Attention Deficit Disorder With HyperactivityNCT06181747
Development of Attention and Its Relationship With Emotions in Children and Adolescents
A study testing a serious mobile device-based game prototype (Save the Muse Home) in people with Attention Deficit Disorder With Hyperactivity, run by Institute of Psychology, Chinese Academy of Sciences at 2 sites in China.
Trial summary
Our aim was to describe the development and usability of a mobile device-based game therapy software for ADHD. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity
- What is being tested?
- a serious mobile device-based game prototype (Save the Muse Home)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 2 sitesChina
- Study dates
- 1 Mar 2023to 10 May 2023
- 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
- Healthy volunteers accepted
- Child
Who may be able to join
- ADHD-a. Age between 6-12 years, any gender.
- ADHD-b. Outpatient patients diagnosed with ADHD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.
- ADHD-c. Patients and/or their guardians willing to participate in the study and provide informed consent. Participants aged 8 and above should also sign a child's informed consent form.
- HC. The control group of healthy participants are recruited from a secondary school in Nanjing, matching the age and gender of the ADHD group.
Who cannot join
- a. Neurodevelopmental disorders such as cerebral palsy, epilepsy, adrenoleukodystrophy, and other similar conditions.
- b. Severe mental disorders including tic disorders, autism spectrum disorders, intellectual disability, schizophrenia, bipolar disorder, depressive disorders, specific learning disorders, and other significant psychiatric conditions.
- c. Individuals exhibiting ADHD-like symptoms due to hearing impairments.
- d. Requirement of any central nervous system medication (including both traditional and Western medicine as well as dietary supplements) such as antipsychotics or antidepressants at any stage of the study.
- e. Patients who have received systematic treatment with two different categories of ADHD medications without improvement.
- f. Individuals with color blindness or any other condition that would prevent proper use of the software.
- g. History of or current gaming addiction.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Institute of Psychology, Chinese Academy of Sciences
Beijing
Nanjing Normal University
Nanjing, Jiangsu
About this study
Official title: Research on the Development of Attention and Its Relationship With Emotions in Children and Adolescents
Our aim was to describe the development and usability of a mobile device-based game therapy software for ADHD.
Read the detailed description
A total of 51 ADHD children and 52 healthy children were included in the study. At baseline, subjects underwent tests such as ADHD symptom-related scale assessments, computer-assisted information processing tests, and physiological-psychological tests, after which participants completed a 4-week game intervention training at home. After complete completion of the intervention, subjects repeated all tests from the baseline period and answered treatment satisfaction questions.
- Being tested
- a serious mobile device-based game prototype (Save the Muse Home)
- 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.
a serious mobile device-based game prototype (Save the Muse Home)Device
The cognitive impairment corresponding to the symptoms, which we are interested in, focuses on executive inhibition, motor inhibition, sustained attention, selective attention, working memory, and planning ability. The training content will be presented in different scenarios as effective training components. The story line of the warrior breakthrough runs through the whole game, each level is adapted according to the functional damage areas of different patients, and each level involves reward and punishment mechanisms to keep the interest of the players, the difficulty gradient of each level is kept moderate, and the game includes design elements such as space, time, object attributes, actions, rules, skills, and probabilities, etc., which ultimately completes Save the Muse Home, a serious game for the treatment of ADHD.
| Study group | Role | What they receive |
|---|---|---|
| ADHD group | Experimental | Participants are required to engage in game training at home for 5 days per week, with each session lasting 20-25 minutes. The game is equipped with anti-addiction measures, limiting the maximum daily game time to 30 minutes. Participants will adjust their game training based on their own abilities, and as the training progresses, the game will adaptively adjust the difficulty level and change levels accordingly. Receives: Device: a serious mobile device-based game prototype (Save the Muse Home) |
| healthy control group | Experimental | Participants are required to engage in game training at home for 5 days per week, with each session lasting 20-25 minutes. The game is equipped with anti-addiction measures, limiting the maximum daily game time to 30 minutes. Participants will adjust their game training based on their own abilities, and as the training progresses, the game will adaptively adjust the difficulty level and change levels accordingly. Receives: Device: a serious mobile device-based game prototype (Save the Muse Home) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuous Performance Test, CPT
CPT software is one of the commonly used tools for examining attention and is a computer-assisted information processing test with objective results, independent of supervisors, and is the most widely used experimental paradigm in current research. The CPT paradigm adopted in this study is the presence of a white boxed area on a black background on the calculator screen, with white squares randomly appearing above or below the white boxed area, requiring the target stimulus to be a right mouse button press when the square appears below it.
