Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Conditions 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
Enrollment 6454
Recruitment Details  
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

Arm/Group Title Test Arm: Completed More Than One Thousand Exercises Control Arm: the Rest of Participants
Hide 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
Arm/Group Title Test Arm Control Arm Total
Hide 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 Number of Baseline Participants 1009 1009 2018
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1009 participants 1009 participants 2018 participants
1009
 100.0%
1009
 100.0%
2018
 100.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1009 participants 1009 participants 2018 participants
Female
262
  26.0%
252
  25.0%
514
  25.5%
Male
747
  74.0%
757
  75.0%
1504
  74.5%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
1.Primary Outcome
Title Improvement of Language as Measured by Autism Therapy Evaluation Checklist (ATEC) and Mental Synthesis Evaluation Checklist (MSEC).
Hide 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:

  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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 1009 1009
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
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)
Hide 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 [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.68
Estimation Comments [Not Specified]
Time Frame Up to 3 years 6 months, on average 481 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Test Arm Control Arm
Hide 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 (%) Affected / at Risk (%)
Total   0/1009 (0.00%)   0/1009 (0.00%) 
Hide Serious Adverse Events
Test Arm Control Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1009 (0.00%)   0/1009 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Test Arm Control Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1009 (0.00%)   0/1009 (0.00%) 
The observational design of this study cannot definitively prove causality since unknown confounders may influence the study results.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Andrey Vyshedskiy, Founder
Organization: ImagiRation LLC
Phone: 6174338577
EMail: vysha@bu.edu
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)
Layout table for additonal information
Responsible Party: ImagiRation, LLC
ClinicalTrials.gov Identifier: NCT02708290    
Other Study ID Numbers: MITA001
First Submitted: March 1, 2016
First Posted: March 15, 2016
Results First Submitted: September 30, 2019
Results First Posted: December 20, 2019
Last Update Posted: November 27, 2020