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NCT04258254 · ClinicalTrials.gov registry record · NA
The Effect of Play on Social and Motor Skills of Children With ASD
A NA study, sponsored by University of Delaware.
- Completed
- Registry status
- NA
- Development phase
- 46
- Enrollment target
NCT04258254: Completed NA study, sponsored by University of Delaware.
NCT04258254 is a NA study that has completed, run by University of Delaware. The registered enrollment target is 46 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04258254, a NA study, has completed, sponsored by University of Delaware.
- COMPLETED
- Registry status
- NA
- Development phase
- 46 participants
- Enrollment target
Study Summary
In this study, the investigators will compare effects of two types of 8-weeklong interventions: a) multimodal or b) general movement to facilitate social communication and motor skills of school-age children with Autism Spectrum Disorder (ASD). Recently, the investigators have identified cortical dysfunction patterns as markers of imitation/interpersonal synchrony difficulties in children with ASD using functional near-infrared spectroscopy. In this project, the investigators want to validate whether cortical markers can determine treatment responders and if such markers are sensitive to training-related changes. Following training, the investigators expect to see a variety of behavioral and neural changes in both groups. If the study aims are achieved, the investigators will validate the use of cortical markers as a treatment response measure. This research will build evidence for the use of various movement interventions for school-age children with ASD.
Primary Outcome
The 3 gross motor coordination and 1 fine manual control composite of the Bruininks-Oseretsky Test of Motor Proficiency-Second Edition (BOT-2) were administered as a measure of gross and fine motor coordination at each time point. BOT-2 standard scores will be reported for each composite: (i) body coordination composite comprises of balance and bilateral coordination, (ii) the strength/agility composite is comprised of running speed and agility, (iii) upper-limb coordination composite is compris
Interventions
- BEHAVIORAL Standard of Care
- BEHAVIORAL General
- BEHAVIORAL Multimodal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2020-06-04 |
| Est. Completion | 2022-05-31 |
| Phase | NA |
What the finished NCT04258254 record still lists
NCT04258254 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 3 interventions - of which Standard of Care is the first listed.
NCT04258254 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04258254 about?
NCT04258254 is a clinical study titled "The Effect of Play on Social and Motor Skills of Children With ASD". In this study, the investigators will compare effects of two types of 8-weeklong interventions: a) multimodal or b) general movement to facilitate social communication and motor skills of school-age children with Autism Spectrum Disorder (ASD). Recently, the investigators have identified cortical dy...
What is the current status of trial NCT04258254?
This trial is currently completed. It is a NA study. The enrollment target is 46 participants. The study started on 2020-06-04. Estimated completion is 2022-05-31.
What interventions are being tested in trial NCT04258254?
The interventions under investigation include: Standard of Care (BEHAVIORAL), General (BEHAVIORAL), Multimodal (BEHAVIORAL).
Who is sponsoring clinical trial NCT04258254?
This trial is sponsored by University of Delaware, which has 106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04258254's enrollment target sits among peer trials
46 1402nd of 2000 higher than 590 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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