Measured: baseline and post (an average of 30days after baseline)
Secondary outcomes (5)
Swanson Nolan, and Pelham-IV rating scales, SNAP-IV
The SNAP-IV rating scales (Swanson Nolan, and Pelham-IV rating scales, SNAP-IV) is a revised version of the Swanson, Nolan Pelham (SNAP) (Swanson, et al., 1983), which was developed based on the description of ADHD symptoms in the Diagnostic and Statistical Manual of Mental Disorders (DSM). It consists of three subscales: attention deficit, hyperactivity-impulsivity, and oppositional defiance, and is mainly used for screening, diagnostic support, and assessment of treatment efficacy and symptom improvement in children and adolescents between the ages of 6 and 18 years. Although SNAP-IV consists of 3 subscales, it is one scale, just like SDQ and BRIEF mentioned later.
Measured: baseline and post (an average of 30days after baseline)
Strengths and Difficulties Questionnaire, SDQ
The SDQ is a brief behavioral screening questionnaire designed and developed by American psychologist Goodman R in 1997 based on the Diagnostic and Statistical Manual of Mental Disorders-IV and the Diagnostic Criteria for the Classification of Mental and Behavioral Disorders, 10th Edition (ICD-10). It is used to assess behavioral and emotional problems in children and adolescents and has good reliability and validity.
Measured: baseline and post (an average of 30days after baseline)
Behavior Rating Inventory of Executive Function, BRIEF
The scale consists of 86 entries in two major areas: the Behavior Management Index (BMI), which includes the three subscales of Inhibition, Conversion, and Affect, and Control, Conversion and Affect, and Control subscales; and the Metacognitive Functioning Index: five subscales including Task Initiation, Working Memory, Planning, Organization, and Monitoring. It has good reliability and validity.
Measured: baseline and post (an average of 30days after baseline)
Anti-saccade task
First, present the central gaze point cross for 2s, the central cross disappeared while the target appeared as a green dot, randomly present four positions at 3°, 6° left and right sides horizontally, presentation time 1000ms, each angle randomly appeared 5 times for a total of 20 times, when the response is over a 300ms feedback point will appear in the correct position.
Measured: baseline and post (an average of 30days after baseline)
Delay-saccade task
Presentation of the central gaze point cross for 2 s, the target stimulus appeared (the cross continued to exist) for the green origin randomly presented at four positions 3°, 6° left and right sides horizontally, presentation time 100 ms. Subsequently, the gaze point was presented only at the center of the screen for 1, 3, and 5 s, staring at the cross intently, and then the screen appeared to go blank for 1.4 s, the subject recalled looking at the beginning of the target, and the latter a 200-ms feedback point appeared at the correct location.
Measured: baseline and post (an average of 30days after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start1 Mar 2023
- Primary completion5 May 2023
- Study completion10 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Disorder With HyperactivityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Psychology, Chinese Academy of Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhengkui Liu, Ph.D., Principal investigator, Institute of Psychology, Chinese Academy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06181747
- Sponsor's protocol ID
- E2KM011639-K12023000015
- Status last verified
- Nov 2023
- First submitted
- 1 Dec 2023
- Last updated
- 1 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Luo J, Li F, Wu Y, Liu X, Zheng Q, Qi Y, Huang H, Xu G, Liu Z, He F, Zheng Y. A mobile device-based game prototype for ADHD: development and preliminary feasibility testing. Transl Psychiatry. 2024 Jun 10;14(1):251. doi: 10.1038/s41398-024-02964-2.
PubMed 38858375
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Development of Attention and Its Relationship With Emotions in Children and Adolescents
- ClinicalTrials.gov ID
- NCT06181747
- Acronym / sponsor ID
- E2KM011639-K12023000015
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Institute of Psychology, Chinese Academy of SciencesUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 5 May 2023 (actual)
- Study completion
- 10 May 2023 (actual)
- First posted
- 26 Dec 2023 (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.
Our aim was to describe the development and usability of a mobile device-based game therapy software for ADHD.
