Executive FunctionCOSMICNCT07680075
Influence of a Parent-mediated mHealth Motor Skill Intervention on Preschool Children's Motor Skills and Cognitive Function
A study testing COSMIC in people with Executive Function and Motor Skills, run by University of Tennessee.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Executive Function, Motor Skills, Healthy
- What is being tested?
- COSMIC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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).
Who cannot join
- Child exclusion criteria: Physical or cognitive disability that parent feels will preclude participation in activity breaks or assessments (physical activity or gross motor skill activities).
- Parent exclusion criteria: No parental access to a smartphone, tablet or computer; physical limitation that impairs modeling of activities; parent cannot read and understand English.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
This quasi-experimental study aims to examine how the PLAY app influences cognitive function (attention, working memory, inhibition, and cognitive flexibility) in preschool-age children. This study will include a 12-week intervention that encompasses 3 assessments across 6 months; measurements will be taken before (pre-; Month 0) and after (post-; Month 3) the home-based intervention and 3 months later (retention; Month 6) to examine the sustained effects of the program.
Utilizing the PLAY app, parents will deliver the intervention in the home to their preschool-age child (3-5 yrs). Parents will access weekly instructional lessons, peer modeling videos, and activity breaks to deliver 12 hrs of structured FMS instruction time to their child over a 3-month period. The PLAY app program comprised of 12-minute segments of varied activities that children perform, called "activity breaks" (12-min activity breaks, 5 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, 10 minutes of FMS practice, and then a 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. Parents monitor time of each activity through an embedded timer in the app and have short (5-20 second) video clips of young children completing each activity for reference. Videos can also serve as a peer model for children to emulate movements. At the end of each "activity break" (i.e., daily 12-minute bout of FMS practice), parents will indicate they completed the daily practice and will receive a badge that shows up in the child's app profile to serve as a motivator.
Behavioral scaffolding and social cognitive theory inform the intervention and target 6 developmentally appropriate FMS through short activities parents and children can participate in together. Behavioral scaffolding is a cognitive learning approach to problem-solving that allows children to master skills just beyond their current inability and is effective in helping parents assist children in attaining behavior goals. According to social cognitive theory, for modeling to elicit behavior change effectively, the child must undergo a process involving attention, retention, reproduction, and motivation. Attention is garnered through the app via videos of peers (modeled and narrated by children), with auditory and visual stimuli to enhance arousal/engagement. Retention is reinforced through multiple exposures to the video segments and push notifications (SMS text message) to parents to reinforce strategies to facilitate their child's engagement, including FMS practice. Reproduction is elicited via the child producing the modeled activities. Motivation is encouraged intrinsically through perceived competence and extrinsically via encouragement from in-app rewards.
All communication (outside of assessment visits) occurs in the app and is built to accommodate families with limited data. Reminders are sent via push notifications and scheduled with the parents to support compliance with the program. An in-app reinforcement schedule uses the principles of shaping to promote continued motivation.
Participants The researchers will employ rolling recruitment through preexisting contacts with childcare centers and the utilization of technology and social media ads. The study will recruit 35 parent-child dyads to participate in the proposed study. Inclusion criteria: Children will be included if they are 3-5 years of age at the time of enrollment. Exclusion criteria: Child exclusion criteria: Physical or cognitive disability that parent feels will preclude participation in activity breaks or assessments; FMS being too high at baseline (i.e., TGMD-3 rating of "Superior" or "Gifted/Advanced") to eliminate potential participants to avoid a ceiling effect, which would limit the ability to detect improvement from intervention. Parent exclusion criteria: No parental access to a smartphone, tablet or computer; physical limitation that impairs modeling of activities; parent cannot read and understand English.
Measures (Measured at 0, 3, and 6 months)
- Executive function skills will be assessed using the Head, Toes, Knees, and Shoulders - Revised (HTKS-R) task. The HTKS-R task measures executive function skills (attention, working memory, and inhibitory control) and behavioral self-regulation in young children aged 4-8 yrs and takes 6 minutes to complete. HTKS-R has been validated in the study's target population. Attention, working memory, inhibitory control, and additional components of cognition will also be assessed using the NIH ToolBox. The NIH Toolbox Early Childhood Cognition Battery is recommended for ages 3-6 yrs old. This test battery offers five (5) subtests that measure various components of cognitive function including cognitive flexibility, attention, inhibitory control, episodic memory, processing speed, and nonverbal and visual reasoning.
- FMS will be assessed using the TGMD-3, a criterion- and norm-referenced assessment to measure 13 FMS in children aged 3-10 yrs. This is considered the gold-standard assessment for FMS in this age group. Assessments will be led and recorded by a trained staff member and coded by trained research assistants blinded to the study. mPI Webster established reliability and validity for the TGMD-3.
- Parent Implementation Fidelity [Potential Covariate] will be assessed as the percentage of instructional videos watched by the parent, and the percentage of possible activity breaks marked as completed. This outcome may be used to determine the dose-response effect of the PLAY app.
