Cognitive intervention to enhance executive function skills in young children
In-Home Parent-Child Training System: Validation Study
This study is testing a smartphone program that helps parents improve their young children's thinking and self-control skills through fun games and activities.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 2 Years to 5 Years |
| Sex | All |
| Sponsor | Koronis Biomedical Technologies Industry-sponsored |
| Locations | 2 sites (Minneapolis, Minnesota and 1 other locations) |
| Trial ID | NCT06924307 on ClinicalTrials.gov |
What this trial studies
This intervention aims to promote the healthy development of executive function (EF) skills in children aged 2-5 years through a smartphone-based training program designed for parents. The program includes non-computerized play activities and child-facing EF video games, along with a clinician-facing portal for monitoring progress. By engaging in short, adaptive cognitive training activities with their children, parents can help address potential delays in EF skills, which are crucial for emotional regulation and social interactions. The study builds on previous feasibility research and seeks to validate the intervention with a larger sample size and additional outcome measures.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 2-5 years who may be experiencing delays in executive function skills, along with their caregivers.
Not a fit: Children with physical disabilities affecting vision, hearing, or mobility, as well as those with severe developmental delays or disorders, may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this intervention could provide parents with an effective and accessible tool to enhance their children's executive function skills, potentially improving their overall development and academic performance.
How similar studies have performed: Previous studies have shown promise in using cognitive interventions to improve executive function skills in children, indicating that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children ages 2-5 years. * Caregivers/guardian of the participating child. Exclusion Criteria: * Children with physical disabilities affecting vision, hearing, or basic mobility. * Children with severe developmental delays or disorders * Parents or caregivers who cannot read and understand English
Where this trial is running
Minneapolis, Minnesota and 1 other locations
- University of Minnesota, Institute of Child Development — Minneapolis, Minnesota, United States (Recruiting)
- Mount Sinai General Pediatrics — New York, New York, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Stephanie M. Carlson, PhD — University of Minnesota
- Study coordinator: Stephanie M. Carlson, PhD
- Email: smc@umn.edu
- Phone: 612-626-3187
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.