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Набор скоро начнётся NCT05148260

Tackling Postnatal Depression: Culturally Adapted Learning Through Play Plus (LTP+) Intervention for British Mothers of African and Caribbean Origin

Без фазы С лечением Postnatal 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: Learning Through Play plus (LTP+), Psychoeducation.
Кому может быть актуально
Состояния в реестре: Postnatal Depression. Базовые параметры: 18 лет — 60 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
Список центров уточняется — проверьте первичный протокол.
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

Tackling Postnatal Depression: Culturally Adapted Learning Through Play Plus (LTP+) Intervention for Depressed British Mothers of African and Caribbean Origin

Обзор

By 2030, depression will be the leading global disease burden. Postnatal depression due to childbirth/parenting leads to long-term negative consequences for mothers, their children and their families. The British African/Caribbean communities are worse hit by the unprecedented impact of post-Covid-19-syndromes, leading to an exponential increase in postnatal depression. Yet, the uptake of mental healthcare by British mothers of African and Caribbean origin is low due to limited access to culturally appropriate care. Theories of attachment and cognitivism were innovatively integrated to examine Learning-Through-Play plus (LTP+) intervention for postnatal depression using a pilot randomised controlled trial. The proposed LTP+ is co-developed and ecologically friendly because it is manualised and can be delivered by non-mental health specialists such as trained community health workers who are more culturally knowledgeable. Findings will be disseminated through academic publications/presentations, policy briefs, original animated videos and podcast series laying the foundations for a psychosocial approach to tackling postnatal depression

Вмешательства

  • Поведенческое Learning Through Play plus (LTP+)
    Group-1: Experimental (n=40 participants) will receive the LTP+ which consist of a total of 12-group integrated treatment sessions lasting approximately 60-90 minutes per session every fortnight with 10 mother/child pair per sub-group.
  • Поведенческое Psychoeducation
    Group-2: Controlled (n=40 participants) will receive 'psychoeducation' which consist of a total of 12-group sessions lasting approximately 60-90 minutes per session every fortnight with 10 mother-child pair per sub-group.

Первичные конечные точки

  • Change in postnatal depression is being assessed [Срок оценки: Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention]
  • Change in postnatal anxiety is being assessed [Срок оценки: Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention]
  • Change in social support is being assessed [Срок оценки: Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention]
  • Change in health-related quality of life is being assessed [Срок оценки: Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention]
  • Change in service satisfaction is being assessed [Срок оценки: Change is being assessed at 12 weeks end of intervention]
  • Change in child physio-emotional development is being assessed [Срок оценки: Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention]
  • Change in parenting knowledge of child development is being assessed [Срок оценки: Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention]

Критерии участия

Критерии включения

Only British mothers of African and Caribbean heritage:

  • experiencing emotional distress due to childbirth or parenting and scored 5 or above on the patient health questionnaire (PHQ-9)
  • who have children age 0-3 years
  • residents of designated communities and available for follow-up
  • are 18 years and above
  • able to give informed consent.

Критерии исключения

Are mothers:

  • with a medical condition that would prevent their participation such as active suicidal ideation, tuberculosis, or heart failure
  • temporary residents are unlikely to be available for follow up
  • who are less than 18 years
  • unable to provide consent.
  • with non-British African and Caribbean heritage.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT05148260 · 0000-0001-5034-0335b

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