Attention Deficit Hyperactivity DisorderNCT05435651
Digital Therapy for Treating Attention Deficit Hyperactivity Disorder
A study testing Multitask game-based digital therapy and Schulte Grid digital game in people with Attention Deficit Hyperactivity Disorder, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
This study is designed to explore the effect of Multitask game-based digital therapy versus Schulte Grid digital game on attentional functioning (measured by the TOVA), ADHD symptoms, executive functioning, and clinical impairment, in children diagnosed with ADHD. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Multitask game-based digital therapy and Schulte Grid digital game
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 16 Jul 2022to 1 Jul 2024
- Phase
- Interventional
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Children's hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
About this study
Official title: A Randomized Clinical Trial to Assess The Effectiveness and Safety of Digital Therapy for Treating Attention Deficit Hyperactivity Disorder in Children
This study is designed to explore the effect of Multitask game-based digital therapy versus Schulte Grid digital game on attentional functioning (measured by the TOVA), ADHD symptoms, executive functioning, and clinical impairment, in children diagnosed with ADHD. Investigators will also evaluate the safety of digital therapy for intervention treatment of childhood attention deficit hyperactivity disorder.
Read the detailed description
ADHD is a common neurodevelopmental disorder characterized by a persistent pattern of inattention and/or hyperactivity and impulsivity, resulting in functional impairment in multiple settings.The prevalence in China is estimated to be 6.26%. Front-line intervention for ADHD includes pharmacological and non-pharmacological interventions, which have shown short-term efficacy.There are limitations to current best practices for the treatment of ADHD.
Relating to pharmacotherapy, they are accompanied by adverse events in many children, do not normalize functioning , and adherence rates over time are generally low. Pharmacotherapy may not be suitable for some patients.Relating to non-pharmacological interventions, barriers to access limit the use of non-pharmacological interventions, given a shortage of properly trained paediatric mental health specialists and variability in insurance coverage for such services.
Digital therapy for ADHD may address these limitations with improved access, minimal side-effects, and low potential for abuse.There are studies show that digital intervention can significantly increase attentional functioning of children with ADHD.At present, there are few related researches on digital therapy in China.The total number of ADHD children is large in China, and electronic products are very popular in Chinese families.If digital therapies suitable for ADHD children in China can be developed, it will be of great significance for the promotion of human health.
Therefore, investigators designed the study to explore the effect of Multitask game-based digital therapy versus Schulte Grid digital game on attentional functioning (measured by the TOVA), ADHD symptoms, executive functioning, and clinical impairment, in children diagnosed with ADHD in China.Safety, tolerability, and compliance were also assessed.
The study will be a blinded (investigators and outcome assessors), randomized, parallel group, follow-up study of the sustained effects of 28 days of treatment with either Multitask game-based digital therapy or Schulte Grid digital game.
The trial will consist of 3 visits: Screening, FU-Day 14 visit and FU-Day 28 visit.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Multitask game-based digital therapy, Schulte Grid digital game
- Keywords
- Digital therapy
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multitask game-based digital therapyBehavioural
To practice multitask-game on the system for approximately 25 minutes/day at least 5 days a week.
Schulte Grid digital gameBehavioural
To practice Schulte Grid digital game on the system for approximately 25 minutes/day at least 5 days a week.
| Study group | Role | What they receive |
|---|---|---|
| Multitask game-based digital therapy | Experimental | Multitask game-based digital therapy group will be asked to practice multitask-game on the system for approximately 25 minutes/day at least 5 days a week. Compliance will be monitored electronically. Receives: Behavioral: Multitask game-based digital therapy |
| Schulte Grid digital game | Active comparator | Schulte Grid digital game group will be asked to practice Schulte Grid digital game on the system for approximately 25 minutes/day at least 5 days a week. Compliance will be monitored electronically. Receives: Behavioral: Schulte Grid digital game |
What is being measured
The primary outcome is the main question the study is designed to answer.
the TOVA API
The primary outcome measure was the mean change in The Attention Performance Index (API) of TOVA. The TOVA is a validated, computerised, continuous performance test that objectively measures attention and inhibitory control, normalised by age and sex.
The API is calculated from variability, response time, and d' (D Prime) using the following formula: API = Response Time Z score (Half 1) + d' Z score (Half 2) + Variability Z score (Total) + 1.80
API tells how similar the score is to the ADHD profile. A score of less than 0 indicates that the subject had similar performance to a normative ADHD population. A lower score indicates a more severe ADHD profile.
Measured: Baseline
the TOVA API
The primary outcome measure was the mean change in The Attention Performance Index (API) of TOVA. The TOVA is a validated, computerised, continuous performance test that objectively measures attention and inhibitory control, normalised by age and sex.
