Evaluation of Peer Group Connection - Middle School
PGC-MS
1 other identifier
interventional
1,400
1 country
1
Brief Summary
The goal of this randomized trial is to learn if the Peer Group Connection - Middle School (PGC-MS) intervention delays initiation of sexual intercourse in middle school-aged youth. The primary research question it aims to answer is: Sixteen months after being offered the intervention, does PGC-MS impact youth's initiation of sexual intercourse? 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 (either 6th or 7th grade). Participants randomized to the control group will be offered class-as-usual.
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
Click on a node to explore related trials.
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
November 14, 2024
October 1, 2024
3.2 years
August 30, 2024
November 11, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Initiation of sexual intercourse
Participants are asked the following item: 1) Have you ever had sexual intercourse? The resulting variable is dichotomous with values 0 or 1, where 0 indicates a person who has never 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)
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 45-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
November 14, 2024
Record last verified: 2024-10
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.