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Can a smartphone app boost brain power in kids with intellectual disability?

NCT ID NCT05933005

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

11 people

The number who actually took part.

Started

Aug 2023

Finished

May 2024

Lead sponsor

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

4 to 8 years

Sex

Anyone

Healthy volunteers

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

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

  • UCSF Nancy Friend Pritzker Psychiatry Building

    San Francisco, California, 94107, United States

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