NCT07680075

Brief Summary

The proposed study uses a mHealth application "app" to help parents teach their preschool-age child motor skill (FMS) activities in the home environment. This app guides families to participate in 10-min activity breaks, 7 days/week for 12 weeks and the app includes weekly instructional lessons, peer modeling videos, behavioral scaffolding, and structured activities. This study builds on prior work by assessing whether improvements in FMS generalize to cognitive domains, including executive function skills such as working memory, attention, and inhibitory control. By examining both motor and cognitive outcomes, the project will provide essential evidence on whether enhanced FMS uniquely contributes to cognitive development. Based on findings from the proposed study, there may be a need to develop additional modules that address diverse needs of children or that contribute to broader, multifaceted improvement in both motor competence and cognitive function. Findings will inform the potential of technology-based motor skill interventions to support broader aspects of child development in diverse populations, guiding future practice and policy in education, health, and early intervention.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
11mo left

Started Jun 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress9%
Jun 2026Jun 2027

First Submitted

Initial submission to the registry

June 25, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

June 30, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 2, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

July 2, 2026

Status Verified

June 1, 2026

Enrollment Period

1 year

First QC Date

June 25, 2026

Last Update Submit

June 25, 2026

Conditions

Keywords

mHealthpreschoolmotor skillexecutive functionparent-mediated

Outcome Measures

Primary Outcomes (2)

  • Change in executive functioning skills based on COSMIC intervention

    Heads, Toes, Knees, and Shoulders - Revised, Attention, working memory, inhibitory control

    Measured at three time points: enrollment (Week 0), end of intervention (Week 12), and 12-week retention (Week 24)

  • Change in motor skills based on COSMIC intervention

    Actual and perceived motor skills assessed by the Test of Gross Motor Development - 3rd edition and Perceived Movement Skill Competence assessment

    Measured at three time points: enrollment (Week 0), end of intervention (Week 12), and 12-week retention (Week 24)

Secondary Outcomes (2)

  • Parent implementation fidelity using the COSMIC app

    Measured throughout the duration of the intervention (12 weeks)

  • Changes in habitual physical activity based on engagement with COSMIC app

    Measured at three time points: enrollment (Week 0), end of intervention (Week 12), and 12-week retention (Week 24)

Study Arms (1)

COSMIC

EXPERIMENTAL

mHealth intervention

Behavioral: COSMIC

Interventions

COSMICBEHAVIORAL

Parents will deliver the FMS intervention at home to their preschool-age child (3-5 yrs). Each day, Parents will access weekly instructional lessons, peer modeling videos and activity breaks to deliver approximately 12 hrs of structured FMS instruction time to their child over a 3-month period. The Mission PLAY app program is comprised of 10-minute segments of varied activities that children perform, called "activity breaks" (10-min activity breaks, 7 days/week for 12 weeks) Each week parent-child dyads will work on one featured FMS (e.g., jumping) and will complete short bouts of activity that include a one-minute warm-up, 8 minutes of FMS practice, and one-minute cool down. During the FMS practice, parents will help their child practice this skill through a series of developmentally appropriate activities that aim to incrementally increase their child's performance through continued practice.

Also known as: PLAY App
COSMIC

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children will be included if they are 3-5 years of age at the time of enrollment and their accompanying parents (Age 18 or above).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Cosmic composite resin

Central Study Contacts

Kip Webster, PhD

CONTACT

Dawn Coe, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2026

First Posted

July 2, 2026

Study Start

June 30, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

July 2, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share