Mio-Training: a metacognitive program for children and adolescents with ADHD
Official title: Metacognitive Intervention in Children and Adolescents With ADHD - MiA Study
Run by Insel Gruppe AG, University Hospital Bern · NCT07162831 · Data updated 2026-11-12
This trial tests whether the Mio-Training—a set of cognitive and coordination exercises with metacognitive questions—helps children and adolescents (ages 8–16) with ADHD improve thinking skills and self-awareness.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 8 Years to 16 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 1 site (Bern) |
| Status | Recruiting |
| Started | August 1, 2025 |
| Main results expected | August 31, 2027 |
| Study ends | August 31, 2027 |
| Registry record updated | September 9, 2025 |
| Trial ID | NCT07162831 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are German- or French-speaking children and adolescents aged 8–16 with a clinical ADHD diagnosis, IQ above 85, informed consent, and willingness to attend study visits without ADHD medication.
✕Probably not a fit
Patients with unstable neurological conditions, severe psychiatric disease or learning disabilities that markedly impair development, known non-compliance, or those unable to follow procedures (including language barriers) are unlikely to benefit from this program.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In a randomized controlled design conducted at Inselspital, University Hospital Bern, participants with ADHD will be assigned to receive the Mio-Training, which combines cognitive and coordinative tasks with prospective and retrospective metacognitive questions. The trial measures changes in metacognitive thinking and core executive functions and examines whether effects transfer to untrained tasks. Investigators will analyze moderators of effectiveness such as age, sex, compliance, and ADHD severity, and study visits are conducted without ADHD medication. The program is designed to be deliverable with limited specialist staffing to support broader implementation if effective.
Why it matters
Potential benefit: If successful, the Mio-Training could strengthen metacognition and executive functions and help those gains carry over into school and daily life.
How similar studies have gone: Similar cognitive and metacognitive training programs for ADHD have shown mixed and often modest or short-lived benefits, so the Mio-Training approach remains relatively novel and not yet proven.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Insespital, University Hospital Bern
Bern, Switzerland Recruiting
Study contacts
- Principal investigator: Regula Everts, Prof. Dr. phil. — Division of Neuropaediatrics, Development and Rehabilitation, Department of Paediatrics, Inselspital, Bern University Hospital, University of Bern, Switzerland
- Study coordinator: Regula Everts, Prof. Dr. phil.
- Email: regula.everts@insel.ch
- Phone: +41 31 632 84 97
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.