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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02708290
Other study ID # MITA001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2015
Est. completion date July 1, 2020

Study information

Verified date November 2020
Source ImagiRation, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 6454
Est. completion date July 1, 2020
Est. primary completion date July 1, 2020
Accepts healthy volunteers No
Gender All
Age group 2 Years to 12 Years
Eligibility Inclusion Criteria: Autism Spectrum Disorder Exclusion Criteria: none

Study Design


Related Conditions & MeSH terms


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.

Locations

Country Name City State
United States ImagiRation LLC Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
ImagiRation, LLC

Country where clinical trial is conducted

United States, 

References & Publications (3)

Braverman J, Dunn R, Vyshedskiy A. Development of the Mental Synthesis Evaluation Checklist (MSEC): A Parent-Report Tool for Mental Synthesis Ability Assessment in Children with Language Delay. Children (Basel). 2018 May 20;5(5). pii: E62. doi: 10.3390/children5050062. — View Citation

Dunn & Vyshedskiy (2015). Mental Imagery Therapy for Autism (MITA)-an early intervention computerized brain training program for children with ASD. Autism Open Access; 5(3)

Rimland, B. & Edelson, S. Autism Research Institute. Autism Treat. Eval. Checkl. ATEC (1999)

Outcome

Type Measure Description Time frame Safety issue
Primary Improvement of Language as Measured by Autism Therapy Evaluation Checklist (ATEC) and Mental Synthesis Evaluation Checklist (MSEC). 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:
Receptive Language (range: 0 to 40 points; based on MSEC evaluation described in Braverman, J. et.al.)
Expressive Language (range 0 to 28 points; based on ATEC evaluation subscale 1 described in Rimland, B. et al.)
Sociability (range: 0 to 40 points; based on ATEC evaluation subscale 2)
Cognitive Awareness (range: 0 to 36 points; based on ATEC evaluation subscale 3)
Health (range: 0 to 75 points; based on ATEC evaluation subscale 4)
up to three years, assessed at 3 months intervals
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