NCT03254992

Brief Summary

Individuals with Autism Spectrum Disorder (ASD) are known to have difficulty with socio-communicative functioning and restricted or repetitive behaviors or interests, and there is considerable evidence that the majority also struggle with associated emotional problems. Speech is typically delayed or may regress, comprehension is impaired, if not at the word level, then at the level of sentences, nonverbal and verbal language are affected, and pretend play is delayed or absent, some children are nonverbal or have sparse, impoverished, poorly articulated, and grammatical speech. Objective: To assess in which interface has ASD best performance or functionality. Method: Will be evaluated 100 individuals divided into two groups: 50 individuals with diagnosis of Autistic Spectrum Disorder (ASD-group), aged 7 to 15 years old, males and females; and 50 individuals with typical development (TD-group) matched by age and sex to the ASD-group. Individuals with comorbidities and functional disabilities that would impede the completion of the task were excluded.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 2, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 21, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2017

Completed
Last Updated

November 27, 2017

Status Verified

November 1, 2017

Enrollment Period

12 months

First QC Date

June 1, 2017

Last Update Submit

November 22, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in performance, measured by coincident timing task

    The participants who will perform the abstract task first, will present decrease on performance, measured by the coincident timing task.

    1 day

Study Arms (4)

ASD - Abstract task

EXPERIMENTAL

Experimental group using Kinect with more virtual activity.

Device: ASD - Abstract task

ASD - Tangible task

EXPERIMENTAL

Experimental group using Keyboard with more real activity.

Device: ASD - Tangible task

TD - Abstract task

ACTIVE COMPARATOR

Control group using Kinect with more virtual activity.

Device: TD - Abstract task

TD - Tangible task

ACTIVE COMPARATOR

Control group using Keyboard with more real activity.

Device: TD - Tangible task

Interventions

Experimental group using Kinect with more virtual activity.

ASD - Abstract task

Experimental group using Keyboard with more real activity.

ASD - Tangible task

Control group using Kinect with more virtual activity.

TD - Abstract task

Control group using Keyboard with more real activity.

TD - Tangible task

Eligibility Criteria

Age7 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • need to understand the task, assessed by the ability to properly perform three attempts explanatory statement by the evaluator.

You may not qualify if:

  • of incomprehension.
  • no completion of the task.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Escola de Artes,Ciencias e Humanidades da Universidade d Sao Paulo

São Paulo, 03828-000, Brazil

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Carlos BM Monteiro, Ph.D.

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 1, 2017

First Posted

August 21, 2017

Study Start

November 2, 2016

Primary Completion

October 20, 2017

Study Completion

November 20, 2017

Last Updated

November 27, 2017

Record last verified: 2017-11

Locations