The API is calculated from variability, response time, and d' (D Prime) using the following formula: API = Response Time Z score (Half 1) + d' Z score (Half 2) + Variability Z score (Total) + 1.80
API tells how similar the score is to the ADHD profile. A score of less than 0 indicates that the subject had similar performance to a normative ADHD population. A lower score indicates a more severe ADHD profile.
Measured: 14 days after enrollment
the TOVA API
The primary outcome measure was the mean change in The Attention Performance Index (API) of TOVA. The TOVA is a validated, computerised, continuous performance test that objectively measures attention and inhibitory control, normalised by age and sex.
The API is calculated from variability, response time, and d' (D Prime) using the following formula: API = Response Time Z score (Half 1) + d' Z score (Half 2) + Variability Z score (Total) + 1.80
API tells how similar the score is to the ADHD profile. A score of less than 0 indicates that the subject had similar performance to a normative ADHD population. A lower score indicates a more severe ADHD profile.
Measured: 28 days after enrollment
Secondary outcomes (10)
The ADHD-Rating Scale
The ADHD-Rating Scale is an 18-item scale assessing the frequency of each ADHD symptom based on DSM-IV criteria. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). Each item is scored on a 4-point scale ranging from 0 (rarely or never) to 3 (very often) with total scores ranging from 0-54. A higher score indicates more severe ADHD symptoms and behaviors.
Measured: Baseline
The ADHD-Rating Scale
The ADHD-Rating Scale is an 18-item scale assessing the frequency of each ADHD symptom based on DSM-IV criteria. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). Each item is scored on a 4-point scale ranging from 0 (rarely or never) to 3 (very often) with total scores ranging from 0-54. A higher score indicates more severe ADHD symptoms and behaviors.
Measured: 14 days after enrollment
The ADHD-Rating Scale
The ADHD-Rating Scale is an 18-item scale assessing the frequency of each ADHD symptom based on DSM-IV criteria. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). Each item is scored on a 4-point scale ranging from 0 (rarely or never) to 3 (very often) with total scores ranging from 0-54. A higher score indicates more severe ADHD symptoms and behaviors.
Measured: 28 days after enrollment
The Clinical Global Impression Scale - Improvement (CGI-I)
The Clinical Global Impression Scale - Improvement (CGI-I) is a clinician's comparison of the participant's overall clinical condition at follow up to the overall clinical condition at baseline. The CGI-S is a 7-point scale where 1 = Very much improved, 2=Much improved, 3=Minimally improved, 4=No change, 5=Minimally worse, 6=Much worse, and 7=Very much worse.
A score of 1, 2, or 3 would indicate overall improvement of ADHD severity.
Measured: 14 days after enrollment
The Clinical Global Impression Scale - Improvement (CGI-I)
The Clinical Global Impression Scale - Improvement (CGI-I) is a clinician's comparison of the participant's overall clinical condition at follow up to the overall clinical condition at baseline. The CGI-S is a 7-point scale where 1 = Very much improved, 2=Much improved, 3=Minimally improved, 4=No change, 5=Minimally worse, 6=Much worse, and 7=Very much worse.
A score of 1, 2, or 3 would indicate overall improvement of ADHD severity.
Measured: 28 days after enrollment
BRIEF Inhibit Percentile
The Behavior Rating Inventory of Executive Function (BRIEF) is a parent-rated form that assesses everyday behavior associated with specific domains of the executive functions of their child. The BRIEF working memory metacognition subscale measures the participants ability to hold information when completing a task in a sequential manner.
A lower subscale score indicates better ability of working memory.
Measured: Baseline
BRIEF Inhibit Percentile
The Behavior Rating Inventory of Executive Function (BRIEF) is a parent-rated form that assesses everyday behavior associated with specific domains of the executive functions of their child. The BRIEF working memory metacognition subscale measures the participants ability to hold information when completing a task in a sequential manner.
A lower subscale score indicates better ability of working memory.
Measured: 14 days after enrollment
BRIEF Inhibit Percentile
The Behavior Rating Inventory of Executive Function (BRIEF) is a parent-rated form that assesses everyday behavior associated with specific domains of the executive functions of their child. The BRIEF working memory metacognition subscale measures the participants ability to hold information when completing a task in a sequential manner.
A lower subscale score indicates better ability of working memory.
Measured: 28 days after enrollment
Adverse Device Effects
The expectedness of an ADE shall be documented in case Report Form（CRF）. 1. Dizziness,2. Nausea,3. Headache,4. Increased and unusual levels of frustration during game play.
