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Tennessee Youth Prepared for Success (TYPS)

Primary Purpose

Adolescent Behavior, Adolescent Problem Behavior, Risk Reduction

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tennessee Youth Prepared for Success
Sponsored by
Centerstone Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Adolescent Behavior focused on measuring adolescent pregnancy prevention, adult preparation

Eligibility Criteria

14 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Be in Charge

    Adolescent Health Curricula

    Arm Description

    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.

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    July 24, 2023
    Last Updated
    August 17, 2023
    Sponsor
    Centerstone Research Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06001892
    Brief Title
    Tennessee Youth Prepared for Success
    Acronym
    TYPS
    Official Title
    Tennessee Youth Prepared for Success- Be in Charge Intervention
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 15, 2023 (Anticipated)
    Primary Completion Date
    May 31, 2026 (Anticipated)
    Study Completion Date
    May 31, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centerstone Research Institute

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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).
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Adolescent Behavior, Adolescent Problem Behavior, Risk Reduction
    Keywords
    adolescent pregnancy prevention, adult preparation

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Masking Description
    Participants will be masked during consent and baseline data collection. They will know the intervention once it begins.
    Allocation
    Randomized
    Enrollment
    1200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Be in Charge
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Adolescent Health Curricula
    Arm Type
    Active Comparator
    Arm Description
    Adolescent Health Curriculum which is designed to navigate youth through the emotional components of adolescence in preparation for adulthood.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Tennessee Youth Prepared for Success
    Intervention Description
    both 5 day classroom interventions.
    Primary Outcome Measure Information:
    Title
    Sexual activity
    Description
    Number of participants who have abstained from sexual intercourse in the last three months, change from baseline at six months
    Time Frame
    baseline and six months
    Title
    Sexting
    Description
    Number of participants who have abstained from sending nude images in the last three months, change from baseline at six months
    Time Frame
    baseline and six months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    14 Years
    Maximum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: younger than 14 or older 19 those with debilitating intellectual, mental health, or cognitive impairment those without consent at the time of data collection
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jordan L Nelon, PhD, MPH
    Phone
    2147332946
    Email
    jordan.nelon@centerstone.org

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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