UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038566 |
|---|---|
| Receipt number | 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 | 2022/11/15 09:11:46 |
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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
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
itapan322@gmail.com
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037284
