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

Sponsor
ImagiRation, LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT02708290
Collaborator
(none)
6,454
1
58
111.3

Study Details

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 Phase
  • 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 :
Sep 1, 2015
Actual Primary Completion Date :
Jul 1, 2020
Actual Study Completion Date :
Jul 1, 2020

Arms and Interventions

Arm 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). [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: 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

Autism Spectrum Disorder

Exclusion Criteria:

none

Contacts and Locations

Locations

Site City State Country Postal Code
1 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)

More Information

Additional Information:

Publications

Responsible Party:
ImagiRation, LLC
ClinicalTrials.gov Identifier:
NCT02708290
Other Study ID Numbers:
  • MITA001
First Posted:
Mar 15, 2016
Last Update Posted:
Nov 27, 2020
Last Verified:
Nov 1, 2020
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail 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: Consistency: at least three ATEC evaluations completed. The interval between the first and the last evaluation was six months or longer. Diagnosis: ASD Age: 2 to 12 years This resulted in 6454 participants, from whom we have selected the test and control groups
Arm/Group Title Test Arm: Completed More Than One Thousand Exercises Control Arm: the Rest of Participants
Arm/Group Description The test group (assigned at the end of the three-year study) included participants who demonstrated engagement with the intervention by completing more than one thousand MITA exercises and making 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. The control group (assigned at the end of the three-year study) included the participants matched by age, gender, expressive language, receptive language, sociability, cognitive awareness, and health score at the 1st evaluation to the test group participants. The participants that were not matched to the test group were not included into the comparison between the groups.
Period Title: Overall Study
STARTED 1009 1009
COMPLETED 1009 1009
NOT COMPLETED 0 0

Baseline Characteristics

Arm/Group Title Test Arm Control Arm Total
Arm/Group Description 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. 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. Total of all reporting groups
Overall Participants 1009 1009 2018
Age, Customized (Count of Participants)
Count of Participants [Participants]
1009
100%
1009
100%
2018
100%
Sex: Female, Male (Count of Participants)
Female
262
26%
252
25%
514
25.5%
Male
747
74%
757
75%
1504
74.5%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]
0
0%

Outcome Measures

1. Primary Outcome
Title Improvement of Language as Measured by Autism Therapy Evaluation Checklist (ATEC) and Mental Synthesis Evaluation Checklist (MSEC).
Description 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)
Time Frame up to three years, assessed at 3 months intervals

Outcome Measure Data

Analysis Population Description
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/Group Title Test Arm Control Arm
Arm/Group Description The test group included participants who completed more than one thousand 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. 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.
Measure Participants 1009 1009
Receptive Language improvement over 3 years
8.49
(0.65)
4.87
(0.85)
Expressive Language improvement over three years
5.03
(0.43)
3.53
(0.57)
Sociability improvement over 3 years
1.88
(0.59)
0.72
(0.78)
Cognitive Awareness improvement over 3 years
2.43
(0.52)
2.19
(0.68)
Health improvement over 3 years
1.68
(0.94)
1.38
(1.23)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test Arm, Control Arm
Comments 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.
Type of Statistical Test Other
Comments Participants in the MITA group were matched to those in Control (treatment-as-usual) group using propensity score analysis based on age and all four ATEC subscales at baseline. Least squares means were calculated for all subscales at all visits.
Statistical Test of Hypothesis p-Value <0.0001
Comments
Method Regression, Linear
Comments
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.68
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type:
Value:
Estimation Comments

Adverse Events

Time Frame Up to 3 years 6 months, on average 481 days
Adverse Event Reporting Description
Arm/Group Title Test Arm Control Arm
Arm/Group Description The test group included participants who completed more than one thousand 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. 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.
All Cause Mortality
Test Arm Control Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/1009 (0%) 0/1009 (0%)
Serious Adverse Events
Test Arm Control Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/1009 (0%) 0/1009 (0%)
Other (Not Including Serious) Adverse Events
Test Arm Control Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/1009 (0%) 0/1009 (0%)

Limitations/Caveats

The observational design of this study cannot definitively prove causality since unknown confounders may influence the study results.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Dr. Andrey Vyshedskiy, Founder
Organization ImagiRation LLC
Phone 6174338577
Email vysha@bu.edu
Responsible Party:
ImagiRation, LLC
ClinicalTrials.gov Identifier:
NCT02708290
Other Study ID Numbers:
  • MITA001
First Posted:
Mar 15, 2016
Last Update Posted:
Nov 27, 2020
Last Verified:
Nov 1, 2020