ADHD - Attention Deficit Disorder With HyperactivityNCT07922018
AI-assisted Home-based Intervention for ADHD Children
A study testing Generative artificial intelligence assisted diary platform home-based intervention and Consultations and psychoeducation on child emotional management in people with ADHD - Attention Deficit Disorder With Hyperactivity and ADHD - Combined Type, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The goal of this clinical trial is to evaluate the effectiveness of online diary platforms for socio-emotional learning training in children with attention deficit hyperactivity disorder (ADHD). Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- ADHD - Attention Deficit Disorder With Hyperactivity, ADHD - Combined Type, ADHD - Inattentive Type
- What is being tested?
- Generative artificial intelligence assisted diary platform home-based intervention and Consultations and psychoeducation on child emotional management
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2026to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 8-12 years with a professional diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD), who are enrolled in the study only after obtaining informed consent from their parents or legal guardians, as well as the assent of the children themselves.
Who cannot join
- Intellectual disability, defined as a Full Scale Intelligence Quotient (FSIQ) score of less than 70.
- Severe language or communication impairments.
- Lack of access to internet-connected devices.
- Inability to effectively use the platform for mood logging and self-reflection.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital Hsin-Chu Branch
Hsinchu
Pou-Leng Cheong, PhD, +886 972654171, cheong.pouleng@gmail.com
About this study
Official title: Generative Artificial Intelligence Assisted Home-based Intervention for Attention Deficient Hyperactivity Disorder (ADHD) Children
The goal of this clinical trial is to evaluate the effectiveness of online diary platforms for socio-emotional learning training in children with attention deficit hyperactivity disorder (ADHD). The main questions it aims to answer are:
Does the online diary platform training enhance children's emotion regulation and its connection to positive thinking? Does the online diary platform training provide an immediate, interactive, and effective emotion training tool during the wait for follow-up visits and treatment?
Read more
Researchers will compare online diary platforms training to counselling to see if online diary platforms training enhance children's emotion regulation.
Participants will use the MangaChat diary platform to log their daily moods and events, which the platform transforms into comic strips to offer an engaging visual story of their emotional experiences. Participants are requested to use the platform daily (or at least 3 times per week) for approximately 10 to 15 minutes per session over a 12-week period.
- Conditions
- ADHD - Attention Deficit Disorder With Hyperactivity, ADHD - Combined Type, ADHD - Inattentive Type
- Being tested
- Generative artificial intelligence assisted diary platform home-based intervention, Consultations and psychoeducation on child emotional management
- Keywords
- Generative artificial intelligence, Home-based intervention, Social emotional learing, Attention-deficit/hyperactivity disorder
- 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.
Generative artificial intelligence assisted diary platform home-based interventionDevice
Participants will use the MangaChat diary platform to log their daily moods and events, which the platform transforms into comic strips to offer an engaging visual story of their emotional experiences. Participants are requested to use the platform daily (or at least 3 times per week) for approximately 10 to 15 minutes per session over a 12-week period. Prior to using the platform, a 1-hour online orientation session will be provided to guide parents on how to support their child's emotional management at home using the digital tool.
Consultations and psychoeducation on child emotional managementBehavioural
A clinical psychologist will provide weekly 30-minute telephone consultations and psychoeducation for parents on child emotional management over a 12-week period. These sessions will focus on discussing real-life situations and establishing coping strategies. (If parents express interest in using the online platform, free access equivalent to the 12-week intervention given to the platform group will be provided after study completion, ensuring their rights and benefits are fully preserved regardless of group assignment.)
| Study group | Role | What they receive |
|---|---|---|
| Online diary platforms group | Experimental | Not described Receives: Device: Generative artificial intelligence assisted diary platform home-based intervention |
| Consultation group | Active comparator | Not described Receives: Behavioral: Consultations and psychoeducation on child emotional management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conners CPT 3™ (The Conners Continuous Performance Test Third Edition™ )
A 14-minute, computerized visual attention assessment that evaluates objective performance to assist in the assessment of ADHD. The test evaluates performance across four primary dimensions: inattentiveness, impulsivity, sustained attention an vigilance.
