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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030012
Receipt No. R000033373
Scientific Title Case study on trauma-focused cognitive behavioral therapy to children with pervasive developmental disorder with trauma in Japan
Date of disclosure of the study information 2018/01/01
Last modified on 2017/12/06

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Basic information
Public title Case study on trauma-focused cognitive behavioral therapy to children with pervasive developmental disorder with trauma in Japan
Acronym Case study on trauma-focused cognitive behavioral therapy to children with pervasive developmental disorder with trauma
Scientific Title Case study on trauma-focused cognitive behavioral therapy to children with pervasive developmental disorder with trauma in Japan
Scientific Title:Acronym Case study on trauma-focused cognitive behavioral therapy to children with pervasive developmental disorder with trauma
Region
Japan

Condition
Condition Post Traumatic Stress Disorder
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this case study is to exam Trauma focused cognitive behavioral
therapy (TF-CBT) on autism spectrum disorder children with trauma.
Basic objectives2 Others
Basic objectives -Others exploratory study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The difference of the score on UCLA PTSD-RI between pre and post intervention.
Key secondary outcomes The difference of the score on Depression Self-Rating Scale for Children between pre and post intervention.

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 The TF-CBT program uses a component-based cognitive behavioral approach over 8-18 sessions. Each session is held once a week and lasts 80-90 minutes. Each component is offered to the child and caregiver in both parallel and joint sessions, and are flexibly adjusted for each session.
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
7 years-old <=
Age-upper limit
15 years-old >=
Gender Male and Female
Key inclusion criteria 1. being diagnosed pervasive developmental disorder
2. Meets the criteria of PTSD on DSM-5; meets A criteria and more than one on B, C, D criteria.
Key exclusion criteria 1. disruptive behavior, such as rebellion, disobedience, aggressiveness or illegal acts is dominant
2. serious depression or suicidal thoughts are in foreground
3. substance abuse is in foreground
Target sample size 3

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Saeko SAKAI
Organization Osaka University
Division name United Graduate School of Child Development
Zip code
Address 2-2 Yamada-oka, Suita
TEL 06-6879-3863
Email sakai@ugscd.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Saeko SAKAI
Organization Osaka University
Division name United Graduate School of Child Development
Zip code
Address 2-2 Yamada-oka, Suita
TEL 06-6879-3863
Homepage URL
Email sakai@ugscd.osaka-u.ac.jp

Sponsor
Institute Osaka University
Institute
Department

Funding Source
Organization not applicable
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 01 Month 01 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
2017 Year 11 Month 21 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 15 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
2017 Year 11 Month 17 Day
Last modified on
2017 Year 12 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033373

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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