Mental Imagery Therapy for Autism (MITA) - an Early Intervention Computerized Language Training P… (NCT07326423) | Clinical Trial Compass
By InvitationNot Applicable
Mental Imagery Therapy for Autism (MITA) - an Early Intervention Computerized Language Training Program for Children With Autism
Brazil60 participantsStarted 2021-09-01
Plain-language 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.
Who can participate
Age range
2 Years – 5 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* age 2 and 5 years at the time of enrollment
* diagnosis of ASD confirmed by a study investigator who was experienced in ASD diagnosis.
Exclusion Criteria:
* 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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Childhood Autism Rating Scale (CARS-2)
Timeframe: the baseline, 6-months, 12-months, 18-months, 24-months, and 30-months