UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025350 |
|---|---|
| Receipt number | R000029182 |
| Scientific Title | Efficacy of Relationship Developmental Intervention program in the treatment of Autism Spectrum Disorder |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2016/12/21 15:20:45 |
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Basic information
Public title
Efficacy of Relationship Developmental Intervention program in the treatment of Autism Spectrum Disorder
Acronym
Efficacy of Relationship Developmental Intervention program
Scientific Title
Efficacy of Relationship Developmental Intervention program in the treatment of Autism Spectrum Disorder
Scientific Title:Acronym
Efficacy of Relationship Developmental Intervention program
Region
| Japan |
Condition
Condition
Autism Spectrum Disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To detect the efficacy of Relationship Developmental Intervention
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Vineland Adaptive Behavior Scales, Second Edition(1 and 2 year after Intervention)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Relationship Developmental Intervention for 1 year
Interventions/Control_2
Interventions/Control_3
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
| 4 | years-old | <= |
Age-upper limit
| 6 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Diagnosed as Autism Spectrum Disorder using ADOS-2, ADI-R, PARS-TR, DSM-5 by research team.
2.Patient who have not experienced RDI.
Key exclusion criteria
1.IQ scores less than 70
2.Major physical problems, significan sensory or motor impairment
3.Apparent genetic disorder
4.History of a serious head injury and/or nuerologic disease
5.Seizures of past history
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Manabu Takaki |
Organization
Okayama University Graduate school of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Neuropsychiatry
Zip code
Address
2-5-1, Shikata-cyo, kitaku, Okayama Japan, Zip 700-8558
TEL
0862357242
manabuta@cc.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makiko Kishimoto |
Organization
Okayama University Graduate school of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Neuropsychiatry
Zip code
Address
2-5-1, Shikata-cyo, kitaku, Okayama Japan, Zip 700-8558
TEL
0862357242
Homepage URL
kiko973@hb.tp1.jp
Sponsor or person
Institute
Okayama University Graduate school of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department
Personal name
Funding Source
Organization
The Foundation of Growth Science
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 21 | Day |
Last modified on
| 2016 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029182
