UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060464 |
|---|---|
| Receipt number | R000069160 |
| Scientific Title | Transdiagnostic child mental health trajectories in Japan: a nationwide web-based longitudinal open cohort study |
| Date of disclosure of the study information | 2026/01/28 |
| Last modified on | 2026/01/27 17:16:08 |
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Basic information
Public title
Child Mental Health Cohort Study
Acronym
J-TRAC
Scientific Title
Transdiagnostic child mental health trajectories in Japan: a nationwide web-based longitudinal open cohort study
Scientific Title:Acronym
J-TRAC (Japan Transdiagnostic Research on Adolescent and Child Mental Health)
Region
| Japan |
Condition
Condition
Child and adolescent mental health problems (transdiagnostic mental health symptoms) and neurodevelopmental disorders
Classification by specialty
| Pediatrics | Psychiatry | Child |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
This study is a prospective longitudinal observational study. Mental health trajectories will be assessed using questionnaire-based surveys, with optional saliva-based genetic and epigenetic analyses conducted in a subset of participants.
Basic objectives2
Others
Basic objectives -Others
This study is a prospective longitudinal observational study. Mental health trajectories will be assessed using questionnaire-based surveys, with optional saliva-based genetic and epigenetic analyses conducted in a subset of participants.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Longitudinal changes in child and adolescent mental health indicators assessed using validated standardized questionnaires (e.g., Strengths and Difficulties Questionnaire [SDQ], Patient Health Questionnaire-9 [PHQ-9/PHQ-9a], and Generalized Anxiety Disorder-7 [GAD-7]) at baseline and annual follow-up assessments.
Key secondary outcomes
Key secondary outcomes assessed at baseline and annual follow-up include:
Incidence or worsening of mental health problems based on questionnaire scores exceeding established clinical cut-offs;
Caregiver-reported new diagnoses of mental disorders;
School attendance and school functioning;
Differences in mental health trajectories according to neurodevelopmental disorder status;
Associations between mental health indicators and familial, school, and psychosocial factors;
Associations between genetic indicators (in participants providing saliva samples) and mental health outcomes.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 1 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Caregivers and their children residing in Japan
Caregivers aged 18 years or older
Children aged from birth (0 years) to 18 years at enrollment
Ability to participate in web-based surveys
Provision of electronic informed consent (and assent, where applicable)
Key exclusion criteria
Inability to understand the study information or complete questionnaires in Japanese
Inability to participate in web-based surveys using a smartphone, tablet, or computer
Any condition judged by the investigators to make participation inappropriate
Target sample size
7000
Research contact person
Name of lead principal investigator
| 1st name | Kuriko |
| Middle name | |
| Last name | Shimono |
Organization
The University of Osaka
Division name
United Graduate School of Child Development
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Osaka
TEL
06-6879-3347
shimono.kuriko.ugscd@osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Yamada |
Organization
The University of Osaka
Division name
United Graduate School of Child Development
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Osaka
TEL
06-6879-3347
Homepage URL
yamada.takashi.ugscd@osaka-u.ac.jp
Sponsor or person
Institute
The University of Osaka
Institute
Department
Personal name
Funding Source
Organization
the OU Master Plan Implementation Project
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The University of Osaka Hospital Review Board
Address
2-2 Yamadaoka, Suita, Osaka
Tel
06-6210-8296
rin-sokatu@dmi.med.osaka-u.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 | 01 | Month | 28 | 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
Terminated
Date of protocol fixation
| 2025 | Year | 12 | Month | 26 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2035 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study has been transferred to the Japan Registry of Clinical Trials (jRCT), a WHO-recognized primary registry.
This update reflects an administrative transfer of registration from UMIN-CTR to jRCT and does not indicate termination of the study.
jRCT registration number: jRCT1050250205
Management information
Registered date
| 2026 | Year | 01 | Month | 26 | Day |
Last modified on
| 2026 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069160
