Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06647693
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-10-16
Brief Title:
Do Motor Synchrony Games Improve Self Regulation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Do Motor Synchrony Games Improve Self Regulation
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MSG
Brief Summary:
The goal of this study is to determine if progressively more challenging playground games motor synchrony games improve executive function in preschool-aged children
Detailed Description:
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 eg 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None