Clinical trial NCT06924307: Parent-Child EF Intervention
Official title: In-Home Parent-Child Training System: Validation Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cognitive Intervention to Promote Healthy Development of Executive Function (EF) Skills in Young Children
Keywords: Executive Function
Lead sponsor: Koronis Biomedical Technologies
Sponsor class: INDUSTRY
Collaborators: name: University of Minnesota
name: National Institute of Mental Health (NIMH)
name: Mount Sinai General Pediatrics Faculty Practice
First posted: 2025-04-11
Enrollment: 140
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Parent Knowledge Questionaire
timeFrame: Week 1, 5, 9
measure: Minnesota Executive Function Scale (MEFS)
timeFrame: Week 1, 5, 9
measure: Peg Tapping
timeFrame: Week 1, 5, 9
measure: Forward/Backward Word Span
timeFrame: Week 1, 5, 9
measure: Behavior Rating Inventory of Executive Functioning - Preschool (BRIEF-P)
timeFrame: Week 1, 5, 9
measure: Self-reported usage
timeFrame: Week 5
measure: ReadyRosie App Usage
timeFrame: During the intervention
measure: ReadyRosie Learning Outcome Opportunities
timeFrame: During the intervention
measure: ReadyRosie Family Outcome Opportunities
timeFrame: During the intervention
measure: MindMovers Usage Frequency
timeFrame: During the intervention
measure: MindMovers Activity Duration
timeFrame: During the intervention
measure: MindMovers Game/Activity Levels Achieved
timeFrame: During the intervention
measure: MindMovers Reflection Prompts
timeFrame: During the intervention
measure: MindMovers Badges Earned
timeFrame: During the intervention
Secondary outcomes:
measure: Family Information Questionnaire
timeFrame: Week 1
measure: Parenting Stress Index - Short Form
timeFrame: Week 1, 5, 9
measure: Children's Social Understanding Scale - Short Form
timeFrame: Week 1, 5, 9
measure: Ages & Stages Questionnaires: Social-Emotional, Second Edition (ASQ:SE-2)
timeFrame: Week 1, 5, 9
measure: Usability Survey
timeFrame: Week 5
measure: Open-ended Interview
timeFrame: Week 5
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota, Institute of Child Development
state: Minnesota
city: New York
country: United States
facility: Mount Sinai General Pediatrics
state: New York
Study officials:
affiliation: University of Minnesota
name: Stephanie M. Carlson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mount Sinai General Pediatrics
name: Blair Hammond, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: S. M. Carlson and P. D. Zelazo, "Minnesota Executive Function Scale," Reflect. Sci. Inc St Paul MN, 2014.