N/A
N=46
The Effect of Play on Social and Motor Skills of Children With ASD
Autism Spectrum Disorder
Bottom Line
View on ClinicalTrials.gov: NCT04258254 ↗Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcome: Primary: Bruininks-Oseretsky Test of Motor Proficiency-Second Edition (BOT-2) — 36.4; 36.9; 36.5; 40.9 score on a scale BOT-2
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Multimodal (Behavioral); General (Behavioral); Standard of Care (Behavioral)
- Age
- Pediatric · 5+ yrs
- Sex
- All
- Sponsor
- University of Delaware
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bruininks-Oseretsky Test of Motor Proficiency-Second Edition (BOT-2) |
36.4; 36.9; 36.5; 40.9; 44.0; 37.7 | — |
| PRIMARY Praxis Subtests of the Sensory Integration and Praxis Testing (SIPT) - Postural Praxis Error |
21.5; 23.1; 22.4; 17.6; 20.1; 17 | — |
| PRIMARY Flanker Task of Executive Functioning (EF) |
3.6; 2.4; 2.1; 2.4; 1.8; 1.9 | — |
| PRIMARY Synchrony Errors During the Rhythmic Synchrony Task |
1.9; 1.9; 2.1; 1.3; 1.4; 2 | — |
| PRIMARY Number of Prosocial Behaviors |
8.4; 9.3; 7.4; 9; 8.6; 8.9 | — |
| SECONDARY 2-Minute Walk Test |
481.9; 416; 471.3; 496.9; 478.9; 497.1 | — |
| SECONDARY Timed-Up & Go Test (TUG) |
7.1; 6.3; 7.3; 6.1; 6.3; 7.3 | — |
| SECONDARY Developmental Coordination Disorder-Questionnaire |
41.3; 44.3; 41.2; 42.9; 48.9; 44.3 | — |
| SECONDARY Sensory Processing Measure (SPM) |
67.4; 68.9; 65; 66.9; 66.3; 64.9 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Children with Autism Spectrum Disorder (ASD) between 5 and 15 years of age
Exclusion Criteria
- Significant hearing or vision impairment
- Significant behavioral problems
- Significant medical (cardiovascular or respiratory), orthopedic, or surgical problems that prevent study participation.
- History of seizures.
- Significant mobility problems that prevent study participation.
Data sourced from ClinicalTrials.gov (NCT04258254). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.