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Parent-Child EF Intervention

NCT06924307 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2025-04-11

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DEVICE

Executive Function 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 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.

Sponsors & Collaborators

  • University of Minnesota

    collaborator OTHER

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Mount Sinai General Pediatrics Faculty Practice

    collaborator UNKNOWN

  • Koronis Biomedical Technologies

    lead INDUSTRY

Principal Investigators

  • Stephanie M. Carlson, PhD · University of Minnesota

  • Blair Hammond, MD · Mount Sinai General Pediatrics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-10
Primary Completion
2026-02-28
Completion
2026-05-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06924307 on ClinicalTrials.gov