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Mental Imagery Therapy for Autism (MITA) - an Early Intervention Computerized Language Training Program for Children With ASD

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ClinicalTrials.gov Identifier: NCT02708290
Recruitment Status : Completed
First Posted : March 15, 2016
Results First Posted : December 20, 2019
Last Update Posted : November 27, 2020
Sponsor:
Information provided by (Responsible Party):
ImagiRation, LLC

Tracking Information
First Submitted Date March 1, 2016
First Posted Date March 15, 2016
Results First Submitted Date September 30, 2019
Results First Posted Date December 20, 2019
Last Update Posted Date November 27, 2020
Study Start Date September 2015
Actual Primary Completion Date July 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 24, 2020)
Improvement of Language as Measured by Autism Therapy Evaluation Checklist (ATEC) and Mental Synthesis Evaluation Checklist (MSEC). [ Time Frame: up to three years, assessed at 3 months intervals ]
Parents complete children's evaluations every three-month. These regular assessments evaluate children over 5 orthogonal subscales. In all subscales a lower score indicates lower severity of ASD symptoms and a higher score indicates more severe symptoms of ASD:
  1. Receptive Language (range: 0 to 40 points; based on MSEC evaluation described in Braverman, J. et.al.)
  2. Expressive Language (range 0 to 28 points; based on ATEC evaluation subscale 1 described in Rimland, B. et al.)
  3. Sociability (range: 0 to 40 points; based on ATEC evaluation subscale 2)
  4. Cognitive Awareness (range: 0 to 36 points; based on ATEC evaluation subscale 3)
  5. Health (range: 0 to 75 points; based on ATEC evaluation subscale 4)
Original Primary Outcome Measures
 (submitted: March 9, 2016)
Reduction of Autism severity as measured by Autism Therapy Evaluation Checklist (ATEC) [ Time Frame: through study completion, an average of 1 year ]
Autism Therapy Evaluation Checklist (ATEC) is completed by parents every three months
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Mental Imagery Therapy for Autism (MITA) - an Early Intervention Computerized Language Training Program for Children With ASD
Official Title Mental Imagery Therapy for Autism (MITA) - an Early Intervention Computerized Language Training Program for Children With ASD
Brief Summary

Mental Imagery Therapy for Autism (MITA) is a unique, early-intervention application for children with Autism Spectrum Disorder (ASD). The app includes bright, interactive puzzles designed to help children learn how to mentally integrate multiple features of an object, an ability that has proven to lead to vast improvements in general learning. Success with MITA puzzles could overtime result in significant improvements in a child's overall development, specifically in the realms of language, attention and visual skills.

SCIENCE BEHIND THE PROJECT:

MITA verbal activities start with simple vocabulary-building exercises and progress towards exercises aimed at higher forms of language, such as noun-adjective combinations, spatial prepositions, recursion, and syntax. For example, a child can be instructed to select the {small/large} {red/ blue/green/orange} ball or to put the cup {on/under/behind/in front of} the table. All exercises are deliberately limited to as few nouns as possible since the aim is not to expand a child's one-word vocabulary, but rather to teach him/her to integrate mental objects in novel ways using active imagination.

MITA nonverbal activities aim to provide the same active imagination training visually through implicit instructions. E.g., a child can be presented with two separate images of a train and a window pattern, and a choice of complete trains. The task is to find the correct complete train and place it into the empty square. This exercise requires not only attending to a variety of different features in both the train and its windows, but also combining two separate pieces into a single image (in other words, mentally integrating separate train parts into a single unified gestalt). As levels progress, the exercises increase in difficulty, requiring attention to more and more features and details. Upon attaining the most difficult levels, the child must attend to as many as eight features simultaneously. Previous results from our studies have demonstrated that children who cannot follow the explicit verbal instruction can often follow an equivalent command implicit in the visual set-up of the puzzle.

As a child progresses through MITA's systematic exercises, he or she is developing the ability to simultaneously attend to a greater number of features, reducing the propensity towards tunnel vision, and thus developing an essential component of language. The ability to mentally build an image based on a combination of multiple features is absolutely necessary for understanding syntax, spatial prepositions and verb tenses.

MITA is designed for early childhood and intended for long-term, daily use. It is designed to be engaging and educational, as well as adaptive and responsive to the individual abilities of each child.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Autism Spectrum Disorder
Condition
  • Autistic Disorder
  • Autism
  • ASD
Intervention Other: MITA Prefrontal Synthesis exercises - each activity adapts to deliver the exercise that is at the exact level of difficulty appropriate for a child at any given point in time

Mental Imagery Therapy for Autism (MITA) is an early-intervention application for children with Autism Spectrum Disorder (ASD). MITA app uses adaptive-learning technologies, with fun, educational exercises that adapt to a child's abilities, resulting in a highly-customized learning experience. The MITA application is available for free in the Apple Store, Google Play, and Amazon App Store.

MITA verbal activities start with simple vocabulary-building exercises and progress toward exercises aimed at higher forms of language, such as noun-adjective combinations, spatial prepositions, recursion, and syntax. All exercises are deliberately limited to as few nouns as possible since the aim is not to expand a child's one-word vocabulary, but rather to teach him/her to integrate mental objects in novel ways by utilizing prefrontal synthesis (PFS). MITA activities outside of the verbal domain aim to provide the same PFS training visually through implicit instructions.

Study Groups/Cohorts
  • Test arm
    The test group included participants who completed more than one thousand exercises and made no more than one error per exercise.
    Intervention: Other: MITA Prefrontal Synthesis exercises - each activity adapts to deliver the exercise that is at the exact level of difficulty appropriate for a child at any given point in time
  • Control arm
    The control group included the rest of participants. The test group participants were matched to the control group by age, gender, expressive language, receptive language, sociability, cognitive awareness, and health at the 1st evaluation.
    Intervention: Other: MITA Prefrontal Synthesis exercises - each activity adapts to deliver the exercise that is at the exact level of difficulty appropriate for a child at any given point in time
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 24, 2020)
6454
Original Estimated Enrollment
 (submitted: March 9, 2016)
10000
Actual Study Completion Date July 1, 2020
Actual Primary Completion Date July 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

Autism Spectrum Disorder

Exclusion Criteria:

none

Sex/Gender
Sexes Eligible for Study: All
Ages 2 Years to 12 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02708290
Other Study ID Numbers MITA001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party ImagiRation, LLC
Study Sponsor ImagiRation, LLC
Collaborators Not Provided
Investigators
Principal Investigator: Dr. Andrey Vyshedskiy, Ph.D. ImagiRation, LLC
PRS Account ImagiRation, LLC
Verification Date November 2020