Clinical Trials Directory

Trials / Completed

CompletedNCT04258254

The Effect of Play on Social and Motor Skills of Children With ASD

A Multisystem, Multimodal Intervention for Children With ASD

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
46 (actual)
Sponsor
University of Delaware · Academic / Other
Sex
All
Age
5 Years – 15 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALMultimodalMultimodal intervention will involve hello songs, warm up mainly involve sensory and stretching games, music time involves playing instruments, moving game involves use of music or songs to move the whole body, yoga involves themes/songs to perform yoga poses, and good bye involves a goodbye song and reflections about the session. In all movement conditions, trainers emphasize complex and multilimb coordination (asymmetrical and ipsi/contralateral movements) and balance.
BEHAVIORALGeneralThe general exercise group will begin with hello games/set up and end with reflections and cleanup. Children will engage in limb and body warmup routines, specific strengthening exercises (single-joint/single-limb/symmetrical), moderate intensity endurance exercises involving various obstacle courses, and a cool down routine.
BEHAVIORALStandard of CareThe seated play group will also begin with hello/icebreaker games and end with goodbye and cleanup. In between, they will read books and review the story line and overall message and engage in fine-motor activities involving building supplies and art-craft.

Timeline

Start date
2020-06-04
Primary completion
2022-05-31
Completion
2022-05-31
First posted
2020-02-06
Last updated
2023-11-21
Results posted
2023-11-21

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04258254. Inclusion in this directory is not an endorsement.