Measured: (1) Pre-test session to serve as baseline (2) Post-test session immediately after 12weeks
SNAP-IV (Swanson, Nolan, and Pelham, Version IV)
A 26-Item standardized behavior rating scale completed by parents to compare a child's behavior across home and school environments. This scale evaluates inattention, hyperactivity/impulsivity, oppositional defiant/conduct behaviors.
Measured: (1) Pre-test session to serve as baseline (2) Post-test session immediately after 12weeks
BYI-II (Beck Youth Inventories Second Edition)
A standardized psychological assessment designed to evaluate emotional and social impairment in children and adolescents, completed by parents. The BYI-II consists of 100 total items, assesses symptoms of depression, anxiety, anger, disruptive behavior, and self-concept.
Measured: (1) Pre-test session to serve as baseline (2) Post-test session immediately after 12weeks
CBCL Ages 6-18 (Child Behavior Checklist for Ages 6-18)
A standardized questionnaire completed by parents or primary caregivers to evaluate a child's behavioral, emotional, and social functioning over the past 6 months. The questionnaire is divided into competence Items , measures the child's active participation and performance, and problem Items , evaluates emotional and behavioral difficulties, yielding several key groups of scales, including anxious/depressed, withdrawn/depressed, somatic complaints, social problems, thought problems, attention problems, rule-breaking behavior and aggressive behavior.
Measured: (1) Pre-test session to serve as baseline (2) Post-test session immediately after 12weeks
PSI (Parenting Stress Index, 3rd edition)
A questionnaire designed to measure the relative magnitude of stress in the parent-child system for parents of children, completed by parents or primary caregivers to. Consists of 120 items on a 5-point Likert scale divided into two main domains plus an optional life stress measure:
- Child domain (47 items): Evaluates child characteristics across six subscales:
- Distractibility/Hyperactivity
- Adaptability
- Reinforces Parent
- Demandingness
- Mood
- Acceptability (of the child to the parent)
- Parent Domain (54 items): Evaluates parental characteristics across seven subscales:
- Competence
- Isolation
- Attachment
- Health
- Role Restriction
- Depression
- Spouse (relationship with spouse/partner)
- Life Stressors Domain (Optional, 19 items): Measures extraneous/situational life events (e.g., job loss, financial hardship, family moves).
Measured: (1) Pre-test session to serve as baseline (2) Post-test session immediately after 12weeks
Parental Satisfaction Questionnaire
A 24-item questionnaire completed by parents or primary caregivers to understand the actual impact of this training on the child and their parents.
Measured: (1) Pre-test session to serve as baseline (2) Post-test session immediately after 12weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start1 Aug 2026
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for ADHD - Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07922018
- Sponsor's protocol ID
- 202410059RINE
- Status last verified
- Oct 2026
- First submitted
- 1 Nov 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
SU, Shih-Wen, et al. Development of an AI-based system to enhance school counseling models for Asian elementary students with emotional disorders. Ieee Access, 2024, 12: 159121-159136.
SHOKRI, Reza; SHMATIKOV, Vitaly. Privacy-preserving deep learning. In: Proceedings of the 22nd ACM SIGSAC conference on computer and communications security. 2015. p. 1310-1321.
LIU, Bing. Sentiment analysis and opinion mining. Synthesis Lectures on Human Language Technologies, 2012, 5(1), 1-184.
VASWANI, Ashish, et al. Attention is all you need. Advances in neural information processing systems, 2017, 30.
DEVLIN, Jacob, et al. Bert: Pre-training of deep bidirectional transformers for language understanding. In: Proceedings of the 2019 conference of the North American chapter of the association for computational linguistics: human language technologies, volume 1 (long and short papers). 2019. p. 4171-4186.
