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Идёт набор NCT07607613

Parents and Babies Pilot

Без фазы С лечением Perinatal Depression Postpartum Depression (PPD)

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: Parents and Babies Virtual Group Intervention, Parents and Babies Hybrid Group Intervention.
Кому может быть актуально
Состояния в реестре: Perinatal Depression, Postpartum Depression (PPD). Базовые параметры: от 18 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

Parents and Babies: Pilot Testing an Inclusive Preventive Postpartum Depression Intervention

Обзор

The goal of this study will be piloting the Parents and Babies perinatal depression prevention intervention to examine its feasibility and acceptability and to obtain preliminary data on its efficacy. This includes exploring/understanding users' experiences navigating the interventions (e.g., from an implementation perspective) and preliminary evaluations of clinical outcomes, including mental health and minority stress. With data gathered from this pilot study, we will make final adaptations to the Parents and Babies manuals and plan to develop a randomized-control trial to evaluate efficacy of the intervention.

Вмешательства

  • Поведенческое Parents and Babies Virtual Group Intervention
    Parents and Babies is a 10-session intervention adapted from Mothers and Babies, a nationally recognized intervention for depression during pregnancy and postpartum built on principles of cognitive-behavioral therapy (CBT), attachment theory, and psychoeducation. Sessions are delivered virtually and led by a clinical psychologist.
  • Поведенческое Parents and Babies Hybrid Group Intervention
    Parents and Babies is a 10-session intervention adapted from Mothers and Babies, a nationally recognized intervention for depression during pregnancy and postpartum built on principles of cognitive-behavioral therapy (CBT), attachment theory, and psychoeducation. Sessions are delivered virtually and led by a clinical psychologist, with an option for in-person participation at three sessions.

Первичные конечные точки

  • Patient Health Questionnaire - 9 (PHQ-9) [Срок оценки: T1 (prior to starting intervention), T2 (immediately post-intervention), T3 (3 months post-intervention)]
  • Perceived Stress Scale (PSS-10) [Срок оценки: T1 (prior to starting intervention), T2 (immediately post-intervention), T3 (3 months post-intervention)]
  • Generalized Anxiety Disorder Scale (GAD-7) [Срок оценки: T1 (prior to starting intervention), T2 (immediately post-intervention), T3 (3 months post-intervention)]
  • Multidimensional Scale of Perceived Social Support (MSPSS) [Срок оценки: T1 (prior to starting intervention), T2 (immediately post-intervention), T3 (3 months post-intervention)]
  • The Acceptability of Intervention Measure (AIM) [Срок оценки: T2 (immediately post-intervention)]
  • Intervention Appropriateness Measure (IAM) [Срок оценки: T2 (immediately post-intervention)]
  • Feasibility of Intervention Measure (FIM) [Срок оценки: T2 (immediately post-intervention)]
  • Implementation of Parents and Babies skills [Срок оценки: T2 (immediately post-intervention), T3 (3-months post-intervention)]

Критерии участия

Критерии включения

  • self-identify as LGBTQ+
  • 18 years old or older
  • live in the USA or territories
  • speak and understand English
  • Currently pregnant or within one year of childbirth
  • Endorse current mild depressive symptoms or risk factors for postpartum depression

Критерии исключения

  • Are unable to consent/have impaired decision making capacity
  • Have current active suicidal or homicidal ideation, active psychosis, or current mania
  • Are currently experiencing a severe depressive episode
  • Do not have audio and/or video capacity for attending group sessions remotely.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

США · 1 центр
  • Northwestern University — Chicago

Идентификаторы

NCT: NCT07607613 · STU00225523 · 5K23MD018092-03

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