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 UMIN000038566
Receipt No. R000037284
Scientific Title An investigation of symptom change based on biological and behavioral data in children with developmental disorder centering on the child-parent relationship
Date of disclosure of the study information 2019/11/13
Last modified on 2019/11/13

* 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
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 showa-crc@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 Enrolling by invitation
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
2019 Year 11 Month 13 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.