Determining the effect of life skills training on high-risk behaviors
Design
Randomized clinical trial, double blind, random quadruple block, 100 students, Four groups (two intervention groups and two control groups)
Settings and conduct
Secondary Secondary Schools in Borujerd, Analyzer, coding of Questionnaires, Advisor, luck of data knowledge
Participants/Inclusion and exclusion criteria
second grade high school students
Inclusion criteria
• The sample cooperates with the study
• Sample obtains at least fifty percent of the score
• Samples reside in Boroujerd
• Second grade high school students
• The sample could participate in all sessions
• No interference between sessions and classes of the sample
Exit criteria
- Already under stay on psychological counseling or psychiatry
- Parental and sample discontent
Intervention groups
Education life skill to Intervention group(Self-knowledge skill, communication skill, Emotion Management Skill, Problem-solving skill, Decision-making skill, Critical thinking skill), At the end of the study, the training is given as a pamphlet to the control group
Main outcome variables
high risk behavior
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180103038210N2
Registration date:2019-02-20, 1397/12/01
Registration timing:retrospective
Last update:2019-02-20, 1397/12/01
Update count:0
Registration date
2019-02-20, 1397/12/01
Registrant information
Name
Elham Fallah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3291 1047
Email address
eli885falah@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-04, 1397/10/14
Expected recruitment end date
2019-02-03, 1397/11/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of life skills training on tendency toward high-risk behaviors in second grade high school students
Public title
Effect of life skills training on tendency toward high-risk behaviors
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The sample cooperates with the study
Sample obtains at least fifty percent of the score
Sample reside in Boroujerd
Second grade high school students
No interference between sessions and classes of the sample
The sample could participate in all sessions
Exclusion criteria:
Already under stay on psychological counseling or psychiatry
Parental and sample discontent
Age
From 14 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
startified randomized(Girls 'and boys' schools were considered as class), Systematic(Taking into account the city surface map), cluster(Schools were considered as clusters), randomization of quadrilateral block(Balance the number of samples in each group), coding of Questionnaires and failure to inform counsel & analyzer of codes
Blinding (investigator's opinion)
Double blinded
Blinding description
Analyzer: Data coding, Clinical watchful: Lack of data knowledge (Through clinical analyzer and clinical watchful have been blinded)
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Lorestan University of Medical Sciences
Street address
khorramabad
City
khorramabad
Province
Lorestan
Postal code
6813833946
Approval date
2019-01-05, 1397/10/15
Ethics committee reference number
IR.LUMS.REC.1397.151
Health conditions studied
1
Description of health condition studied
high risk behavior
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
high risk behavior
Timepoint
Before, immediately after and twenty days later
Method of measurement
Risk Assessment Questionnaire for Iranian Adolescents
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:girl(Life skills training), 8 sessions 45-minute for 2 months and a follow-up meeting Twenty days after the last session, The sessions are arranged by clinical psychologists.
Category
Behavior
2
Description
Control group: girl(Lack of training)
Category
Behavior
3
Description
Intervention group: boy (Life skills training), 8 sessions 45-minute for 2 months and a follow-up meeting Twenty days after the last session, The sessions are arranged by clinical psychologists.
Category
Behavior
4
Description
Control group: boy(Lack of training)
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
High school
Full name of responsible person
ElhamFallh
Street address
Boroujerd
City
Boroujerd
Province
Lorestan
Postal code
6814967851
Phone
+98 66 3291 1047
Email
eli885falah@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
dr.saki
Street address
khorramabad
City
khorramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3331 6303
Email
pr@lums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khoram-Abad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Elham Fallah
Position
Nursing student
Latest degree
A Level or less
Other areas of specialty/work
Nursery
Street address
Bahar street
City
Khoramabad
Province
Lorestan
Postal code
6814967851
Phone
+98 66 3291 1047
Fax
Email
eli885falah@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
ElhamFallah
Position
Nursingstudent
Latest degree
A Level or less
Other areas of specialty/work
Nursery
Street address
Bahar street
City
khorramabad
Province
Lorestan
Postal code
6814967851
Phone
+66 32 911 047
Email
eli885fala@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
ElhamFallah
Position
Nursing student
Latest degree
A Level or less
Other areas of specialty/work
Nursery
Street address
Bahar street
City
khorramabad
Province
Lorestan
Postal code
6814967851
Phone
+66 32 911 047
Email
eli885falah@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
After publishing the article in the magazine
When the data will become available and for how long
3 months after the publication of the article
To whom data/document is available
researchers
Under which criteria data/document could be used
Expression of the source of the data
From where data/document is obtainable
ElhamFallah
eli885falah@gmail.com
What processes are involved for a request to access data/document
Send email and state the reason for receiving the data