Metacognitive Intervention in Children and Adolescents With ADHD - MiA Study

Insel Gruppe AG, University Hospital Bern

Status

Enrolling

Conditions

ADHD

Treatments

Behavioral: Mio-Training

Study type

Interventional

Funder types

Other

Identifiers

NCT07162831

BASEC2025-01189

Details and patient eligibility

About

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.

Full description

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.

Enrollment

40 estimated patients

Sex

All

Ages

8 to 16 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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)

Exclusion criteria

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