UMIN-CTR Clinical Trial

Basic information
Public title	Effectiveness of a parent training program: Towards improving daily living skills of teens with Autism Spectrum Disorder
Acronym	Effectiveness of a parent training program in adolescence
Scientific Title	Effectiveness of a parent training program: Towards improving daily living skills of teens with Autism Spectrum Disorder
Scientific Title:Acronym	Effectiveness of a parent training program in adolescence
Region	Japan

Condition
Condition	Autism Spectrum Disorders
Classification by specialty	Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study examine the efficacy of the Parent Training (PT) for Japanese adolescents with Autism Spectrum Disorder (ASD)
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	On children ChildBehaviorChecklist:Achenbach,2001 SocialResponsivenessScale-2:Constantino,Gruber,2012 CANTAB Vineland Adaptive Behavior Scales Second Edition OnParents Parent`sConfidenceDegree;Iwasaka,2001 Beck Depression Inventory 2edition Parentinf Stress Index
Key secondary outcomes

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	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Participants are divided into the Immediate Treatment (IT) and Delayed Treatment Control (DTC) groups. OnePT course comprised six consecutive sessions and was completed within three months.Each sessions are 90-minute with groups of 3-5 participants. The sessions consisted mainly of training for parenting skills,understanding the children`s inappropriate behaviors,and helping the children adapt to school.
Interventions/Control_2	Delayed Treatment Control (DTC)Group The DTC group receive PT after a waiting period of three months.
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	10 years-old <
Age-upper limit	15 years-old >
Gender	Male and Female
Key inclusion criteria	Child participants are required a comprehensive assessments for a diagnosis of ASD by pediatricians in accordance with DSM-5(APA,2013) as well as by certified clinical psychologists using ADOS-G(Lord et al.,2000).
Key exclusion criteria	children receiving other types of behavioral intervention are excluded Having issues that need to be addressed immediately at the time of the commencement of PT (abuse etc.).
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hiroko OKUNO
Organization	United Graduate school of child Development
Division name	United Graduate school of child Development
Zip code
Address	2-2Yamadaoka, Suita city,Osaka 565-0871
TEL	0668793863
Email	okuno.h@kokoro.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Hiroko OKUNO
Organization	United Graduate school of child Development
Division name	United Graduate school of child Development
Zip code
Address	2-2Yamadaoka, Suita city,Osaka 565-0871
TEL	0668793863
Homepage URL
Email	okuno.h@kokoro.med.osaka-u.ac.jp

Sponsor
Institute	osaka University
Institute
Department

Funding Source
Organization	Osaka University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2018 Year 09 Month 10 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	2018 Year 07 Month 18 Day
Date of IRB
Anticipated trial start date	2018 Year 08 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	2018 Year 07 Month 17 Day
Last modified on	2018 Year 07 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038095

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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