Detailed description
A total of 51 ADHD children and 52 healthy children were included in the study. At baseline, subjects underwent tests such as ADHD symptom-related scale assessments, computer-assisted information processing tests, and physiological-psychological tests, after which participants completed a 4-week game intervention training at home. After complete completion of the intervention, subjects repeated all tests from the baseline period and answered treatment satisfaction questions.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADHD group | Experimental | Device: a serious mobile device-based game prototype (Save the Muse Home)Participants are required to engage in game training at home for 5 days per week, with each session lasting 20-25 minutes. The game is equipped with anti-addiction measures, limiting the maximum daily game time to 30 minutes. Participants will adjust their game training based on their own abilities, and as the training progresses, the game will adaptively adjust the difficulty level and change levels accordingly. |
| healthy control group | Experimental | Device: a serious mobile device-based game prototype (Save the Muse Home)Participants are required to engage in game training at home for 5 days per week, with each session lasting 20-25 minutes. The game is equipped with anti-addiction measures, limiting the maximum daily game time to 30 minutes. Participants will adjust their game training based on their own abilities, and as the training progresses, the game will adaptively adjust the difficulty level and change levels accordingly. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- ADHD-a. Age between 6-12 years, any gender.
- ADHD-b. Outpatient patients diagnosed with ADHD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.
- ADHD-c. Patients and/or their guardians willing to participate in the study and provide informed consent. Participants aged 8 and above should also sign a child's informed consent form.
- HC. The control group of healthy participants are recruited from a secondary school in Nanjing, matching the age and gender of the ADHD group.
Key exclusion criteria (7 listed)
- a. Neurodevelopmental disorders such as cerebral palsy, epilepsy, adrenoleukodystrophy, and other similar conditions.
- b. Severe mental disorders including tic disorders, autism spectrum disorders, intellectual disability, schizophrenia, bipolar disorder, depressive disorders, specific learning disorders, and other significant psychiatric conditions.
- c. Individuals exhibiting ADHD-like symptoms due to hearing impairments.
- d. Requirement of any central nervous system medication (including both traditional and Western medicine as well as dietary supplements) such as antipsychotics or antidepressants at any stage of the study.
- e. Patients who have received systematic treatment with two different categories of ADHD medications without improvement.
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 |
|---|---|---|
| a serious mobile device-based game prototype (Save the Muse Home)The cognitive impairment corresponding to the symptoms, which we are interested in, focuses on executive inhibition, motor inhibition, sustained attention, selective attention, working memory, and planning ability. The training content will be presented in different scenarios as effective training components. The story line of the warrior breakthrough runs through the whole game, each level is adapted according to the functional damage areas of different patients, and each level involves reward and punishment mechanisms to keep the interest of the players, the difficulty gradient of each level is kept moderate, and the game includes design elements such as space, time, object attributes, actions, rules, skills, and probabilities, etc., which ultimately completes Save the Muse Home, a serious game for the treatment of ADHD. | Device | ADHD group, healthy control group |
Primary outcome
Continuous Performance Test, CPT
Time frame: baseline and post (an average of 30days after baseline)
CPT software is one of the commonly used tools for examining attention and is a computer-assisted information processing test with objective results, independent of supervisors, and is the most widely used experimental paradigm in current research. The CPT paradigm adopted in this study is the presence of a white boxed area on a black background on the calculator screen, with white squares randomly appearing above or below the white boxed area, requiring the target stimulus to be a right mouse button press when the square appears below it.
5 secondary outcomes
Swanson Nolan, and Pelham-IV rating scales, SNAP-IV
Time frame: baseline and post (an average of 30days after baseline)
Strengths and Difficulties Questionnaire, SDQ
Time frame: baseline and post (an average of 30days after baseline)
Behavior Rating Inventory of Executive Function, BRIEF
Time frame: baseline and post (an average of 30days after baseline)
Anti-saccade task
Time frame: baseline and post (an average of 30days after baseline)
Delay-saccade task
Time frame: baseline and post (an average of 30days after baseline)
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 1 Mar 2024.
- Derived from this study: PubMed 38858375Luo J, Li F, Wu Y, Liu X, Zheng Q, Qi Y, Huang H, Xu G, Liu Z, He F, Zheng Y. A mobile device-based game prototype for ADHD: development and preliminary feasibility testing. Transl Psychiatry. 2024 Jun 10;14(1):251. doi: 10.1038/s41398-024-02964-2.
- 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.
Zhengkui Liu, Ph.D. principal investigator
Institute of Psychology, Chinese Academy of Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing a serious mobile device-based game prototype (Save the Muse Home) in people with Attention Deficit Disorder With Hyperactivity, run by Institute of Psychology, Chinese Academy of Sciences at 2 sites 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 4 inclusion and 7 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 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Continuous Performance Test, CPT (time frame: baseline and post (an average of 30days after baseline)). 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 NCT06181747, which also lists 1 linked publication.
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 1 Mar 2024.