Game on: digital therapy shows promise for ADHD in kids
NCT ID NCT05435651
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether playing a specially designed multitask game for 25 minutes a day, at least 5 days a week, could improve attention in children aged 8-12 with ADHD. Forty children participated, and researchers measured changes in attention using a computer test called TOVA. The goal was to see if this digital therapy could be a safe, effective non-drug treatment for ADHD symptoms.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- multitask game-based digital therapy
- What this could lead to
- If it works, this could offer a safe, non-drug treatment option to help children with ADHD improve their attention and reduce symptoms.
- What could go wrong
- This is a small, early-stage trial with only 40 participants. The digital game may not prove more effective than a standard game, and results may not apply to all children with ADHD.
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
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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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40 people
The number who actually took part.
- Started
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Jul 2022
- Finished
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Jul 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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6 to 12 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: * Age 8 years to 12 years, inclusive, at the time of parental informed consent. * Male or female. * Confirmed ADHD diagnosis , any presentation , at Screening based on DSM-V criteria and established via the MINI-KID administered by a trained clinician. * Screening/Baseline score on the clinician-rated ADHDRS-IV score 24. * Screening/Baseline score on the TOVA API -1.8. * Not undergoing pharmacological treatment with methylphenidate or amphetamine-based products at time of Screening ; or, if undergoing pharmacolog ical treatment , must be willing and appropriate (i.e. not optimally treated in the investigator's judgment) to wash out of current regimen. * Estimated IQ score\~ 80 as assessed by Wechsler Intelligence Scale for Children-Fourth Edition ,WISC-IV. * Ability to comply with all the testing and requirements. Exclusion Criteria: * Current, controlled (requiring a restricted medicatio n) or uncontrolled, comorbid psychiatric diagnosis , based on MINI-KID and subsequent clinical interviewing, with significant symptoms including but not limited to post-traumatic stress disorder , psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder , conduct disorder , or other symptomatic manifestatio ns that in the opinion of the Investigator may confound study data/assessments . * Children who are currently at risk of suicide or have attempted suicide; children who have a history of suicide or are currently exhibiting active suicidal ideation or self-harm. * Unable to stop taking ADHD medication. * Motor condition (e.g., physical deformity of the hands/arms ; prostheses) that prevents playing the digital therapy as reported by the parent or observed by the investigator . * Recent history (within the past 6 months) of suspected substance abuse or dependence. * History of seizures (exclusive of febr ile seizures) , or significant motor or vocal tics, including but not limited to Tourette 's Disorder. * Diagnosis of or parent-reported color blindness. * Uncorrected visual acuity (Confirmed in-clinic via ability of subject to play the game). * With severe mental retardation. * Any other medical condition that in the opinion of the investigato r may confound study data/assessments.
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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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Children's hospital of Fudan University
Shanghai, Shanghai Municipality, 201102, China
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