UMIN-CTR Clinical Trial

Basic information
Public title	An investigation of symptom change based on biological and behavioral data in children with developmental disorder centering on the child-parent relationship
Acronym	Biological and Behavioral Development in Developmental Disorder
Scientific Title	An investigation of symptom change based on biological and behavioral data in children with developmental disorder centering on the child-parent relationship
Scientific Title:Acronym	Biological and Behavioral Development in Developmental Disorder
Region	Japan

Condition
Condition	Children with developmental disorder, infants at 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 elucidate association between symptom change and biological and behavioral changes in children with developmental disorder and infants at high risk of developmental disorder.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Psychological tests Neuroimaging Gene information Behavioral data
Key secondary outcomes	Questionnaires

Base
Study type	Interventional

Study design
Basic design	Parallel
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	Device,equipment
Interventions/Control_1	children with developmental disorder
Interventions/Control_2	Siblings of children with developmental disorder
Interventions/Control_3	Parents of children with developmental disorder
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	Children with developmental disorder 1) Children who are diagnosed as either of ASD or ADHD 2) Individuals who do not have any other neurological or psychiatric disorders 3) Children who have parental consent Siblings of children with developmental disorder 1) Children who are siblings of children with DD 2) Individuals who do not have any other neurological or psychiatric disorders 3) Children who have parental consent Parents 1) Individuals who have children with DD 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) 7) with pregnancy and at risk of becoming pregnant 8) Subjects who are judged as unsuitable for participation in this study by their primary doctor
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Takashi Middle name Last name Itahashi
Organization	Showa University
Division name	Medical Institute of Developmental Disabilities Research
Zip code	157-0057
Address	6-11-11 Kita-karasuyama, Setagaya-ku, Tokyo, Japan
TEL	03-3300-5231
Email	itapan322@gmail.com

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	157-0057
Address	6-11-11 Kita-karasuyama, Setagaya-ku, Tokyo, Japan
TEL	03-3300-5231
Homepage URL
Email	itapan322@gmail.com

Sponsor
Institute	Showa University
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	National Center for Child Health and Development Hospital
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	YES
Study ID_1	1801
Org. issuing International ID_1	National Center for Child Health and Development Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2019 Year 11 Month 13 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	Completed
Date of protocol fixation	2019 Year 09 Month 10 Day
Date of IRB	2018 Year 03 Month 15 Day
Anticipated trial start date	2019 Year 09 Month 10 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	2019 Year 11 Month 13 Day
Last modified on	2022 Year 11 Month 15 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037284