UMIN-CTR Clinical Trial

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
Last 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
1st 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