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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a smartphone-based program designed to help young children develop important thinking skills known as Executive Function (EF). It explores how parents can use this program to support their child's cognitive growth. Participants will be divided into two groups: one will try the "Mind Movers" intervention (an Executive Function Intervention), and the other will serve as a control group. The trial seeks children aged 2 to 5 years, whose parents or guardians can read and understand English, and who do not have physical disabilities or severe developmental issues. As an unphased trial, this study offers a unique opportunity for parents to contribute to innovative research that could enhance their child's cognitive development.

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 prior data suggests that this cognitive intervention is safe for young children?

Research shows that programs designed to improve thinking skills, such as planning and memory, are generally safe for young children. These programs typically enhance these skills without causing major issues.

The specific program under testing, the Mind Movers Intervention, has not demonstrated harm. While the study lacks detailed safety information, its design as a smartphone app for home use suggests a low-risk intention. Similar programs used in schools have also shown positive results with minimal risks.

Overall, these programs are well-received by children and aim to enhance their thinking skills in a supportive manner. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Executive Function Intervention, specifically the Mind Movers program, because it focuses on enhancing brain function in young children through cognitive exercises. Unlike traditional methods that often rely on medication or behavioral therapy, this approach aims to directly stimulate brain development and improve cognitive skills through interactive activities. This innovative method could offer a non-invasive, engaging way to boost mental processes like attention, memory, and problem-solving, potentially leading to long-term cognitive benefits without the side effects associated with medication.

What evidence suggests that this intervention is effective for developing Executive Function skills in young children?

Research has shown that when parents lead activities, it can improve young children's thinking skills, such as memory, attention, and problem-solving, in those aged 2 to 5. Studies also find that mindfulness programs in schools enhance these skills, though the improvements are usually small. Activities involving learning through movement have boosted these skills in preschoolers. Additionally, physical activity programs have positively affected young children's thinking abilities. Overall, this evidence suggests that the Mind Movers Intervention, which participants in this trial may receive, could enhance cognitive skills in young children. ^{4 6 7 8 9}

Who Is on the Research Team?

Stephanie M. Carlson, PhD

Principal Investigator

University of Minnesota

Blair Hammond, MD

Principal Investigator

Mount Sinai General Pediatrics

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1.

nature.com

nature.com/articles/s41598-025-01385-5

The impact of structured motor learning intervention on ...

This study aimed to compare the effects of structured motor learning activities and outdoor free play on the executive functions of preschool ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12044745/

The mindful movement program in primary schools

Mindfulness-based interventions delivered in the classroom have shown effectiveness with significant, albeit small, effects for cognitive (EFs, ...

3.

ies.ed.gov

ies.ed.gov/ncer/2025/01/executive-function-implications-education

Executive Function: Implications for Education

As discussed more fully in chapter 6, behavioral interventions targeting EF have demonstrated the potential to help children at risk for difficulty in school.

4.

srcd.onlinelibrary.wiley.com

srcd.onlinelibrary.wiley.com/doi/10.1111/cdev.14014

Physical activity intervention improves executive function and ...

This study aimed to determine the effects of the Active Early Learning (AEL) childcare center-based physical activity intervention on early childhood executive ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S0273229725000139

A systematic review and meta-analysis of parent-led ...

A systematic review and meta-analysis of the literature on parent/caregiver-led interventions designed to foster children's executive function from ages 2 to 5 ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06924307

Study Details | NCT06924307 | Parent-Child EF Intervention

The intervention is an in-home cognition training system that provides parents with a modular series of short, easy-to-follow, collaborative cognitive training ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10920464/

Far Transfer Effects of Trainings on Executive Functions in ...

This systematic review and metanalysis aims to investigate the far effect outcomes after EF training in children with different types of neurodevelopmental ...

8.

bmcpsychology.biomedcentral.com

bmcpsychology.biomedcentral.com/articles/10.1186/s40359-025-02689-x

The mindful movement program in primary schools: a single ...

The development of executive functions (EFs) during early childhood establishes the critical foundations for socio-emotional development and ...

9.

withpower.com

withpower.com/trial/phase-cognitive-intervention-to-promote-healthy-development-of-executive-function-ef-skills-in-young-children-2-2025-d611d

Brain Training for Young Children

The Executive Function Intervention is unique because it uses a computer-based cognitive training program specifically designed to enhance planning skills ...