CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 46 enrolled
Drug / intervention
Multimodal +2 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04258254
NCT04258254N/ACompleted

A Multisystem, Multimodal Intervention for Children With ASD

University of Delaware·interventional·Posted Feb 6, 2020·Updated Nov 21, 2023

In Brief

A clinical study evaluating Multimodal, General, and 1 other intervention for Autism Spectrum Disorder. Completed, enrolled 46 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedFeb 6, 2020
Enrollment StartJun 4, 2020
Primary CompletionMay 31, 2022
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 6.4 years ago

Interventions

Multimodalbehavioral

Multimodal 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.

Generalbehavioral

The 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.

Standard of Carebehavioral

The 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.