Parent-Child EF Intervention

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
Koronis Biomedical Technologies
Study ID
NCT06924307
Status
Recruiting
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Conditions

  • Cognitive Intervention to Promote Healthy Development of Executive Function (EF) Skills in Young Children

Eligibility Criteria

Sex
ALL
Age
2 Years - 5 Years
Healthy Volunteers
Accepted

Interventions

  • Executive Function Intervention — DEVICE
    The intervention is an in-home cognition training system that provides parents with a modular series of short, easy-to-follow, collaborative cognitive training activities they will share with their child to address the needs of families with young children identified with deficits in executive function (EF), a critical cognitive process associated with self-control. The system employs a novel two-generational training model that views parental involvement as a critical component of the intervention process. In this model, an engaging, parent-facing smartphone application will deliver personalized daily training activities consisting of both traditional hands-on activities as well as collaborative, parent-controlled, child-facing video games. This approach supports multiple pathways for learning and building strong personal relationships between parent and child.

Study Details

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.

Key Dates

Start date
Mar 10, 2025
Status verified
Apr 2025
Primary completion
Feb 28, 2026
Completion
May 31, 2026

Study Design

Enrollment
140 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Mind Movers Intervention
    This arm will be administered the Mind Movers Intervention
  • No Intervention: Control

Primary Outcome Measure

Parent Knowledge Questionaire [ Time Frame: Week 1, 5, 9 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Minnesota, Institute of Child DevelopmentMinneapolisMinnesota55455
Stephanie M. Carlson, PhD
[email protected]
612-626-3187
Tae Won Park, M.Ed.
[email protected]
(612) 889-9605
Stephanie M. Carlson, PhD (PRINCIPAL_INVESTIGATOR)
Mount Sinai General PediatricsNew YorkNew York10029
Blair S. Hammond, MD
[email protected]
212-241-4242
Blair S. Hammond, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Minnesota, Institute of Child Development· Minneapolis, MNMount Sinai General Pediatrics· New York, NY