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Идёт набор NCT07226401

Virtual Village for Young Parents

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: Virtual Safe Dates for Young Parents, HealthSmart.
Кому может быть актуально
Состояния в реестре: Gender-based Violence, Intimate Partner Violence. Базовые параметры: 16 лет — 21 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

Preventing Intimate Partner Violence Among Teens Who Are Pregnant or Parenting

Обзор

This project will study virtual delivery of Safe Dates for Young Parents (SDYP), a 10-session, group-based intimate partner violence (IPV) prevention program tailored for adolescents and young adults who are pregnant or parenting. This program has the potential to improve the health and well-being of young parents and their children, and virtual delivery may improve participants' ability to attend. The main questions it aims to answer are: (1) Is it feasible and acceptable to implement SDYP in a virtual setting? (2) Are SDYP participants less likely to experience IPV than participants in an alternate health education program? Participants will be invited to a series of virtual program sessions for either SDYP or a health education program focused on physical activity and nutrition and will be asked to complete surveys before the programs begin and up to 6 months later.

Подробное описание

As many as two-thirds of teens who are pregnant or parenting have been the victims or perpetrators of physical intimate partner violence (IPV) and there is an even higher prevalence of psychological abuse in this population. IPV can endanger teen mothers' own health, the health of their pregnancies, and the well- being of their children. Despite this detrimental impact, there is a lack of evidence-based IPV prevention programs that are tailored for pregnant and parenting teens. Moreover, despite the promise of virtual program delivery, which may help improve teens' ability to attend, research has yet to determine feasibility and outcomes of virtual delivery of IPV prevention programs for teens who are pregnant or parenting. This study is a pilot test of the Safe Dates for Young Parents (SDYP) program adapted for virtual delivery. The original Safe Dates is a 10-session, theoretically based, interactive program with demonstrated efficacy in preventing psychological, physical, and sexual dating abuse among teens. The investigators previously adapted Safe Dates for young parents who are pregnant or parenting by integrating pregnancy and parenting themes throughout program sessions, increasing the focus on overcoming barriers to seeking help for intimate partner violence (IPV), and revising sexual assault content. The programs were delivered exclusively in person. A virtual approach to delivery could improve scale-up of SDYP, via increased reach and lower costs. The investigators recently pre-tested selections from the SDYP program over Zoom with 9 young parents to adapt the prevention curriculum and related intervention materials for virtual delivery. In this study, the investigators will build on this work by evaluating the virtual SDYP intervention in a pilot randomized trial to assess implementation outcomes (i.e. feasibility, acceptability, fidelity, and appropriateness) and preliminary effects on IPV outcomes. The study will randomize 80 individual pregnant and parenting young people 1:1 to intervention (SDYP) or equal attention control (virtual health education program lessons that do not address IPV) conditions, and conduct surveys at baseline and 3-6-month follow-up to assess IPV and related behavioral outcomes. The investigators will assess implementation outcomes (feasibility, acceptability, fidelity, and appropriateness) through program data, qualitative in-depth interviews (IDIs) with facilitators and participants, and survey data from the intervention group. Research activities will be done virtually with participants recruited from several locations around the United States.

Вмешательства

  • Поведенческое Virtual Safe Dates for Young Parents
    Safe Dates for Young Parents (SDYP) is a healthy relationship and intimate partner violence (IPV) prevention program, adapted from "Safe Dates (Foshee et al., 1998; Foshee et al., 1996)" for pregnant or parenting young adults. The investigators adapted the prevention curriculum and related intervention materials for virtual delivery via Zoom. The program consists of ten group-based sessions (50 minutes of content each) led by a trained facilitator. The program includes interactive discussions, a
  • Поведенческое HealthSmart
    The HealthSmart program will use 10 digital high school curriculum lessons focused on physical activity and nutrition. The sessions will be formatted appropriately to be delivered via zoom. Participants may be asked to complete handouts, listen to presentations, and participate in discussions. Topics may include information about different nutrients, how nutrients affect health, how to read food labels, healthy eating, and guidelines for physical activity.

Первичные конечные точки

  • Participant attendance [Срок оценки: From the first to the last session of SDYP (typically 10 weeks)]
  • Participant engagement [Срок оценки: From the first to the last session of SDYP (typically 10 weeks)]
  • Program adherence [Срок оценки: From the first to the last session of SDYP (typically 10 weeks)]
  • Physical IPV perpetration [Срок оценки: Past 3 months measured at baseline and 3 to 6 months after baseline]
  • Physical IPV victimization [Срок оценки: Past 3 months measured at baseline and 3 to 6 months after baseline]
  • Psychological IPV perpetration [Срок оценки: Past 3 months measured at baseline and 3 to 6 months after baseline]
  • Psychological IPV victimization [Срок оценки: Past 3 months measured at baseline and 3 to 6 months after baseline]

Критерии участия

Критерии включения

Pregnant or parenting youth (Pilot RCT participants)

  • Aged 16-21 years.
  • Currently pregnant, partner of a pregnant person, or parenting a child (i.e., have contact with child at least once per week).
  • Able to speak and read English.
  • Willing and able to provide written informed consent.
  • Willing and able to provide adequate contact/locator information.

Facilitators (IDI participants)

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

Exclusion Criteria (Pilot RCT participants):

  • Has any other condition that, in the opinion of the 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.
  • Currently participating or will be participating in a violence prevention education program in the next 3 months.
  • Previously participated in the Empowering Young Parents study.

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
  • RTI International — Durham

Идентификаторы

NCT: NCT07226401 · R21HD111729 · R21HD111729

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