UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039804 |
|---|---|
| Receipt number | 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 | 2022/03/15 10:40:07 |
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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)
Victim Empathy Scale Questionnaire of Sexual crime and sexual preferences
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
20
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
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
ando@marianna-u.ac.jp
Sponsor or person
Institute
MEXT
Institute
Department
Personal name
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
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（大阪府）
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
Enrolling by invitation
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
| 2022 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045392