Measured: 14 days after enrollment
Adverse Device Effects
The expectedness of an ADE shall be documented in case Report Form（CRF）. 1. Dizziness,2. Nausea,3. Headache,4. Increased and unusual levels of frustration during game play.
Measured: 28 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start16 Jul 2022
- Primary completion1 Jun 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The present study will be carried out using a parallel randomized study design. Each participant will be randomly assigned either to Multitask game-based digital therapy or to Schulte Grid digital game control group.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daqian Zhu, PhD, Study chair, Department of Psychological Medicine, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05435651
- Sponsor's protocol ID
- SZLFADHD2022
- Status last verified
- Mar 2026
- First submitted
- 23 Jun 2022
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kollins SH, DeLoss DJ, Canadas E, Lutz J, Findling RL, Keefe RSE, Epstein JN, Cutler AJ, Faraone SV. A novel digital intervention for actively reducing severity of paediatric ADHD (STARS-ADHD): a randomised controlled trial. Lancet Digit Health. 2020 Apr;2(4):e168-e178. doi: 10.1016/S2589-7500(20)30017-0. Epub 2020 Feb 24.
PubMed 33334505Kollins SH, Childress A, Heusser AC, Lutz J. Effectiveness of a digital therapeutic as adjunct to treatment with medication in pediatric ADHD. NPJ Digit Med. 2021 Mar 26;4(1):58. doi: 10.1038/s41746-021-00429-0.
PubMed 33772095Davis NO, Bower J, Kollins SH. Proof-of-concept study of an at-home, engaging, digital intervention for pediatric ADHD. PLoS One. 2018 Jan 11;13(1):e0189749. doi: 10.1371/journal.pone.0189749. eCollection 2018.
PubMed 29324745
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial to Assess The Effectiveness and Safety of Digital Therapy for Treating Attention Deficit Hyperactivity Disorder in Children
- ClinicalTrials.gov ID
- NCT05435651
- Acronym / sponsor ID
- SZLFADHD2022
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Digital therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 16 Jul 2022 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 28 Jun 2022 (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.
This study is designed to explore the effect of Multitask game-based digital therapy versus Schulte Grid digital game on attentional functioning (measured by the TOVA), ADHD symptoms, executive functioning, and clinical impairment, in children diagnosed with ADHD. Investigators will also evaluate the safety of digital therapy for intervention treatment of childhood attention deficit hyperactivity disorder.
Detailed description
ADHD is a common neurodevelopmental disorder characterized by a persistent pattern of inattention and/or hyperactivity and impulsivity, resulting in functional impairment in multiple settings.The prevalence in China is estimated to be 6.26%. Front-line intervention for ADHD includes pharmacological and non-pharmacological interventions, which have shown short-term efficacy.There are limitations to current best practices for the treatment of ADHD.
Relating to pharmacotherapy, they are accompanied by adverse events in many children, do not normalize functioning , and adherence rates over time are generally low. Pharmacotherapy may not be suitable for some patients.Relating to non-pharmacological interventions, barriers to access limit the use of non-pharmacological interventions, given a shortage of properly trained paediatric mental health specialists and variability in insurance coverage for such services.
Digital therapy for ADHD may address these limitations with improved access, minimal side-effects, and low potential for abuse.There are studies show that digital intervention can significantly increase attentional functioning of children with ADHD.At present, there are few related researches on digital therapy in China.The total number of ADHD children is large in China, and electronic products are very popular in Chinese families.If digital therapies suitable for ADHD children in China can be developed, it will be of great significance for the promotion of human health.
Therefore, investigators designed the study to explore the effect of Multitask game-based digital therapy versus Schulte Grid digital game on attentional functioning (measured by the TOVA), ADHD symptoms, executive functioning, and clinical impairment, in children diagnosed with ADHD in China.Safety, tolerability, and compliance were also assessed.
The study will be a blinded (investigators and outcome assessors), randomized, parallel group, follow-up study of the sustained effects of 28 days of treatment with either Multitask game-based digital therapy or Schulte Grid digital game.
