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Идёт набор NCT06574217

Evaluation of Stepping Stones

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: Stepping Stones (StSt), Like.
Кому может быть актуально
Состояния в реестре: Teen Pregnancy Prevention. Базовые параметры: 12 лет — 22 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 →

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Обзор

The goal of this randomized trial is to learn if the Stepping Stones (StSt) intervention has a positive impact on the sexual health and relationship behaviors of sexually active youth between the ages of 12 and 22 years old who are at risk for or involved in the legal or child welfare systems. The primary research questions it aims to answer are: * Three months after being offered the intervention, does StSt impact youth's receipt of sexually transmitted infection testing in the past four months? * Nine months after being offered the intervention, does StSt impact youth's frequency of having vaginal and anal sex without condoms in the past four months? * Nine months after being offered the intervention, does StSt impact youth's perpetration of emotional abuse in the past four months? Researchers will compare participants randomized to receive StSt (treatment group) to participants randomized to receive a control condition that contains no sexual or reproductive health information (control group). Participants randomized to the treatment group will be offered StSt as an in-person or virtual, individual-based intervention delivered over four sessions during a 6-8 week period. Participants randomized to the control group will be offered a virtually delivered control condition.

Подробное описание

This is an individual-level, randomized control trial to rigorously evaluate the impact of the Stepping Stones (StSt) intervention. Participant outcomes will be assessed using self-reported, individual-level data gathered using a structured questionnaire administered at three time points: baseline (enrollment); three months post-intervention (five months after baseline); and nine months post-intervention (eleven months after baseline).

Вмешательства

  • Поведенческое Stepping Stones (StSt)
    StSt is an individual-level intervention designed to help youth make healthy decisions. StSt is delivered in-person or virtually by an adult guide during four \~30-50 minute sessions over a period of up to 8 weeks. The adult guide leads the youth through health-focused discussions related to identifying personal values, making a social network map, and then creating and refining individualized plans.
  • Поведенческое Like
    Like is an hour-long film that discusses the impact of social media on the brain. Study staff will organize for each individual participant to watch the film in-person. The film does not include information related to the outcomes of interest for the study.

Первичные конечные точки

  • Receipt of sexually transmitted infection (STI) testing in the past four months [Срок оценки: Assessed three months after the intervention period has ended (five months post-baseline)]
  • Times having vaginal and anal sex without condoms in the past four months [Срок оценки: Assessed nine months after the intervention period has ended (eleven months post-baseline)]
  • Perpetration of emotional abuse [Срок оценки: Assessed nine months after the intervention period has ended (eleven months post-baseline)]

Критерии участия

Критерии включения

  • At risk for or involved in the legal or child welfare systems
  • Report ever having vaginal and/or anal sex and plan to have sex in the next six months
  • Comfortable reading, speaking, and writing in English

Критерии исключения

  • Currently trying to start a pregnancy
  • Currently in jail or being detained in a facility
  • Enrolled in an ongoing PRG-run TPP study, the No Baby No study, or the Yes \& Know study
  • Living in regions where the FLASH curriculum is widely implemented (King County, WA, Ramsey County, MN, Hennepin County, MN)
  • Identified as fraudulent (only for individuals recruited online)

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: NCT06574217 · 1 TP2AH000093-01-00

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