
Program staff (i.e., Prevention Specialist facilitators/educators) will administer pre/post 
surveys to Tennessee Youth Prepared for Success participants to assess whether the 
program is having its intended effects on behavior, intentions, knowledge, and risk 
avoidance/reduction skills. Surveys will be refined based on feedback from the pilot phase 

 
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in which participants will complete cognitive pre-testing by rating each section and survey 
question according to clarity, conciseness, and time required. (A subset of these pilot 
participants will participate in a follow-up interview, which will utilize think-aloud and 
verbal probing techniques to explore thoughts during survey completion, including those 
specific to cognitive processes involved in answering survey questions (e.g., 
comprehension, retrieval). RI-supported, web-based data collection tools (e.g., REDCap, 
Qualtrics, Smartsheet) will be used to collect all data, including participant surveys, 
observer- and facilitator-reported fidelity data, pilot data, program output (e.g., 
dissemination, referrals, partnerships) and quality data. Electronic data collection allows 
for real-time data quality control and availability of current data for use in program 
management. Prevention Specialists will also be trained to use paper-based surveys at 
program entry/exit with participants as an alternative in scenarios where there are barriers 
to technology use (e.g., limited internet connection, settings with device restrictions). 
Short-term (i.e., 6-month) and long-term (i.e., 12-month) follow-up survey invitations will 
be distributed via email, phone, and text messages, based on contact information provided 
by participants at program entry. Accomadations will be made for any participants who 
prefer to speak or wish to take the survey in Spanish. After data collection, data will be 
shared with ACF and the Family and Youth Service Bureau (FYSB) in accordance with 
grant reporting requirements. 
 
 
9.0 
Research with Vulnerable Populations 
Recruitment will take place at community-based or school-based settings where parents 
may or may not be. If parents/guardians are available, we will obtain a verbal consent for 
the participant to join in person or on the phone. If parents/guardians are not available, 
pariticpants will be sent home with a permission slip with the consent form attached and 
will not be able to participate in the program until we receive their parent’s consent form. 
We will also give the participants youth assent when they first take their survey to ensure 
they want to participate. Youth assent is based on the age of consent in Tennessee, those 
who are of age will receive a youth-focused consent form that is tailored to their 
developmental stage. Data collection will be collected in an online survey the youth can 
complete at home in their own time. This way the youth will not feel pressured to answer 
in a certain way and their privacy will be kept. If the youth does not have access to the 
internet, we will provide a paper copy that they can fill out with the other youth. 
Participants will be given a privacy paper to cover their answers as they complete the 
survey and will be staggered so the participants cannot view each others surveys.  
 
 
10.0 Incomplete Disclosure or Deception: 
N/A 
 
 
11.0 Consent Process:  

 
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It is essential individuals involved in the program be properly informed of their rights, 
responsibilities, risks, alternative treatments, and confidentiality. Following state law, 
staff/partnering organization personnel will obtain parent/guardian consent prior to 
delivering curricula/services to participants who are minors. Participants and their legal 
guardians (if under age 16) will receive information (e.g., electronic & physical consent 
forms) about the program evaluation component and responsibilities associated with these 
procedures at least 30 days prior to program implementation. Consent forms will include 
contact information for Tennessee Youth Prepared for Success staff, the PI and Program 
Evaluator (PE), and IRB of record will be included on the consent form to ensure ample 
opportunity to address questions prior to program implementation. Individuals wishing to 
participate will be invited to sign the Consent to Participate form. Participants will be 
provided a copy of the consent form. All consent forms will need to be signed by a 
parent/guardian and/or youth before the first day of implementation, and received by 
Tennessee Youth Prepared for Success on the first day of implementation. Youth under the 
age of 16, who require guardian consent, will also complete an assent form to document 
their agreement to participate. Consent forms will cover the entire length of the study and 
will not reoccur throughout longitudinal follow-up. All participation is voluntary, and each 
participant has the right to withdraw from the study at any time, without explanation or 
fear of derogatory treatment. Individuals who do not consent to the collection of 
individually identifiable data will be allowed to participate in Tennessee Youth Prepared 
for Success services. Accommodations will be made to meet the needs of participants with 
disabilities, low literacy, or other factors limiting their ability to provide full informed 
consent. 
 
