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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000039493
Receipt No. R000045018
Scientific Title The effect of psychological and social interventions on risky driving:A clinical trial study by using simulated and real driving
Date of disclosure of the study information 2020/02/15
Last modified on 2021/07/13

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Basic information
Public title En The effect of psychological and social interventions on risky driving
Acronym P&SIORD
Scientific Title The effect of psychological and social interventions on risky driving:A clinical trial study by using simulated and real driving
Scientific Title:Acronym P&SIORD
Region
Asia(except Japan)

Condition
Condition Risky driving
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Determination of the effect of psychological and social interventions on risky driving of youth and novice drivers
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1- Driving offenses recorded by the traffic police before intervention and 6 months and one year after intervention
Key secondary outcomes 1-Driving offense score while driving with a simulator before and after intervention
2-Driving anger before and after intervention
3-Driving anger expressing before and after intervention
4-Anger before and after intervention
5-Driving behavior before intervention and after intervention

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 4
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Intervention1:Mind fullness; 6-8 sessions by psychologist during 3-4 weeks
Interventions/Control_2
Intervention2: Meta cognition;6 sessions by psychologist during 3 weeks
Interventions/Control_3 Intervention 3: Social marketing ;A four-hour program prepared by a social medicine specialist
Interventions/Control_4
Interventions/Control_5 control:Wait list control group
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
45 years-old >=
Gender Male and Female
Key inclusion criteria The 18-45 years old drivers who have driving license and their license has been seized by the traffic police for driving violations are participants of this study.
Key exclusion criteria If participants had a specific illness that affects the results of the study, they will not be included in the study.
Target sample size 280

Research contact person
Name of lead principal investigator
1st name Farideh
Middle name
Last name Sadeghian
Organization Shahroud University of Medical sciences
Division name Center for Health Related Social and Behavioral Sciences Research
Zip code 36147-73947
Address Haftetir Square, Shahroud University of Medical Sciences, Shahroud, IRAN
TEL +98-23-32394091
Email farsadeghian@shmu.ac.ir

Public contact
Name of contact person
1st name Farideh
Middle name
Last name Sadeghian
Organization Shahroud University of Medical sciences
Division name farsadeghian@shmu.ac.ir
Zip code 36147-73947
Address Haftetir Square, Shahroud University of Medical Sciences, Shahroud, IRAN
TEL +98-23-32394091
Homepage URL http://shmu.ac.ir/fa
Email info@shmu.ac.ir

Sponsor
Institute Shahroud University of Medical Sciences






Center for Health Related Social and Behavioral Sciences Research
Institute
Department

Funding Source
Organization Shahroud University of Medical Sciences







Center for Health Related Social and Behavioral Sciences Research
Organization
Division
Category of Funding Organization Outside Japan
Nationality of Funding Organization Iranian

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Shahroud University of Medical Sciences-Center for Health Related Social and Behavioral Sciences Research
Address Haftetir Square, Shahroud University of Medical Sciences, Center for Health Related Social and Behavioral Sciences Research,Shahroud, IRAN
Tel +98-23-32394091
Email info@shmu.ac.ir, roudbari@shmu.ac.ir

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 Shahroud University of Medical Sciences-Center for Health Related Social and Behavioral Sciences Research

Other administrative information
Date of disclosure of the study information
2020 Year 02 Month 15 Day

Related information
URL releasing protocol http://ris.shmu.ac.ir/main/cartable.action#
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 0
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 Enrolling by invitation
Date of protocol fixation
2018 Year 10 Month 23 Day
Date of IRB
2018 Year 11 Month 17 Day
Anticipated trial start date
2020 Year 03 Month 01 Day
Last follow-up date
2022 Year 03 Month 01 Day
Date of closure to data entry
2022 Year 06 Month 01 Day
Date trial data considered complete
2022 Year 06 Month 07 Day
Date analysis concluded
2022 Year 10 Month 30 Day

Other
Other related information Outcomes:
1-Driving offenses score record by the traffic police
2-Driving offense score while driving with a simulator record by simulator
3-Driving anger,driving anger expression,Anger and driving behavior measure by valid questionnaire.

Management information
Registered date
2020 Year 02 Month 15 Day
Last modified on
2021 Year 07 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045018

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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