The trial will consist of 3 visits: Screening, FU-Day 14 visit and FU-Day 28 visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The present study will be carried out using a parallel randomized study design. Each participant will be randomly assigned either to Multitask game-based digital therapy or to Schulte Grid digital game control group.
| Arm | Type | Receives |
|---|---|---|
| Multitask game-based digital therapy | Experimental | Behavioral: Multitask game-based digital therapyMultitask game-based digital therapy group will be asked to practice multitask-game on the system for approximately 25 minutes/day at least 5 days a week. Compliance will be monitored electronically. |
| Schulte Grid digital game | Active comparator | Behavioral: Schulte Grid digital gameSchulte Grid digital game group will be asked to practice Schulte Grid digital game on the system for approximately 25 minutes/day at least 5 days a week. Compliance will be monitored electronically. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
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 |
|---|---|---|
| Multitask game-based digital therapyTo practice multitask-game on the system for approximately 25 minutes/day at least 5 days a week. | Behavioural | Multitask game-based digital therapy |
| Schulte Grid digital gameTo practice Schulte Grid digital game on the system for approximately 25 minutes/day at least 5 days a week. | Behavioural | Schulte Grid digital game |
Primary outcome
the TOVA API
Time frame: Baseline
The primary outcome measure was the mean change in The Attention Performance Index (API) of TOVA. The TOVA is a validated, computerised, continuous performance test that objectively measures attention and inhibitory control, normalised by age and sex. The API is calculated from variability, response time, and d' (D Prime) using the following formula: API = Response Time Z score (Half 1) + d' Z score (Half 2) + Variability Z score (Total) + 1.80 API tells how similar the score is to the ADHD profile. A score of less than 0 indicates that the subject had similar performance to a normative ADHD population. A lower score indicates a more severe ADHD profile.
the TOVA API
Time frame: 14 days after enrollment
The primary outcome measure was the mean change in The Attention Performance Index (API) of TOVA. The TOVA is a validated, computerised, continuous performance test that objectively measures attention and inhibitory control, normalised by age and sex. The API is calculated from variability, response time, and d' (D Prime) using the following formula: API = Response Time Z score (Half 1) + d' Z score (Half 2) + Variability Z score (Total) + 1.80 API tells how similar the score is to the ADHD profile. A score of less than 0 indicates that the subject had similar performance to a normative ADHD population. A lower score indicates a more severe ADHD profile.
the TOVA API
Time frame: 28 days after enrollment
The primary outcome measure was the mean change in The Attention Performance Index (API) of TOVA. The TOVA is a validated, computerised, continuous performance test that objectively measures attention and inhibitory control, normalised by age and sex. The API is calculated from variability, response time, and d' (D Prime) using the following formula: API = Response Time Z score (Half 1) + d' Z score (Half 2) + Variability Z score (Total) + 1.80 API tells how similar the score is to the ADHD profile. A score of less than 0 indicates that the subject had similar performance to a normative ADHD population. A lower score indicates a more severe ADHD profile.
10 secondary outcomes
The ADHD-Rating Scale
Time frame: Baseline
The ADHD-Rating Scale
Time frame: 14 days after enrollment
The ADHD-Rating Scale
Time frame: 28 days after enrollment
The Clinical Global Impression Scale - Improvement (CGI-I)
Time frame: 14 days after enrollment
The Clinical Global Impression Scale - Improvement (CGI-I)
Time frame: 28 days after enrollment
BRIEF Inhibit Percentile
Time frame: Baseline
BRIEF Inhibit Percentile
Time frame: 14 days after enrollment
BRIEF Inhibit Percentile
Time frame: 28 days after enrollment
Adverse Device Effects
Time frame: 14 days after enrollment
Adverse Device Effects
Time frame: 28 days after enrollment
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 27 Mar 2026.
- Background: PubMed 33334505Kollins SH, DeLoss DJ, Canadas E, Lutz J, Findling RL, Keefe RSE, Epstein JN, Cutler AJ, Faraone SV. A novel digital intervention for actively reducing severity of paediatric ADHD (STARS-ADHD): a randomised controlled trial. Lancet Digit Health. 2020 Apr;2(4):e168-e178. doi: 10.1016/S2589-7500(20)30017-0. Epub 2020 Feb 24.
- Background: PubMed 33772095Kollins SH, Childress A, Heusser AC, Lutz J. Effectiveness of a digital therapeutic as adjunct to treatment with medication in pediatric ADHD. NPJ Digit Med. 2021 Mar 26;4(1):58. doi: 10.1038/s41746-021-00429-0.
- Background: PubMed 29324745Davis NO, Bower J, Kollins SH. Proof-of-concept study of an at-home, engaging, digital intervention for pediatric ADHD. PLoS One. 2018 Jan 11;13(1):e0189749. doi: 10.1371/journal.pone.0189749. eCollection 2018.
- Individual participant dataSharing planned: No
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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.
Daqian Zhu, PhD study chair
Department of Psychological Medicine, Children's Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multitask game-based digital therapy and Schulte Grid digital game in people with Attention Deficit Hyperactivity Disorder, run by Children's Hospital of Fudan University at 1 site in China.
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 8 inclusion and 10 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 27 Mar 2026. 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 China. 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?
the TOVA API (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05435651, which also lists 3 linked publications.
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 27 Mar 2026.