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

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 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

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

Value
https://center6.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