ASD, Autism, Autistic Disorder
Conditions
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.
Interventions
OTHERMITA 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.
Sponsors
ImagiRation, LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
Autism Spectrum Disorder
Exclusion criteria
none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of Language as Measured by Autism Therapy Evaluation Checklist (ATEC) and Mental Synthesis Evaluation Checklist (MSEC). | 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) |
Countries
United States
Participant flow
Pre-assignment details
MITA was made available gratis at all app stores from 2015 to 2020. From this pool of potential study participants, we selected participants for the observation clinical study based on the following criteria: 1. Consistency: at least three ATEC evaluations completed. 2. The interval between the first and the last evaluation was six months or longer. 3. Diagnosis: ASD 4. Age: 2 to 12 years This resulted in 6454 participants, from whom we have selected the test and control groups
Participants by arm
| Arm | Count |
|---|---|
| Test Arm The test group included participants who completed more than one thousand MITA exercises and made no more than one error per exercise.
MITA imagination 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. | 1,009 |
| 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. | 1,009 |
| Total | 2,018 |
Baseline characteristics
| Characteristic | Test Arm | Control Arm | Total |
|---|---|---|---|
| Age, Customized | 1009 Participants | 1009 Participants | 2018 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 262 Participants | 252 Participants | 514 Participants |
| Sex: Female, Male Male | 747 Participants | 757 Participants | 1504 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1,009 | 0 / 1,009 |
| other Total, other adverse events | 0 / 1,009 | 0 / 1,009 |
| serious Total, serious adverse events | 0 / 1,009 | 0 / 1,009 |
Outcome results
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: 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)
Time frame: up to three years, assessed at 3 months intervals
Population: The framework for evaluation of score changes over time was explained in Mahapatra et al. Autism Dev Disord, 2018. In short, changes in the score were modeled by applying the Linear Model with repeated measures. Least squares means differences generated by the model are reported below. Participants were matched using propensity score analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Test Arm | Improvement of Language as Measured by Autism Therapy Evaluation Checklist (ATEC) and Mental Synthesis Evaluation Checklist (MSEC). | Expressive Language improvement over three years | 5.03 units on a scale | Standard Error 0.43 |
| Test Arm | Improvement of Language as Measured by Autism Therapy Evaluation Checklist (ATEC) and Mental Synthesis Evaluation Checklist (MSEC). | Cognitive Awareness improvement over 3 years | 2.43 units on a scale | Standard Error 0.52 |
| Test Arm | Improvement of Language as Measured by Autism Therapy Evaluation Checklist (ATEC) and Mental Synthesis Evaluation Checklist (MSEC). | Sociability improvement over 3 years | 1.88 units on a scale | Standard Error 0.59 |
| Test Arm | Improvement of Language as Measured by Autism Therapy Evaluation Checklist (ATEC) and Mental Synthesis Evaluation Checklist (MSEC). | Health improvement over 3 years | 1.68 units on a scale | Standard Error 0.94 |
| Test Arm | Improvement of Language as Measured by Autism Therapy Evaluation Checklist (ATEC) and Mental Synthesis Evaluation Checklist (MSEC). | Receptive Language improvement over 3 years | 8.49 units on a scale | Standard Error 0.65 |
| Control Arm | Improvement of Language as Measured by Autism Therapy Evaluation Checklist (ATEC) and Mental Synthesis Evaluation Checklist (MSEC). | Health improvement over 3 years | 1.38 units on a scale | Standard Error 1.23 |
| Control Arm | Improvement of Language as Measured by Autism Therapy Evaluation Checklist (ATEC) and Mental Synthesis Evaluation Checklist (MSEC). | Receptive Language improvement over 3 years | 4.87 units on a scale | Standard Error 0.85 |
| Control Arm | Improvement of Language as Measured by Autism Therapy Evaluation Checklist (ATEC) and Mental Synthesis Evaluation Checklist (MSEC). | Expressive Language improvement over three years | 3.53 units on a scale | Standard Error 0.57 |
| Control Arm | Improvement of Language as Measured by Autism Therapy Evaluation Checklist (ATEC) and Mental Synthesis Evaluation Checklist (MSEC). | Sociability improvement over 3 years | 0.72 units on a scale | Standard Error 0.78 |
| Control Arm | Improvement of Language as Measured by Autism Therapy Evaluation Checklist (ATEC) and Mental Synthesis Evaluation Checklist (MSEC). | Cognitive Awareness improvement over 3 years | 2.19 units on a scale | Standard Error 0.68 |
Comparison: The concept of a Visit was developed by dividing the three-year-long observation interval into 3-month periods. All evaluations were mapped into 3-month-long bins (Reference: Mahapatra, S. et al. Autism Dev. Disord. 2018, 1). It was then hypothesized that there was a three-way interaction between an age group, Visit, and treatment. This hypothesis was modeled by applying the Linear Model with repeated measures, where a three-way interaction term was introduced to test the hypothesis.p-value: <0.0001Regression, Linear