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 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

Participant Flow

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: 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 Number of Baseline Participants		1009	1009	2018
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.

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.
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)

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]

Adverse Events

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
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%)
Serious Adverse Events
	Test Arm	Control Arm
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/1009 (0.00%)	0/1009 (0.00%)
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%)

Limitations and 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.

Results Point of Contact

• 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)

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 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