Evaluation of Peer Group Connection - Middle School

NCT06582641 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1400

Last updated 2026-05-18

No results posted yet for this study

Summary

This study is a randomized controlled trial to assess the impact of the Peer Group Connection - Middle School (PGC-MS) intervention on pre-sexual behaviors and sexual initiation in middle school-aged youth. The primary research questions it aims to answer are:

1. What is the impact of the offer to participate in PGC-MS relative to the control group on participants' reported initiation of sexual intercourse at sixteen months post-intervention?
2. What is the impact of the offer to participate in PGC-MS relative to the control group on participants' reports of ever smoking a cigarette at four months post-intervention?
3. What is the impact of the offer to participate in PGC-MS relative to the control group on participants' reports of ever using an electronic vapor product at four months post-intervention?
4. What is the impact of the offer to participate in PGC-MS relative to the control group on participants' reports of ever having a drink of alcohol at four months post-intervention?
5. What is the impact of the offer to participate in PGC-MS relative to the control group on participants' reports of ever using marijuana at four months post-intervention?

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 (6th grade). Participants randomized to the control group will be offered class-as-usual.

Conditions

  • Teen Pregnancy Prevention

Interventions

BEHAVIORAL

Peer Group Connection - Middle School (PGC-MS)

Peer Group Connection - Middle School (PGC-MS) is the treatment condition. PGC-MS is a school-based positive youth development program for students entering the transition year into middle school (6th or 7th grade). PGC-MS aims to improve school engagement and social-emotional learning skills that support adolescent health and educational outcomes for program participants. Participants receive 40-minute outreach sessions held 3 to 4 times per month for the full school year. Schools are expected to implement a minimum of 18 outreach sessions over the school year. PGC-MS outreach sessions are delivered by older peer leaders (8th, 9th, or 10th graders) who are carefully selected by faculty advisors and trained on how to deliver program content.

Sponsors & Collaborators

  • Department of Health and Human Services

    collaborator FED
  • Mathematica Policy Research, Inc.

    collaborator OTHER
  • Reproductive Health National Training Center

    collaborator UNKNOWN
  • Center for Supportive Schools

    collaborator UNKNOWN
  • The Policy & Research Group

    lead OTHER

Principal Investigators

  • Sarah Walsh, PhD · The Policy & Research Group

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
11 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-01
Primary Completion
2027-12-31
Completion
2028-09-14

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06582641 on ClinicalTrials.gov