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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000048064
Receipt No. R000054782
Scientific Title Randomized Controlled Trial of Videoconference delivered Cognitive Behavioral Therapy for children and adolescents with Attention Deficit/Hyperactivity Disorder
Date of disclosure of the study information 2022/06/15
Last modified on 2022/06/15

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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


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