Peer Group Connection for Teen Pregnancy Prevention

(PGC-MS Trial)

Overseen By Kelly Burgess, MPH

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: The Policy & Research Group

Disqualifiers: Repeating transition year

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: Unknown

1400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the Peer Group Connection - Middle School (PGC-MS) program can delay sexual activity among middle school students. The study compares students in PGC-MS to those in regular classes without sexual health education. It targets students entering 6th or 7th grade at participating schools who have parental consent and can complete a survey in English or Spanish within an hour. As an unphased study, this trial provides a unique opportunity for students to contribute to important educational research that could benefit their peers.

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 the Peer Group Connection - Middle School (PGC-MS) intervention is safe for middle school-aged youth?

Research shows that Peer Group Connection - Middle School (PGC-MS) aims to help middle school students delay the onset of sexual activity. This program emphasizes peer support and communication. As a program rather than a medication, it does not cause physical side effects like those associated with drugs.

Studies on similar programs, such as comprehensive sex education, have shown they can effectively reduce teen birth rates without causing harm. Since PGC-MS involves group activities and discussions, any "safety" concerns relate to the social and emotional experience. No reports have linked negative effects directly to programs like this.

In summary, PGC-MS is well-tolerated as a social and educational program, not a medical treatment. Participants can feel confident that the program is safe and free from negative physical effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Peer Group Connection - Middle School (PGC-MS) program because it takes a fresh approach to teen pregnancy prevention by focusing on peer influence and support. Unlike traditional methods that might rely on classroom instruction or abstinence-only education, PGC-MS harnesses the power of peer leaders to create a supportive environment for middle school students. This method aims to build strong social connections and foster open discussions, helping teens make informed decisions. By involving students directly in the process, it offers a dynamic and engaging way to address an important issue, potentially leading to more effective outcomes.

What evidence suggests that the Peer Group Connection - Middle School (PGC-MS) intervention could be effective for delaying initiation of sexual intercourse in middle school-aged youth?

Research has shown that the Peer Group Connection - Middle School (PGC-MS) program, which participants in this trial may receive, can delay the onset of sexual activity among middle school students. Studies on similar school programs have found they can lead to better outcomes for teenagers, such as reducing risky behaviors. In one study, participants were 28% less likely to have sex without using birth control three months after the program ended. This suggests that PGC-MS can positively impact decision-making and peer relationships, making it a promising method for preventing teen pregnancy. ^{1 6 7 8 9}

Who Is on the Research Team?

Sarah Walsh, PhD

Principal Investigator

The Policy & Research Group

Are You a Good Fit for This Trial?

This trial is for middle school students entering either 6th or 7th grade, depending on the school's transition year. They must be enrolled at a participating school, have parental consent and student assent to join, and be able to complete a questionnaire in English or Spanish within an hour.

Inclusion Criteria

I am a student at a middle school involved in the study.

Provide parental consent and student assent to participate in the study

I am entering middle school for the first time.

Exclusion Criteria

I am repeating the 6th or 7th grade.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the Peer Group Connection - Middle School (PGC-MS) intervention during their transition year into middle school

1 academic year

Structured questionnaire administered at baseline and post-intervention

Post-intervention Follow-up

Participants are monitored for outcomes using self-reported data four months after the intervention

4 months

Structured questionnaire administered

Long-term Follow-up

Participants are assessed for initiation of sexual intercourse sixteen months after the intervention

16 months post-intervention

Structured questionnaire administered

What Are the Treatments Tested in This Trial?

Interventions

• Peer Group Connection - Middle School (PGC-MS)

Trial Overview

The study tests if Peer Group Connection - Middle School (PGC-MS) can delay the start of sexual activity among young teens. It compares those who receive PGC-MS with those who get regular classes without sexual health info over their first middle school year.

How Is the Trial Designed?

Group I: Peer Group Connection - Middle School (PGC-MS) Experimental Treatment 1 Intervention

Group II: Class as usual Active Control 1 Intervention

Peer Group Connection - Middle School (PGC-MS) is already approved in United States for the following indications:

Approved in United States as PGC-MS for:

• Middle school transition support
• Social-emotional learning
• Prevention of risky behaviors

Who Is Running the Clinical Trial?

The Policy & Research Group

Lead Sponsor

Trials

12

Recruited

12,700+

Center for Supportive Schools

Collaborator

Trials

1

Recruited

1,400+

Reproductive Health National Training Center

Collaborator

Trials

4

Recruited

5,400+

Department of Health and Human Services Office of Population Affairs

Collaborator

Trials

4

Recruited

5,400+

Mathematica Policy Research, Inc.

Collaborator

Trials

68

Recruited

31,130,000+

Department of Health and Human Services

Collaborator

Trials

240

Recruited

944,000+

Published Research Related to This Trial

The implementation of a preimplantation genetic diagnosis (PGD) service showed promising results, with a 40% pregnancy rate per couple treated, indicating effective strategies for couples at risk of genetic conditions.

