NCT07162831

Metacognitive Intervention in Children and Adolescents With ADHD - MiA Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Insel Gruppe AG, University Hospital Bern · Academic / Other
• Sex: All
• Age: 8 Years – 16 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• ADHD

Interventions

Type	Name	Description
BEHAVIORAL	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.

Timeline

• Start date: 2025-08-01
• Primary completion: 2027-08-31
• Completion: 2027-08-31
• First posted: 2025-09-09
• Last updated: 2025-09-09

Locations

1 site across 1 country: Switzerland