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

Trial Summary

What is the purpose of this trial?

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).

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 data supports the effectiveness of the treatment Tennessee Youth Prepared for Success, Be In Charge (BIC), Adolescent Health Curriculum?

The Youth Empowerment Implementation Project showed that similar health education programs can improve dietary habits among adolescents, such as increasing fruit and vegetable intake and reducing junk food consumption. This suggests that educational programs like BIC could be effective in promoting healthier behaviors in adolescents. ^{1 2 3 4 5}

Is the Education Program for Adolescent Risk Reduction safe for participants?

The research articles provided do not contain specific safety data for the Education Program for Adolescent Risk Reduction or its related programs. ^{6 7 8 9 10}

How is the Education Program for Adolescent Risk Reduction treatment different from other treatments?

The Tennessee Youth Prepared for Success program, also known as Be In Charge (BIC), is unique because it focuses on empowering adolescents through education to reduce risky behaviors, rather than using medication or traditional therapy. This program emphasizes skill-building and personal responsibility, which is different from other treatments that might focus on direct medical interventions. ^{2 3 11 12 13}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Pediatric Obesity Empowerment Model Group Medical Visits (POEM-GMV) as Treatment for Pediatric Obesity in an Underserved Community. [2019]

2. Switzerland 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. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

New Moves: a school-based obesity prevention program for adolescent girls. [2022]

4. United States 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. [2022]

5. United States 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. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Safer Choices: a multicomponent school-based HIV/STD and pregnancy prevention program for adolescents. [2004]

7. United States pubmed.ncbi.nlm.nih.gov

Safer choices: reducing teen pregnancy, HIV, and STDs. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

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

9. United States pubmed.ncbi.nlm.nih.gov

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

10. United States pubmed.ncbi.nlm.nih.gov

Identifying Implementation Drivers for Teen Sexual Health Education Curricula. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Teaching children self-care for chronic disease prevention: obesity reduction and smoking prevention. [2019]

12. England 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. [2021]

13. United States pubmed.ncbi.nlm.nih.gov

Top 10 Lessons Learned from Project Healthy Schools. [2019]