Using sequential embryo culture media significantly improved success rates, with a 33.5% pregnancy rate per embryo transfer compared to only 13% with nonsequential media, highlighting the importance of media choice in PGD outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies and outcomes of the first 100 cycles of preimplantation genetic diagnosis at the Guy's and St. Thomas' Center. Pickering, S., Polidoropoulos, N., Caller, J., et al.[2019]

Preimplantation genetic diagnosis (PGD) was successfully developed for three cancer predisposition syndromes (APC, NF2, and BRCA1), allowing for the selection of embryos free from these mutations before pregnancy.

In 11 clinical cycles of PGD, an unaffected girl was born, demonstrating the efficacy of this method in preventing the transmission of genetic mutations associated with adult-onset cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preimplantation genetic diagnosis for cancer predisposition syndromes. Spits, C., De Rycke, M., Van Ranst, N., et al.[2019]

The Pregnancy-Free Club (PFC) program, implemented by public health nurses in collaboration with local health organizations, successfully reduced the repeat adolescent pregnancy rate from 25% to 7.2% over 9 years, demonstrating the efficacy of school-based interventions.

Key components of the program included daily access to nonjudgmental public health nurses, health counseling, and supportive educational resources, which were crucial in promoting healthy choices among adolescent mothers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pregnancy-free club: a strategy to prevent repeat adolescent pregnancy. Schaffer, MA., Jost, R., Pederson, BJ., et al.[2009]

The peer-centered prenatal care program for adolescent mothers led to a lower rate of low birth weight babies (6.6% vs. 12.5%) compared to those receiving standard individual care, suggesting improved perinatal outcomes.

Participants in the experimental group were more likely to continue their education during and after pregnancy, indicating that the program may also support long-term educational goals for adolescent mothers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a prenatal care intervention for adolescent mothers on birth weight, repeat pregnancy, and educational outcomes at one year postpartum. Ford, K., Weglicki, L., Kershaw, T., et al.[2020]

In a study using prepubertal rats, high levels of steroids in polycystic ovaries (PCO) were found to correlate with the expression of the multidrug resistance protein P-glycoprotein (Pgp) in granulosa cells, suggesting a potential mechanism for steroid regulation.

The research indicates that progesterone produced by granulosa cells may enhance the expression of Pgp, which could modulate the efflux of steroids, highlighting a possible autocrine regulatory mechanism in ovarian function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multidrug resistance gene expression correlates with progesterone production in dehydroepiandrosterone-induced polycystic and equine chorionic gonadotropin-stimulated ovaries of prepubertal rats. Lee, GY., Croop, JM., Anderson, E.[2019]

The CenteringPregnancy model of group prenatal care has been successfully implemented with 124 adolescents, promoting better health care compliance and satisfaction during pregnancy.

This model has also resulted in low rates of preterm births and low birth weight infants, highlighting its effectiveness in addressing the unique needs of pregnant adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pregnancy outcomes of adolescents enrolled in a CenteringPregnancy program. Grady, MA., Bloom, KC.[2022]

New regulations introduced in 2010 have improved the quality of medical information and counseling related to preimplantation genetics (PGD) and prenatal diagnosis (PND), emphasizing the need for interdisciplinary expertise that includes psychological and social considerations.

Successful multidisciplinary counseling in PGD and PND relies on timely referrals to appropriate medical specialists, clear communication between healthcare providers, and the qualifications of psychosocial counselors to support patients effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Preimplantation and prenatal counseling. Interdisciplinary and multiprofessional approach]. Woopen, C.[2022]

Prenatal peer counseling is proposed as an effective community-based strategy to support pregnant women from low socioeconomic backgrounds, addressing specific needs that traditional prenatal programs may overlook.

Research indicates that such programs can positively impact psychosocial factors like anxiety, social support, and self-esteem, which are crucial for improving pregnancy outcomes in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prenatal peer counseling: an answer to the persistent difficulties with prenatal care for low-income women. Lapierre, J., Perreault, M., Goulet, C.[2019]

Recent advancements in molecular biology and genetic diagnostics have led to improved strategies for preimplantation genetic testing for monogenic disorders (PGT-M), which helps prevent the transmission of inherited diseases.

A consensus statement developed by Chinese experts outlines essential guidelines for the application of PGT-M, covering patient selection, counseling, informed consent, diagnostic strategies, and follow-up, aiming to establish evidence-based practices in clinical and laboratory settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chinese experts' consensus guideline on preimplantation genetic testing of monogenic disorders. Yan, L., Cao, Y., Chen, ZJ., et al.[2023]

The weekly group sessions, led by an interdisciplinary team, provide a supportive environment for adolescents to discuss sexual issues and personal relationships, fostering trust and understanding within the clinic.

Over five years, the program has helped adolescents gain insights into their lives and concerns, leading to better engagement with the overall Adolescent Program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a sex rap group in an adolescent medical clinic. Scharff, D., Silber, T., Tripp, G., et al.[2019]

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This is an individual-level, randomized control trial to rigorously evaluate the impact of the Peer Group Connection - Middle School (PGC-MS) intervention.

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More comprehensive sex education reduced teen births

Our results show that federal funding for more comprehensive sex education reduced county-level teen birth rates by more than 3%.