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Mental Imagery Therapy for Autism (MITA) - an Early Intervention Computerized Brain 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 : December 20, 2019
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 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
Enrollment 8766
Recruitment Details  
Pre-assignment Details

MITA was made available gratis at all app stores from 2016 to 2019.

From this pool of potential study participants, we selected participants based on the following criteria:

  1. Consistency: at least three ATEC evaluations six months apart.
  2. Diagnosis: ASD.
  3. Max. age: 12
  4. Min. age: 2
  5. Min. ATEC severity: 20
  6. Language: English
Arm/Group Title Test Arm: Children Who Worked With MITA for 6 Months or Longer Control Arm: Children Who Did Not Use MITA Intervention
Hide Arm/Group Description

All caregivers of ASD children were encouraged to use free MITA imagination exercises for as long as possible. Those participants who used MITA for at least six months were included into the test group.

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.

Autism Treatment Evaluation Checklists (ATEC) responses were collected by the Autism Institute from participants voluntarily completing online ATEC evaluations from 2013 to 2019 21. It is unlikely that many of them used MITA. Accordingly, these participants served as a ‘treatment as usual’ control (TaU group).
Period Title: Overall Study
Started 3540 5226
Completed 3540 5226
Not Completed 0 0
Arm/Group Title Test Arm: Participants Who Work With MITA for 6 Months+ Control Arm: Children Who do Not Use MITA Total
Hide Arm/Group Description

All caregivers of ASD children are encouraged to use free MITA imagination exercises for as long as possible. Those participants who used MITA for at least six months are included into the test group.

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.

Autism Treatment Evaluation Checklists (ATEC) responses were collected by the Autism Institute from participants voluntarily completing online ATEC evaluations from 2013 to 2019 21. It is unlikely that many of them used MITA. Accordingly, these participants served as a ‘treatment as usual’ control (TaU group). Total of all reporting groups
Overall Number of Baseline Participants 3540 5226 8766
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
2-5 years of age Number Analyzed 3540 participants 5226 participants 8766 participants
2614
  73.8%
2558
  48.9%
5172
  59.0%
5-12 years of age Number Analyzed 3540 participants 5226 participants 8766 participants
926
  26.2%
2668
  51.1%
3594
  41.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3540 participants 5226 participants 8766 participants
Female
760
  21.5%
958
  18.3%
1718
  19.6%
Male
2780
  78.5%
4268
  81.7%
7048
  80.4%
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 Reduction of Autism Severity as Measured by Autism Therapy Evaluation Checklist (ATEC). Reference: Rimland, B. & Edelson, S. Autism Research Institute. Autism Treat. Eval. Checkl. ATEC (1999)
Hide Description Autism Therapy Evaluation Checklist (ATEC) is completed by parents every three months. ATEC is comprised of four subscales: 1) Speech/Language/Communication, 2) Sociability, 3) Sensory/Cognitive Awareness, and 4) Physical/Health/Behavior. The first subscale, Speech/Language/Communication, contains 14 items and its score ranges from 0 to 28 points. The Sociability subscale contains 20 items within a score range from 0 to 40 points. The third subscale, Sensory/Cognitive awareness, has 18 items and scores range from 0 to 36 points. Finally, the Health/Physical/Behavior subscale contains 25 items and scores range from 0 to 75 points. The scores from each subscale are combined in order to calculate a Total Score, which ranges from 0 to 179 points. A lower score indicates lower severity of ASD symptoms and a higher score correlates with more severe symptoms of ASD.
Time Frame up to three years, assessed at 3 months intervals
Hide Outcome Measure Data
Hide Analysis Population Description
The framework for evaluation of ATEC 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: Children Age 2-5 Who Worked With MITA for 6 Months+ Control Arm: Children Age 2-5, Who Did Not Use MITA Test Arm: Children Age 5-12 Who Worked With MITA for 6 Months+ Control Arm: Children Age 5-12, Who Did Not Use MITA
Hide Arm/Group Description:

All caregivers of ASD children were encouraged to use free MITA imagination exercises for as long as possible. Those participants who used MITA for at least six months were included into the test group.

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.

Autism Treatment Evaluation Checklists (ATEC) responses were collected by the Autism Institute from participants voluntarily completing online ATEC evaluations from 2013 to 2019. It is unlikely that many of them used MITA. Accordingly, these participants served as a ‘treatment as usual’ control (TaU group).

All caregivers of ASD children were encouraged to use free MITA imagination exercises for as long as possible. Those participants who used MITA for at least six months were included into the test group.

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.

Autism Treatment Evaluation Checklists (ATEC) responses were collected by the Autism Institute from participants voluntarily completing online ATEC evaluations from 2013 to 2019. It is unlikely that many of them used MITA. Accordingly, these participants served as a ‘treatment as usual’ control (TaU group).
Overall Number of Participants Analyzed 2614 2558 926 2668
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Language improvement: three years - baseline
8.64
(8.17 to 9.11)
2.88
(2.34 to 3.42)
3.27
(2.41 to 4.13)
2.41
(2.13 to 2.69)
Sociability improvement: three years - baseline
3.76
(3.11 to 4.41)
2.05
(1.30 to 2.80)
0.72
(-0.47 to 1.91)
2.04
(1.65 to 2.43)
Cognitive Awareness improvement: 3 years -baseline
4.62
(4.04 to 5.20)
4.47
(3.81 to 5.13)
1.27
(0.21 to 2.33)
2.5
(2.15 to 2.85)
Health improvement: three years - baseline
1.54
(0.53 to 2.55)
3.43
(2.26 to 4.60)
-0.84
(-2.7 to 1.02)
3.7
(3.09 to 4.31)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test Arm: Children Age 2-5 Who Worked With MITA for 6 Months+, Control Arm: Children Age 2-5, Who Did Not Use MITA, Test Arm: Children Age 5-12 Who Worked With MITA for 6 Months+, Control Arm: Children Age 5-12, Who Did Not Use MITA
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 469 day
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Test Arm: Participants Who Work With MITA for 6 Months+ Control Arm: Children Who do Not Use MITA
Hide Arm/Group Description

All caregivers of ASD children are encouraged to use free MITA imagination exercises for as long as possible. Those participants who used MITA for at least six months are included into the test group.

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.

Autism Treatment Evaluation Checklists (ATEC) responses were collected by the Autism Institute from participants voluntarily completing online ATEC evaluations from 2013 to 2019 21. It is unlikely that many of them used MITA. Accordingly, these participants served as a ‘treatment as usual’ control (TaU group).
All-Cause Mortality
Test Arm: Participants Who Work With MITA for 6 Months+ Control Arm: Children Who do Not Use MITA
Affected / at Risk (%) Affected / at Risk (%)
Total   0/3540 (0.00%)   0/5226 (0.00%) 
Hide Serious Adverse Events
Test Arm: Participants Who Work With MITA for 6 Months+ Control Arm: Children Who do Not Use MITA
Affected / at Risk (%) Affected / at Risk (%)
Total   0/3540 (0.00%)   0/5226 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Test Arm: Participants Who Work With MITA for 6 Months+ Control Arm: Children Who do Not Use MITA
Affected / at Risk (%) Affected / at Risk (%)
Total   0/3540 (0.00%)   0/5226 (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)
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: December 20, 2019