Skip to main content
Clinical Trials/NCT04258254
NCT04258254
Completed
N/A

A Multisystem, Multimodal Intervention for Children With ASD

University of Delaware1 site in 1 country46 target enrollmentJune 4, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Autism Spectrum Disorder
Sponsor
University of Delaware
Enrollment
46
Locations
1
Primary Endpoint
Flanker Task of Executive Functioning (EF)
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 4, 2020
End Date
May 31, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Flanker Task of Executive Functioning (EF)

Time Frame: Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test

In the EF task data will be collected. Children will completed the response inhibition task using the Flanker test. This involves making decisions about where a group of fish shown on the screen are looking (right or left). Reaction time in msec were calculated for each response and averaged across trials. Lower values of reaction times indicate faster or better responses.

Number of Prosocial Behaviors

Time Frame: Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test

In a structured play task, the tester assessed a child's ability to engage in prosocial behaviors across multiple helping bids to engage the child in helping behaviors (e.g., clean up of pennies, peg, blocks, cards, and dropped pencils). There are no T or standard scores available for this behavioral measure (not a standardized test). Higher number indicates more prosocial behaviors by the child during the helping bids.

Bruininks-Oseretsky Test of Motor Proficiency-Second Edition (BOT-2)

Time Frame: Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test

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 comprised of upper-limb coordination and manual dexterity, and (iv) the fine manual control composite is comprised of fine motor precision and integration. Standard composite scores on the BOT-2 have a Mean=50 and a standard deviation (SD)=10 for body coordination, strength \& agility, manual coordination and fine motor coordination composite domains. Higher standard scores represent a better outcome. Note there are no T-scores as such for BOT-2; the term often used is a standard BOT composite score.

Praxis Subtests of the Sensory Integration and Praxis Testing (SIPT) - Postural Praxis Error

Time Frame: Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test

The praxis subtests of Sensory Integration and Praxis Testing (SIPT) are standardized and normed measures of examining motor coordination, sensory integration, and praxis. Specifically, the investigators are planning to use items from subtest of postural praxis subtest. The praxis subtests will examine a child's ability to generalize the imitation skills to novel actions involved in the SIPT postural praxis subtest. This test provides the number of errors per action copied and a total number of errors. There is no fixed range as such but the scores could range from 0 to 100. There are no T or standard scores available for this subtest. Higher number of errors indicates a poor outcome.

Synchrony Errors During the Rhythmic Synchrony Task

Time Frame: Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test

In the rhythmic synchrony task children will perform social drumming (i.e., move in synchrony with an adult as the child follows the adult's drumming motions). Synchrony errors were coded when the child was not matching with the adult for each movement cycle. Higher number of errors indicate a poor outcome. This was an experimental paradigm, and not a standardize measure. Hence, there are no T-scores to report.

Secondary Outcomes

  • Timed-Up & Go Test (TUG)(Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test)
  • 2-Minute Walk Test(Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test)
  • Developmental Coordination Disorder-Questionnaire(Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test)
  • Sensory Processing Measure (SPM)(Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test)

Study Sites (1)

Loading locations...

Similar Trials