Metacognitive Intervention in Children and Adolescents With ADHD - MiA Study

NCT07162831 | Recruiting

• 1 other identifier: BASEC2025-01189
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

ADHD

Keywords

Metacognition; ADHD; Cognitive training; Children; Adolescents; Cognitive development

Outcome Measures

Primary Outcomes (1)

• Junior Metacognitive Awareness Inventory (Jr.MAI)

  Total score of the Junior Metacognitive Awareness Inventory over the three timepoints (baseline, immediate followup \& 3-months follow-up). Raw values ranging 18-90. Higher scores mean better outcome.

  At baseline; immediately (up to 1 week) after the training or waiting period; at 3-months follow-up

Secondary Outcomes (8)

• Wechsler Intelligence Scale For Children: 5th Ed (WISC-V)

  At baseline; immediately (up to 1 week) after the training or waiting period.

• Color-Word Interference Test (Delis-Kaplan Executive Function System; D-KEFS)

  At baseline; immediately (up to 1 week) after the training or waiting period.

• Tower of Hanoi (D-KEFS)

  At baseline; immediately (up to 1 week) after the training or waiting period.

• Verbal learning and memory test (VLMT)

  At baseline; immediately (up to 1 week) after the training or waiting period.

• Pattern learning (Memory and Learning Test; Basic-MLT)

  At baseline; immediately (up to 1 week) after the training or waiting period.

Other Outcomes (3)

• Physical Self-Description Questionnaire (PSDQ-S)

  At baseline; immediately (up to 1 week) after the training or waiting period; at 3-months follow-up.

• Conners-3 short form

  At baseline

• Questionnaire for the Assessment of Resources and Competencies in Childhood and Adolescence (FRKJ)

  At baseline; immediately (up to 1 week) after the training or waiting period; at 3-months follow-up.

Study Arms (2)

Training group

ACTIVE COMPARATOR

Training with Mio-Training for 5 weeks, three times per week.

Behavioral: Mio-Training

Control group

NO INTERVENTION

Waiting control group. Participants may use the Mio-Training after completion of the last follow-up assessment.

Interventions

Mio-Training BEHAVIORAL

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.

Training group

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Insespital, University Hospital Bern

Bern, 3010, Switzerland

RECRUITING

Related Links

• Webpage MiA-study (german)

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Regula Everts, Prof. Dr. phil.

  Division of Neuropaediatrics, Development and Rehabilitation, Department of Paediatrics, Inselspital, Bern University Hospital, University of Bern, Switzerland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Regula Everts, Prof. Dr. phil.

CONTACT

+41 31 632 84 97; regula.everts@insel.ch

Saskia Salzmann, MSc

CONTACT

+41 31 664 59 84; saskia.salzmann@insel.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: September 9, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)