Metacognitive Intervention in Children and Adolescents With ADHD - MiA Study

Sponsor
Insel Gruppe AG, University Hospital Bern
Study ID
NCT07162831
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
8 Years - 16 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Sep 9, 2025
Start date
Aug 1, 2025
Status verified
Sep 2025
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: Training group
    Training with Mio-Training for 5 weeks, three times per week.
  • No Intervention: Control group
    Waiting control group. Participants may use the Mio-Training after completion of the last follow-up assessment.

Primary Outcome Measure

Junior Metacognitive Awareness Inventory (Jr.MAI) [ Time Frame: At baseline; immediately (up to 1 week) after the training or waiting period; at 3-months follow-up ]

Central Contacts

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