Trial Outcomes & Findings for Mental Imagery Therapy for Autism (MITA) - an Early Intervention Computerized Language Training Program for Children With ASD (NCT NCT02708290)

Results Overview

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)

Recruitment status

COMPLETED

Target enrollment

6454 participants

Primary outcome timeframe

up to three years, assessed at 3 months intervals

Results posted on

2020-11-27

Participant Flow

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

Participant milestones

Participant milestones
Measure	Test Arm: Completed More Than One Thousand Exercises 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.	Control Arm: the Rest of Participants 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.
Overall Study STARTED	1009	1009
Overall Study COMPLETED	1009	1009
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Test Arm n=1009 Participants 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.	Control Arm n=1009 Participants 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 n=2018 Participants Total of all reporting groups
Age, Customized	1009 Participants n=1009 Participants	1009 Participants n=1009 Participants	2018 Participants n=2018 Participants
Sex: Female, Male Female	262 Participants n=1009 Participants	252 Participants n=1009 Participants	514 Participants n=2018 Participants
Sex: Female, Male Male	747 Participants n=1009 Participants	757 Participants n=1009 Participants	1504 Participants n=2018 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: up to three years, assessed at 3 months intervals

Population: 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.

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)

Outcome measures

Outcome measures
Measure	Test Arm n=1009 Participants 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.	Control Arm n=1009 Participants 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.
Improvement of Language as Measured by Autism Therapy Evaluation Checklist (ATEC) and Mental Synthesis Evaluation Checklist (MSEC). Receptive Language improvement over 3 years	8.49 units on a scale Standard Error 0.65	4.87 units on a scale Standard Error 0.85
Improvement of Language as Measured by Autism Therapy Evaluation Checklist (ATEC) and Mental Synthesis Evaluation Checklist (MSEC). Expressive Language improvement over three years	5.03 units on a scale Standard Error 0.43	3.53 units on a scale Standard Error 0.57
Improvement of Language as Measured by Autism Therapy Evaluation Checklist (ATEC) and Mental Synthesis Evaluation Checklist (MSEC). Sociability improvement over 3 years	1.88 units on a scale Standard Error 0.59	0.72 units on a scale Standard Error 0.78
Improvement of Language as Measured by Autism Therapy Evaluation Checklist (ATEC) and Mental Synthesis Evaluation Checklist (MSEC). Cognitive Awareness improvement over 3 years	2.43 units on a scale Standard Error 0.52	2.19 units on a scale Standard Error 0.68
Improvement of Language as Measured by Autism Therapy Evaluation Checklist (ATEC) and Mental Synthesis Evaluation Checklist (MSEC). Health improvement over 3 years	1.68 units on a scale Standard Error 0.94	1.38 units on a scale Standard Error 1.23

Adverse Events

Test Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Andrey Vyshedskiy, Founder

ImagiRation LLC

Phone: 6174338577

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place