Evaluation of Peer Group Connection - Middle School

Not Applicable

Recruiting

• Conditions: Teen Pregnancy Prevention

• Registration Number: NCT06582641
• Lead Sponsor: The Policy & Research Group

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.

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 or 7th grade); post-intervention (spring semester of 6th or 7th grade); four months post-intervention (fall semester of 7th or 8th grade); and sixteen months post-intervention (fall semester of 8th or 9th grade).

Study Timeline

• Study First Submitted: 2024-08-30
• Study First Submitted QC: 2024-08-30
• Study Start: 2024-09-01
• Study First Posted: 2024-09-03
• Status Verified: 2024-10
• Last Update Submitted: 2024-11-11
• Last Update Posted: 2024-11-14
• Primary Completion: 2027-12
• Study Completion: 2028-09-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1400

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Initiation of sexual intercourse	Assessed 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: 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.

Trial Locations

Locations (1)

The Policy & Research Group; 🇺🇸 New Orleans, Louisiana, United States