- Physical activity [Potential Covariate] will be assessed using an ActiGraph GT3X-BT accelerometer worn for 7-days on the right hip at all times except sleeping, swimming, and bathing. The validity and reliability of accelerometers have been well established in preschoolers, and our team has extensive experience using accelerometry in preschoolers. Accelerometers will be initialized to 15-sec epochs, and established cut-points will be used to estimate time spent in activity intensity levels of light, moderate, and vigorous.
- Height and weight will be assessed using standard procedures. BMI (kg•m-2) will be calculated as body mass (kg) divided by height (m) squared, then percentiles and z-scores derived from age- and sex-specific normative values.
- Conditions
- Executive Function, Motor Skills, Healthy
- Being tested
- COSMIC
- Keywords
- mHealth, preschool, motor skill, executive function, parent-mediated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COSMICBehavioural
Also called PLAY App
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.
| Study group | Role | What they receive |
|---|---|---|
| COSMIC | Experimental | mHealth intervention Receives: Behavioral: COSMIC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in executive functioning skills based on COSMIC intervention
Heads, Toes, Knees, and Shoulders - Revised, Attention, working memory, inhibitory control
Measured: 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: 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
The percentage of instructional videos watched by the parent, and the percentage of possible activity breaks marked as completed
Measured: Measured throughout the duration of the intervention (12 weeks)
Changes in habitual physical activity based on engagement with COSMIC app
Assessed using an ActiGraph GT3X-BT accelerometer worn for 7-days on the right hip at all times except sleeping, swimming, and bathing
Measured: Measured at three time points: enrollment (Week 0), end of intervention (Week 12), and 12-week retention (Week 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start30 Jun 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Executive FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Collaborators
- Woodcock Institute for the Advancement of Neurocognitive Research and Applied Practice
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07680075
- Sponsor's protocol ID
- STUDY00000124
- Acronym
- COSMIC
- Status last verified
- Jun 2026
- First submitted
- 25 Jun 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of a Parent-mediated mHealth Motor Skill Intervention on Preschool Children's Motor Skills and Cognitive Function
- ClinicalTrials.gov ID
- NCT07680075
- Acronym / sponsor ID
- COSMIC / STUDY00000124
- Conditions
- Executive Function, Motor Skills, Healthy
- Keywords
- mHealth, preschool, motor skill, executive function, parent-mediated
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Collaborators
- Woodcock Institute for the Advancement of Neurocognitive Research and Applied Practice
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 2 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This quasi-experimental study aims to examine how the PLAY app influences cognitive function (attention, working memory, inhibition, and cognitive flexibility) in preschool-age children. This study will include a 12-week intervention that encompasses 3 assessments across 6 months; measurements will be taken before (pre-; Month 0) and after (post-; Month 3) the home-based intervention and 3 months later (retention; Month 6) to examine the sustained effects of the program.
Utilizing the PLAY app, parents will deliver the intervention in the home to their preschool-age child (3-5 yrs). Parents will access weekly instructional lessons, peer modeling videos, and activity breaks to deliver 12 hrs of structured FMS instruction time to their child over a 3-month period. The PLAY app program comprised of 12-minute segments of varied activities that children perform, called "activity breaks" (12-min activity breaks, 5 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, 10 minutes of FMS practice, and then a 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. Parents monitor time of each activity through an embedded timer in the app and have short (5-20 second) video clips of young children completing each activity for reference. Videos can also serve as a peer model for children to emulate movements. At the end of each "activity break" (i.e., daily 12-minute bout of FMS practice), parents will indicate they completed the daily practice and will receive a badge that shows up in the child's app profile to serve as a motivator.
Behavioral scaffolding and social cognitive theory inform the intervention and target 6 developmentally appropriate FMS through short activities parents and children can participate in together. Behavioral scaffolding is a cognitive learning approach to problem-solving that allows children to master skills just beyond their current inability and is effective in helping parents assist children in attaining behavior goals. According to social cognitive theory, for modeling to elicit behavior change effectively, the child must undergo a process involving attention, retention, reproduction, and motivation. Attention is garnered through the app via videos of peers (modeled and narrated by children), with auditory and visual stimuli to enhance arousal/engagement. Retention is reinforced through multiple exposures to the video segments and push notifications (SMS text message) to parents to reinforce strategies to facilitate their child's engagement, including FMS practice. Reproduction is elicited via the child producing the modeled activities. Motivation is encouraged intrinsically through perceived competence and extrinsically via encouragement from in-app rewards.
All communication (outside of assessment visits) occurs in the app and is built to accommodate families with limited data. Reminders are sent via push notifications and scheduled with the parents to support compliance with the program. An in-app reinforcement schedule uses the principles of shaping to promote continued motivation.
