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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | Autism Spectrum Disorders | |
Classification by specialty |
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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 |
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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. |
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Interventions/Control_2 | Delayed Treatment Control (DTC)Group
The DTC group receive PT after a waiting period of three months. |
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Interventions/Control_3 | ||
Interventions/Control_4 | ||
Interventions/Control_5 | ||
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Interventions/Control_7 | ||
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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Name of lead principal investigator |
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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 |
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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 | |
Institute | osaka University |
Institute | |
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Funding Source | |
Organization | Osaka University |
Organization | |
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Category of Funding Organization | Other |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
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IND to MHLW |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Baseline Characteristics | |
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Progress | |||||||
Recruitment status | Preinitiation | ||||||
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Management information | |||||||
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Last modified on |
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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 |