YYC...MSC! Program for Teen Pregnancy Prevention

(YYC! Trial)

Recruiting at 12 trial locations

Overseen By Peggy Cowan

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: New Jersey Physicians Advisory Group

Disqualifiers: Severe cognitive, mental, behavioral impairments, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 15

Duration: 2 weeks

2600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate a program designed to prevent teen pregnancy and promote smart decision-making among high school freshmen. Participants will either attend a special two-week educational program called "Yes You Can! (YYC!) Making Smart Choices" or continue their usual health class. The study will assess whether those who attended the program report less sexual activity after a year compared to those who did not. Ninth graders in Newark public schools, who do not have severe cognitive or behavioral impairments and do not opt out of the survey, are encouraged to participate. As an unphased trial, this study offers participants the chance to contribute to important educational research that could benefit future students.

Do I have to stop taking my current medications for the trial?

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

What prior data suggests that the YYC…MSC! program is safe for teen pregnancy prevention?

Research has shown that the Yes You Can! (YYC!) Making Smart Choices program enhances young people's understanding and behavior regarding sexual health. This program educates middle school students about safe sexual practices. No evidence of harm or negative effects has emerged from participation in this program. It is important to note that this is an educational program, not a drug or medical treatment.

Although specific safety data is unavailable, the program has been used without any reported issues, suggesting it is well-received by participants. The trial phase is listed as "Not Applicable," indicating it is evaluated like a school program, not tested like a new drug, to assess its educational effectiveness.

In summary, based on past use and current research, there are no known safety concerns with the Yes You Can! program. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Yes You Can! Making Smart Choices" program because it's an innovative approach to teen pregnancy prevention that emphasizes education and behavior change. Unlike traditional programs that might focus solely on abstinence or contraception, this program delivers 11 interactive lessons over two weeks, encouraging teens to make informed decisions through engaging content. By being integrated directly into schools and delivered intensively over a short period, it aims to have a more immediate impact, empowering students with the knowledge and skills to make smart choices.

What evidence suggests that the YYC…MSC! program is effective for preventing teen pregnancy?

Research has shown that the Yes You Can...Make Smart Choices! (YYC…MSC!) program, which participants in this trial may receive, is designed to help prevent teen pregnancy and encourage better decision-making among young people. Although detailed studies have not yet tested the program, it is based on a strong plan, and early signs suggest it could work well. Similar programs, like Making Proud Choices!, have successfully changed behaviors and improved sexual health in teens. These programs have helped teens make safer choices about sexual activity. The YYC…MSC! program aims to build on these successes by encouraging smart choices and character development in teens, which could lead to lower rates of sexual activity and teen pregnancy. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for 9th graders in regular classroom settings at selected Newark Public Schools who don't have severe cognitive, mental, or behavioral impairments. It's not for students in restricted placements or those opting out.

Inclusion Criteria

I am a 9th grader without severe cognitive, mental, or behavioral issues.

I am a student with an IEP and attend regular classes.

Exclusion Criteria

I am a student with an IEP in a special education program.

Students that bring back 'opt-out' written notices

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Participants receive the YYC...MSC! program, consisting of 11 lessons delivered over 2 weeks

2 weeks

11 visits (in-person)

Post-survey

Participants complete a post-survey immediately following the completion of the program

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in sexual activity and life skills 3 months after the pre-survey

3 months

1 visit (in-person)

Long-term Follow-up

Participants are monitored for changes in sexual activity and life skills 12 months after the pre-survey

12 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Text messaging
• Yes You Can! (YYC!) Making Smart Choices

Trial Overview The 'Yes You Can...Make Smart Choices!' program aims to prevent teen pregnancy and promote character development. The study will test its effectiveness by comparing students who participate with those who do not over a year.

How Is the Trial Designed?

Group I: Yes You Can…Make Smart Choices! (YYC…MSC!) Program Experimental Treatment 1 Intervention

The intervention/treatment participants in the treatment condition will be exposed to NJPAG's YYC…MSC! program. The program is designed to be delivered five days a week for two weeks and contains 11 lessons.

Group II: Control Active Control 1 Intervention

The control schools were randomly selected out of a list of eligible schools in the Newark Public School system. Control schools will receive their health class as "business-as-usual" with no additional programming. There is no other place that provides the YYC…MSC! program in which participants could receive programming or information. Also, there are no future plans to provide the control group with the intervention. To our knowledge, there is no other similar programming operating in the Newark Public School area.

Yes You Can! (YYC!) Making Smart Choices is already approved in United States for the following indications:

Approved in United States as Yes You Can... Make Smart Choices! for:

• Teen pregnancy prevention
• Character development in youth

Who Is Running the Clinical Trial?

New Jersey Physicians Advisory Group

Lead Sponsor

Trials

1

Recruited

2,600+

AMTC & Associates

Collaborator

Trials

2

Recruited

4,900+

Published Research Related to This Trial

All five reviewed adolescent pregnancy prevention programs effectively emphasized abstinence, decision-making skills, and education on sexuality and contraception, with four providing access to contraceptive services.

