NCT07162831 Metacognitive Intervention in Children and Adolescents With ADHD - MiA Study
| NCT ID | NCT07162831 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Insel Gruppe AG, University Hospital Bern |
| Condition | ADHD |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-08-01 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2025-08-01 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Regula Everts, Prof. Dr. phil.
PRINCIPAL INVESTIGATOR
Division of Neuropaediatrics, Development and Rehabilitation, Department of Paediatrics, Inselspital, Bern University Hospital, University of Bern, Switzerland
Frequently Asked Questions
Who can join the NCT07162831 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 16 Years, studying ADHD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07162831 currently recruiting?
Yes, NCT07162831 is actively recruiting participants. Contact the research team at regula.everts@insel.ch for enrollment information.
Where is the NCT07162831 trial being conducted?
This trial is being conducted at Bern, Switzerland.
Who is sponsoring the NCT07162831 clinical trial?
NCT07162831 is sponsored by Insel Gruppe AG, University Hospital Bern. The principal investigator is Regula Everts, Prof. Dr. phil. at Division of Neuropaediatrics, Development and Rehabilitation, Department of Paediatrics, Inselspital, Bern University Hospital, University of Bern, Switzerland. The trial plans to enroll 40 participants.