Clinical trial NCT04258254: The Effect of Play on Social and Motor Skills of Children With ASD
Official title: A Multisystem, Multimodal Intervention for Children With ASD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Movement
Play
Social
Communication
Motor
Lead sponsor: University of Delaware
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of General Medical Sciences (NIGMS)
First posted: 2020-02-06
Enrollment: 46
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participating children are matched on age, gender, and level of functioning. Matched pairs will be randomized to a) multimodal or b) general movement or c) standard of care, seated play group.
Primary purpose: TREATMENT

Brief 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.

Detailed description: 46 children with ASD between 5 and 15 years of age will be randomly assigned to the multimodal or general play or seated play groups. Each child will participate in 9 testing sessions (4 pretests, 3 posttests, and 3, 2-month follow-ups) and 8 weeks of multimodal or general intervention between pre-tests and post-tests. In the 8-week phase between the pre- and post-tests, each child will complete group-specific intervention-related activities with the expert clinician twice per week via telehealth or face-to-face interactions. Each session will last for around 1-1.5 hours. If the study aims are achieved, the investigators will validate the use of cortical markers as a treatment response measure. Findings from this research will offer evidence for the use of various movement interventions to promote motor, social communication, and cognitive skills in 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.

Primary outcomes:
measure: Bruininks-Oseretsky Test of Motor Proficiency-Second Edition (BOT-2)
timeFrame: Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test
measure: Praxis Subtests of the Sensory Integration and Praxis Testing (SIPT) - Postural Praxis Error
timeFrame: Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test
measure: Flanker Task of Executive Functioning (EF)
timeFrame: Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test
measure: Synchrony Errors During the Rhythmic Synchrony Task
timeFrame: Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test
measure: Number of Prosocial Behaviors
timeFrame: Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test
Secondary outcomes:
measure: 2-Minute Walk Test
timeFrame: Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test
measure: Timed-Up & Go Test (TUG)
timeFrame: Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test
measure: Developmental Coordination Disorder-Questionnaire
timeFrame: Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test
measure: Sensory Processing Measure (SPM)
timeFrame: Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test
Other outcomes:
measure: Social Communication Questionnaire (SCQ)
timeFrame: In the screening phase after initial contact with researchers
measure: Vineland Adaptive Behavioral Scales (VABS)
timeFrame: In the baseline period
measure: Social Responsiveness Scale-Second Edition (SRS-2)
timeFrame: Only completed once at pretest.
Locations:
city: Newark
country: United States
facility: University of Delaware
state: Delaware
Study officials:
affiliation: University of Delaware
name: Anjana N Bhat, PhD
role: PRINCIPAL_INVESTIGATOR
References: