UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033414 |
|---|---|
| Receipt number | 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 16:20:47 |
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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
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
okuno.h@kokoro.med.osaka-u.ac.jp
Sponsor or person
Institute
osaka University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038095
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
