UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010699 |
|---|---|
| Receipt number | 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 09:23:23 |
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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
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/
kensyu@j-hits.org
Sponsor or person
Institute
Hyogo Earthquake Memorial 21th Century Research Institute
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012501
