Do Motor Synchrony Games Improve Self Regulation?

NCT06647693 | Active Not Recruiting

• 1 other identifier: HS-24-110
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Preschool Child; Executive Function (Cognition)

Keywords

Executive Function; Behavioral Self-Regulation; Autism; Preschool child

Outcome Measures

Primary Outcomes (3)

• 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)

  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)

  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.

  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

  Twice weekly for approximately 12 weeks

• Patient reported outcome measures

  Twice weekly for approximately 12 weeks

• BRIEF-P

  Initial and about 12 weeks after (twice)

• Stop latency

  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

Study Arms (3)

First cohort

EXPERIMENTAL

These participants begin the intervention after 6 sessions

Behavioral: Motor Synchrony Games (MSG)

Second cohort

EXPERIMENTAL

These participants enter the intervention after 9 baseline sessions

Behavioral: Motor Synchrony Games (MSG)

Third cohort

EXPERIMENTAL

These participants enter the intervention after 12 baseline sessions (and 3 sessions post-hurricane Helene)

Behavioral: Motor Synchrony Games (MSG)

Interventions

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).

First cohort; Second cohort; Third cohort

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Appalachian State University: lead

Study Sites (1)

Appalachian State University

Boone, North Carolina, 28607, United States

Location

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Investigator and research assistant will not be blind. A second blinded research assistant will complete reliability.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: October 18, 2024
• Study Start: August 23, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: October 21, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.

Locations

US (1)