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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000020672
Receipt No. 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

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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
Email 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
Email kokoroparent@gmail.com

Sponsor
Institute Department of Child Neuropsychiatry
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010658

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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