UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032859 |
|---|---|
| Receipt number | R000037471 |
| Scientific Title | An investigation of longitudinal changes in the severity of symptoms based on behaviors, neuroimaging, and biosamples in children with developmental disorder centered on the child-parent relationships |
| Date of disclosure of the study information | 2018/06/04 |
| Last modified on | 2021/12/10 10:27:38 |
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Basic information
Public title
An investigation of longitudinal changes in the severity of symptoms based on behaviors, neuroimaging, and biosamples in children with developmental disorder centered on the child-parent relationships
Acronym
Child biobehavioral development study
Scientific Title
An investigation of longitudinal changes in the severity of symptoms based on behaviors, neuroimaging, and biosamples in children with developmental disorder centered on the child-parent relationships
Scientific Title:Acronym
Child biobehavioral development study
Region
| Japan |
Condition
Condition
Children with developmental disorder, children at the high risk of developmental disorder, and their biological parents
Classification by specialty
| Pediatrics | Psychiatry | Adult |
| Child |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To investigate the developmental trajectories of the brain, behaviors, and genetic informations using a longitudinal design.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Neuroimaging, genetic information, and behavioral data
Key secondary outcomes
Psychological tests, questionnaires
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Diagnosis
Type of intervention
| Gene | Device,equipment | Behavior,custom |
Interventions/Control_1
Children with developmental disorder
Interventions/Control_2
Infants/children at high risk of developmental disorder
Interventions/Control_3
Biological parents
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 | months-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Infants/Children at high risk of developmental disorder
(1) Infants/children who have brothers/sisters diagnosed as either of ASD or ADHD
(2) Individuals who do not have any other neurological or psychiatric disorders
(3) Infants/children whose guardians fully understand the contents of this study and gave the consent.
Children with developmental disorder
(1) Child who is diagnosed as either of ASD or ADHD
(2) Individuals who do not have any other neurological or psychiatric disorders
(3) Children whose guardians fully understand the contents of this study and gave the consent.
Parents
(1) Individuals who are the biological parents of children with developmental disorders and at the high risk of developmental disorder
(2) Individuals who do not have any other neurological or psychiatric disorders
(3) Individuals who have capability of informed consent
Key exclusion criteria
1) with implanted cardiac pacemaker
2) with surgical aneurysm clips
3) with neurostimulator
4) with implanted pumps
5) with metal fragments in body
6) with tattoos, permanent eyeliner (if ink contains metallic specks)
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yuta |
| Middle name | |
| Last name | Aoki |
Organization
Showa University
Division name
Medical Institute of Developmental Disabilities Research
Zip code
157-8577
Address
6-11-11 Kitakarasuyama, Setagaya, Tokyo, Japan
TEL
03-3300-5231
yuta.aoki@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Itahashi |
Organization
Showa University
Division name
Medical Institute of Developmental Disabilities Research
Zip code
157-8577
Address
6-11-11 Kitakarasuyama, Setagaya, Tokyo
TEL
03-3300-5231
Homepage URL
ita3@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Center for Child Health and Development
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Showa University, Karasuyama Hospital
Address
6-11-11 Kitakarasuyama,Setagaya-ku,Tokyo,157-8577 Japan
Tel
03-3300-5247
scri@ofc.showa-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
昭和大学発達障害医療研究所（東京都）、国立成育医療研究センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | Month | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 06 | Month | 04 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 04 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 06 | Month | 04 | Day |
Last modified on
| 2021 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037471
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