Preschool ChildMSGNCT06647693
Do Motor Synchrony Games Improve Self Regulation?
A study testing Motor Synchrony Games (MSG) in people with Preschool Child and Executive Function (Cognition), run by Appalachian State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Preschool Child, Executive Function (Cognition)
- What is being tested?
- Motor Synchrony Games (MSG)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2024to Jan 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Enrolled in the preschool classroom
- Express at least one word
- Runs independently
Who cannot join
- Known motor disorder
- Parents report the child cannot hear spoken language
- Parents report the child cannot see person gesturing 10 feet away
Trial locations and contacts
1 site in 1 country.
United States1 site
Appalachian State University
Boone, North Carolina, 28607
About this study
The goal of this study is to determine if progressively more challenging playground games (motor synchrony games) improve executive function in preschool-aged children.
Read the 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 (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.
- Conditions
- Preschool Child, Executive Function (Cognition)
- Being tested
- Motor Synchrony Games (MSG)
- Keywords
- Executive Function, Behavioral Self-Regulation, Autism, Preschool child
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor Synchrony Games (MSG)Behavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| First cohort | Experimental | These participants begin the intervention after 6 sessions Receives: Behavioral: Motor Synchrony Games (MSG) |
| Second cohort | Experimental | These participants enter the intervention after 9 baseline sessions Receives: Behavioral: Motor Synchrony Games (MSG) |
| Third cohort | Experimental | These participants enter the intervention after 12 baseline sessions (and 3 sessions post-hurricane Helene) Receives: Behavioral: Motor Synchrony Games (MSG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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.
Measured: 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)
Secondary outcomes (4)
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.
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start23 Aug 2024
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preschool ChildStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Sequential is the best match for the intervention study model. The primary intervention model is a single case experimental design called a multiple baseline design. The investigators randomized participants into one of three start dates for the beginning of the intervention. Data is taken on a twice weekly basis during the baseline phase and intervention phase. The investigators also will add formal testing upon initial contact, right before intervention, upon completion of intervention procedures, and a follow-up without intervention.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Appalachian State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, George Wolford, Appalachian State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06647693
- Sponsor's protocol ID
- HS-24-110
- Acronym
- MSG
- Status last verified
- Oct 2024
- First submitted
- 16 Oct 2024
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Motor Synchrony Games Improve Self Regulation?
- ClinicalTrials.gov ID
- NCT06647693
- Acronym / sponsor ID
- MSG / HS-24-110
- Conditions
- Preschool Child, Executive Function (Cognition)
- Keywords
- Executive Function, Behavioral Self-Regulation, Autism, Preschool child
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Appalachian State UniversityUniversity, hospital or other
- Study start
- 23 Aug 2024 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 18 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Sequential is the best match for the intervention study model. The primary intervention model is a single case experimental design called a multiple baseline design. The investigators randomized participants into one of three start dates for the beginning of the intervention. Data is taken on a twice weekly basis during the baseline phase and intervention phase. The investigators also will add formal testing upon initial contact, right before intervention, upon completion of intervention procedures, and a follow-up without intervention.
| Arm | Type | Receives |
|---|---|---|
| First cohort | Experimental | Behavioral: Motor Synchrony Games (MSG)These participants begin the intervention after 6 sessions |
| Second cohort | Experimental | Behavioral: Motor Synchrony Games (MSG)These participants enter the intervention after 9 baseline sessions |
| Third cohort | Experimental | Behavioral: Motor Synchrony Games (MSG)These participants enter the intervention after 12 baseline sessions (and 3 sessions post-hurricane Helene) |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Enrolled in the preschool classroom
- Express at least one word
- Runs independently
Key exclusion criteria (3 listed)
- Known motor disorder
- Parents report the child cannot hear spoken language
- Parents report the child cannot see person gesturing 10 feet away
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Behavioural | First cohort, Second cohort, Third cohort |
Primary outcome
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)
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)
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.
4 secondary outcomes
Imitation Score
Time frame: Twice weekly for approximately 12 weeks
Patient reported outcome measures
Time frame: Twice weekly for approximately 12 weeks
BRIEF-P
Time frame: Initial and about 12 weeks after (twice)
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
- Individual participant dataSharing planned: 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.
Related trials for Preschool Child
Not yet recruiting
Effect of AI-Based Image Generation on Children's Ecological Footprint Awareness
Environmental Awareness, Ecological Footprint
Active, not recruiting
A Mobile App to Improve 24-Hour Movement Guideline Adherence in Preschoolers
Healthy, 24-Hour Movement Guidelines
Active, not recruiting
Parent-Educator Action Response
Attention Deficit and Disruptive Behavior Disorders
Recruiting
Distraction Cards Versus Emotion-Regulation Toy Squeezing During Intramuscular Vaccination in Preschool Children
Procedural Pain, Pain-related Fear
Recruiting
Development & Validation of a Life Balance Program for Parents of Preschoolers: A Pilot Study
Parenting Stress, Mental Health
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motor Synchrony Games (MSG) in people with Preschool Child and Executive Function (Cognition), run by Appalachian State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stop and Go Sequence (time frame: Twice weekly for approximately 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2024.