UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030012 |
|---|---|
| Receipt number | 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 | 2020/05/30 00:21:09 |
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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
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
sakai@ugscd.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
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
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
0
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
Terminated
Date of protocol fixation
| 2017 | Year | 11 | Month | 21 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 18 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
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
| 2020 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033373
