Mental Imagery Therapy for Autism (MITA) - an Early Intervention Computerized Brain 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: December 20, 2019
• 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 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

Participant Flow

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: Consistency: at least three ATEC evaluations six months apart.; Diagnosis: ASD.; Max. age: 12; Min. age: 2; Min. ATEC severity: 20; 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
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

Baseline Characteristics

Arm/Group Title		Test Arm: Participants Who Work With MITA for 6 Months+	Control Arm: Children Who do Not Use MITA	Total
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
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.

Outcome Measures

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)
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

Outcome Measure Data

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
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)

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]

Adverse Events

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
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%)
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%)
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%)

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)

• 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