PANAYIOTOU, Margarita; HUMPHREY, Neil; WIGELSWORTH, Michael. An empirical basis for linking social and emotional learning to academic performance. Contemporary Educational Psychology, 2019, 56: 193-204.
CORCORAN, Roisin P., et al. Effective universal school-based social and emotional learning programs for improving academic achievement: A systematic review and meta-analysis of 50 years of research. Educational Research Review, 2018, 25: 56-72.
SU, Shih-Wen, et al. Application of generative adversarial network algorithm on journaling system with comics and cognitive-behavioral theory in social-emotional learning for intermediate elementary students: A pilot study. In: 2023 IEEE 6th International Conference on Knowledge Innovation and Invention (ICKII). IEEE, 2023. p. 224-228.
YOON, So Young, et al. Effects of Comic Strip Conversations Intervention on Academic Engagement Behaviors of Elementary School Students with Autism Spectrum Disorders. Journal of Behavior Analysis and Support, 2016, 3.1: 69-89.
Sivaratnam CS, Cornish K, Gray KM, Howlin P, Rinehart NJ. Brief report: assessment of the social-emotional profile in children with autism spectrum disorders using a novel comic strip task. J Autism Dev Disord. 2012 Nov;42(11):2505-12. doi: 10.1007/s10803-012-1498-8.
PubMed 22419380Terlouw G, van 't Veer JT, Prins JT, Kuipers DA, Pierie JEN. Design of a Digital Comic Creator (It's Me) to Facilitate Social Skills Training for Children With Autism Spectrum Disorder: Design Research Approach. JMIR Ment Health. 2020 Jul 10;7(7):e17260. doi: 10.2196/17260.
PubMed 32673273MARTIN, Estefania, et al. "Today I tell" a comics and story creation app for people with autism spectrum condition. International Journal of Human-Computer Interaction, 2019, 35.8: 679-691.
李素芬; 陳凱婷. 書寫療癒: 西方表達性書寫與本土心理位移書寫. 輔導季刊, 2016, 52.4: 59-69.
黎士鳴; 陳進鴻; 徐秀菊. 藝術療癒 HEAL-ing 模式初探. 臺灣教育評論月刊, 2023, 12.9: 166-175.
TOEPFER, Nils F., et al. Examining explanatory mechanisms of positive and expressive writing: Towards a resource-oriented perspective. The Journal of Positive Psychology, 2016, 11.2: 124-134.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Generative Artificial Intelligence Assisted Home-based Intervention for Attention Deficient Hyperactivity Disorder (ADHD) Children
- ClinicalTrials.gov ID
- NCT07922018
- Acronym / sponsor ID
- 202410059RINE
- Conditions
- ADHD - Attention Deficit Disorder With Hyperactivity, ADHD - Combined Type, ADHD - Inattentive Type
- Keywords
- Generative artificial intelligence, Home-based intervention, Social emotional learing, Attention-deficit/hyperactivity disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 6 Nov 2026 (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.
The goal of this clinical trial is to evaluate the effectiveness of online diary platforms for socio-emotional learning training in children with attention deficit hyperactivity disorder (ADHD). The main questions it aims to answer are:
Does the online diary platform training enhance children's emotion regulation and its connection to positive thinking? Does the online diary platform training provide an immediate, interactive, and effective emotion training tool during the wait for follow-up visits and treatment?
Researchers will compare online diary platforms training to counselling to see if online diary platforms training enhance children's emotion regulation.
Participants will use the MangaChat diary platform to log their daily moods and events, which the platform transforms into comic strips to offer an engaging visual story of their emotional experiences. Participants are requested to use the platform daily (or at least 3 times per week) for approximately 10 to 15 minutes per session over a 12-week period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online diary platforms group | Experimental | Device: Generative artificial intelligence assisted diary platform home-based intervention |
| Consultation group | Active comparator | Behavioral: Consultations and psychoeducation on child emotional management |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children aged 8-12 years with a professional diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD), who are enrolled in the study only after obtaining informed consent from their parents or legal guardians, as well as the assent of the children themselves.