Programs targeting younger adolescents were particularly successful, reducing sexual initiation by up to 15 percentage points and increasing contraceptive use by as much as 22 percentage points, with the most effective programs also significantly decreasing pregnancy rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding the impact of effective teenage pregnancy prevention programs. Frost, JJ., Forrest, JD.[2022]

The Power Through Choices (PTC) program significantly improved knowledge about anatomy, fertility, HIV, STIs, and contraception methods among 1,036 youths in out-of-home care, showing lasting effects 12 months post-intervention.

Participants in the PTC program also demonstrated increased self-efficacy in communicating with partners about safe sex and planning for protected sex, indicating the program's effectiveness in promoting safer sexual behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Improvements in Knowledge and Psychosocial Factors of a Teen Pregnancy Prevention Intervention Implemented in Group Homes. Green, J., Oman, RF., Lu, M., et al.[2021]

The 'Yes You Can!' (YYC) curriculum significantly improved sexual knowledge and reduced intent to engage in sexual intercourse among students aged 10-14, as shown by a study involving pre- and post-intervention assessments.

Participants in the YYC program scored higher in sexual knowledge and had lower intent to engage in sexual activities compared to a control group, indicating the program's effectiveness in promoting healthy relationships and sexual education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of the Yes You Can! Curriculum on the Sexual Knowledge and Intent of Middle School Students. Donnelly, J., Horn, RR., Young, M., et al.[2018]

The Wise Guys Male Responsibility Curriculum significantly improved knowledge of sexual behavior, reproductive biology, and STD transmission among 124 seventh-grade boys compared to a control group of 106 boys, with results measured at posttest and 6-month follow-up (p < .000).

Participants in the Wise Guys program also showed more favorable attitudes toward sex and appropriate behaviors in relationships, along with increased rates of condom use and contraception among sexually active adolescents at follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Wise Guys Male Responsibility Curriculum: participant-control comparisons. Gruchow, HW., Brown, RK.[2019]

A systematic review of 21 studies (10 randomized controlled trials and 11 non-randomized trials) on school-based pregnancy prevention programs found that most programs did not significantly reduce pregnancy rates, with 24 out of 30 comparisons showing no statistical significance.

While some programs resulted in either increased or decreased pregnancy rates, the overall evidence quality was low, and all studies had a high risk of bias, indicating that school-based programs may not be consistently effective in preventing youth pregnancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of School-Based Teen Pregnancy Prevention Programs in the USA: a Systematic Review and Meta-Analysis. Marseille, E., Mirzazadeh, A., Biggs, MA., et al.[2019]

Citations

1. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05320666/an-evaluation-of-the-yes-you-can-make-smart-choices-curriculum

An Evaluation of the Yes You Can... Make Smart Choices ... This evaluation aims to conduct a randomized control trial (RCT) to determine the program's effectiveness.

2. opa.hhs.gov opa.hhs.gov/sites/default/files/2022-06/making-proud-choices-evaluation-may-2022.pdf

Evaluation Report: The Impact of the Making Proud Choices ... In this report, we share the findings from an impact and implementation study of Making Proud Choices! (MPC), a teen pregnancy prevention curriculum.

3. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/66/NCT05320666/Prot_SAP_ICF_000.pdf

1 COVER PAGE NJPAG PREIS STUDY PROTOCOL ... Make Smart. Choices! (YYC…MSC!) program with the goal of preventing teen pregnancy and enhancing character development in youth. YYC…MSC! is a ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38099897/

The Impact of Making Proud Choices! on Youth's Sexual ... The evaluation showed that MPC, as it is commonly implemented today, has evidence of effectiveness on improving both risk and protective factors, and sexual ...

5. pediatrics.jmir.org pediatrics.jmir.org/2021/2/e19114/

Efficacy of a Web-Based Intervention (Smart Choices 4 Teens ... Smart Choices 4 Teens demonstrated efficacy in increasing the frequency of sexual communication between parents and adolescents in the long term.

6. withpower.com withpower.com/trial/phase-adolescent-health-3-2022-8fede

YYC...MSC! Program for Teen Pregnancy Prevention The Yes You Can! Making Smart Choices treatment is unique because it focuses on improving sexual knowledge and behavioral intent among middle school students, ...

7. opa.hhs.gov opa.hhs.gov/sites/default/files/2022-09/mpc-teen-pregnancy-prevention-program.pdf

Making Proud Choices! - An Evidence-Based Teen Pregnancy ... The purpose of this review is to identify programs that improve knowledge about STIs and effective methods of contraception, reduce risky sexual ...

8. acf.gov acf.gov/sites/default/files/documents/opre/ny_teen_choice_impact_report_full_text_508.pdf

The Impacts of Teen Choice in New York Teen Choice is a 12-session adolescent pregnancy prevention curriculum that covers abstinence, contraception, STIs, and healthy relationships through ...

9. youtube.com youtube.com/watch?v=60cFCsvvKco

Teen Access to Contraception: Health Impacts and Policy ... Today we'll be talking about how teens can access contraception in Texas to be followed by additional reports and events to highlight policy opportunities.