Autism Spectrum DisorderNCT07299175
Digital Mental Integrated Intervention Technology on Language Improvement on Autistic Patients
An observational study of Autism Spectrum Disorder, run by Ain Shams University at 1 site in Egypt.
Trial summary
Primary aim: evaluate the effect of MITA application on language improvement in children with Autism. Secondary aim: evaluate the effect of MITA application on sociability and cognitive awareness in children with Autism. Read more about this study
- Who is it for?
- Ages 8 to 8 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- application called Mental Imagery Therapy for Autism (MITA)
- Type of treatment
- Pill or oral medicine
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2021to 1 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 8 years
- All sexes
- No healthy volunteers
- Child
Study population: A sample of Children with ASD who were diagnosed by Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria.
Who may be able to join
- Age: 2 year to 8 years.
- Both sexes
- Diagnosed with autism spectrum disorders
Who cannot join
- A history of other developmental disorders or neuropsychiatric disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Digital Mental Integrated Intervention Technology on Language Improvement in Children of Autism: One Centre Study
Primary aim: evaluate the effect of MITA application on language improvement in children with Autism.
Secondary aim: evaluate the effect of MITA application on sociability and cognitive awareness in children with Autism.
Read the detailed description
One of the most important behavioral and developmental features that suggest autism is language delays and deviations, so that social communication and social interaction is a real challenge during management of ASD patients.
Among individuals diagnosed with autism spectrum disorder ASD, the prevalence of prefrontal synthesis (PFS) paralysis is 30 to 40% ,and may be as high as 60% among children enrolled into special ASD schools The management of ASD is mainly non-pharmacological like cognitive, behavioral, speech therapy which may help to maximize communication skills The use of technology in the delivery of much needed therapy called digital therapeutics promises to be effective for shrinking the gap between the therapy that is recommended for children with ASD and the amount they receive. There has been a promising trend towards computer-based interventions which capitalize on the often observed preference children with ASD show for flat screen information.
Mental imaginary therapy for autism MITA application hypothesized to be used in early PFS-targeting intervention can improve language ability in children with ASD .
- Conditions
- Autism Spectrum Disorder
- Being tested
- application called Mental Imagery Therapy for Autism (MITA)
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
application called Mental Imagery Therapy for Autism (MITA)Other
If an application called Mental Imagery Therapy for Autism (MITA) has an effect on language improvement,sociability and cognitive awareness in a sample of children with Autism to seek to provide a tablet-based therapeutic application as a means of reducing the therapy gap and improve quality of care .
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate the effect of MITA application on language improvement in children with Autism.
evaluation through :Autism Treatment Evaluation Checklist and Mental Synthesis Evaluation Checklist.
Measured: baseline , after 3 months and after 6 months .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start1 Oct 2021
- Primary completion1 Jan 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Makari masri isaac mousa, Ain Shams University
- Investigators
- Mohamed Abd EL-Adl El-Sawy, Professor of Pediatrics, Study chair, Professor of Pediatrics ain shams universityOla Ali Khalifa, professor, Study director, professor of medical genitics ain shams universityAzza Mohamed Youssef, professor, Study director, Professor of developmental and behavioral pediatrics ain shams universityAsmaa Wafeek Abdelaziz, assistant professor, Principal investigator, assistant prfessor of pediatrics ain shams universitySarah Farid Mohamed Fahmy, Associate Proffessor, Principal investigator, associate Professor of clinical pharmacy ain shams university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07299175
- Sponsor's protocol ID
- technology effect on ASD child
- Status last verified
- Dec 2025
- First submitted
- 20 Sep 2024
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Digital Mental Integrated Intervention Technology on Language Improvement in Children of Autism: One Centre Study
- ClinicalTrials.gov ID
- NCT07299175
- Acronym / sponsor ID
- technology effect on ASD child
- Conditions
- Autism Spectrum Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 23 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary aim: evaluate the effect of MITA application on language improvement in children with Autism.
Secondary aim: evaluate the effect of MITA application on sociability and cognitive awareness in children with Autism.
Detailed description
One of the most important behavioral and developmental features that suggest autism is language delays and deviations, so that social communication and social interaction is a real challenge during management of ASD patients.
Among individuals diagnosed with autism spectrum disorder ASD, the prevalence of prefrontal synthesis (PFS) paralysis is 30 to 40% ,and may be as high as 60% among children enrolled into special ASD schools The management of ASD is mainly non-pharmacological like cognitive, behavioral, speech therapy which may help to maximize communication skills The use of technology in the delivery of much needed therapy called digital therapeutics promises to be effective for shrinking the gap between the therapy that is recommended for children with ASD and the amount they receive. There has been a promising trend towards computer-based interventions which capitalize on the often observed preference children with ASD show for flat screen information.
Mental imaginary therapy for autism MITA application hypothesized to be used in early PFS-targeting intervention can improve language ability in children with ASD .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 8 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- A sample of Children with ASD who were diagnosed by Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria.
Key inclusion criteria (3 listed)
- Age: 2 year to 8 years.
- Both sexes
- Diagnosed with autism spectrum disorders
Key exclusion criteria (1 listed)
- A history of other developmental disorders or neuropsychiatric disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| application called Mental Imagery Therapy for Autism (MITA)If an application called Mental Imagery Therapy for Autism (MITA) has an effect on language improvement,sociability and cognitive awareness in a sample of children with Autism to seek to provide a tablet-based therapeutic application as a means of reducing the therapy gap and improve quality of care . | Other | – |
Primary outcome
evaluate the effect of MITA application on language improvement in children with Autism.
Time frame: baseline , after 3 months and after 6 months .
evaluation through :Autism Treatment Evaluation Checklist and Mental Synthesis Evaluation Checklist.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Abd EL-Adl El-Sawy, Professor of Pediatrics study chair
Professor of Pediatrics ain shams university
Ola Ali Khalifa, professor study director
professor of medical genitics ain shams university
Azza Mohamed Youssef, professor study director
Professor of developmental and behavioral pediatrics ain shams university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluate the effect of MITA application on language improvement in children with Autism. (time frame: baseline , after 3 months and after 6 months .). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.