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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000039804
Receipt No. R000045392
Scientific Title Exploratory study on psychological effects of Sexual Offender Preventive Intervention and Re-integrative Treatment Schema;SPIRiTS for persons who have LD/ASD
Date of disclosure of the study information 2020/03/13
Last modified on 2020/03/13

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Basic information
Public title Exploratory study on psychological effects of Sexual Offender Preventive Intervention and Re-integrative Treatment Schema;SPIRiTS
Acronym Exploratory study on psychological effects of Sexual Offender Preventive Intervention and Re-integrative Treatment Schema;SPIRiTS
Scientific Title Exploratory study on psychological effects of Sexual Offender Preventive Intervention and Re-integrative Treatment Schema;SPIRiTS for persons who have LD/ASD
Scientific Title:Acronym Exploratory study on psychological effects of Sexual Offender Preventive Intervention and Re-integrative Treatment Schema;SPIRiTS
Region
Japan

Condition
Condition Learning Disorder
Developmental Disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study, we carry out this prevention of sexual crime program :SPIRiTS and clarify it about the psychological effects.
We expect that this program will promote to integrate the person with a disability at risk for the sexual crime into the society safely in the future.
Basic objectives2 Others
Basic objectives -Others Data collection of reserching
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Questionnaire of ordinary sexual behavior
SEX OFFENDER'S SELF-APPRAISAL SCALE(S.O.S.A.S)
MEN'S FEEDBACK TERVIEW-RIVISED
Victim Empathy Scale Questionnaire of Sexual crime and sexual preferences
ARMIDILO-S
Subjective Happiness scale
Key secondary outcomes Re-offence of sexual crime

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 CBT
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
10 years-old <=
Age-upper limit
60 years-old >=
Gender Male
Key inclusion criteria over FIQ 40
Key exclusion criteria Severe Mental Illness Patient
The person that program attendance was prohibited by the study staff and a supporter
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Kumiko
Middle name
Last name Ando
Organization St.Marianna University School of Medicine
Division name Dept of Neuropsychiatry
Zip code 216-8511
Address 2-16-1,Sugao Miyamae-ku Kawasaki City Kanagawa Pref.216-8511,Japan
TEL 0449778111
Email ando@marianna-u.ac.jp

Public contact
Name of contact person
1st name Kumiko
Middle name
Last name Ando
Organization St.Marianna University School of Medicine
Division name Dept of Neuropsychiatry
Zip code 2168511
Address 2-16-1,Sugao Miyamae-ku Kawasaki City Kanagawa Pref.Japan
TEL 0449778111
Homepage URL
Email ando@marianna-u.ac.jp

Sponsor
Institute MEXT
Institute
Department

Funding Source
Organization MEXT(Japan)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization St.Marianna University School of Medicine
Address 2-16-1, Sugao Miyamae-ku Kawasaki City Kanagawa Pref.
Tel 0449778111
Email k-shienbu.mail@marianna-u.ac.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 長崎県地域生活定着支援センター(長崎県)、大阪精神医療センターさくら病棟(大阪府)、東日本少年矯正医療・教育センター(東京都)

Other administrative information
Date of disclosure of the study information
2020 Year 03 Month 13 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
2019 Year 09 Month 04 Day
Date of IRB
2019 Year 10 Month 07 Day
Anticipated trial start date
2020 Year 03 Month 13 Day
Last follow-up date
2026 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
2020 Year 03 Month 13 Day
Last modified on
2020 Year 03 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045392

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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