UMIN-CTR Clinical Trial

Basic information
Public title	Effectiveness of cognitive behavior therapy for pediatric obsessive compulsive disorder
Acronym	Effectiveness of cognitive behavior therapy for pediatric obsessive compulsive disorder
Scientific Title	Effectiveness of cognitive behavior therapy for pediatric obsessive compulsive disorder
Scientific Title:Acronym	Effectiveness of cognitive behavior therapy for pediatric obsessive compulsive disorder
Region	Japan

Condition
Condition	obsessive-compulsive disorder
Classification by specialty	Psychosomatic Internal Medicine Pediatrics Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine effectiveness of cognitive behavioral therapy for pediatric obsessive-compulsive disorder in Japanese clinical setting
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Children's Yale- Brown Obsessive-Compulsive Scale; CYBOCS
Key secondary outcomes	Depression Self-Rating Scale for Children; DSRS-C Spence Children's Anxiety Scale; SCAS Child Behavior Checklist; CBCL

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	Maneuver
Interventions/Control_1	Cognitive behavioral therapy
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	10 years-old <=
Age-upper limit	16 years-old >=
Gender	Male and Female
Key inclusion criteria	Primary diagnosis of obsessive-compulsive disorder
Key exclusion criteria	Individual with who have histories of substance abuse, active sucidality, severe mental and physical condition, intelligence quotient < 80, Schizophrenia, Mood disorder, Antisocial Personality Disorder, Borderline Personality Disorder
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Akiko Middle name Last name Nakagawa
Organization	Graduate School of Medicine, Chiba University
Division name	Research Center for Child Mental Development
Zip code	2608670
Address	1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL	043-226-2975
Email	akikon@chiba-u.jp

Public contact
Name of contact person	1st name Masaru Middle name Last name Kuno
Organization	Chiba University
Division name	Research Center for Child Mental Development
Zip code	2608670
Address	1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL	043-226-2975
Homepage URL
Email	m-kuno@chiba-u.jp

Sponsor
Institute	Research Center for Child Mental Development, Graduate School of Medicine, Chiba University
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
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	Graduate School of Medicine, Chiba University
Address	1-8-1 Inohana, Chuo-ku, Chiba, Japan
Tel	043-222-7171
Email	igaku-rinri@office.chiba-u.jp

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	千葉大学医学部付属病院

Other administrative information
Date of disclosure of the study information	2013 Year 08 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	26
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	Completed
Date of protocol fixation	2013 Year 07 Month 30 Day
Date of IRB	2012 Year 04 Month 01 Day
Anticipated trial start date	2013 Year 08 Month 10 Day
Last follow-up date	2020 Year 07 Month 17 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 07 Month 10 Day
Last modified on	2022 Year 01 Month 19 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013033