Evaluation of Peer Group Connection - Middle School
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Peer Group Connection - Middle School (PGC-MS).
- Who it may be relevant to
- Registry conditions: Teen Pregnancy Prevention. Basic parameters: 11 years — 14 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Peer Group Connection - Middle School (PGC-MS)
Overview
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.
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).
Interventions
- 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
Primary outcome measures
- 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)]
- 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)]
- 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)]
- 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)]
- 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)]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- The Policy & Research Group — New Orleans
Identifiers
NCT: NCT06582641 · 1 TP2AH000083-01-00