UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of treatment with traumatized children
Title of the study (Brief title)	Study of treatment with traumatized children
Region	Japan

Condition
Condition	psychiatric disorder
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aims of this study were to determine the efficacy of TF-CBT with children who have experienced traumatic events and suffer from trauma-related disorders.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1.CAPS(Clinician-Administered PTSD Scale) 2.UPID(UCLA PTSD Index for DSM-4 Japanese version) 3.TSCC-A(Trauma Symptom Checklist for Children-A) 4.CBCL(Child Behavior Checklist)
Key secondary outcomes

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	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	Trauma focused Cognitive behavioral therapy 40min 8-16times
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	3 years-old <=
Age-upper limit	18 years-old >=
Gender	Male and Female
Key inclusion criteria	child who have experienced traumatic events and suffer from trauma-related disorders.
Key exclusion criteria	patients with psychosis, history of suicide attempt, or any signicant behavioral problems, including those with aggressive and/or antisocial behaviors that cause signicant impairment in social, academic, or other important areas of functioning.
Target sample size	30

Research contact person
Name of lead principal investigator	Yoshitaka Iwadare
Organization	National Center of Global Health and Medicine, Kohnodai Hospital
Division name	Child and Adolescent Psychiatry
Address	1-7-1 kohnodai ichikawa chiba
TEL	0473723501
Email	diwadare@hospk.ncgm.go.jp

Public contact
Name of contact person	Yoshitaka Iwadare
Organization	National Center of Global Health and Medicine, Kohnodai Hospital
Division name	Child and Adolescent Psychiatry
Address	1-7-1 kohnodai ichikawa chiba
TEL	0473723501
Homepage URL
Email	diwadare@hospk.ncgm.go.jp

Sponsor
Institute	National Center of Global Health and Medicine
Institute
Department

Funding Source
Organization	National Center of Global Health and Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

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	2016 Year 07 Month 30 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 06 Month 08 Day
Anticipated trial start date	2015 Year 06 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 07 Month 16 Day
Last modified on	2018 Year 07 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026729