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

• 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: ImagiRation, LLC
• Information provided by (Responsible Party): ImagiRation, LLC

Study Description

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.

Condition or disease	Intervention/treatment
Autistic Disorder; Autism; ASD	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

Study Design

• Study Type: Observational
• Actual Enrollment: 6454 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Mental Imagery Therapy for Autism (MITA) - an Early Intervention Computerized Language Training Program for Children With ASD
• Study Start Date: September 2015
• Actual Primary Completion Date: July 1, 2020
• Actual Study Completion Date: July 1, 2020

Groups and Cohorts

Group/Cohort	Intervention/treatment
Test arm; The test group included participants who completed more than one thousand exercises and made no more than one error per exercise.	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.
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.	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.

Outcome Measures

Primary Outcome Measures :

1. 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)

Eligibility Criteria

• Ages Eligible for Study: 2 Years to 12 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Autism Spectrum Disorder

Criteria

Inclusion Criteria:

Autism Spectrum Disorder

Exclusion Criteria:

none

Contacts and Locations

Locations

United States, Massachusetts

ImagiRation LLC

Boston, Massachusetts, United States, 02135

Sponsors and Collaborators

ImagiRation, LLC

Investigators

• Principal Investigator: Dr. Andrey Vyshedskiy, Ph.D.; ImagiRation, LLC

  Study Documents (Full-Text)

Documents provided by ImagiRation, LLC:

Study Protocol and Statistical Analysis Plan  [PDF] September 30, 2019

More Information

Additional Information:

ImagiRation website with links to MITA download 

A peer-reviewed article describing MITA 

MITA download for iPad and iPhone 

MITA download for Amazon Kindle Fire 

MITA download for Android tablet or smartphone 

MITA FAQs 

MITA Testimonials 

MITA News 

Publications:

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)

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.

• Responsible Party: ImagiRation, LLC
• ClinicalTrials.gov Identifier: NCT02708290
• Other Study ID Numbers: MITA001
• First Posted: March 15, 2016
• Results First Posted: December 20, 2019
• Last Update Posted: November 27, 2020
• Last Verified: November 2020

Additional relevant MeSH terms:

Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders