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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035429
Receipt No. R000040276
Scientific Title Development of service user participation type assessment for risk and protective factors of future violence - Verify the clinical significance of and differences between professional judgement and the perspective of the service users.
Date of disclosure of the study information 2019/01/04
Last modified on 2019/03/23

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Basic information
Public title Development of service user participation type assessment for risk and protective factors of future violence - Verify the clinical significance of and differences between professional judgement and the perspective of the service users.
Acronym Development of service user participation type assessment for risk and protective factors of future violence.
Scientific Title Development of service user participation type assessment for risk and protective factors of future violence - Verify the clinical significance of and differences between professional judgement and the perspective of the service users.
Scientific Title:Acronym Development of service user participation type assessment for risk and protective factors of future violence.
Region
Japan

Condition
Condition forensic psychiatric patients
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the clinical effects and adverse events on service users after sharing the SAPROF (Structured Assessment of Protective Factors for violence risk), which is a strength-based assessment for future violence.
To investigate the differences between professional judgement and the perspective of the service users using the SAPROF self-appraisal interview.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Health Locus of Control
Intrinsic Motivation Inventory(IMI)
Key secondary outcomes Structured Assessment of PROtective Factors for violence risk (SAPROF)
SAPROF Interview Self-Appraisal(SAPROF-ISA)
Kyoutu Hyouka Koumoku
Positive and Negative Syndrome Scale(PANSS)
General Self-Efficacy Scale(GSES)
Self-Rating Depression Scale(SDS)
Buss-Perry Aggression Questionnaire
BIS-11(Barratt Impulsiveness Scale 11th)
STAXI(State-Trait Anger Expression Inventory)


Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Sharing the SAPROF with service users.
Interventions/Control_2 Not sharing the SAPROF with service users.
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
70 years-old >
Gender Male and Female
Key inclusion criteria Individuals who gave consent to participate in this study and have spent more than 1 month on the MTSA (Medical Treatment and Supervision Act) ward after hospitalization.
Key exclusion criteria Individuals who are diagnosed with moderate or severe mental retardation, dementia, moderate or severe depression or those with severe suicidal thoughts. Individuals with whom the multiple disciplinary teams in charge refused to participate in this study.
Target sample size 30

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Hiroko Kashiwagi
Organization National Center of Neurology and Psychiatry
Division name Department of Forensic Psychiatry
Zip code
Address 4-1-1, Ogawahigashicho, Kodaira, Tokyo
TEL 042-341-2711
Email hkashiwagi@ncnp.go.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Hiroko Kashiwagi
Organization National Center of Neurology and Psychiatry
Division name Department of Forensic Psychiatry
Zip code
Address 4-1-1, Ogawahigashicho, Kodaira, Tokyo
TEL 042-341-2711
Homepage URL
Email hkashiwagi@ncnp.go.jp

Sponsor
Institute National Center of Neurology and Psychiatry
Institute
Department

Funding Source
Organization Jaoan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2019 Year 01 Month 04 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
2019 Year 03 Month 01 Day
Date of IRB
2019 Year 03 Month 11 Day
Anticipated trial start date
2019 Year 03 Month 25 Day
Last follow-up date
2021 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
2019 Year 01 Month 03 Day
Last modified on
2019 Year 03 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040276

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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