Parent-Child EF Intervention

NCT ID: NCT06924307

Last Updated: 2025-04-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-10
• Study Completion Date: 2026-05-31

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.

Detailed Description

The proposed intervention includes non-computerized play activities, child-facing EF video games with parental controls, and a clinician-facing portal to monitor and analyze progress, building on prior feasibility studies and expanding validation with a larger sample size and additional outcome variables. EF skills provide a foundation for learning and adaptation across a wide range of situations, and are necessary for emotion regulation, social interactions, and school/work performance. Difficulties with EF skills serve as a transdiagnostic indicator of many clinical conditions with childhood onset, including ADHD, autism, and conduct disorder, among others. There have been major advances in the reliable and validated assessment of EF skills in children, such as the NIH Toolbox for the Assessment of Neurological and Behavioral Function (Zelazo et al., 2013) and the Minnesota Executive Function Scale (Carlson & Zelazo, 2014). Parents of children with potential delays in EF skills have an unmet need, however, for an affordable and timely intervention option. This research seeks to fill this need by developing an in-home cognitive training system that provides parents with short (20-minute), adaptive collaborative cognitive training activities they will engage in with their child. This study will be conducted at two sites: the University of Minnesota's Institute of Child Development (ICD) and the Mount Sinai General Pediatric Faculty Practice. Both sites provide exceptional resources and expertise in early childhood development, EF research, and parent-child interaction studies. Their complementary strengths ensure a robust foundation for participant recruitment and data collection.

Preliminary Data - In Phase I, KBT engineers, working together with researchers from the University of Minnesota, developed and tested a prototype Executive Function (EF) cognitive training system. 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/tablet application delivers personalized daily training activities consisting of both short, easy-to-follow, hands-on cognitive training activities, as well as collaborative, parent-directed, child-facing video games. In Phase I, a demonstration child-facing video game called Spin the Pots was fully developed and tested. Our approach supports multiple pathways for learning and the building of strong personal relationships between parent and child. Parents were issued the MindMovers and Spin the Pots via the Google Play store and trained over a Zoom session with the Project Coordinator. They were instructed to use the apps with their child for 10 days within a 14-day period, for a total of 20 minutes per day at any time of their choosing (7 minutes for Spin the Pots and 13 minutes for the parent-child activities). Nineteen families completed the study (95%). One family withdrew prior to the post-test due to lack of time.

Usage Data - Parents used the offline activities with their child an average of 8.06 separate days (SD=3.13, range= 2-13), totaling an average of 148.4 minutes (SD=83.9, range=14.8-325) or 141.6% the recommended per-session dose. Children played Spin the Pots an average of 5.95 separate days (SD=2.35; range=2-10), totaling an average of 54.4 minutes (just under one hour) (SD=38.7, range=12.4-144.7), or 130.6% the recommended per-session dose. This usage reflects a positive experience in busy, real-life conditions.

Quantitative Results - Participating children showed the full range of ability on the working memory game Spin the Pots. Performance (Highest Level Passed) was correlated with age, as expected, r(20) = .391, p = .088. The more times children played the game, the better they got, r(20) = .66, p = .002. Parents began each "MindMovers" activity at the lowest level (1) to help children become acquainted with the basic objective, and then advanced to higher levels to help maintain a challenge as their child improved, which is important for EF growth. There was large variability in usage of each activity across families, yet parents generally moved up the scale on each activity, ending at level 4 (out of 5) on average during the study period. Age was associated with the highest mastery level attempted (rs = .29-.40), although these were not statistically significant given the small sample size in this usability study. There were no sex differences on Spin the Pots or the Launchpad activities. Our Spin the Pots video game was significantly correlated with the "gold standard" Minnesota Executive Function Scale (after controlling for age, r-Pretest = .43, r-Posttest = .53), as well as three of the parent-child activities (BINGO, Breathing, and Freeze Dance). The MEFS was also positively related to Breathing and Freeze Dance. This study provided preliminary evidence that our tool has construct validity, although it did not result in improved EF scores in such a small sample over a brief (2-week) period. A longer time period with a larger variety of activities is needed to fully assess the impact of the training. Qualitatively, parent surveys indicated the app was easy to use and enjoyed by both children and parents.

Purpose of the study:

The purpose of the study is to expand and validate a low-cost, developmentally appropriate, smartphone-based training regimen for parents to help promote parent-child interactions that support the healthy development of EF skills in young children, including those who have been identified as having deficits in their EF skills. Specific Aims 1-4 of the project will result in a smartphone-based EF-training application that provides parents with 20 activities to instruct and support traditional non-computerized play, and two child-facing EF video games with parental controls. Aim 5 is to develop a clinician-facing administrator portal for storing, analyzing, and displaying participants' progress in using the tool and EF assessment results. The specific aim of this human subjects protocol is to assess the validity of the system when used for a longer period of time by families (Aim 6). It includes a larger sample size than the feasibility study, as well as additional outcome variables and a delayed post-test.

The study is a pre/post/delayed post-test design with two conditions including random assignment using a randomization tool (e.g., Sealed Envelope), balanced on child age and sex and parent's education level.

A total of N = 140 children aged 24 to 71 months, and their primary caregivers will be recruited to participate in the validation study. According to pilots and attrition, we anticipate a final sample size of N ≥ 50-70 at each site.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Mind Movers Intervention

This arm will be administered the Mind Movers Intervention

Group Type: EXPERIMENTAL

Executive Function Intervention

Intervention Type: 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.

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Minnesota

OTHER

Sponsor Role: collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Mount Sinai General Pediatrics Faculty Practice

UNKNOWN

Sponsor Role: collaborator

Koronis Biomedical Technologies

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephanie M. Carlson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Blair Hammond, MD

Role: PRINCIPAL_INVESTIGATOR

Mount Sinai General Pediatrics

Locations

University of Minnesota, Institute of Child Development

Minneapolis, Minnesota, United States

Site Status: RECRUITING

Mount Sinai General Pediatrics

New York, New York, United States

Site Status: NOT_YET_RECRUITING

Countries

United States

Central Contacts

Stephanie M. Carlson, PhD

Role: CONTACT

smc@umn.edu

612-626-3187

Shane Anderson, MS

Role: CONTACT

sanderson@koronisbiotech.com

612-730-1091

Facility Contacts

Stephanie M. Carlson, PhD

Role: primary

smc@umn.edu

612-626-3187

Tae Won Park, M.Ed.

Role: backup

park1561@umn.edu

(612) 889-9605

Blair S. Hammond, MD

Role: primary

blair.hammond@mssm.edu

212-241-4242

References

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

Reference Type: BACKGROUND

Other Identifiers

5R44MH121664

Identifier Type: NIH

Identifier Source: secondary_id

View Link

A-2024

Identifier Type: -

Identifier Source: org_study_id