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Идёт набор NCT06248762

PPI and Mindfulness App for Parents of Children with a NDD

Без фазы С лечением Stress Mental Health Mental Well-being

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: Adappt.
Кому может быть актуально
Состояния в реестре: Stress, Mental Health, Mental Well-being. Базовые параметры: от 18 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
Нидерланды
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Effectiveness of a Positive Psychology and Mindfulness Based App for Parents of Children with a Neurodevelopmental Disorder (NDD): Study Protocol of a Pragmatic Randomized Controlled Trial

Обзор

An app based on positive psychology and mindfulness to support the mental well-being of parents of children with a Neurodevelopmental Disorder (NDD) was developed and will be evaluated on effectiveness.

Подробное описание

This pragmatic randomized controlled trial aims to assess the effectiveness of the Adappt app, an app developed to support the mental well-being of parents of children with a neurodevelopmental disorder (NDD), such as autism and ADHD. This app was developed since research has shown that these parents experience higher stress levels than parents of typically developing children. Furthermore, the app was developed in collaboration with parents of children with a NDD, mental health care professionals and scientists in Europe.

Вмешательства

  • Другое Adappt
    An app to support parents of children with a NDD

Первичные конечные точки

  • Ability to Adapt [Срок оценки: Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)]
Вторичные конечные точки (11)
  • Mental well-being [Срок оценки: Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)]
  • Stress [Срок оценки: Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)]
  • Anxiety [Срок оценки: Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)]
  • Depressive symptoms [Срок оценки: Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)]
  • Parenting self-efficay and behavior of child [Срок оценки: Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)]
  • Savoring the moment [Срок оценки: Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)]
  • Self-reassuring [Срок оценки: Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)]
  • Postive aspects of caregiving [Срок оценки: Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)]
  • Psychological flexibility [Срок оценки: Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)]
  • Positive coping skills [Срок оценки: Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)]
  • Mindfulness [Срок оценки: Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)]

Критерии участия

Критерии включения

  • at least 18 years
  • parent of one or more children (< 18 years) diagnosed with or suspected of a NDD
  • having access to internet
  • in possession of an e-mail address,
  • in possession of a smartphone or tablet
  • willing to use the digital intervention for a month, daily for approximately 15 minutes a day.

Критерии исключения

  • presence of severe anxiety symptoms
  • presence of moderately severe to severe depressive symptoms
  • being in treatment for mental health issues (the parent self)

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
Поддерживающая терапия

Центры проведения

Нидерланды · 1 центр
  • University of Twente — Enschede

Публикации

  • Tonis KJM, Drossaert CHC, Ten Klooster PM, Schaer M, Bourgeron T, Buitelaar JK, Sadaka Y, Freitag CM, Lapidus KM, Chiocchetti AG, Staal WG, Bohlmeijer ET. Effectiveness of a positive psychology and mindfulness-based app on mental health for parents of children with a neurodevelopmental disorder: study protocol of a pragmatic international randomized controlled trial. Trials. 2024 Jun 26;25(1):412. PMID 38926739

Идентификаторы

NCT: NCT06248762 · University of Twente

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