Parent-Child EF Intervention

NCT06924307 | Recruiting

• 2 other identifiers: A-20245R44MH121664
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Executive Function

Outcome Measures

Primary Outcomes (14)

• Parent Knowledge Questionaire

  Understanding of EF (From Parent)

  Week 1, 5, 9

• Minnesota Executive Function Scale (MEFS)

  Standardized EF Assessment (From Child)

  Week 1, 5, 9

• Peg Tapping

  EF Assessment (From the Child)

  Week 1, 5, 9

• Forward/Backward Word Span

  EF Assessment (From the Child)

  Week 1, 5, 9

• Behavior Rating Inventory of Executive Functioning - Preschool (BRIEF-P)

  EF questionnaire (about Child from the Parent)

  Week 1, 5, 9

• Self-reported usage

  Usage of Apps (Parent)

  Week 5

• ReadyRosie App Usage

  The total number of videos viewed by participants, representing overall engagement frequency with the app.

  During the intervention

• ReadyRosie Learning Outcome Opportunities

  The cumulative number of learning opportunities accessed by participants, categorized into four developmental domains: Language and Literacy, Math, Social-Emotional, and Health and Well-Being. This reflects both viewing activity and engagement with the child during or after the video.

  During the intervention

• ReadyRosie Family Outcome Opportunities

  The aggregate number of instances in which families engaged with their child in activities tagged according to the Head Start Family Engagement Framework. This measure captures the breadth of family involvement across key developmental categories.

  During the intervention

• MindMovers Usage Frequency

  The total number of times participants logged into the app, including timestamps that indicate the day and time of each login.

  During the intervention

• MindMovers Activity Duration

  The recorded time (in minutes and seconds) spent on each game or activity, as tracked by the app's internal portal.

  During the intervention

• MindMovers Game/Activity Levels Achieved

  Each game session records both the session duration and the final level reached. For both Spin the Pots and Beachcomber, the highest achievable level is 7. This metric captures the highest level completed by the child participant per session.

  During the intervention

• MindMovers Reflection Prompts

  The duration (ranging from 1 to 20 minutes) of parent-guided reflection activities conducted after gameplay. Parents and children rated their enjoyment and engagement with the activity on a 5-point scale.

  During the intervention

• MindMovers Badges Earned

  The total number of badges awarded to participants during gameplay in Spin the Pots and Beachcomber. Badges are earned based on in-game performance and milestones.

  During the intervention

Secondary Outcomes (6)

• Family Information Questionnaire

  Week 1

• Parenting Stress Index - Short Form

  Week 1, 5, 9

• Children's Social Understanding Scale - Short Form

  Week 1, 5, 9

• Ages & Stages Questionnaires: Social-Emotional, Second Edition (ASQ:SE-2)

  Week 1, 5, 9

• Usability Survey

  Week 5

Study Arms (2)

Mind Movers Intervention

EXPERIMENTAL

This arm will be administered the Mind Movers Intervention

Device: Executive Function Intervention

Control

NO INTERVENTION

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.

Mind Movers Intervention

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children ages 2-5 years.
• Caregivers/guardian of the participating child.

You may not qualify if:

• 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

Sponsors & Collaborators

• Koronis Biomedical Technologies: lead
• University of Minnesota: collaborator
• National Institute of Mental Health (NIMH): collaborator
• Mount Sinai General Pediatrics Faculty Practice: collaborator

Study Sites (2)

University of Minnesota, Institute of Child Development

Minneapolis, Minnesota, 55455, United States

RECRUITING

Mount Sinai General Pediatrics

New York, New York, 10029, United States

NOT YET RECRUITING

Related Publications (1)

• S. M. Carlson and P. D. Zelazo, "Minnesota Executive Function Scale," Reflect. Sci. Inc St Paul MN, 2014.

  BACKGROUND

Study Officials

• Stephanie M. Carlson, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

• Blair Hammond, MD

  Mount Sinai General Pediatrics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie M. Carlson, PhD

CONTACT

612-626-3187; smc@umn.edu

Shane Anderson, MS

CONTACT

612-730-1091; sanderson@koronisbiotech.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study will involve identical procedures across both sites to ensure consistency and comparability. Participating families will be randomly assigned (with stratification) to the MindMovers or active control condition, instructed to utilize the assigned app for 4 weeks, and given pre, post, and delayed post-test assessments. The primary caregiver for the purposes of the study and the child will come to the site for a pre-test visit. Caregivers will be trained to use the assigned app by a researcher. The MindMovers will include 20 activities and 2 video games. Then families will have a 4-week in-home practice period, with the goal of 20-min per day on 20 training days (5 days per week).

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: April 11, 2025
• Study Start: March 10, 2025
• Primary Completion: February 28, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: April 11, 2025

Record last verified: 2025-04

Locations

US (2)