Recruiting

Observational Study

Sponsor:

The Policy & Research Group

Code:

NCT06582641

Conditions

Teen Pregnancy Prevention

Eligibility Criteria

Sex: All

Age: 11 - 14

Healthy Volunteers: Accepted

Interventions

Peer Group Connection - Middle School (PGC-MS)

Study Details

Brief 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

Study ID

NCT06582641

Start date

Sep 1, 2024

Status verified date

Apr, 2026

Completion date

Sep 14, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 11 - 14

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Be enrolled at a middle school participating in the study
  • Entering the middle school transition grade for the first time (6th or 7th grade depending on the middle school transition year) at a participating study school
  • Provide parental consent and student assent to participate in the study
  • Have the ability to complete a self-administered questionnaire in either English or Spanish in a classroom or group setting, unassisted, in 60 minutes or less.

Exclusion Criteria:

\- Repeating the middle school transition year (6th or 7th grade)

Study Design

Enrollment

1400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Peer Group Connection - Middle School (PGC-MS)

no intervention: Class as usual

Interventions

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.

Primary outcome measure

  • Initiation of sexual intercourse [ Time Frame: Assessed 16 months after the intervention period has ended (beginning of the second fall semester following the end of the program) ]
  • Ever smoked a cigarette [ Time Frame: Assessed 4 months after the intervention period has ended (beginning of the first fall semester following the end of the program) ]
  • Ever used an electronic vapor product [ Time Frame: Assessed 4 months after the intervention period has ended (beginning of the first fall semester following the end of the program) ]
  • Ever had a drink of alcohol [ Time Frame: Assessed 4 months after the intervention period has ended (beginning of the first fall semester following the end of the program) ]
  • Ever used marijuana [ Time Frame: Assessed 4 months after the intervention period has ended (beginning of the first fall semester following the end of the program) ]

Central Contacts and Locations

Central contacts

Hilary Demby, MPH

504-655-0982hilary@policyandresearch.com

Kelly Burgess, MPH

225-773-9162kelly@policyandresearch.com

Locations

The Policy & Research Group

Recruiting

New Orleans, Louisiana, United States, 70118

Contacts

Hilary Demby, MPH

504-865-1545hilary@policyandresearch.com

More Information

Sponsor

The Policy & Research Group

Last update posted

May 18, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Policy & Research Group on 2026-05-18.