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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033414
Receipt No. R000038095
Scientific Title Effectiveness of a parent training program: Towards improving daily living skills of teens with Autism Spectrum Disorder
Date of disclosure of the study information 2018/09/10
Last modified on 2018/07/26

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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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