Key exclusion criteria (4 listed)
- Intellectual disability, defined as a Full Scale Intelligence Quotient (FSIQ) score of less than 70.
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 |
|---|---|---|
| Generative artificial intelligence assisted diary platform home-based interventionParticipants will use the MangaChat diary platform to log their daily moods and events, which the platform transforms into comic strips to offer an engaging visual story of their emotional experiences. Participants are requested to use the platform daily (or at least 3 times per week) for approximately 10 to 15 minutes per session over a 12-week period. Prior to using the platform, a 1-hour online orientation session will be provided to guide parents on how to support their child's emotional management at home using the digital tool. | Device | Online diary platforms group |
| Consultations and psychoeducation on child emotional managementA clinical psychologist will provide weekly 30-minute telephone consultations and psychoeducation for parents on child emotional management over a 12-week period. These sessions will focus on discussing real-life situations and establishing coping strategies. (If parents express interest in using the online platform, free access equivalent to the 12-week intervention given to the platform group will be provided after study completion, ensuring their rights and benefits are fully preserved regardless of group assignment.) | Behavioural | Consultation group |
Primary outcome
Conners CPT 3™ (The Conners Continuous Performance Test Third Edition™ )
Time frame: (1) Pre-test session to serve as baseline (2) Post-test session immediately after 12weeks
A 14-minute, computerized visual attention assessment that evaluates objective performance to assist in the assessment of ADHD. The test evaluates performance across four primary dimensions: inattentiveness, impulsivity, sustained attention an vigilance.
SNAP-IV (Swanson, Nolan, and Pelham, Version IV)
Time frame: (1) Pre-test session to serve as baseline (2) Post-test session immediately after 12weeks
A 26-Item standardized behavior rating scale completed by parents to compare a child's behavior across home and school environments. This scale evaluates inattention, hyperactivity/impulsivity, oppositional defiant/conduct behaviors.
BYI-II (Beck Youth Inventories Second Edition)
Time frame: (1) Pre-test session to serve as baseline (2) Post-test session immediately after 12weeks
A standardized psychological assessment designed to evaluate emotional and social impairment in children and adolescents, completed by parents. The BYI-II consists of 100 total items, assesses symptoms of depression, anxiety, anger, disruptive behavior, and self-concept.
CBCL Ages 6-18 (Child Behavior Checklist for Ages 6-18)
Time frame: (1) Pre-test session to serve as baseline (2) Post-test session immediately after 12weeks
A standardized questionnaire completed by parents or primary caregivers to evaluate a child's behavioral, emotional, and social functioning over the past 6 months. The questionnaire is divided into competence Items , measures the child's active participation and performance, and problem Items , evaluates emotional and behavioral difficulties, yielding several key groups of scales, including anxious/depressed, withdrawn/depressed, somatic complaints, social problems, thought problems, attention problems, rule-breaking behavior and aggressive behavior.
PSI (Parenting Stress Index, 3rd edition)
Time frame: (1) Pre-test session to serve as baseline (2) Post-test session immediately after 12weeks
A questionnaire designed to measure the relative magnitude of stress in the parent-child system for parents of children, completed by parents or primary caregivers to. Consists of 120 items on a 5-point Likert scale divided into two main domains plus an optional life stress measure: 1. Child domain (47 items): Evaluates child characteristics across six subscales: * Distractibility/Hyperactivity * Adaptability * Reinforces Parent * Demandingness * Mood * Acceptability (of the child to the parent) 2. Parent Domain (54 items): Evaluates parental characteristics across seven subscales: * Competence * Isolation * Attachment * Health * Role Restriction * Depression * Spouse (relationship with spouse/partner) 3. Life Stressors Domain (Optional, 19 items): Measures extraneous/situational life events (e.g., job loss, financial hardship, family moves).
