UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of Relationship Developmental Intervention program in the treatment of Autism Spectrum Disorder
Title of the study (Brief title)	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	Manabu Takaki
Organization	Okayama University Graduate school of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Department of Neuropsychiatry
Address	2-5-1, Shikata-cyo, kitaku, Okayama Japan, Zip 700-8558
TEL	0862357242
Email	manabuta@cc.okayama-u.ac.jp

Public contact
Name of contact person	Makiko Kishimoto
Organization	Okayama University Graduate school of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Department of Neuropsychiatry
Address	2-5-1, Shikata-cyo, kitaku, Okayama Japan, Zip 700-8558
TEL	0862357242
Homepage URL
Email	kiko973@hb.tp1.jp

Sponsor
Institute	Okayama University Graduate school of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2019 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029182