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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035429
Receipt No. R000040276
Official scientific title of the study 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 2018/12/23

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Basic information
Official scientific title of the study 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.
Title of the study (Brief title) 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, and/or the Kyoutu Hyouka Koumoku, which is a risk-focused 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)


Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
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 and the Kyoutu Hyouka Koumoku with service users.
Interventions/Control_2 Sharing the Kyoutu Hyouka Koumoku 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
Name of lead principal investigator Hiroko Kashiwagi
Organization National Center of Neurology and Psychiatry
Division name Department of Forensic Psychiatry
Address 4-1-1, Ogawahigashicho, Kodaira, Tokyo
TEL 042-341-2711
Email hkashiwagi@ncnp.go.jp

Public contact
Name of contact person Hiroko Kashiwagi
Organization National Center of Neurology and Psychiatry
Division name Department of Forensic Psychiatry
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)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2019 Year 01 Month 15 Day
Anticipated trial start date
2019 Year 01 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2019 Year 01 Month 03 Day
Last modified on
2018 Year 12 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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