UMIN-CTR Clinical Trial

Basic information
Public title	Randomized Controlled Trial of Videoconference delivered Cognitive Behavioral Therapy for children and adolescents with Attention Deficit/Hyperactivity Disorder
Acronym	Randomized Controlled Trial of Videoconference delivered Cognitive Behavioral Therapy for children and adolescents with Attention Deficit/Hyperactivity Disorder
Scientific Title	Randomized Controlled Trial of Videoconference delivered Cognitive Behavioral Therapy for children and adolescents with Attention Deficit/Hyperactivity Disorder
Scientific Title:Acronym	Randomized Controlled Trial of Videoconference delivered Cognitive Behavioral Therapy for children and adolescents with Attention Deficit/Hyperactivity Disorder
Region	Japan

Condition
Condition	Attention Deficit/Hyperactivity Disorder
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify that the Videoconference delivered Cognitive Behavioral Therapy for children and adolescents with ADHD(CBT) is significantly more effective than a wait-list control(WLC).
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Phase II

Assessment
Primary outcomes	the ADHD-RS-IV Japanese Version
Key secondary outcomes	ADHD Symptoms Checklist Patient Health Questionnaire-9 (PHQ-9) Generalized Anxiety Disorder-7 (GAD-7) Euro Qol 5 Dimension 5 level (EQ-5D-5L) Rosenberg's Self-esteem Scale

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	No treatment
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	Video-conference based cognitive behavioral therapy for ADHD(12weeks)
Interventions/Control_2	Wait-list control (12weeks)
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	11 years-old <=
Age-upper limit	17 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Patients who meet the diagnostic criteria in the DSM5. (2) Male or Female, aged 11-17 years (3) Patients who have been informed of the name of the disorder Persons who have been informed of the name of their disease at the time of obtaining consent (4) Patients are willing and able to give informed consent/informed assent for participation in the study. (5) Able to communicate fluently and participate cognitive behavioral therapy sessions in Japanese (6) Able to use the Internet and computer (7) Patients who have been stabilized on medications for ADHD (8) Parent is also able to participate in cognitive behavioral therapy sessions
Key exclusion criteria	(1) Diagnosis of schizophrenia, conduct disorders, organic disorder, mental retardation, autistic spectrum disorder, or substance abuse/substance dependence disorder (2) Active suicidal ideation (3) Unable to communicate fluently in Japanese. (4) Patients who have received cognitive behavioral therapy in the past (5) Other reasons inadequate for study participation
Target sample size	24

Research contact person
Name of lead principal investigator	1st name Eiji Middle name Last name Shimizu
Organization	Graduate School of Medicine Chiba University
Division name	Research Center for Child Mental Development, Department of Cognitive Behavioral Physiology
Zip code	260-8670
Address	1-8-1 Inohana,Chuouku,Chiba,Japan
TEL	043-226-2027
Email	eiji@faculty.chiba-u.jp

Public contact
Name of contact person	1st name Ayumu Middle name Last name Endo
Organization	Graduate School of Medicine Chiba University
Division name	Department of Cognitive Behavioral Physiology
Zip code	260-8670
Address	1-8-1 Inohana,Chuouku,Chiba,Japan
TEL	043-226-2027
Homepage URL
Email	20fd0197@student.gs.chiba-u.jp

Sponsor
Institute	Research Center for Child Mental Development,Department of Cognitive Behavioral Physiology
Institute
Department

Funding Source
Organization	Chiba University
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	Chiba university certified clinical research board
Address	1-8-1 Inohana,Chuouku,Chiba,Japan
Tel	043-222-7171
Email	hsp-chibacrc@chiba-u.jp

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	2022 Year 06 Month 15 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	Preinitiation
Date of protocol fixation	2022 Year 05 Month 27 Day
Date of IRB	2022 Year 05 Month 27 Day
Anticipated trial start date	2022 Year 07 Month 01 Day
Last follow-up date	2024 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	2022 Year 06 Month 15 Day
Last modified on	2022 Year 06 Month 15 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054782

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

Contact us.