An interventional study of Motor Synchrony Games (MSG) in Preschool Child and Executive Function (Cognition), sponsored by Appalachian State University. Active, not recruiting at 1 site in United States. Open to participants aged 2 Years to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-21.
Sponsored by Appalachian State University · Not applicable, Interventional, and Treatment
The goal of this study is to determine if progressively more challenging playground games (motor synchrony games) improve executive function in preschool-aged children.
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.
1,030 studies on the registry are indexed under Autistic Disorder; 266 are open to participants now.
This study's enrollment of 24 is below the median of 49 across 811 interventional studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →Appalachian State University is the lead sponsor of 41 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
These participants begin the intervention after 6 sessions
Behavioral: Motor Synchrony Games (MSG)
These participants enter the intervention after 9 baseline sessions
Behavioral: Motor Synchrony Games (MSG)
These participants enter the intervention after 12 baseline sessions (and 3 sessions post-hurricane Helene)
Behavioral: Motor Synchrony Games (MSG)
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).
Stop and Go Sequence
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)
Time frame: Twice weekly for approximately 12 weeks
NIH Toolbox
Card Sort \& Picture Vocabulary. The purpose is to measure behavioral self-regulation / executive function (Card Sort) and also language (Picture Vocabulary)
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)
Head, Toes, Knees, Shoulders - Revised
HTKS-R (Gonzales, 2021). The purpose is to measure behavioral self-regulation.
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)
Imitation Score
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.
Time frame: Twice weekly for approximately 12 weeks
Patient reported outcome measures
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)
Time frame: Twice weekly for approximately 12 weeks
BRIEF-P
Classroom teachers will complete the BRIEF-P. The purpose is to triangulate measurements of behavioral self-regulation / executive function
Time frame: Initial and about 12 weeks after (twice)
Stop latency
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
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
Plan to share: Yes — De-identified data and outcome measures will be available on OSF ( https://osf.io/ ) following the completion of the study. The investigators plan to amend this record to add that link once present. Some data may be shared directly in a future manuscript.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Data will be available within approximately a year after collection or pending publication.
Access criteria: The data should be available on OSF and publicly available.
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Appalachian State University