 
12.0 Waiver of Participant Signature on Consent Form: 
N/A 
 
 
13.0 Waivers and Alterations of Consent Information: 
N/A 
 
 
14.0 Financial Compensation: 
Participants will be compensated with an electronic gift card for the time spent on study 
activities. The amount, type, and timing of compensation will be structured based on 
participant feedback during pilot. 
 
 
15.0 Audio/Video Recording/Photography 
Participants will not be recorded or photographed.  
 
 

 
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16.0 Potential Benefits of this Research:  
The potential benefit to science and humankind that may result from this research study is 
a better understanding of the effectiveness of prevention programs for youth who are at-
risk for teenage pregnancy and sexually transmitted diseases. The participant may or may 
not benefit from being in this study. 
 
 
17.0 Potential Risks to Participants: 
The potential discomfort or risk of the participant in this study is expected to be low 
because we have taken steps to protect their privacy. In the course of any research study, 
however, there are potential known and unknown risks. They may feel discomfort 
associated with sharing personal feelings and attitudes. There also might be a slight 
discomfort connected with discussing your attitudes about teenage sexual activity with 
program staff. The time it takes to complete the survey for the study may be a slight 
inconvenience. In order to minimize the time, the survey will take approximately 20 
minutes. Should they feel upset, they can stop taking the survey at any time. The Prevention 
Specialist will be present to get them in touch with someone who can help. The Research 
Associate and Prevention Specialist will closely follow designated procedures for 
protection of confidential data and materials. 
 
 
18.0 Provisions to Protect Participant Privacy and Data Confidentiality: 
Tennessee Youth Prepared for Success adheres to all OHRP and HIPAA privacy guidelines 
to fully protect confidential/sensitive participant information. Participant confidentiality 
will be maintained by assigning ID numbers to participants via computer algorithm. 
 
Pre/post survey data will be stored in secure, locked, and password protected locations 
(e.g., REDCap, Excel, secure filing cabinet), accessible only by data collection staff. All 
staff involved in data collection and evaluation will maintain valid HIPAA and human 
subject’s research certification throughout the project, and will be trained on techniques to 
assist participants who need individualized assistance due to cultural norms/values, 
literacy, disability, language barriers, etc. The data collection plan will be approved by an 
Institutional Review Board to ensure adequate human subjects protection, including 
appropriate informed consent and assent for data measuring behavioral intentions and 
sexual risk avoidance outcomes. 
 
A separate encrypted file will be maintained to match ID numbers with identifying 
information (accessible only by evaluation staff). Documents containing individually 
identifiable information (e.g., consent forms) will be stored separately from data, and in 
confidential files accessible only to employees trained in federal and state requirements 
and who have signed confidentiality agreements. Once the data are uploaded to the server 
and verified, working data files will be deleted from local workstations in order to ensure 
maximum confidentiality. Files will be converted to statistical formats (e.g., SAS, SPSS) 
for management and analysis. Variables and datasets will be labeled using an organized 

 
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coding scheme taking into account the specific data element, sample, and time point. 
Codebooks will be generated to enhance capacity to organize data. All treatment and 
evaluation information will be maintained in accordance with guidelines for 45 CFR 46, 
HIPAA regulations, and Confidentiality of Alcohol and Drug Abuse Patient Records (42 
CFR Part II). 
 
 
19.0 Data Monitoring Plan to Ensure the Safety of Participants: 
Prevention Specialists will be trained by the evaluation team to confidentially collect 
participant-level measures in a manner that is age-appropriate, culturally competent, and 
aligned with trauma-informed and Positive Youth Development approaches. If any 
participants show distress during the lesson, program staff will be trained to identify and 
provide support and referrals if nessecary. 
 
 
20.0 Long-term Data and Specimen Storage and Sharing:  
N/A 
 
 
21.0 Qualifications of Research Team to Conduct the Research: 
Tennessee Youth Prepared for Success’ prevention services team has a collective 75+ 
years’ experience providing school- and community-based educational services, including 
teen pregnancy and HIV/STI prevention, as well as experience creating innovative teen 
pregnancy and STI prevention content. Tennessee Youth Prepared for Success’ leadership 
team has demonstrated experience in overseeing and monitoring similarly sized projects, 
including adjusting services to meet changing needs and growth, and managing staff and 
partnerships. Each member has experience/expertise implementing evidence-based TPP 
programs, coordinating large-scale implementation efforts at the community level, 
mobilizing multiple partners and decision-makers, monitoring and providing 
training/technical assistance to partners, and collecting/using performance measure data.