Education Program for Adolescent Risk Reduction

(TYPS Trial)

Overseen By Jordan L Nelon, PhD, MPH

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Centerstone Research Institute

Disqualifiers: Debilitating intellectual, mental health, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 6 months

1200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests innovative strategies to prevent adolescent pregnancies and sexually transmitted infections (STIs) by educating teens about abstinence and contraception. It includes two groups: one focuses on sexual health education, and the other on overall adolescent health. The study uses a trauma-informed approach to support youth who may have experienced maltreatment or abuse. Teens aged 14-19 living in rural Tennessee, especially in areas with high teen birth rates, are ideal candidates. Participants should not have severe mental health or cognitive challenges and must be open to discussing sexual health education. The program, Tennessee Youth Prepared for Success (also known as Be In Charge or Adolescent Health Curriculum), equips adolescents with the knowledge and skills needed for healthy decision-making. As an unphased trial, this study offers participants the chance to contribute to research that could shape future health education programs.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this education program is safe for adolescents?

A previous study demonstrated that educational programs like Tennessee Youth Prepared for Success are safe for participants. These programs teach teens about sexual health, abstinence, and contraception. Research shows that young people handle these programs well, with no reports of harmful side effects or negative experiences.

The program creates a supportive environment, helping teens feel comfortable and involved. It also considers the emotional needs of those who might have faced tough experiences, adopting a trauma-informed approach. This careful planning ensures the program is both safe and helpful for teens. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Be in Charge" program because it uses a trauma-informed approach to teaching sexual health, which is not commonly integrated into traditional Adolescent Health Curricula. This program incorporates the theory of planned behavior, aiming to change not just knowledge but also attitudes, social norms, and perceived control over sexual health decisions. Additionally, it engages young people through creative activities and focuses on building skills progressively in a safe environment, which could lead to better long-term outcomes in sexual health behavior among adolescents.

What evidence suggests that this education program is effective for reducing adolescent pregnancies and STIs?

Research has shown that education programs focused on risk reduction can decrease risky sexual behaviors in teenagers. These programs address both abstinence and the use of birth control to prevent pregnancies and sexually transmitted infections (STIs). In this trial, the Tennessee Youth Prepared for Success program employs a curriculum called "Be in Charge" in one treatment arm to build on this research. This curriculum aims to enhance teens' knowledge, attitudes, and behaviors regarding sexual health. Early results suggest that these programs can guide teens toward healthier choices. Another arm of the trial uses the Adolescent Health Curricula, designed to help youth navigate the emotional aspects of adolescence in preparation for adulthood. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for youth aged 14-19 in rural Tennessee who are at high risk of pregnancy and STIs. They must have guardian consent, be willing to discuss sexual health training experiences, and not have severe intellectual or mental impairments.

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)

I, or my guardian, have signed the necessary consent forms.

I am willing to discuss my sexual health and training experiences.

Exclusion Criteria

Those without consent at the time of data collection

Those with debilitating intellectual, mental health, or cognitive impairment

I am either younger than 14 or older than 19.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Be In Charge (BIC) intervention or Adolescent Health Curriculum over 7 units

6 months

Weekly sessions

Follow-up

Participants are monitored for changes in sexual activity and sexting behavior

6 months

1-year follow-up assessment

What Are the Treatments Tested in This Trial?

Interventions

• Tennessee Youth Prepared for Success

Trial Overview

The 'Tennessee Youth Prepared for Success' program aims to reduce pregnancies, births, and STIs among teens through education on abstinence and contraception. It includes adulthood preparation subjects (APS) and a positive development approach within a randomized controlled trial.

How Is the Trial Designed?

Group I: Be in Charge Experimental Treatment 1 Intervention

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.

Group II: Adolescent Health Curricula Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Centerstone Research Institute

Lead Sponsor

Trials

4

Recruited

1,700+

Published Research Related to This Trial

A three-year health education program involving 1,252 students showed that while general health education was well-received, it had minimal impact on reducing risk factors like obesity and smoking in the overall population.

Intensive interventions targeting small groups of at-risk children, particularly those who are obese, were effective in reducing obesity rates and preventing new smokers, suggesting that focused behavioral change strategies are more effective than general education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teaching children self-care for chronic disease prevention: obesity reduction and smoking prevention. Williams, CL., Arnold, CB.[2019]

Project Healthy Schools (PHS) has demonstrated significant improvements in health metrics and lifestyle behaviors among middle school students in Michigan, indicating its effectiveness in addressing childhood obesity.

The program's success is linked to collaborative efforts among stakeholders and changes in the school environment, suggesting that such comprehensive approaches can be replicated to combat childhood obesity in other settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Top 10 Lessons Learned from Project Healthy Schools. Rogers, R., Krallman, R., Jackson, EA., et al.[2019]

The pediatric obesity empowerment model group medical visit program (POEM-GMV) led to a significant reduction in BMI z-scores among participants, with an average decrease from 2.99 to 2.88, indicating effective management of obesity in children aged 5-18 over a 3-year period.

