- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07680075
Influence of a Parent-mediated mHealth Motor Skill Intervention on Preschool Children's Motor Skills and Cognitive Function (COSMIC)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kip Webster, PhD
- Phone Number: 865-974-3752
- Email: kipwebster@utk.edu
Study Contact Backup
- Name: Dawn Coe, PhD
- Phone Number: 865-974-0294
- Email: dcoe@utk.edu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: COSMIC
mHealth intervention
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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
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
|
Measured at three time points: enrollment (Week 0), end of intervention (Week 12), and 12-week retention (Week 24)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parent implementation fidelity using the COSMIC app
Time Frame: Measured throughout the duration of the intervention (12 weeks)
|
The percentage of instructional videos watched by the parent, and the percentage of possible activity breaks marked as completed
|
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)
|
Assessed using an ActiGraph GT3X-BT accelerometer worn for 7-days on the right hip at all times except sleeping, swimming, and bathing
|
Measured at three time points: enrollment (Week 0), end of intervention (Week 12), and 12-week retention (Week 24)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00000124
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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