Participants The researchers will employ rolling recruitment through preexisting contacts with childcare centers and the utilization of technology and social media ads. The study will recruit 35 parent-child dyads to participate in the proposed study. Inclusion criteria: Children will be included if they are 3-5 years of age at the time of enrollment. Exclusion criteria: Child exclusion criteria: Physical or cognitive disability that parent feels will preclude participation in activity breaks or assessments; FMS being too high at baseline (i.e., TGMD-3 rating of "Superior" or "Gifted/Advanced") to eliminate potential participants to avoid a ceiling effect, which would limit the ability to detect improvement from intervention. Parent exclusion criteria: No parental access to a smartphone, tablet or computer; physical limitation that impairs modeling of activities; parent cannot read and understand English.
Measures (Measured at 0, 3, and 6 months)
- Executive function skills will be assessed using the Head, Toes, Knees, and Shoulders - Revised (HTKS-R) task. The HTKS-R task measures executive function skills (attention, working memory, and inhibitory control) and behavioral self-regulation in young children aged 4-8 yrs and takes 6 minutes to complete. HTKS-R has been validated in the study's target population. Attention, working memory, inhibitory control, and additional components of cognition will also be assessed using the NIH ToolBox. The NIH Toolbox Early Childhood Cognition Battery is recommended for ages 3-6 yrs old. This test battery offers five (5) subtests that measure various components of cognitive function including cognitive flexibility, attention, inhibitory control, episodic memory, processing speed, and nonverbal and visual reasoning.
- FMS will be assessed using the TGMD-3, a criterion- and norm-referenced assessment to measure 13 FMS in children aged 3-10 yrs. This is considered the gold-standard assessment for FMS in this age group. Assessments will be led and recorded by a trained staff member and coded by trained research assistants blinded to the study. mPI Webster established reliability and validity for the TGMD-3.
- Parent Implementation Fidelity [Potential Covariate] will be assessed as the percentage of instructional videos watched by the parent, and the percentage of possible activity breaks marked as completed. This outcome may be used to determine the dose-response effect of the PLAY app.
- Physical activity [Potential Covariate] will be assessed using an ActiGraph GT3X-BT accelerometer worn for 7-days on the right hip at all times except sleeping, swimming, and bathing. The validity and reliability of accelerometers have been well established in preschoolers, and our team has extensive experience using accelerometry in preschoolers. Accelerometers will be initialized to 15-sec epochs, and established cut-points will be used to estimate time spent in activity intensity levels of light, moderate, and vigorous.
- Height and weight will be assessed using standard procedures. BMI (kg•m-2) will be calculated as body mass (kg) divided by height (m) squared, then percentiles and z-scores derived from age- and sex-specific normative values.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COSMIC | Experimental | Behavioral: COSMICmHealth intervention |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (2 listed)
- Child exclusion criteria: Physical or cognitive disability that parent feels will preclude participation in activity breaks or assessments (physical activity or gross motor skill activities).
- Parent exclusion criteria: No parental access to a smartphone, tablet or computer; physical limitation that impairs modeling of activities; parent cannot read and understand English.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COSMICAlso: PLAY AppParents 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. | Behavioural | COSMIC |
Primary outcome
Change in executive functioning skills based on COSMIC intervention
Time frame: Measured at three time points: enrollment (Week 0), end of intervention (Week 12), and 12-week retention (Week 24)
Heads, Toes, Knees, and Shoulders - Revised, Attention, working memory, inhibitory control
Change in motor skills based on COSMIC intervention
Time frame: Measured at three time points: enrollment (Week 0), end of intervention (Week 12), and 12-week retention (Week 24)
Actual and perceived motor skills assessed by the Test of Gross Motor Development - 3rd edition and Perceived Movement Skill Competence assessment
2 secondary outcomes
Parent implementation fidelity using the COSMIC app
Time frame: Measured throughout the duration of the intervention (12 weeks)
Changes in habitual physical activity based on engagement with COSMIC app
Time frame: Measured at three time points: enrollment (Week 0), end of intervention (Week 12), and 12-week retention (Week 24)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Executive Function
Not yet recruiting
Cognitive-Motor Training With the DextEgg in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
Recruiting
Virtual Reality in Rehabilitation of Executive Functions in Children With Mild or Moderate Traumatic Brain Injury
Traumatic Brain Injury
Recruiting
Neocortical Microarchitecture of Executive Function
Parkinson Disease
Active, not recruiting
Learning by Heart: The Effectiveness of an EF Training Program for Pre-schoolers With Critical CHD
Congenital Heart Disease, Executive Dysfunction
Recruiting
Acupuncture for ADHD: Acupoint Data Mining, Clinical Effectiveness, and Interviews to Explore Treatment Outcomes.
Acupuncture, ADHD - Attention Deficit Disorder With Hyperactivity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing COSMIC in people with Executive Function and Motor Skills, run by University of Tennessee.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kip Webster, PhD (865-974-3752, kipwebster@utk.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in executive functioning skills based on COSMIC intervention (time frame: Measured at three time points: enrollment (Week 0), end of intervention (Week 12), and 12-week retention (Week 24)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.