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

Trial Summary

What is the purpose of this trial?

The New Jersey Physicians Advisory Group (NJPAG) previously created the Yes You Can...Make Smart Choices! (YYC...MSC!) program with the goal of preventing teen pregnancy and enhancing character development in youth. YYC...MSC! is a fully developed intervention that NJPAG has experience implementing that is grounded in a theoretical framework with promising evidence of effectiveness. However, this intervention has not yet undergone a rigorous evaluation with a control or comparison group. This evaluation aims to conduct a randomized control trial (RCT) to determine the program's effectiveness. This evaluation will focus on the entire PREIS planned intervention, YYC...MSC!. The intervention will be implemented in 13 Newark Public Schools in New Jersey, including Weequahic High School and Newark School of Global Studies. Findings from this study will expand the evidence base on adolescent pregnancy prevention through this innovative program. After the study, findings will be disseminated to encourage program interest, support, and adoption in real-world service systems or communities, including schools. The primary research question is, "What is the effect of the 2-week YYC...MSC! program on 9th grade students in Northeast urban school districts' reports of engaging in sexual intercourse 12-months after the pre-survey compared to those that do not receive the program?" The outcome for the primary research questions is sexual intercourse in the last 3 months and the domain is sexual activity.

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.

How is the Yes You Can! Making Smart Choices treatment different from other teen pregnancy prevention treatments?

The Yes You Can! Making Smart Choices treatment is unique because it focuses on improving sexual knowledge and behavioral intent among middle school students, emphasizing abstinence and decision-making skills, rather than just providing access to contraceptive services. ^{1 2 3 4 5}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

References

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

The Effects of the Yes You Can! Curriculum on the Sexual Knowledge and Intent of Middle School Students. [2018]

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

Understanding the impact of effective teenage pregnancy prevention programs. [2022]

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

Effectiveness of School-Based Teen Pregnancy Prevention Programs in the USA: a Systematic Review and Meta-Analysis. [2019]

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

Long-Term Improvements in Knowledge and Psychosocial Factors of a Teen Pregnancy Prevention Intervention Implemented in Group Homes. [2021]

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

Evaluation of the Wise Guys Male Responsibility Curriculum: participant-control comparisons. [2019]