Parent-Child EF Intervention

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.

Parent Knowledge Questionaire

Time frame: Week 1, 5, 9

Understanding of EF (From Parent)

Minnesota Executive Function Scale (MEFS)

Time frame: Week 1, 5, 9

Standardized EF Assessment (From Child)

Peg Tapping

Time frame: Week 1, 5, 9

EF Assessment (From the Child)

Forward/Backward Word Span

Time frame: Week 1, 5, 9

EF Assessment (From the Child)

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

Time frame: Week 1, 5, 9

EF questionnaire (about Child from the Parent)

Self-reported usage

Time frame: Week 5

Usage of Apps (Parent)

ReadyRosie App Usage

Time frame: During the intervention

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

ReadyRosie Learning Outcome Opportunities

Time frame: 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

Time frame: 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 Usage Frequency

Time frame: 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

Time frame: During the intervention

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

MindMovers Game/Activity Levels Achieved

Time frame: 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

Time frame: 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

Time frame: 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.

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.