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Influence of a Parent-mediated mHealth Motor Skill Intervention on Preschool Children's Motor Skills and Cognitive Function (COSMIC)

25 giugno 2026 aggiornato da: University of Tennessee
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.

Panoramica dello studio

Stato

Non ancora reclutamento

Intervento / Trattamento

Descrizione dettagliata

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)

  1. 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.
  2. 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.
  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.
  4. 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.
  5. 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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

35

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

  • Nome: Dawn Coe, PhD
  • Numero di telefono: 865-974-0294
  • Email: dcoe@utk.edu

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino

Accetta volontari sani

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Altri nomi:
  • PLAY App

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in executive functioning skills based on COSMIC intervention
Lasso di tempo: 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
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Parent implementation fidelity using the COSMIC app
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

30 giugno 2026

Completamento primario (Stimato)

30 giugno 2027

Completamento dello studio (Stimato)

30 giugno 2027

Date di iscrizione allo studio

Primo inviato

25 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

25 giugno 2026

Primo Inserito (Effettivo)

2 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

2 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

25 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • STUDY00000124

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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