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Идёт набор NCT06576193

Empowering Young Parents: Building Healthy Relationships Study

Без фазы С лечением Gender-based Violence Intimate Partner Violence

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: Safe Dates for Young Parents (SDYP).
Кому может быть актуально
Состояния в реестре: Gender-based Violence, Intimate Partner Violence. Базовые параметры: 14 лет — 21 лет · Женщины.
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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Официальное название

Empowering Young Parents: Building Health Relationships Study Evaluation of the Safe Dates for Young Parents Intervention

Обзор

The goal of this trial is to learn how the Safe Dates for Young Parents (SDYP) intervention affects the sexual and reproductive health behaviors, and quality of, and attitudes surrounding intimate partner relationships in adolescents and young adults (AYA) assigned female sex at birth who are pregnant or parenting. The main questions it aims to answer are: * Will the SDYP intervention have any effect on the sexual and reproductive health behaviors during the study period? * Will the SDYP intervention have any effect on the prevention or reduction of intimate partner violence (IPV)? * Will the SDYP intervention have any effect on the attitudes and beliefs about healthy relationships? Researchers will compare the behaviors, attitudes, and beliefs about sexual and reproductive health and relationships of participants assigned to the SDYP intervention group to participants assigned to the control (non-SDYP intervention) group to see if there is any difference or changes in those behaviors, attitudes, and beliefs before-and-after or without the SDYP intervention. Participants in the SDYP intervention will attend ten (10) 50-minute group sessions that will involve interactive discussions, thinking through life-like scenarios, games, role-plays, brainstorming, and a poster contest and theatrical play.

Вмешательства

  • Поведенческое Safe Dates for Young Parents (SDYP)
    SDYP is a healthy relationship and intimate partner violence (IPV) prevention program, adapted from "Safe Dates (Foshee et al., 1998; Foshee et al., 1996)" designed for teens, that focuses on pregnant or parenting females. The program consists of ten group-based sessions (50 minutes each) led by a trained facilitator which include interactive discussions, analysis of scenarios, games, role-plays, brainstorming, and a poster contest and theatrical play.

Первичные конечные точки

  • Condomless vaginal or anal sex (Month 12) [Срок оценки: Three months, Twelve months]
Вторичные конечные точки (5)
  • Condomless vaginal or anal sex (Month 6) [Срок оценки: Three months, Six months]
  • Sexual and Reproductive Coercion [Срок оценки: Month 12]
  • Negotiation of condom use and contraception [Срок оценки: Month 6]
  • Intimate Partner Violence (IPV) [Срок оценки: Month 12]
  • Healthy relationship attitudes, beliefs, and behaviors [Срок оценки: Month 6]

Критерии участия

Критерии включения

Adolescent and Young Adult (AYA) \[EYP study participants\]

  • Aged 14-21 years (inclusive) at Screening.
  • Assigned female sex at birth.
  • Currently pregnant or parenting their child who lives with them at least part-time.
  • Able to speak and read English or Spanish.
  • Able and willing to provide verbal informed consent for enrollment in the EYP study.
  • Able and willing to provide adequate contact/locator information.
  • Able and willing to complete protocol requirements, including completion of three study interviews over one year.

Study Facilitators (process evaluation participants)

  • Aged 18 years or older.
  • Trained and served as a facilitator of the SDYP intervention.
  • Able to speak and read English.
  • Able and willing to provide verbal informed consent.

Критерии исключения

  • Per participant report at Screening or Enrollment, intends to travel away from their geographic area of residence for a time period that would interfere with study participation, including with intervention participation should the participant be randomized to the SDYP intervention.
  • Has any other condition that, in the opinion of the Principal Investigator (PI) or their designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.

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
Простое слепое
Основная цель
Другое

Центры проведения

США · 12 центров
  • Delaware Adolescent Program, Inc. (DAPI) - Kent County — Camden
  • Delaware Adolescent Program, Inc. (DAPI) - Sussex County — Georgetown
  • Healthy Generations Program at Children's National Hospital — Washington D.C.
  • GCAPP and Communities In Schools of Albany/Dougherty — Albany
  • GCAPP and Covenant House Georgia — Atlanta
  • Berrien County Health Department — Benton Harbor
  • Eaton Regional Education Service Agency (RESA) — Charlotte
  • Pathways Academy — Detroit
  • … и ещё 4 центра

Идентификаторы

NCT: NCT06576193 · TP2AH000082

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