UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035429 |
|---|---|
| Receipt number | 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 | 2020/07/06 21:09:35 |
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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
Name of lead principal investigator
| 1st name | Hiroko |
| Middle name | |
| Last name | Kashiwagi |
Organization
National Center of Neurology and Psychiatry
Division name
Department of Forensic Psychiatry
Zip code
187-8551
Address
4-1-1, Ogawahigashicho, Kodaira, Tokyo
TEL
042-341-2711
hkashiwagi@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Hiroko |
| Middle name | |
| Last name | Kashiwagi |
Organization
National Center of Neurology and Psychiatry
Division name
Department of Forensic Psychiatry
Zip code
187-8551
Address
4-1-1, Ogawahigashicho, Kodaira, Tokyo
TEL
042-341-2711
Homepage URL
hkashiwagi@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
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
National Center of Neurology and Psychiatry
Address
4-1-1, Ogawahigashicho, Kodaira, Tokyo
Tel
042-341-2711
rinri-jimu@ncnp.go.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
32
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
Main results already published
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
| 2019 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2019 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2019 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 03 | Day |
Last modified on
| 2020 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040276
