Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT06001892 |
Other study ID # |
PREIS |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
September 25, 2023 |
Est. completion date |
May 31, 2026 |
Study information
Verified date |
February 2024 |
Source |
Centerstone Research Institute |
Contact |
Jordan L Nelon, PhD, MPH |
Phone |
2147332946 |
Email |
jordan.nelon[@]centerstone.org |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical 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 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).
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).