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Идёт набор NCT06582641

Evaluation of Peer Group Connection - Middle School

Без фазы С лечением Teen Pregnancy Prevention

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Peer Group Connection - Middle School (PGC-MS).
Кому может быть актуально
Состояния в реестре: Teen Pregnancy Prevention. Базовые параметры: 11 лет — 14 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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).

Вмешательства

  • Поведенческое 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

Первичные конечные точки

  • Initiation of sexual intercourse [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Assessed 4 months after the intervention period has ended (beginning of the first fall semester following the end of the program)]
  • Ever used marijuana [Срок оценки: Assessed 4 months after the intervention period has ended (beginning of the first fall semester following the end of the program)]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

\- Repeating the middle school transition year (6th or 7th grade)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

США · 1 центр
  • The Policy & Research Group — New Orleans

Идентификаторы

NCT: NCT06582641 · 1 TP2AH000083-01-00

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