UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032859
Receipt No. R000037471
Official scientific title of the study 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 2018/06/06

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Official scientific title of the study 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
Title of the study (Brief title) 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 Yuta Aoki
Organization Showa University
Division name Medical Institute of Developmental Disabilities Research
Address 6-11-11 Kitakarasuyama, Setagaya, Tokyo, Japan
TEL 03-5315-9357
Email yuta.aoki@med.showa-u.ac.jp

Public contact
Name of contact person Takashi Itahashi
Organization Showa University
Division name Medical Institute of Developmental Disabilities Research
Address 6-11-11 Kitakarasuyama, Setagaya, Tokyo
TEL 03-5315-9357
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
Name of secondary funder(s)

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

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2018 Year 06 Month 04 Day
Anticipated trial start date
2018 Year 06 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 06 Month 04 Day
Last modified on
2018 Year 06 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037471

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.