UMIN-CTR Clinical Trial

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
Email	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
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	National Center of Neurology and Psychiatry
Address	4-1-1, Ogawahigashicho, Kodaira, Tokyo
Tel	042-341-2711
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040276