Evaluation of Peer Group Connection - Middle School
PGC-MS
1 other identifier
interventional
1,400
1 country
1
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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2024
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 30, 2024
CompletedStudy Start
First participant enrolled
September 1, 2024
CompletedFirst Posted
Study publicly available on registry
September 3, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 14, 2028
May 18, 2026
April 1, 2026
3.2 years
August 30, 2024
May 13, 2026
Conditions
Outcome Measures
Primary Outcomes (5)
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)
Study Arms (2)
Peer Group Connection - Middle School (PGC-MS)
EXPERIMENTALClass as usual
NO INTERVENTIONInterventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- \- Repeating the middle school transition year (6th or 7th grade)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Policy & Research Grouplead
- Department of Health and Human Servicescollaborator
- Mathematica Policy Research, Inc.collaborator
- Reproductive Health National Training Centercollaborator
- Center for Supportive Schoolscollaborator
Study Sites (1)
The Policy & Research Group
New Orleans, Louisiana, 70118, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Sarah Walsh, PhD
The Policy & Research Group
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2024
First Posted
September 3, 2024
Study Start
September 1, 2024
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
September 14, 2028
Last Updated
May 18, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- SAP
- Time Frame
- The individual participant dataset will become available twelve months after the study has concluded.
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.