NCT06001892

Brief 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 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).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for not_applicable

Timeline
1mo left

Started Sep 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
Sep 2023May 2026

First Submitted

Initial submission to the registry

July 24, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

August 21, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

September 25, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

2.7 years

First QC Date

July 24, 2023

Last Update Submit

March 16, 2026

Conditions

Keywords

adolescent pregnancy preventionadult preparation

Outcome Measures

Primary Outcomes (2)

  • Sexual activity

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

    baseline and six months

  • Sexting

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

    baseline and six months

Study Arms (2)

Be in Charge

EXPERIMENTAL

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.

Behavioral: Tennessee Youth Prepared for Success

Adolescent Health Curricula

ACTIVE COMPARATOR

Adolescent Health Curriculum which is designed to navigate youth through the emotional components of adolescence in preparation for adulthood.

Behavioral: Tennessee Youth Prepared for Success

Interventions

both 5 day classroom interventions.

Adolescent Health CurriculaBe in Charge

Eligibility Criteria

Age14 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centerstone Research Institute

Nashville, Tennessee, 37228, United States

Location

MeSH Terms

Conditions

Adolescent BehaviorRisk Reduction Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will be masked during consent and baseline data collection. They will know the intervention once it begins.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2023

First Posted

August 21, 2023

Study Start

September 25, 2023

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2026

Last Updated

March 18, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations