Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
24 participants
INTERVENTIONAL
2024-08-23
2025-01-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
SINGLE
Study Groups
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First cohort
These participants begin the intervention after 6 sessions
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).
Second cohort
These participants enter the intervention after 9 baseline sessions
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).
Third cohort
These participants enter the intervention after 12 baseline sessions (and 3 sessions post-hurricane Helene)
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* Express at least one word
* Runs independently
Exclusion Criteria
* Parents report the child cannot hear spoken language
* Parents report the child cannot see person gesturing 10 feet away
2 Years
5 Years
ALL
Yes
Sponsors
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Appalachian State University
OTHER
Responsible Party
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George Wolford
Assistant Professor
Locations
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Appalachian State University
Boone, North Carolina, United States
Countries
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Other Identifiers
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HS-24-110
Identifier Type: -
Identifier Source: org_study_id
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