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Идёт набор NCT05872737

FAB Programme for Parents of Children With NDD

Без фазы С лечением Autism Spectrum Disorder Attention Deficit Hyperactivity Disorder Neurodevelopmental Disorders Intellectual Disability

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: Facilitator-guided Acceptance and Commitment Bibliotherapy (FAB), General Parenting Education and Advice.
Кому может быть актуально
Состояния в реестре: Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder, Neurodevelopmental Disorders, Intellectual Disability. Базовые параметры: от 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
Гонконг
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Facilitator-guided Acceptance and Commitment Bibliotherapy for Parents of Young Children With Neurodevelopmental Disorders: A Randomised Controlled Trial

Обзор

The study aims to examine the effectiveness of a psychotherapy approach called Facilitator-guided Acceptance and Commitment Bibliotherapy (FAB) in improving the psychological health of parents of young children with neurodevelopmental disorders (NDD) and reducing the emotional and behavioral symptoms of NDD children. The study will involve 154 Cantonese-speaking parents of children aged 2-6 years diagnosed with NDD in Hong Kong. The study hopes to find that FAB can improve parent-child dyads' health outcomes by enhancing psychological flexibility, parental psychological health, and mindful parenting skills.

Подробное описание

Background: Neurodevelopmental disorders (NDDs) are heterogeneous disorders that typically develop in early childhood and are characterised by developmental deficits that result in impaired personal, social, and/or occupational functioning. In Hong Kong, according to the latest statistical report from the Education Bureau, it is estimated that at least 71,320 preschool and school-age children have been diagnosed with NDD and are currently receiving special education and/or health care services. It is well documented that NDD children have less clear communication signals to their parents and poorer prosocial skills.

Continued failures and difficulties in understanding and responding to children's needs may prevent parents from developing positive parenting behaviours, which can negatively impact parents' psychology and ultimately snowballing their NDD child's emotional and behavioural symptoms. To our knowledge, effective interventions that specifically target the mental health of parents caring for young children with NDD to improve outcomes for both parents and children are extremely scarce. To address this study gap, this study will implement and examine the effectiveness of the Facilitator-guided Acceptance and Commitment Bibliotherapy, a facilitator-guided manual reading psychotherapy approach that explicitly targets the psychological needs of parents, in parents of young children with NDD in On-site Pre-school Rehabilitation Service (OPRS) teams.

Objectives: To examine the effectiveness of the Facilitator-guided Acceptance and Commitment Bibliotherapy (FAB) and general parenting advice, in comparison to the control (general parenting advice only), on outcomes related to parental psychological health (parenting stress, symptoms of depression and anxiety, psychological flexibility), parenting behaviour, as well as the child's emotional and behavioural symptoms over 6 months of post-intervention period.

Hypotheses to be tested: Compared to the control group alone, FAB participation could achieve the following goals: reduce parents' parenting stress and NDD children's emotional and behavioural symptoms, reduce parental depressive and anxiety symptoms, improve psychological flexibility and nurturing behaviours of mindful parenting, and reduce the use of health care and rehabilitation services for young children with NDD over 6 months of post-intervention period.

Design: A multi-centre, two-arm randomised controlled trial (RCT) with a repeated-measures parallel-group design

Subjects: 154 Cantonese-speaking parents of children aged 2-6 years diagnosed with neurodevelopmental disorders

Instruments: Validated questionnaires

Interventions: Facilitator-guided Acceptance and Commitment Bibliotherapy (FAB)

Main outcome measures: parental psychological health outcomes and the child's emotional and behavioural symptoms

Data analysis: Generalised estimating equation analyses with covariates adjustments

Expected results: After participating in FAB, parents will become more psychologically flexible in caring for their children with NDD. Parents also acquire better psychological health and mindful parenting skills, leading to eventful improvements in parent-child dyads health outcomes.

Вмешательства

  • Поведенческое Facilitator-guided Acceptance and Commitment Bibliotherapy (FAB)
    The Facilitator-guided Acceptance and Commitment Bibliotherapy (FAB) is a 12-week self-help parenting program that integrates Acceptance and Commitment Therapy (ACT) principles with web-based modules and group-based sessions. The program includes a self-help workbook/manual and ACT protocols that cover various self-help exercises such as guided imagery, grounding, mindfulness, and values clarifications. To make the programme more relatable to Hong Kong parents caring for children with NDD, story
  • Поведенческое General Parenting Education and Advice
    Both the FAB group and the Control Group will receive routine family support services from collaborating NGOs, including education on managing the emotional and behavioral symptoms of children with NDD. To control for the interaction/social effect present in the FAB group, the Control Group will also receive four video-conferencing sessions guided by a trained research assistant over 12 weeks. These sessions will facilitate parents to discuss their parenting challenges, identify parenting traps,

Первичные конечные точки

  • Parenting stress [Срок оценки: Change from baseline assessment to immediate and 6 months post-intervention]
  • Child's emotional and behavioural symptoms [Срок оценки: Change from baseline assessment to immediate and 6 months post-intervention]
Вторичные конечные точки (4)
  • Parental symptoms of anxiety and depression [Срок оценки: Change from baseline assessment to immediate and 6 months post-intervention]
  • Parental psychological flexibility [Срок оценки: Change from baseline assessment to immediate and 6 months post-intervention]
  • Parenting behaviour [Срок оценки: Change from baseline assessment to immediate and 6 months post-intervention]
  • Child's use of health care and rehabilitation services [Срок оценки: Change from baseline assessment to immediate and 6 months post-intervention]

Критерии участия

Parents of young children with NDD who fulfil the following criteria will be recruited:

  • Cantonese-speaking Hong Kong residents,
  • aged ≥ 21 years,
  • have a child aged between two and six years old (preschool age) with a clinically documented diagnosis/suspected NDD diagnosis according to DSM-5 criteria (e.g., ASD, ADHD, developmental delay) and enrolled in the SWD subvented pre-school rehabilitation services offered by NGOs,
  • caregivers who adopted the responsibility of taking care of the child, living together with the child, and
  • have device(s) with internet access.

Parents of young children with NDD will be excluded if:

  • has been diagnosed with severe mental illness(es),
  • cognitive/language/communication/visual/hearing impairment(s) or disorders that may present difficulties in comprehending the content of the intervention; and/or
  • are currently receiving another psychosocial, psychoeducational, or parenting intervention(s).

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
Тройное слепое
Основная цель
Лечение

Центры проведения

Гонконг · 2 центра
  • Hong Kong Sheng Kung Hui Welfare Council Limited — Гонконг
  • The Chinese University of Hong Kong — Shatin

Идентификаторы

NCT: NCT05872737 · NTEC-2022-0091

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