UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012425 |
|---|---|
| Receipt number | R000014530 |
| Scientific Title | Efficacy validation study of the psychosocial support program for adult attention deficit / hyperactivity disorder (ADHD) |
| Date of disclosure of the study information | 2013/12/01 |
| Last modified on | 2013/11/28 09:10:02 |
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Basic information
Public title
Efficacy validation study of the psychosocial support program for adult attention deficit / hyperactivity disorder (ADHD)
Acronym
Validation of psychosocial support program for adult ADHD
Scientific Title
Efficacy validation study of the psychosocial support program for adult attention deficit / hyperactivity disorder (ADHD)
Scientific Title:Acronym
Validation of psychosocial support program for adult ADHD
Region
| Japan |
Condition
Condition
Attention Deficit / Hyperactivity Disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To development and to validate the psychosocial support program for adult attention deficit / hyperactivity disorder (ADHD). Core symptoms of ADHD, executive function, anxiety, depression, personality, empathy, tendency of autistic, living conditions and QOL will be compered between before and after program intervention.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The following psychological test will be performed both before and after program.
CPT(Continuous Performance Test)
stroop test
Wisconsin Card Sorting Test
CAARS(Conners' Adult ADHD Rating Scale
STAI(State-Trait Anxiety Inventory)
PHQ-9(Patient Health Questionnaire)
Key secondary outcomes
Before program only (for assessment of participants)
IRI-J(Interpersonal Reactivity Index)
EPQ(Eysenk Personality Questionnaire)
SPQ(Schizotypal Personality Questionnaire)
SFS-J(Social Functioning Scale)
WHO QOL26
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
psychosocial support program
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Adult outpatients at Showa University Karasuyama hospital
2. Patients who diagnosed as ADHD
3. Mentally stable judged by the investigator
4. Patients who understand the content of the study
Key exclusion criteria
Patients who are unsuitable for participation judged by investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Iwanami |
Organization
Showa University
Division name
School of Medicine, Department of Psychiatry
Zip code
Address
6-11-11, Kitakarasuyama, Setagaya-ku, Tokyo 157-8577
TEL
03-3300-5231
iwanami@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Miki Igarashi |
Organization
Showa University
Division name
School of Medicine, Department of Psychiatry
Zip code
Address
6-11-11, Kitakarasuyama, Setagaya-ku, Tokyo 157-8577
TEL
03-3300-5231
Homepage URL
m-igarashi@cmed.showa-u.ac.jp
Sponsor or person
Institute
Department of Psychiatry Showa University, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Meiji Yasuda Mental Health Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
昭和大学附属烏山病院 発達障害医療研究センター
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 01 | 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
| 2013 | Year | 11 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 16 | Day |
Last follow-up date
| 2014 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 11 | Month | 28 | Day |
Last modified on
| 2013 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014530
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| Registered date | File name |
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| Registered date | File name |
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