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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010699
Receipt No. R000012501
Scientific Title Randomized controlled trial on the efficacy of the Trauma-Focused Cognitive Behavioral Therapy for children with posttraumatic stress disorder
Date of disclosure of the study information 2013/05/13
Last modified on 2019/05/17

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Basic information
Public title Randomized controlled trial on the efficacy of the Trauma-Focused Cognitive Behavioral Therapy for children with posttraumatic stress disorder
Acronym RCT of TF-CBT for child PTSD
Scientific Title Randomized controlled trial on the efficacy of the Trauma-Focused Cognitive Behavioral Therapy for children with posttraumatic stress disorder
Scientific Title:Acronym RCT of TF-CBT for child PTSD
Region
Japan

Condition
Condition Posttraumatic Stress Disorder(PTSD)
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the efficacy of the Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) for children with PTSD by comparing posttreatment outcomes including the PTSD symptoms change between groups of TF-CBT and TAU in a RCT design.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The severity of PTSD symptoms measured by the K-SADS-pl
Key secondary outcomes 1.PTSD diagnosis confirmed by the K-SADS- pl
2.The severity of PTSD symptoms measured by the UPID
3.Psychological symptoms other than PTSD,i.e., DSRS-C, & SCAS for a child, CBCL, BDI, STAI, WHO QOL26, UPID for parents

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 TF-CBT
Interventions/Control_2 Treatment as usual
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
6 years-old <=
Age-upper limit
18 years-old >=
Gender Male and Female
Key inclusion criteria 1.Meet A and F criteria of DSM-4 PTSD with at least one symptom in each of the B, C, D symptom clusters
2.Have a parent or other caretaker (including a long-term foster parent) who is available in treatment sessions.
3.Fixed medication regimen for at least 8 weeks prior to the treatrment
Key exclusion criteria 1.Comorbidity of active psychotic symptoms and/or substance abuse
2.Presence of severe depressive symptoms and/or serious suicidal risk
3.Presence of oppositional attitude, severe aggression and/or antisocial behaviors
4.A parent of a caretaker who will participant in treatment has 1, 2, and/or 3
5.Apparent developmental disorder of a child or parent/caretaker
6.Receiving psychotherapy outside of the study
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Satomi
Middle name
Last name Kameoka
Organization Hyogo Institute for Traumatic Stress
Division name Research Division
Zip code 651-007
Address 1-3-2 Wakinohama-Kaigandori Chuo-ku, Kobe, Hyogo, 651-0073, JAPAN
TEL 078-200-3010
Email kameoka@j-hits.org

Public contact
Name of contact person
1st name Satomi
Middle name
Last name Kameoka
Organization Hyogo Institute for Traumatic Stress
Division name Research Division
Zip code 5720014
Address Neyagawa
TEL 09088214049
Homepage URL http://www.j-hits.org/
Email kensyu@j-hits.org

Sponsor
Institute Hyogo Earthquake Memorial 21th Century Research Institute
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor The Victim Support Center of Tokyo
Tokyo Metropolitan Institute of Medical Science
Name of secondary funder(s)

IRB Contact (For public release)
Organization IRB in Hyogo Institute for Traumatic Stress
Address 1-3-2 Wakinohama-Kaigandori, Chuo-ku, Kobe, Hyogo, 651-0073, JAPAN
Tel +81-78-200-3010
Email Eiko_Kamino@j-hits.org

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 公益財団法人ひょうご震災記念21世紀研究機構 兵庫県こころのケアセンター附属診療所(兵庫県)
公益財団法人被害者支援都民センター(東京都)

Other administrative information
Date of disclosure of the study information
2013 Year 05 Month 13 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 Completed
Date of protocol fixation
2013 Year 04 Month 14 Day
Date of IRB
2013 Year 06 Month 01 Day
Anticipated trial start date
2013 Year 06 Month 15 Day
Last follow-up date
2019 Year 03 Month 30 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 05 Month 12 Day
Last modified on
2019 Year 05 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012501

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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