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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000012425
Receipt No. 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

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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
Email 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
Email m-igarashi@cmed.showa-u.ac.jp

Sponsor
Institute Department of Psychiatry Showa University, School of Medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014530

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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