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

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 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

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

Value
https://center6.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