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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Teen Pregnancy Prevention
• Intervention / Treatment: Behavioral: Peer Group Connection - Middle School (PGC-MS)

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).

• Study Type: Interventional
• Enrollment (Estimated): 1400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hilary Demby, MPH; Phone Number: 504-655-0982; Email: hilary@policyandresearch.com
• Study Contact Backup: Name: Kelly Burgess, MPH; Phone Number: 225-773-9162; Email: kelly@policyandresearch.com

Study Locations

• United States
  • Louisiana
    • New Orleans, Louisiana, United States, 70118
      • Recruiting
      • The Policy & Research Group
      • Contact: Hilary Demby, MPH; Phone Number: 504-865-1545; Email: hilary@policyandresearch.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Peer Group Connection - Middle School (PGC-MS)	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.
No Intervention: Class as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Initiation of sexual intercourse	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.	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	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.	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	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.	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	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.	Assessed 4 months after the intervention period has ended (beginning of the first fall semester following the end of the program)
Ever used marijuana	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.	Assessed 4 months after the intervention period has ended (beginning of the first fall semester following the end of the program)

Collaborators and Investigators

• Sponsor: The Policy & Research Group
• Collaborators: Department of Health and Human Services; Mathematica Policy Research, Inc.; Reproductive Health National Training Center; Center for Supportive Schools
• Investigators: Principal Investigator: Sarah Walsh, PhD, The Policy & Research Group

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): September 14, 2028

Study Registration Dates

• First Submitted: August 30, 2024
• First Submitted That Met QC Criteria: August 30, 2024
• First Posted (Actual): September 3, 2024

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 1 TP2AH000083-01-00

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: A dataset will be prepared at the conclusion of the study, which includes de-identified individual-level data on all study participants who contributed self-report data. Respondents will be represented only by a research ID number. Included in the dataset will be self-report data collected across all survey administrations (including demographic characteristics, sexual behaviors, and theoretical antecedents to those behaviors) and select information on program participation (e.g., which program components were completed). Basic data cleaning steps will be taken in order to ensure data are unidentifiable and to increase usability.
• IPD Sharing Time Frame: The individual participant dataset will become available twelve months after the study has concluded.
• IPD Sharing Supporting Information Type: SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No