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Evaluation of Peer Group Connection - Middle School

Evaluation of Peer Group Connection - Middle School (PGC-MS)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06582641
Acronym
PGC-MS
Enrollment
1400
Registered
2024-09-03
Start date
2024-09-01
Completion date
2028-09-14
Last updated
2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Teen Pregnancy Prevention

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.

Detailed description

This is an individual-level, randomized control trial to rigorously evaluate the impact of the Peer Group Connection - Middle School (PGC-MS) intervention. Participant outcomes will be assessed using self-reported, individual-level data gathered using a structured questionnaire administered at four time points: baseline (fall semester of 6th grade); post-intervention (spring semester of 6th grade); four months post-intervention (fall semester of 7th grade); and sixteen months post-intervention (fall semester of 8th grade).

Interventions

BEHAVIORALPeer 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

The Policy & Research Group
Lead SponsorOTHER
Department of Health and Human Services
CollaboratorFED
Mathematica Policy Research, Inc.
CollaboratorOTHER
Reproductive Health National Training Center
CollaboratorUNKNOWN
Center for Supportive Schools
CollaboratorUNKNOWN

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
11 Years to 14 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Initiation of sexual intercourseAssessed 16 months after the intervention period has ended (beginning of the second fall semester following the end of the program)Participants are asked the following item: Have you ever had sexual intercourse?. The resulting variable is dichotomous with values 0 or 1, where 0 indicates a person who has never had sexual intercourse and 1 indicates a person who has had sexual intercourse.
Ever smoked a cigaretteAssessed 4 months after the intervention period has ended (beginning of the first fall semester following the end of the program)Description: Participants are asked the following item: Have you ever smoked a cigarette, even one or two puffs?. The resulting variable is dichotomous with values 0 or 1, where 0 indicates a person who has never smoked a cigarette and 1 indicates a person who has smoked a cigarette.
Ever used an electronic vapor productAssessed 4 months after the intervention period has ended (beginning of the first fall semester following the end of the program)Participants are asked the following item: Have you ever used an electronic vapor product?. The resulting variable is dichotomous with values 0 or 1, where 0 indicates a person who has never used an electronic vapor product and 1 indicates a person who has used an electronic vapor product.
Ever had a drink of alcoholAssessed 4 months after the intervention period has ended (beginning of the first fall semester following the end of the program)Participants are asked the following item: Have you ever had a drink of alcohol?. The resulting variable is dichotomous with values 0 or 1, where 0 indicates a person who has never had a drink of alcohol and 1 indicates a person who has had a drink of alcohol.
Ever used marijuanaAssessed 4 months after the intervention period has ended (beginning of the first fall semester following the end of the program)Participants are asked the following item: Have you ever used marijuana?. The resulting variable is dichotomous with values 0 or 1, where 0 indicates a person who has never used marijuana and 1 indicates a person who has used marijuana.

Countries

United States

Contacts

CONTACTHilary Demby, MPH
hilary@policyandresearch.com504-655-0982
CONTACTKelly Burgess, MPH
kelly@policyandresearch.com225-773-9162
PRINCIPAL_INVESTIGATORSarah Walsh, PhD

The Policy & Research Group

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 19, 2026