Brain Training for Young Children

Recruiting at 1 trial location

Overseen By Shane Anderson, MS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Koronis Biomedical Technologies

Disqualifiers: Physical disabilities, Severe developmental delays, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

140 Participants Needed

Trial Summary

What is the purpose of this trial?

Koronis Biomedical Technologies Corporation (KBT) is developing a cognitive intervention to promote healthy development of Executive Function (EF) skills in young children by leveraging a smartphone-based training regime designed for parents.

Do I need to stop my child's current medications for the trial?

The trial information does not specify whether participants need to stop taking current medications.

What data supports the effectiveness of the treatment Executive Function Intervention in the clinical trial Brain Training for Young Children?

Research shows that training executive functions can lead to improvements in daily life skills and reduce symptoms in children with neurodevelopmental disorders. Additionally, a computer-based program has been effective in enhancing planning skills in young children, suggesting that similar interventions can improve executive functions. ^{1 2 3 4 5}

Is brain training for young children safe?

The studies reviewed do not report any specific safety concerns related to brain training interventions for young children, suggesting they are generally safe. However, caution is advised when choosing programs without strong evidence to support their claims. ^{6 7 8 9 10}

How is the Executive Function Intervention treatment different from other treatments for improving executive functions in young children?

The Executive Function Intervention is unique because it uses a computer-based cognitive training program specifically designed to enhance planning skills in young children, with sessions conducted three times a week over six weeks. This approach is particularly effective for children with lower initial planning abilities, offering a targeted and structured method to improve executive functions compared to other treatments that may not focus on planning or use computer-based methods. ^{2 7 11 12 13}

Research Team

Blair Hammond, MD

Principal Investigator

Mount Sinai General Pediatrics

Stephanie M. Carlson, PhD

Principal Investigator

University of Minnesota

Eligibility Criteria

This trial is for caregivers of children aged 2-5 years who are interested in a brain training program to develop their child's Executive Function (EF) skills. Participants must understand English. Children with severe developmental delays, disorders, or physical disabilities affecting vision, hearing, or mobility cannot participate.

Inclusion Criteria

Caregivers/guardian of the participating child

My child is between 2 and 5 years old.

Exclusion Criteria

Parents or caregivers who cannot read and understand English

My child has severe developmental delays or disorders.

My child has a disability that affects their sight, hearing, or ability to move.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Parents engage in a smartphone-based training regimen with their children, including non-computerized play activities and child-facing EF video games.

9 weeks

Ongoing virtual engagement

Follow-up

Participants are monitored for the effectiveness of the intervention through various assessments and questionnaires.

4 weeks

3 visits (virtual)

Delayed Post-test

A delayed post-test is conducted to assess the long-term impact of the intervention.

4 weeks

Treatment Details

Interventions

• Executive Function Intervention

Trial Overview Koronis Biomedical Technologies Corporation is testing a smartphone-based training program designed for parents to help improve their young children's Executive Function (EF) skills through cognitive exercises and activities.

Participant Groups

Group I: Mind Movers Intervention Experimental Treatment 1 Intervention

This arm will be administered the Mind Movers Intervention

Group II: Control Active Control 1 Intervention

Who Is Running the Clinical Trial?

Koronis Biomedical Technologies

Lead Sponsor

Trials

4

Recruited

200+

Mount Sinai General Pediatrics Faculty Practice

Collaborator

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

University of Minnesota

Collaborator

Trials

1,459

Recruited

1,623,000+

Findings from Research

There is limited research on interventions aimed at improving executive function in high-risk infants and toddlers, with significant variability in the types of interventions studied.

Parenting style interventions show promise, as they are associated with improved cognitive and behavioral outcomes in children as they reach prekindergarten and school age.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions for Executive Function in High-Risk Infants and Toddlers. Duncan, AF.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Far Transfer Effects of Trainings on Executive Functions in Neurodevelopmental Disorders: A Systematic Review and Metanalysis. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Efficacy of a computer-based cognitive training program to enhance planning skills in 5 to 7-year-old normally-developing children. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Executive Function Training for Preschool Children With ADHD: A Randomized Controlled Trial. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Informing the Structure of Executive Function in Children: A Meta-Analysis of Functional Neuroimaging Data. [2023]

5. Austria pubmed.ncbi.nlm.nih.gov

Metacognitive executive function training for young children with ADHD: a proof-of-concept study. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Interventions for Executive Function in High-Risk Infants and Toddlers. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

How child's play impacts executive function--related behaviors. [2022]

8. China pubmed.ncbi.nlm.nih.gov

Executive Function Training for Children with Attention Deficit Hyperactivity Disorder. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Comparing the Efficacy of Two School-Based Approaches of Neurocognitive Training for Enhancing Executive Functions. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Generating Attention, Inhibition, and Memory: A Pilot Randomized Trial for Preschoolers With Executive Functioning Deficits. [2020]

11. Switzerland pubmed.ncbi.nlm.nih.gov

A Short Executive Function Training Program Improves Preschoolers' Working Memory. [2020]

12. England pubmed.ncbi.nlm.nih.gov

The Promotion of Executive Functioning in a Brazilian Public School: A Pilot Study. [2022]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Executive Function Training Improves Emotional Competence for Preschool Children: The Roles of Inhibition Control and Working Memory. [2023]