UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060846 |
|---|---|
| Receipt number | R000069621 |
| Scientific Title | Guided Internet-delivered Cognitive Behavioral Therapy for Children with ADHD: A Multicenter Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/03/06 |
| Last modified on | 2026/03/06 12:38:31 |
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Basic information
Public title
Guided Internet-delivered Cognitive Behavioral Therapy for Children with ADHD: A Multicenter Randomized Controlled Trial
Acronym
Guided ICBT for Children with ADHD
Scientific Title
Guided Internet-delivered Cognitive Behavioral Therapy for Children with ADHD: A Multicenter Randomized Controlled Trial
Scientific Title:Acronym
Guided ICBT for Children with ADHD
Region
| Japan | Europe |
Condition
Condition
Attention-Deficit/Hyperactivity Disorder
Classification by specialty
| Pediatrics | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the efficacy and safety of a therapist-guided internet-delivered cognitive behavioral therapy program involving parents for children with attention-deficit/hyperactivity disorder in a multicenter randomized controlled trial.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in ADHD symptom severity based on the parent-rated ADHD Rating Scale-5 total score
Key secondary outcomes
ADHD Rating Scale-5: Inattention and Hyperactivity-Impulsivity
SNABB: ADHD monitoring scale
SDQ: Strengths and Difficulties Questionnaire
DSRS-C: Depression Self-Rating Scale for Children
SCAS: Spence Children's Anxiety Scale
Conners 3: Conners 3rd Edition
PSI-SF: Parenting Stress Index-Short Form
PHQ-9: Patient Health Questionnaire-9
GAD-7: Generalized Anxiety Disorder-7
WAI-SF: Working Alliance Inventory-Short Form
CSQ-8: Client Satisfaction Questionnaire-8
CGI: Clinical Global Impression
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
Therapist-guided internet-delivered cognitive behavioral therapy program
Interventions/Control_2
Sham control program consisting of internet-delivered psychoeducation and related components
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 6 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Children
Diagnosed with attention-deficit/hyperactivity disorder (ADHD) by a pediatrician or psychiatrist based on DSM-5-TR criteria.
Aged 6 to 15 years at the time of consent (elementary or junior high school students).
Receiving regular outpatient care at a pediatric or psychiatric clinic.
Pharmacological treatment is allowed; however, there are no plans to initiate or change medication during the study period.
Parents
Able to read and write Japanese sufficiently to participate in the program.
Living with the target child and not planning to move out during the study period.
Own and routinely use a computer, tablet, or smartphone.
Have access to the internet.
Have not received psychosocial interventions for children with neurodevelopmental disorders (e.g., parent training, CBT, social skills training) within the past 12 months.
Key exclusion criteria
Children
Diagnosis of severe organic brain disease or post-traumatic stress disorder (PTSD).
Full-scale IQ (FSIQ) below 80.
Severe autism spectrum disorder (ASD) with behavioral difficulties judged to make behavioral modification difficult.
Imminent risk of suicide.
Currently experiencing school refusal or school absenteeism, including reluctance to attend school, refusal to attend school, or attending a separate classroom.
Cases in which child consultation centers, administrative agencies, or social workers are involved, and environmental adjustment or safety management is prioritized.
Parents
Presence of serious mental disorders, including organic brain disorders (e.g., intellectual disability or dementia), psychotic disorders, PTSD, or substance dependence.
Imminent risk of suicide or significant risk of self-harm or harm to others.
Presence of a serious progressive physical illness.
Pregnant women, those who may be pregnant, or parents planning pregnancy or childbirth within one year.
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Yoshifumi |
| Middle name | |
| Last name | Mizuno |
Organization
University of Fukui
Division name
Research Center for Child Mental Development
Zip code
9101193
Address
23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui 910-1193, Japan
TEL
0776-61-8707
mizunoy@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | Sayo |
| Middle name | |
| Last name | Hamatani |
Organization
University of Fukui
Division name
Research Center for Child Mental Development
Zip code
9101193
Address
23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui 910-1193, Japan
TEL
0776-61-8707
Homepage URL
https://www.iterapi.se/sites/carp/
sayoh@u-fukui.ac.jp
Sponsor or person
Institute
University of Fukui
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology (MEXT)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Chiba University
Dokkyo Medical University Saitama Medical Center
Tokyo Medical University
Jichi Medical University
Nagoya City University
Osaka University
Tokushima University
Kagoshima University
Hiratani Child Development Clinic
Linkoping University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Research Ethics Committee of University of Fukui
Address
23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui 910-1193, Japan
Tel
0776-61-8529
chiken@ml.u-fukui.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 12 | Month | 21 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 16 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 10 | Day |
Last follow-up date
| 2027 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 03 | Month | 06 | Day |
Last modified on
| 2026 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069621
