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

Trial Summary

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 Peer Group Connection - Middle School (PGC-MS) for teen pregnancy prevention?

Research on similar peer-centered programs, like the mastery modeling peer-support intervention and the CenteringPregnancy model, shows positive outcomes such as lower rates of low birth weight and preterm births, as well as improved educational continuation among adolescent mothers. These findings suggest that peer group interventions can be effective in supporting young mothers and potentially preventing teen pregnancies. ^{1 2 3 4 5}

How is the Peer Group Connection - Middle School (PGC-MS) treatment different from other treatments for teen pregnancy prevention?

The Peer Group Connection - Middle School (PGC-MS) treatment is unique because it focuses on peer-led group sessions to support and educate middle school students, which is different from traditional methods that might rely more on adult-led education or medical interventions. This approach leverages the influence of peers to encourage positive behaviors and decision-making among teens. ^{6 7 8 9 10}

What is the purpose of this trial?

The goal of this randomized trial is to learn if the Peer Group Connection - Middle School (PGC-MS) intervention delays initiation of sexual intercourse in middle school-aged youth. The primary research question it aims to answer is: Sixteen months after being offered the intervention, does PGC-MS impact youth's initiation of sexual intercourse? Researchers will compare participants randomized to receive PGC-MS (treatment group) to participants randomized to class-as-usual (which contains no sexual or reproductive health information (control group)). Participants randomized to the treatment group will be offered PGC-MS over the course of their transition year into middle school (either 6th or 7th grade). Participants randomized to the control group will be offered class-as-usual.

Research Team

Sarah Walsh, PhD

Principal Investigator

The Policy & Research Group

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

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

Pregnancy-free club: a strategy to prevent repeat adolescent pregnancy. [2009]

2. United States 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. [2020]

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

Pregnancy outcomes of adolescents enrolled in a CenteringPregnancy program. [2022]

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

Prenatal peer counseling: an answer to the persistent difficulties with prenatal care for low-income women. [2019]

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

Use of a sex rap group in an adolescent medical clinic. [2019]

6. United States 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. [2019]

7. United States 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. [2019]

8. Germany pubmed.ncbi.nlm.nih.gov

[Preimplantation and prenatal counseling. Interdisciplinary and multiprofessional approach]. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Chinese experts' consensus guideline on preimplantation genetic testing of monogenic disorders. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Preimplantation genetic diagnosis for cancer predisposition syndromes. [2019]