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

NCT07326423 | Enrolling By Invitation

• 1 other identifier: 4924876
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Mental Imagery Therapy for Autism (MITA) is a highly innovative adaptive language therapy application for children with autism. MITA exercises are limitless in variations, therefore avoiding routinization. Each activity is dynamic, quickly adjusting to the child's exact ability level. All activities are disguised as games that engage children. A 3-year observational clinical study of 6,454 children with ASD demonstrated that children who engaged with MITA showed 2.2-fold greater language improvement than children with similar initial evaluations (p\<0.0001). This study explores MITA intervention in a randomized controlled trial of 60 children with ASD. Two- to five-year-old ASD children will be randomly assigned to one of two groups. The MITA group will supplement their conventional language therapy with MITA exercises. The control group will receive treatment-as-usual. The hypothesis is that the MITA group will show greater improvement in developmental milestones.

Conditions

ASD

Keywords

autism; intellectual disability; language; language acquisition; syntactic language; imagination; imagiration

Outcome Measures

Primary Outcomes (1)

• Childhood Autism Rating Scale (CARS-2)

  The Childhood Autism Rating Scale, Second Edition (CARS-2) is a 15-item behavioral rating scale developed to quantitatively assess the severity of ASD. CARS-2 works by rating a child's behavior, characteristics, and abilities against the expected developmental growth of a typical child. Each item is scored from 1 to 4: 1 being normal for a child's age, 2 for mildly abnormal, 3 for moderately abnormal, and 4 as severely abnormal. CARS-2 score ranges from 15 (no pathology) to 60 (severe ASD) with 30 being the cutoff rate for a diagnosis of mild autism. Scores 30-37 indicate mild to moderate autism, while scores between 38 and 60 are characterized as severe autism 36.

  the baseline, 6-months, 12-months, 18-months, 24-months, and 30-months

Other Outcomes (1)

• Mental Synthesis Evaluation Checklist (MSEC)

  the baseline, 6-months, 12-months, 18-months, 24-months, and 30-months

Study Arms (2)

MITA-treatment

EXPERIMENTAL

The treatment group received PFS-training activities emphasizing mental-juxtaposition-of-objects organized into the gamified application MITA

Behavioral: Mental Imagery Therapy for Autism (MITA)

Control

ACTIVE COMPARATOR

The active-control group received the same standard clinic-based early intervention but, during the tablet-computer-based therapy unit, used non-MITA applications targeting memory and executive functions (e.g., matching colors and shapes, logical sequences, same/different discrimination, sound discrimination, imitation and musicalization, early literacy and graphomotor skills, animal-sound matching, quantity-number association, comparison, counting, and introductory fractions).

Behavioral: General executive function

Interventions

Mental Imagery Therapy for Autism (MITA) BEHAVIORAL

The treatment group received Prefrontal Synthesis (PFS)-training activities emphasizing mental-juxtaposition-of-objects organized into the gamified application MITA. MITA includes both verbal and nonverbal exercises aiming to develop voluntary imagination ability in general and PFS ability in particular. MITA verbal activities use higher forms of language, such as noun-adjective combinations, spatial prepositions, recursion, and syntax to train PFS: e.g., a child can be instructed to "put the large red dog behind the orange chair" or "identify the wet animal after the lion was showered by the monkey;" or "take animals home following an explanation that the lion lives above the monkey and under the cow". In every activity a child listens to a short story and then works within immersive interface to generate an answer. Correct answers are rewarded with pre-recorded encouragement.

MITA-treatment

General executive function BEHAVIORAL

The active-control group received the same standard clinic-based early intervention but, during the tablet-computer-based therapy unit, used non-MITA applications targeting memory and executive functions (e.g., matching colors and shapes, logical sequences, same/different discrimination, sound discrimination, imitation and musicalization, early literacy and graphomotor skills, animal-sound matching, quantity-number association, comparison, counting, and introductory fractions).

Control

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• age 2 and 5 years at the time of enrollment
• diagnosis of ASD confirmed by a study investigator who was experienced in ASD diagnosis.

You may not qualify if:

• a neurodevelopmental disorder of known etiology (e.g., fragile X syndrome)
• significant sensory or motor impairment,
• major physical problems such as a chronic serious health condition,
• seizures at time of entry. Children who developed seizures during the course of the study were not excluded.
• use of psychoactive medications,
• history of a serious head injury and/or neurologic disease,
• alcohol or drug exposure during the prenatal period,
• CARS-2 total score \> 48 (severe ASD).

Sponsors & Collaborators

• ImagiRation, LLC: lead

Study Sites (1)

Espacosomare

Foz do Iguaçu, Paraná, 85865-370, Brazil

Location

MeSH Terms

Conditions

Autistic Disorder; Intellectual Disability; Language

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Communication; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: January 8, 2026
• Study Start: September 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)