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临床试验/NCT06924307
NCT06924307招募中不适用

In-Home Parent-Child Training System: Validation Study

Koronis Biomedical Technologies4 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2025年3月10日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
140
试验地点
4
主要终点
Parent Knowledge Questionaire

研究概览

简要总结

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.

详细描述

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:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
2 Years 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Parent Knowledge Questionaire

时间窗: Week 1, 5, 9

Understanding of EF (From Parent)

Minnesota Executive Function Scale (MEFS)

时间窗: Week 1, 5, 9

Standardized EF Assessment (From Child)

Peg Tapping

时间窗: Week 1, 5, 9

EF Assessment (From the Child)

Forward/Backward Word Span

时间窗: Week 1, 5, 9

EF Assessment (From the Child)

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

时间窗: Week 1, 5, 9

EF questionnaire (about Child from the Parent)

Self-reported usage

时间窗: Week 5

Usage of Apps (Parent)

ReadyRosie App Usage

时间窗: During the intervention

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

MindMovers Usage Frequency

时间窗: During the intervention

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

MindMovers Activity Duration

时间窗: During the intervention

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

ReadyRosie Learning Outcome Opportunities

时间窗: During the intervention

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.

ReadyRosie Family Outcome Opportunities

时间窗: During the intervention

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.

MindMovers Game/Activity Levels Achieved

时间窗: During the intervention

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.

MindMovers Reflection Prompts

时间窗: During the intervention

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.

MindMovers Badges Earned

时间窗: During the intervention

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.

次要结局

  • 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)
  • Open-ended Interview(Week 5)

研究者

发起方
Koronis Biomedical Technologies
申办方类型
Industry
责任方
Sponsor

研究点 (4)

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