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Can a smartphone app boost brain power in kids with intellectual disability?
NCT ID NCT05933005
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This small study tested a cognitive training app called D-kit/EF1 in 11 children aged 4-8 with borderline or mild intellectual disability. Children used the app for 30 minutes a day, 5 times a week for 12 weeks, while a comparison group watched educational videos. The goal was to see if the app could improve executive function and thinking skills. Results are still being analyzed.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- computerized cognitive rehabilitation program (D-kit/EF1 app)
- What this could lead to
- If it works, this could offer a home-based, non-drug way to help children with mild intellectual disability improve their thinking and executive function skills.
- What could go wrong
- This is a very small, early exploratory trial with only 11 participants. The app may not show meaningful improvement over watching educational videos, and results may not apply to all children.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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11 people
The number who actually took part.
- Started
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Aug 2023
- Finished
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May 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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4 to 8 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Children aged 4-8 years (48-96 months) of both genders at the time of obtaining consent. 2. Children with borderline intellectual functioning or mild intellectual disability (FSIQ 50-85) who meet the following criteria within 3 months of screening: * Stanford-Binet Intelligence Scale - 5th edition (SB-5) criteria: FSIQ 50-85. * NIH Toolbox Cognition Battery (NIHTB-CB) DCCS score of 7 or lower. 3. Children who are capable of communicating and behaving at a level sufficient to participate in the required tests and therapeutic activities of this clinical trial. 4. Individuals for whom the legal guardian and primary caregiver have voluntarily decided to participate in this clinical trial after receiving sufficient explanation and have provided written consent to comply with the requirements of the clinical trial. Exclusion Criteria: 1. If the parents or primary caregiver of the trial subjects, who will perform the key assessments on the trial subjects, are unable to read or write in English, thus are impossible to conduct the assessments. 2. Patients with conditions (e.g., blindness, color blindness, hearing loss, or deafness) that make it difficult to perform the digital therapy of the medical device for the clinical trial, D-kit/EF1, and the key assessment item for the clinical trial, NIHTB-CB DCCS test. 3. If the subject has participated in another clinical trial or has been administered investigational drugs for clinical trial purposes within the 4 weeks prior to screening (except, cases where the subject has not received investigational drugs or has participated in non-interventional observational studies are eligible for enrollment). 4. Other subjects who are deemed unsuitable for participation in this clinical trial based on the judgment of the investigators.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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UCSF Nancy Friend Pritzker Psychiatry Building
San Francisco, California, 94107, United States
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Other studies related to the condition(s) this trial covers.
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