Parental Satisfaction Questionnaire
Time frame: (1) Pre-test session to serve as baseline (2) Post-test session immediately after 12weeks
A 24-item questionnaire completed by parents or primary caregivers to understand the actual impact of this training on the child and their parents.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- BackgroundSU, Shih-Wen, et al. Development of an AI-based system to enhance school counseling models for Asian elementary students with emotional disorders. Ieee Access, 2024, 12: 159121-159136.
- BackgroundSHOKRI, Reza; SHMATIKOV, Vitaly. Privacy-preserving deep learning. In: Proceedings of the 22nd ACM SIGSAC conference on computer and communications security. 2015. p. 1310-1321.
- BackgroundLIU, Bing. Sentiment analysis and opinion mining. Synthesis Lectures on Human Language Technologies, 2012, 5(1), 1-184.
- BackgroundVASWANI, Ashish, et al. Attention is all you need. Advances in neural information processing systems, 2017, 30.
- BackgroundDEVLIN, Jacob, et al. Bert: Pre-training of deep bidirectional transformers for language understanding. In: Proceedings of the 2019 conference of the North American chapter of the association for computational linguistics: human language technologies, volume 1 (long and short papers). 2019. p. 4171-4186.
- BackgroundPANAYIOTOU, Margarita; HUMPHREY, Neil; WIGELSWORTH, Michael. An empirical basis for linking social and emotional learning to academic performance. Contemporary Educational Psychology, 2019, 56: 193-204.
- BackgroundCORCORAN, Roisin P., et al. Effective universal school-based social and emotional learning programs for improving academic achievement: A systematic review and meta-analysis of 50 years of research. Educational Research Review, 2018, 25: 56-72.
- BackgroundSU, Shih-Wen, et al. Application of generative adversarial network algorithm on journaling system with comics and cognitive-behavioral theory in social-emotional learning for intermediate elementary students: A pilot study. In: 2023 IEEE 6th International Conference on Knowledge Innovation and Invention (ICKII). IEEE, 2023. p. 224-228.
- BackgroundYOON, So Young, et al. Effects of Comic Strip Conversations Intervention on Academic Engagement Behaviors of Elementary School Students with Autism Spectrum Disorders. Journal of Behavior Analysis and Support, 2016, 3.1: 69-89.
- Background: PubMed 22419380Sivaratnam CS, Cornish K, Gray KM, Howlin P, Rinehart NJ. Brief report: assessment of the social-emotional profile in children with autism spectrum disorders using a novel comic strip task. J Autism Dev Disord. 2012 Nov;42(11):2505-12. doi: 10.1007/s10803-012-1498-8.
- Background: PubMed 32673273Terlouw G, van 't Veer JT, Prins JT, Kuipers DA, Pierie JEN. Design of a Digital Comic Creator (It's Me) to Facilitate Social Skills Training for Children With Autism Spectrum Disorder: Design Research Approach. JMIR Ment Health. 2020 Jul 10;7(7):e17260. doi: 10.2196/17260.
- BackgroundMARTIN, Estefania, et al. "Today I tell" a comics and story creation app for people with autism spectrum condition. International Journal of Human-Computer Interaction, 2019, 35.8: 679-691.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Generative artificial intelligence assisted diary platform home-based intervention and Consultations and psychoeducation on child emotional management in people with ADHD - Attention Deficit Disorder With Hyperactivity and ADHD - Combined Type, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 6 Nov 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pou-Leng Cheong, PhD (+886 972654171, cheong.pouleng@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conners CPT 3™ (The Conners Continuous Performance Test Third Edition™ ) (time frame: (1) Pre-test session to serve as baseline (2) Post-test session immediately after 12weeks). The study lists 6 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 NCT07922018, which also lists 27 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 6 Nov 2026.