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NCT Number: NCT06582641

Evaluation of Peer Group Connection - Middle School

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.

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Key information

Conditions

Teen Pregnancy Prevention

Age range

11 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Policy & Research Group

New Orleans, Louisiana, 70118, United States

Location status: Recruiting

Location contact

Hilary Demby, MPH

CONTACT

[email protected]

504-865-1545

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Peer Group Connection - Middle School (PGC-MS)

Behavioral

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.

Primary outcomes

  1. Initiation of sexual intercourse

    Time frame: 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: 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.

  2. Ever smoked a cigarette

    Time frame: Assessed 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.

  3. Ever used an electronic vapor product

    Time frame: Assessed 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.

  4. Ever had a drink of alcohol

    Time frame: Assessed 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.

  5. Ever used marijuana

    Time frame: Assessed 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hilary Demby, MPH

CONTACT

[email protected]

504-655-0982

Kelly Burgess, MPH

CONTACT

[email protected]

225-773-9162

Sponsors and collaborators

Lead sponsor

The Policy & Research Group

Other

Collaborators

  • Center for Supportive Schools
  • Department of Health and Human Services
  • Mathematica Policy Research, Inc.
  • Reproductive Health National Training Center

Registry information

Official study title

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

Acronym: PGC-MS

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Sep 3, 2024
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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