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Active, Not Recruiting

NCT Number: NCT06647693

Do Motor Synchrony Games Improve Self Regulation?

The goal of this study is to determine if progressively more challenging playground games (motor synchrony games) improve executive function in preschool-aged children.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Preschool Child Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Executive Function (Cognition) Mental Disorders Neurodevelopmental Disorders

Age range

2 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Appalachian State University

Boone, North Carolina, 28607, United States

About this study

Self-regulation (SR) skills in early childhood predict later academic achievement and protect against developing internalizing and externalizing problems such as depressive symptoms or aggressive behavior (McClelland et al., 2019; Robson et al., 2020). One way to target SR skills is to use a program that involves motor synchrony games (e.g., musical freeze) (Gibb et al., 2021; McClelland et al., 2019; Zelazo et al., 2018). This study seeks to implement a similar motor synchrony games protocol in mixed ability groups to target SR. The investigators plan to use a multiple baseline design, a type of single case experimental design, to characterize the growth for individual participants.

The specific aims are as follows:

Aim 1: To determine if targeted motor synchrony games can achieve an increase in SR.

Aim 2: To examine how individual participants, including those with and without disabilities, respond to the protocol.

(Protocol modified in October:) Aim 3: Determine if hurricane Helene impacted the self-regulation of participants

Schedule: During the study, participants will begin baseline procedures twice a week for (approximately) 6, 9, 12 sessions (12 session group must have 3 sessions post-hurricane Helene). Afterwards, the participants will start the intervention. During baseline and intervention, the investigators measure their completion of a progressively more challenging stop and go task and imitations as the repeated measure. This procedure reflects a multiple baseline design.

As an exploratory analysis, all enrolled participants will complete assessments at 5 times: initial time point, before starting intervention, after hurricane Helene, after intervention procedures complete, and 2 months follow-up. (Post-hurricane data point was added due to the ~3 week shut down that disrupted the study in October. Parents could opt-out of these specific procedures.)

Intervention procedures: In the intervention period, participants will join the investigators in intervention sessions that last approximately 20-25 minutes and will involve rhythm and motor games or activities. All games are designed to have aspects of synchronous movement but should be fun and developmentally appropriate.

Following completion of the intervention, the investigators will graph the results for visual inspection of the stop and go and imitation data. The investigators also will calculate Tau-U statistics (including correcting for baseline trend).

The investigators plan to use the other assessment measures in two ways: the investigators will use an ANOVA to determine if there were significant differences between assessment time points. The investigators also will use a regression to account for the actual time that has passed.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Enrolled in the preschool classroom
  • Express at least one word
  • Runs independently

Exclusion criteria

  • Known motor disorder
  • Parents report the child cannot hear spoken language
  • Parents report the child cannot see person gesturing 10 feet away

Treatment and study plan

Motor Synchrony Games (MSG)

Behavioral

The motor synchrony games (MSG) intervention uses fun but progressively more challenging gross motor and imitation games to promote behavioral self-regulation. Primary activities include: songs and fingerplays, stop and go games, and imitation games. These games get progressively more challenging over time by varying signal/modality. For example, going from a verbal and gestural paired "stop" and "go" signal to only a gestural stop signal. A fidelity checklist is used to ensure the intervention is appropriately used with the following criteria (uses >10 imitation trials, >10 Stop & Go games, >3 trials/min on average with >5 trials/min preferred, use of progressive challenge, opportunities for Child Choice, environmental arrangement, and therapeutic strategies such as modeling).

Primary outcomes

  1. Stop and Go Sequence

    Time frame: Twice weekly for approximately 12 weeks

    Participants are asked to "stop" and then "go" in progressively more challenging ways. The purpose is to measure self-regulation (specifically the inhibition executive function ability)

  2. NIH Toolbox

    Time frame: Implemented 5 times - initial evaluation, before beginning intervention (~6, 9, or 12 sessions), post-hurricane Helene, approximately 12 weeks after initial evaluation, approximately 2 month follow-up)

    Card Sort & Picture Vocabulary. The purpose is to measure behavioral self-regulation / executive function (Card Sort) and also language (Picture Vocabulary)

  3. Head, Toes, Knees, Shoulders - Revised

    Time frame: Implemented 5 times - initial evaluation, before beginning intervention (~6, 9, or 12 sessions), post-hurricane Helene, approximately 12 weeks after initial evaluation, approximately 2 month follow-up)

    HTKS-R (Gonzales, 2021). The purpose is to measure behavioral self-regulation.

Secondary outcomes

  1. Imitation Score

    Time frame: Twice weekly for approximately 12 weeks

    Three trials of imitation. Scored as 2 - immediate and correct imitation, 1 - partial or delayed imitation, 0 - no imitation (for ~2 seconds). The purpose is to measure imitation/synchrony.

  2. Patient reported outcome measures

    Time frame: Twice weekly for approximately 12 weeks

    Participants are asked each time if the intervention or baseline session was "fun," "not fun," "ok," or "sad". The purpose is to measure how the participants felt about the intervention and/or screen for unexpected results (e.g., all participants suddenly saying "sad" after a session)

  3. BRIEF-P

    Time frame: Initial and about 12 weeks after (twice)

    Classroom teachers will complete the BRIEF-P. The purpose is to triangulate measurements of behavioral self-regulation / executive function

  4. Stop latency

    Time frame: The investigators had initially planned four times (initial, after baseline, about 12 weeks after, and the two 2 month follow up), but due to mat availability, the investigators are only going to complete this outcome measure twice

    Using the Zeno Walkway system, the investigators will measure the latency in the participant's stops between when participants hear a beep signal and when participants stop

Sponsors and collaborators

Lead sponsor

Appalachian State University

Other

Registry information

Acronym: MSG

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 18, 2024
Registry last updated
Oct 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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