Clinical trial NCT06647693: Do Motor Synchrony Games Improve Self Regulation?
Official title: Do Motor Synchrony Games Improve Self Regulation?
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Preschool Child
Executive Function (Cognition)
Keywords: Executive Function
Behavioral Self-Regulation
Autism
Preschool child
Lead sponsor: Appalachian State University
Sponsor class: OTHER
First posted: 2024-10-18
Enrollment: 24
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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.
Primary purpose: TREATMENT

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 (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.

Eligibility criteria: 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

Primary outcomes:
measure: Stop and Go Sequence
timeFrame: Twice weekly for approximately 12 weeks
measure: NIH Toolbox
timeFrame: 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)
measure: Head, Toes, Knees, Shoulders - Revised
timeFrame: 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:
measure: Imitation Score
timeFrame: Twice weekly for approximately 12 weeks
measure: Patient reported outcome measures
timeFrame: Twice weekly for approximately 12 weeks
measure: BRIEF-P
timeFrame: Initial and about 12 weeks after (twice)
measure: Stop latency
timeFrame: 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
Other outcomes:
Locations:
city: Boone
country: United States
facility: Appalachian State University
state: North Carolina
Study officials:
References: