UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048064 |
|---|---|
| Receipt number | 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 | 2024/06/17 12:11:26 |
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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
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
20fd0197@student.gs.chiba-u.jp
Sponsor or person
Institute
Research Center for Child Mental Development,Department of Cognitive Behavioral Physiology
Institute
Department
Personal name
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
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
Open public recruiting
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
| 2025 | 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
| 2024 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054782
