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Adolescent BehaviorTYPSNCT06001892

Tennessee Youth Prepared for Success

A study testing Tennessee Youth Prepared for Success in people with Adolescent Behavior and Adolescent Problem Behavior, run by Centerstone Research Institute at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 14 to 19 yearsHealthy volunteers can take part
What is being tested?
Tennessee Youth Prepared for Success
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,200 participants
Where
1 siteUnited States
Study dates
25 Sep 2023to 31 May 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 19 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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)
  • be free of debilitating intellectual, mental health, or cognitive impairment (i.e. psychosis, orientation to time/place, etc. based on screening at program entry)
  • be willing to share their experiences with sexual health \& wellbeing training

Who cannot join

  • younger than 14 or older 19
  • those with debilitating intellectual, mental health, or cognitive impairment
  • those without consent at the time of data collection

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Centerstone Research Institute

    Nashville, Tennessee, 37228

Other trials in United States

About this study

Official title: Tennessee Youth Prepared for Success- Be in Charge Intervention

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. 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).

Read the detailed description

Tennessee Youth Prepared for Success will implement a 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 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).

Being tested
Tennessee Youth Prepared for Success
Keywords
adolescent pregnancy prevention, adult preparation
Medical subject headings
Adolescent Behavior, Risk Reduction Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tennessee Youth Prepared for SuccessBehavioural

    both 5 day classroom interventions.

Study groups in NCT06001892
Study groupRoleWhat they receive
Be in ChargeExperimentalThe 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.
Receives: Behavioral: Tennessee Youth Prepared for Success
Adolescent Health CurriculaActive comparatorAdolescent Health Curriculum which is designed to navigate youth through the emotional components of adolescence in preparation for adulthood.
Receives: Behavioral: Tennessee Youth Prepared for Success

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sexual activity

    Number of participants who have abstained from sexual intercourse in the last three months, change from baseline at six months

    Measured: baseline and six months

  2. Sexting

    Number of participants who have abstained from sending nude images in the last three months, change from baseline at six months

    Measured: baseline and six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2023
  2. Study start25 Sep 2023
  3. Primary completion31 May 2026 (estimated)
  4. Study completion31 May 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
1,200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06001892
Sponsor's protocol ID
PREIS
Acronym
TYPS
Status last verified
Mar 2026
First submitted
24 Jul 2023
Last updated
18 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Tennessee Youth Prepared for Success in people with Adolescent Behavior and Adolescent Problem Behavior, run by Centerstone Research Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sexual activity (time frame: baseline and six months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.

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