Participants showed improvements in various lifestyle factors, such as reduced stress and sugary beverage consumption, which were strongly correlated with weight loss, particularly among boys, suggesting that addressing these factors is crucial in obesity treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric Obesity Empowerment Model Group Medical Visits (POEM-GMV) as Treatment for Pediatric Obesity in an Underserved Community. Geller, JS., Dube, ET., Cruz, GA., et al.[2019]

The New Moves program, a school-based obesity prevention initiative for adolescent girls, was well-received, showing high satisfaction among participants, parents, and school staff, indicating its feasibility for implementation.

While participants reported positive changes in physical activity and self-image, the program did not produce statistically significant differences in most health outcomes compared to control schools, suggesting the need for further evaluation and enhancement of the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Moves: a school-based obesity prevention program for adolescent girls. Neumark-Sztainer, D., Story, M., Hannan, PJ., et al.[2022]

The Youth Empowerment Implementation Project successfully improved dietary habits among 30 low-income African-American middle school students, leading to a reduction in junk food intake and an increase in fruit and vegetable consumption.

Despite the positive changes in diet, the program did not significantly increase physical activity levels among participants, indicating a need for further strategies to enhance physical activity in future interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Youth empowerment implementation project evaluation results: A program designed to improve the health and well-being of low-income African-American adolescents. Lewis, RK., Lee, FA., Brown, KK., et al.[2022]

The B'N Fit POWER initiative is a comprehensive wellness program launched in middle schools to address obesity prevention and treatment, particularly targeting impoverished minority youths at risk for health disparities.

Initial implementation activities focused on enhancing communication and trust among stakeholders, and developing realistic goals, which helped increase student screenings and improve the integration of clinical services with existing school programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot Project to Integrate Community and Clinical Level Systems to Address Health Disparities in the Prevention and Treatment of Obesity among Ethnic Minority Inner-City Middle School Students: Lessons Learned. Rieder, J., Cain, A., Carson, E., et al.[2021]

The Safer Choices intervention is a comprehensive program aimed at reducing risky sexual behaviors among high school students to prevent HIV, STDs, and pregnancy, involving multiple stakeholders like school staff, parents, and community members.

The program includes various components such as curriculum development, peer education, and parent education, all designed to create a supportive school environment and promote protective behaviors among adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safer Choices: a multicomponent school-based HIV/STD and pregnancy prevention program for adolescents. Coyle, K., Kirby, D., Parcel, G., et al.[2004]

The Safer Choices program, evaluated over 31 months with 3869 ninth-grade students, significantly improved condom use and reduced unprotected intercourse, demonstrating its effectiveness in lowering sexual risk behaviors.

While the program enhanced several psychosocial factors related to safe sex, it did not significantly affect the rates of sexual initiation among students.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safer choices: reducing teen pregnancy, HIV, and STDs. Coyle, K., Basen-Engquist, K., Kirby, D., et al.[2022]

The Mentored Planning to Be Active (MBA) program led to significantly greater weight loss in obese Appalachian teens compared to the teacher-led Planning to Be Active (PBA) program, with the MBA group losing 77.5% more weight by the end of the study.

Participants in the MBA program also showed more improvement in body mass index (BMI) and body fat, indicating that this behavioral skills mentoring approach is more effective for increasing physical activity and improving health outcomes in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of "Mentoring to Be Active" on Weight Loss, Body Mass Index, and Body Fat among Obese and Extremely Obese Youth in Rural Appalachia. Smith, LH., Petosa, RL., Laurent, D.[2021]

A study involving nearly 7 million California public school students found that notifying parents about their child's BMI screening results did not lead to a significant change in their weight status over two years.

Despite an increase in parental notification rates from 35% to 52% between 2001 and 2008, the current method of notification did not effectively reduce pediatric obesity, suggesting a need for more effective strategies to improve student health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

School-based body mass index screening and parent notification: a statewide natural experiment. Madsen, KA.[2021]

A study evaluating the impact of continued BMI screening and parental notification in late adolescence found no significant changes in health outcomes, such as BMI-for-age z-scores or dietary and exercise behaviors, among students who had previously been screened in early adolescence.

The results suggest that ongoing BMI screening and reporting in 11th and 12th grades does not improve health outcomes for adolescents, indicating that such policies may need to be re-evaluated for effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

School-Based Body Mass Index Screening and Parental Notification in Late Adolescence: Evidence From Arkansas's Act 1220. Gee, KA.[2019]

The implementation of evidence-based teen pregnancy prevention programs in a school district aimed to address high birth rates among Hispanic or Latino teens, which were 40 births per 1,000 females aged 15 to 19 in 2018.

Despite challenges like funding interruptions and the COVID-19 pandemic, the program successfully provided educational programming to 9,616 youth over a 5-year period, highlighting effective strategies for engaging leadership, training staff, and fostering community support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying Implementation Drivers for Teen Sexual Health Education Curricula. Glinski, A., Cox, J., Lahti, MF.[2023]

The iCook 4-H program, led by high school students, successfully engaged 24 youth and their adult food preparers in improving culinary skills and physical activity, with 93% of adults noting their youth learned valuable kitchen skills.

The program was deemed feasible and effective, with teen leaders reporting high satisfaction with their training and the program's impact on their leadership skills, suggesting that this model could be replicated for other youth health initiatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teens Implementing a Childhood Obesity Prevention Program in the Community: Feasibility and Perceptions of a Partnership with HSTA and iCook 4-H. Hagedorn, RL., White, JA., Franzen-Castle, L., et al.[2019]

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