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Идёт набор NCT04940585

ROSE in Sunset Park

Без фазы С лечением Post Partum Depression

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: ROSE Program.
Кому может быть актуально
Состояния в реестре: Post Partum Depression. Базовые параметры: 18 лет — 100 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
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Официальное название

Reach Out, Stay Strong, Essentials for Mothers of Newborns (ROSE), a Study of a Postpartum Depression Prevention Intervention Among Pregnant Women in a Women's Health Clinic

Обзор

The purpose of this study is to learn more about pregnant women's' experience with Reach Out, Stay Strong, Essentials for mothers of newborns (ROSE) and to evaluate the effectiveness of the ROSE program in preventing and reducing post-partum depressive symptoms, decreasing stress, and increasing social support among pregnant women.

Подробное описание

This is a 2-phase study, including a feasibility phase (Pilot, Phase 1), and an outcomes evaluation phase (Phase 2). Phase 1 tests the acceptability and feasibility of a postpartum depression prevention intervention among pregnant women attending a prenatal clinic in Sunset Park, Brooklyn. NYU research staff will be trained to implement this intervention. Based on the feedback received from women and staff in phase 1, the intervention will be modified accordingly. Phase 2 will be an outcomes evaluation to test the effectiveness of the intervention to decrease maternal stress and depressive symptoms, and increase perceived social support and self-efficacy among new mothers.

Вмешательства

  • Другое ROSE Program
    The program includes 6 group sessions and an individual session 4-6 weeks after birth. Each session will last 60 minutes and will be conducted over Webex. The key areas that will be discussed during the sessions include: Psychoeducation, Adjusting to life with baby, Effective communication, Asking for what you need, and Planning for the future.

Первичные конечные точки

  • Acceptability of the ROSE intervention [Срок оценки: Week 1 group session]
  • Acceptability of the ROSE intervention [Срок оценки: Week 2 group session]
  • Acceptability of the ROSE intervention [Срок оценки: Week 3 group session]
  • Acceptability of the ROSE intervention [Срок оценки: Week 4 group session]
  • Acceptability of the ROSE intervention [Срок оценки: Week 5 group session]
  • Acceptability of the ROSE intervention [Срок оценки: Week 6 group session]
  • Acceptability of the ROSE intervention [Срок оценки: Post-birth Visit (4-5 weeks after birth)]
  • Change in level of postpartum depression [Срок оценки: Baseline Visit, Week 1 group session, Week 2 group session, Week 3 group session, Week 4 group session, Week 5 group session,Week 6 group session,, Post-birth Visit (4-5 weeks after birth)]
Вторичные конечные точки (3)
  • Change in the level of self-efficacy [Срок оценки: Baseline Visit, Week 1 group session, Week 2 group session, Week 3 group session, Week 4 group session, Week 5 group session,Week 6 group session,, Post-birth Visit (4-5 weeks after birth)]
  • Change in perceived social support [Срок оценки: Baseline Visit, Week 1 group session, Week 2 group session, Week 3 group session, Week 4 group session, Week 5 group session,Week 6 group session,, Post-birth Visit (4-5 weeks after birth)]
  • Change in perception of stress [Срок оценки: Baseline Visit, Week 1 group session, Week 2 group session, Week 3 group session, Week 4 group session, Week 5 group session,Week 6 group session,, Post-birth Visit (4-5 weeks after birth)]

Критерии участия

Критерии включения

  • Receive prenatal care at the Sunset Park Family Health Center for Women's Health and Pediatrics (SPWHP)
  • Female
  • At least 18 years of age
  • Speaks and understands English or Spanish (depending on the language of the next group)
  • Is pregnant
  • Is in the second trimester of her pregnancy
  • Capable of providing informed consent.
  • Scores between 4 and 12 on Edinburgh Postnatal Depression Scale or records 2 or more ACEs on adapted ACEs questionnaire

Критерии исключения

  • Not receiving prenatal care at the Sunset Park Family Health Center for Women's Health and Pediatrics (SPWHP)
  • Not female
  • Under18 years of age
  • Does not speak and understand English or Spanish
  • Is not pregnant
  • Is not in the second trimester of her pregnancy
  • Is not capable of providing informed consent.
  • Scoring < 4or >12 on Edinburgh Postnatal Depression Scale and scores 1 or less on adapted ACEs questionnaire.
  • Positive score to #10 on the Edinburgh Postnatal Depression Scale

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

США · 1 центр
  • NYU Langone Health — New York

Идентификаторы

NCT: NCT04940585 · 19-01961

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