UMIN-CTR Clinical Trial

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
Email	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
Email	ita3@med.showa-u.ac.jp

Sponsor
Institute	Showa University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037471