Paediatric Autism Communication Therapy (PACT) in Children With Autism Spectrum Disorder
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: PACT, MAU.
- Кому может быть актуально
- Состояния в реестре: Autism Spectrum Disorder. Базовые параметры: 2 лет — 6 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
- Дания
- 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
Paediatric Autism Communication Therapy (PACT) Combined With Management as Usual Compared to Management as Usual Alone in Children With Autism Spectrum Disorder - a Pragmatic, National, Randomised Clinical Trial
Обзор
Paediatric Autism Communication Therapy (PACT) is a naturalistic developmental behavioural interventions to reduce autism symptoms. The aim of this trial is to assess the beneficial and harmful effects of PACT in 2-6 year-old children with a recent diagnosis of autism spectrum disorder.
Подробное описание
Autism spectrum disorder (ASD) is a neurodevelopmental disorder affecting approximately 2% of children and young people worldwide. ASD is considered a lifelong disorder and interventions significantly reducing the core autistic symptoms have been sparse. Paediatric Autism Communication Therapy (PACT) is among the first naturalistic developmental behavioural interventions to show promising results for reduction in autism symptoms.
The aim of this trial is to assess the beneficial and harmful effects of PACT in 2-6 year-old children with a recent diagnosis of ASD.
This trial is an investigator-initiated, independently funded, pragmatic, national, parallel group, superiority, randomised clinical trial comparing PACT combined with management as usual to management as usual alone.
Вмешательства
- Поведенческое PACT
Paediatric Autism Communication Therapy - Поведенческое MAU
Management as usual
Первичные конечные точки
- Autism Symptoms [Срок оценки: End of intervention (14 months)]
Вторичные конечные точки (4)
- Child adaptive functioning [Срок оценки: End of intervention (14 months)]
- Social interaction of the child [Срок оценки: At 6 month and end of intervention (14 months)]
- Quality of Life (child) [Срок оценки: End of intervention (14 months)]
- Quality of life (parents) [Срок оценки: End of intervention (14 months)]
Критерии участия
Критерии включения
- Children aged 2 through 6 years (both inclusive)
- A diagnosis of ASD meeting the criteria for International Classification of Diseases; Tenth Edition (ICD-10): Diagnose codes: DF84.0, DF84.1, DF84.5, DF84.8
- An Autism Diagnostic Observation Schedule, 2nd Edition Calibrated Severity Score (ADOS-2 CSS) ≥ 4
- The ASD diagnosis must be verified by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), Autism Spectrum Disorder Checklist
- The ASD diagnosis must be the primary developmental disorder (comorbid conditions allowed) and conferred at a clinical conference
- Parents must have sufficient Danish (or English) language skills to communicate with the therapist
- Signed informed consent by parents or holders of legal guardianship
Критерии исключения
- Children having a sibling already included in the trial
- Hearing and visual impairment in child or parent
- Parent not available for regular sessions with the therapist, evaluated at the consent meeting
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
Дания · 6 центров
- Child and Adolescent Mental Health Center, Aabenraa, Region of Southern Denmark — Aabenraa
- Child and Adolescent Mental Health Center, Aalborg, North Denmark Region — Aalborg
- Child and Adolescent Psychiatric Dept., Skejby, Aarhus University Hospital — Aarhus
- Child and Adolescent Mental Health Center, Capital Region of Denmark — Hellerup
- Child and Adolescent Mental Health Center, Odense, Region of Southern Denmark — Odense
- Department of Child and Adolescent Psychiatry, Copenhagen University Hospital — Roskilde
Публикации
- Ziegler SMT, Jeppesen P, Christiansen J, Conrad CE, Davidsen KA, Engkjaer-Trautwein G, Engstrom J, Fagerlund B, Gotzsche MV, Hastrup LH, Jakobsen JC, Kirk AM, Lauritsen MB, Pagsberg AK, Pedersen MA, Kilburn TR, Thomsen PH, Varenne M, Bilenberg N. Paediatric Autism Communication Therapy (PACT) versus management as usual in autistic children: a protocol for a Danish pragmatic, national, randomised c PMID 40883837
Идентификаторы
NCT: NCT05673096 · DAN-PACT