Evaluation of Peer Group Connection - Middle School

Part of paid clinical trials in New Orleans, Louisiana.

Sponsor
The Policy & Research Group
Study ID
NCT06582641
Status
Recruiting
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Conditions

  • Teen Pregnancy Prevention

Eligibility Criteria

Sex
ALL
Age
11 Years - 14 Years
Healthy Volunteers
Accepted

Interventions

  • Peer Group Connection - Middle School (PGC-MS) — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Sep 1, 2024
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Sep 14, 2028

Study Design

Enrollment
1,400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Peer Group Connection - Middle School (PGC-MS)
  • No Intervention: Class as usual

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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Policy & Research GroupNew OrleansLouisiana70118
Hilary Demby, MPH
[email protected]
504-865-1545

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