The Mio-Training: Efficacy of a metacognitive intervention for children and adolescents – a randomized controlled trial (Preprint)

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Abstract
BACKGROUND Disease during childhood and adolescence such as cancer, or ADHD can have an impact on brain development and places children and adolescents at increased risk for cognitive long-term problems. Most cognitive trainings currently available have limited efficacy and lack a transfer to non-trained tasks and everyday functioning. We developed a novel intervention (Mio-Training) aiming to increase metacognitive abilities at the intersection between exercise psychology and cognitive science to strengthen the cognitive development of paediatric patients with atypical brain development in the long-term. OBJECTIVE The study assesses the efficacy of the Mio-Training on the primary (metacognitive abilities) and secondary outcomes (executive functions, processing speed, memory), before, immediately after the training and at 3-months follow-up in patients with atypical development and healthy controls. METHODS We will evaluate the efficacy of a newly developed cognitive training (Mio-Training) on metacognitive abilities and cognitive performance in a randomized controlled clinical trial. We expect a long-term increase in metacognitive abilities relating to an increase in subjective and objective cognitive performance. Intervention: The Mio-Training stimulates metacognition through 38 digital games, which playfully teach mnemonic strategies (i.e. rehearsal, chaining, associations), present intensive verbal and visual working memory training and motor coordination tasks. The training group will train for 5 weeks, 3 times per week for 20 minutes. The waiting control group will receive the training after termination of the study procedure. Participants: The efficacy of the Mio-Training will be investigated in three subgroups (patients with cancer, ADHD and healthy controls, each group n = 40, all aged 8-16 years) using pre- and post-intervention assessments. All participants will be randomly assigned to the Mio-Training or the waiting control group, stratified by age and sex. RESULTS This study protocol describes the study design of the randomized controlled trial evaluating the efficacy of the Mio-Training. Data collection started in August 2025 and will continue until August 2027. First results are expected to be submitted for publication in spring 2027. CONCLUSIONS To strengthen cognitive development in young patients with atypical development, it is necessary to address the current lack of effective treatment options. The combination of cognitive and motor training with metacognitive abilities may support patient’s cognitive maturation trajectory and will enable a transfer of the training effect to everyday and school situations. CLINICALTRIAL Clinicaltrials.gov (Patients with cancer and healthy controls: NCT06464237, date of registration: 12.06.2024, ADHD: NCT07162831, date of registration: 01.09.2025)

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