Mio-Training: a metacognitive program for children and adolescents with ADHD
Metacognitive Intervention in Children and Adolescents With ADHD - MiA Study
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 8 Years to 16 Years |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 1 site (Bern) |
| Trial ID | NCT07162831 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Bern
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.