Metacognitive Intervention in Children and Adolescents With ADHD - MiA Study

Обзор

The aim of the MiA-Study is to address the current lack of effective treatment options to reduce cognitive and physical long-term problems in children and adolescents with Attention Deficit Hyperactivity Disorder (ADHD). Through the use of the Mio-Training, cognitive development will be strengthened and metacognitive thinking and awareness will increase. The MiA-Study is conducted additionally to the Mio-study to evaluate the effectiveness of the Mio-Training specifically within the ADHD population. The Mio-Training for children and adolescence with ADHD includes a combination of cognitive and coordinative training tasks and prospective as well as retrospective metacognitive questions. In a randomized controlled trial, the Mio-Training will be analysed for its efficacy on metacognitive thinking and executive functions. In particular, the investigators are interested in factors that affect the efficacy of the training program such as compliance, age, sex or the severity of the ADHD. This study will give insight into the role of metacognition in cognitive performance and will foster the development of children and adolescents with ADHD in the long-term.

Подробное описание

In the MiA-Study, the investigators investigate a newly developed Training program at the interface between neuropsychology and sports science - the Mio-Training - for its efficacy. The aim of the Mio-Training is to strengthen the cognitive development of children and adolescents with ADHD in the long-term. The Mio-Training contains a combination of cognitive and coordinative training tasks and metacognitive questions to promote knowledge and awareness of one's own thinking. In order to counteract the shortage of skilled workers and the increasing specialization of individual specialist areas, solutions are needed that can be implemented without a lot of staff. From today's perspective, there are hardly any trainings for children and adolescents that show long-term effects on cognitive development and can also be transferred to non-trained tasks in school and everyday life.

The investigators are testing the effectiveness of the Mio-Training in a randomized clinical trial (RCT) and expect a strengthening of metacognition and core cognitive functions (i.e. executive functions). The MiA-Study will provide information about the role of metacognition in cognitive performance and, ideally, provide evidence for a novel, interdisciplinary rehabilitation strategy for children and adolescents with ADHD.

Вмешательства

• Поведенческое Mio-Training
  The Mio-Training aims to increase metacognitive knowledge, teaches mnemonic skills, trains the working memory capacity and coordinative skills to strenghten cognitive development in children and adolescents with ADHD.

Первичные конечные точки

• Junior Metacognitive Awareness Inventory (Jr.MAI) [Срок оценки: At baseline; immediately (up to 1 week) after the training or waiting period; at 3-months follow-up]

Вторичные конечные точки (8)

• Wechsler Intelligence Scale For Children: 5th Ed (WISC-V) [Срок оценки: At baseline; immediately (up to 1 week) after the training or waiting period.]
• Color-Word Interference Test (Delis-Kaplan Executive Function System; D-KEFS) [Срок оценки: At baseline; immediately (up to 1 week) after the training or waiting period.]
• Tower of Hanoi (D-KEFS) [Срок оценки: At baseline; immediately (up to 1 week) after the training or waiting period.]
• Verbal learning and memory test (VLMT) [Срок оценки: At baseline; immediately (up to 1 week) after the training or waiting period.]
• Pattern learning (Memory and Learning Test; Basic-MLT) [Срок оценки: At baseline; immediately (up to 1 week) after the training or waiting period.]
• Test Battery for Attention Assessment (TAP) [Срок оценки: At baseline; immediately (up to 1 week) after the training or waiting period.]
• German Motor Performance Test (DMT) [Срок оценки: At baseline; immediately (up to 1 week) after the training or waiting period.]
• Behaviour Rating Inventory of Executive Function (BRIEF) [Срок оценки: At baseline; immediately (up to 1 week) after the training or waiting period; at 3-months follow-up.]

Критерии участия

Критерии включения

• Informed consent as documented by signature (see Informed Consent Form) of participants and / or one parent / legal guardian
• Age 8-16 years
• A diagnosis of ADHD (mild, moderate or severe)
• Intelligence >85 (WISC-V short form)
• German or french speaking
• Willingness to perform the assessments without the medication (the study visits will take place without ADHD medication)

Критерии исключения

• Any other instable neurological condition (e.g. epilepsy) that significantly impairs development
• A severe psychiatric disease (e.g., eating disorder) or severe learning disability that significantly impairs development
• Known or suspected non-compliance
• Inability to follow the procedures of the study, e.g. due to language problems
• Enrolment of the investigator, his/her family members, employees and other dependent persons

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

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Швейцария · 1 центр

• Insespital, University Hospital Bern — Bern

Идентификаторы

NCT: NCT07162831 · BASEC2025-01189

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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