UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020672 |
|---|---|
| Receipt number | R000010658 |
| Scientific Title | Verification of the efficacy of Behavioral Parent training interventions for children with Attention Deficit Hyperactivity Disorder (ADHD)-open labeled trial |
| Date of disclosure of the study information | 2016/01/20 |
| Last modified on | 2019/04/10 13:27:52 |
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Basic information
Public title
Verification of the efficacy of Behavioral Parent training interventions for children with Attention Deficit Hyperactivity Disorder (ADHD)-open labeled trial
Acronym
Effectiveness of Behavioral Parent Training for ADHD
Scientific Title
Verification of the efficacy of Behavioral Parent training interventions for children with Attention Deficit Hyperactivity Disorder (ADHD)-open labeled trial
Scientific Title:Acronym
Effectiveness of Behavioral Parent Training for ADHD
Region
| Japan |
Condition
Condition
Attention deficit hyperactive disorder(ADHD)
Classification by specialty
| Pediatrics | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the behavioral parent training intervention for children with ADHD by questionnaires and cognitive function tests
Basic objectives2
Others
Basic objectives -Others
To detect the predictors of the efficacy of BPT using baseline assessment
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes from baseline to post-training(10weeks) on the Child behavior check list (CBCL)
Key secondary outcomes
Changes from baseline to post-training on the ADHD-RS, The SNAP-score, The Parental stress Index, The Sensitivity to Punishment and Sensitivity to Reward Questionnaire for Children(SPSRQ-C), The Parent Perception Inventory(PPI-P, PPI-C),
Quality of Life (QOL), The Global Assessment of Functioning (GAF) and The Clinical Global Impression(CGI)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
10weeks parent training program
Interventions/Control_2
usual care
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
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
child
Patients diagnosed with Attention deficit hyperactivity disorder
Parent
Parent who have children diagnosed with Attention deficit hyperactivity disorder
Key exclusion criteria
Child
1.Pervasive developmental disorder
Schizophrenia, Bipolar disorder,
2.A child who has a depression that needed a prompt medical treatment of them.
3.A child who starts a training program after the day of IC acquisition or finishes it before the end of this trial.
Parent
1.under 20 years old more than 60 years old
2.Schizophrenia, Bipolar disorder
3.A parent who has a depression that needed a prompt medical treatment of them.
4.A parent who starts a training program after the day of IC acquisition or finishes it before the end of this trial.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ayaka Ishii-Takahashi |
Organization
The University of Tokyo Hospital
Division name
Department of Tokyo Hospital
Zip code
Address
7-3-1Hongo Bunkyoku Tokyo
TEL
03-3815-5411
ayayak-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukiko Kano |
Organization
The University of Tokyo Hospital
Division name
Department of Child Neuropsychiatry
Zip code
Address
7-3-1Hongo Bunkyoku Tokyo
TEL
03-3815-5411
Homepage URL
kokoroparent@gmail.com
Sponsor or person
Institute
Department of Child Neuropsychiatry
Institute
Department
Personal name
Funding Source
Organization
Japan Medical Association
Organization
Division
Category of Funding Organization
Non profit foundation
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
東京大学医学部附属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 20 | 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
No longer recruiting
Date of protocol fixation
| 2012 | Year | 09 | Month | 18 | Day |
Date of IRB
| 2012 | Year | 10 | Month | 18 | Day |
Anticipated trial start date
| 2012 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2019 | Year | 06 | 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
| 2016 | Year | 01 | Month | 20 | Day |
Last modified on
| 2019 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010658
