Determining the effectiveness of the strategic suicide prevention program based on cognitive therapy and improving life skills in teenagers of Qazvin province
Design
A controlled clinical trial with parallel groups, no blinding, randomized, phase 2 will be conducted on 36 teenagers.
Using the appropriate formula the number of sample size was 14 people for each group, and with the probability of dropping 25% of the studied people in both groups, 36 people were considered.
Randomization.com will be used for randomization.
Settings and conduct
This study will be conducted in selected health centers of Qazvin province. Before and after receiving psychological interventions, they will be examined for the presence of suicidal thoughts.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age, ability to communicate, accessibility, absence of serious mental or physical illnesses
Intervention groups
Implementation of cognitive therapy and life skills training
Approach based on cognitive therapy along with conflict resolution between parents and children. The first session is to assess the level of suicide risk, to carry out a security plan for the individual. The second session of cognitive payment concept is done. The root of the client's issues and problems can be found. The third and fourth sessions are cognitive, emotional, and behavioral adaptive strategies for the client. Increasing the reasons for living and improving family relationships will be done in the fifth and sixth session on the limit of parent-child conflict.
Main outcome variables
Reducing the amount of suicidal thoughts; Increasing distress tolerance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240804062633N1
Registration date:2024-12-10, 1403/09/20
Registration timing:prospective
Last update:2024-12-10, 1403/09/20
Update count:0
Registration date
2024-12-10, 1403/09/20
Registrant information
Name
Zahra Hosseinkhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3336 8124
Email address
zhosseinkhani122@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-12-18, 1403/09/28
Expected recruitment end date
2025-11-21, 1404/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of the strategic suicide prevention program based on cognitive therapy and improving life skills in adolescents
Public title
Investigating the effectiveness of the strategic suicide prevention program based on cognitive therapy and improving life skills in adolescents
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age greater than and equal to 13 years and less than 18 years
Ability to communicate the patient or family with the questioner
Living in Qazvin province
Fixed mobile phone access
Exclusion criteria:
Having severe mental illnesses such as schizophrenia
Suffering from severe physical diseases
Age
From 13 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
28
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization phase will be done using balanced block randomization. Balanced block randomization means dividing participants into small blocks and then randomly assigning treatments within each block. This method is especially useful in clinical studies where the number of participants is limited. Blocks of 4 people will be used, each block will include 2 people in the treatment group and 2 people in the control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qazvin University of Medical Sciences
Street address
Bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
3419915315
Approval date
2024-10-02, 1403/07/11
Ethics committee reference number
IR.QUMS.REC.1403.244
Health conditions studied
1
Description of health condition studied
Suicide prevention
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Suicidal ideation score
Timepoint
At the beginning of the study and after the full implementation of cognitive therapy sessions and life skills training
Method of measurement
Suicidal ideation scale questionnaire
2
Description
Distress tolerance score
Timepoint
At the beginning of the study and after the full implementation of cognitive therapy sessions and life skills training
Method of measurement
Distress Tolerance Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Approach based on cognitive therapy along with conflict resolution between parents and children. The first session is to assess the level of suicide risk, to carry out a security plan for the individual. The second session of the concept of cognitive payment is done. The root of the client's issues and problems can be found. The third and fourth sessions are cognitive, emotional, and behavioral adaptive strategies for the client. Increasing the reasons for living and improving family relations will be done in the fifth and sixth session on the limit of parent-child conflict.
Category
Behavior
2
Description
Control group: 4 training sessions. First session: Psychologist assesses suicide risk level. Then the security plan for the client is checked. Then he takes a commitment from the person not to harm himself. In the second session of the security plan, the contents of the first session will be reviewed. Psychological education is given with the aim of reducing the suffering of the patient and all the assignments are given to the client with this aim. In the third session, the security plan is reviewed again, we have a review of the previous two sessions, and the false beliefs that exist in suicidal thoughts are discussed. In this session, problem solving training is given. In the fourth session, it is based on family education. It is discussed about family protective risk factors and suicide warning factors. Ways to deal with a person who wants to commit suicide.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Aref Comprehensive Health Service Center
Full name of responsible person
Ladan Mohammadizadeh
Street address
Aref Comprehensive Health Service Center, the beginning of Iranshahr street, Padgan street, Qazvin city
City
Qazvin
Province
Qazvin
Postal code
3413987314
Phone
+98 28 3332 1218
Email
phh@qums.ac.ir
2
Recruitment center
Name of recruitment center
Seraj Comprehensive Health Service Center
Full name of responsible person
Ladan Mohammadizadeh
Street address
Seraj Center, 2nd floor, Mohammadieh Specialized Clinic 2, opposite Fatemeh Zahra School, Golsar 1st Street, Mohammadieh City, Alborz County
City
Alborz
Province
Qazvin
Postal code
3491774316
Phone
+98 28 3257 3094
Email
phh@qums.ac.ir
3
Recruitment center
Name of recruitment center
Seraj Comprehensive Health Service Center
Full name of responsible person
Ladan Mohammadizadeh
Street address
Shohada Comprehensive Health Service Center (Seraj), Cinema St., 17 Shahrivar Square, Takestan City
City
Takestan
Province
Qazvin
Postal code
4381965787
Phone
+98 28 3524 7683
Email
phh@qums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Seyed Mehdi Mirhashemi
Street address
Research and Technology Deputy, Mavedat Alley, First Alley , Beheshti Blvd
City
Qazvin
Province
Qazvin
Postal code
3415613911
Phone
+98 28 3333 7006
Email
researchdpt@qums.ac.ir
Web page address
https://qums.ac.ir/fa-IR/vcr.qums.ac/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Zahra Hosseinkhani
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Research and Technology Deputy, Mavedat Alley, First Alley , Beheshti Blvd
City
Qazvin
Province
Qazvin
Postal code
3415613911
Phone
+98 28 3333 7006
Email
zhosseinkhani122@gmail.com
Web page address
https://qums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Zahra Hosseinkhani
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Research and Technology Deputy, Mavedat Alley, First Alley , Beheshti Blvd
City
Qazvin
Province
Qazvin
Postal code
3415613911
Phone
+98 26 3336 8124
Fax
Email
zhosseinkhani122@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Zahra Hosseinkhani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Research and Technology Deputy, Mavedat Alley, First Alley , Beheshti Blvd
City
Qazvin
Province
Qazvin
Postal code
3415613911
Phone
+98 28 3333 7006
Email
zhosseinkhani122@gmail.com
Web page address
https://qums.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
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