Title: "Intervention Based on Didactic Model for Suicidal Behavior in the Framework of Impulsivity and Ideations."
Primary Purpose
Suicidal Ideation and Behavior, Impulsivity
Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Didactic model for suicidal behavior in the framework of impulsivity and ideations
Sponsored by
About this trial
This is an interventional other trial for Suicidal Ideation and Behavior
Eligibility Criteria
Inclusion Criteria:
- Higher Secondary School Students
- Young people at risk of suicide: those who are impulsive and have suicidal thoughts.
Exclusion Criteria:
- Who has a history of suicide attempts
Sites / Locations
- International Islamic UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Experimental condition
Control condition
Arm Description
Didactic intervention based on religious teachings and cultural milieu, the experimental group will receive 12 sessions for three months, 4 sessions per month including focused group discussion.
They will have sessions like the experimental group but the control group will get the knowledge in the form of written material without any explanation (Information Leaflet).
Outcomes
Primary Outcome Measures
Barratt Impulsiveness scale
This is a 4-point likert scale and is scored in the following way; Rarely/Never= 1, Occasionally= 2, Often= 3 & Almost/Always= 4. It contains 30 items that describe common impulsive or non-impulsive behaviors and preferences.
Beck Scale for Suicidal Ideation
This scale entails of 19 items and measures 3 responses from Least severe= 0 to Most severe= 2
Secondary Outcome Measures
Depression Anxiety Stress Scale (DASS)
This scale consists of a set of three self-reported measures in the form of 4-point Likert severity/frequency format. Each scale contains 14 items, subdivided into 2-5 item subscales containing the same contents.
Stroop Test
The Stroop Color Test assesses the ability to prevent cognitive interference, which occurs while processing the stimulus feature affects the simultaneous processing of another attribute of the same stimulus.
Self-Efficacy scale
It is a 4-point Likert-type scale consisting of 10 items, and measures are taken in response from strongly disagree to strongly agree.
Religious commitment inventory (RCI-10)
This scale consists of 10 items. The responses are made in a 5 - point Likert format from Not at all to Totally true of me.
Full Information
NCT ID
NCT05324670
First Posted
April 3, 2022
Last Updated
April 14, 2022
Sponsor
International Islamic University, Islamabad
1. Study Identification
Unique Protocol Identification Number
NCT05324670
Brief Title
Title: "Intervention Based on Didactic Model for Suicidal Behavior in the Framework of Impulsivity and Ideations."
Official Title
Intervention Based on Didactic Model for Suicidal Behavior in the Framework of Impulsivity and Ideations.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
June 1, 2022 (Anticipated)
Study Completion Date
August 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
International Islamic University, Islamabad
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Suicide has become a major public health problem among young people around the world. This study will examine the effects of higher secondary school-based suicide prevention (HSSSP) program on youth suicidal thoughts and impulsive behavior (STIB). Therefore, the purpose of this study is to examine the effects of didactic approach for youth STIB on the HSSSP program.
This study is designed to address this issue at the secondary school level. Therefore, this research is divided into two studies. In the first study, our goal was to arrange a Baseline assessment for the screening process of adolescents at risk of suicide. while in second study we aim to implement a didactic approach based on religious teachings and culture milieu and examine its effects as an evidence based suicide prevention program.
Detailed Description
Suicide has become a major public health problem around the world. according to a recent report by the World Health Organization (WHO) suicide is the fourth leading cause of death among youth. Suicidal thoughts and suicide attempts are on the rise among youth. Therefore, evidence-based prevention programs need to fill this gap with interventions at the higher secondary schools.
For decades, research and prevention efforts have been failed in developing meaningful predictions and reductions in suicide. However, significant efforts are needed to stop the rising tide of suicide. For the purpose, it is important to understand the suicidal thought at first as not everyone who commits suicide attempts suicide first.
Therefore, in this study an attempt has been made to investigate profoundly the understanding of suicide which has been emerged a serious problem around the globe and in particular in Pakistani society. The researcher has planned to conduct psychological measures with established psychometric properties to look at the relationship between suicidal ideation and impulsivity anticipating suicidal behavior. During study the role of moderators i.e. social effectiveness and level of religiosity shall also be investigated. Findings of this study shall comprehensively provide data in order to design an inclusive prophylactic strategy known as didactic intervention to prevent the suicidal act before it occurs. It is expected that this approach grounded on religious teaching and cultural milieu in line with the best practices, will be adapted. Subsequently, this study also aims to evaluate the effectiveness of the didactic approach as an evidence based suicide prevention program in higher secondary schools with selective prevention programs.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicidal Ideation and Behavior, Impulsivity
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Research design of the study will consists single-blind cluster randomized controlled trial (c-RCT). While Randomized Control Trial (RCT) will consists of two groups: written knowledge with explanation (experimental group) and written knowledge without explanation (control group).
Masking
Participant
Masking Description
Single blind Cluster randomized controlled trials
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental condition
Arm Type
Experimental
Arm Description
Didactic intervention based on religious teachings and cultural milieu, the experimental group will receive 12 sessions for three months, 4 sessions per month including focused group discussion.
Arm Title
Control condition
Arm Type
Other
Arm Description
They will have sessions like the experimental group but the control group will get the knowledge in the form of written material without any explanation (Information Leaflet).
Intervention Type
Other
Intervention Name(s)
Didactic model for suicidal behavior in the framework of impulsivity and ideations
Other Intervention Name(s)
Prophylactic Strategy Known as Didactic intervention
Intervention Description
It will be in the form of lectures (Educational approach). Content will be developed one day before the commencement of the session. The Knowledge provided in the form of written material with proper explanation shall not exceed 30 minutes and a Focused group Discussion will be held at the end of each month.
Primary Outcome Measure Information:
Title
Barratt Impulsiveness scale
Description
This is a 4-point likert scale and is scored in the following way; Rarely/Never= 1, Occasionally= 2, Often= 3 & Almost/Always= 4. It contains 30 items that describe common impulsive or non-impulsive behaviors and preferences.
Time Frame
Assessment at baseline (after screening), 8th week after baseline (2 months), 16th week after baseline (4 months). The purpose of the outcome measure is to estimate the change from baseline assessment to follow-up.
Title
Beck Scale for Suicidal Ideation
Description
This scale entails of 19 items and measures 3 responses from Least severe= 0 to Most severe= 2
Time Frame
Assessment at baseline (after screening), 8th week after baseline (2 months), 16th week after baseline (4 months). The purpose of the outcome measure is to estimate the change from baseline assessment to follow-up.
Secondary Outcome Measure Information:
Title
Depression Anxiety Stress Scale (DASS)
Description
This scale consists of a set of three self-reported measures in the form of 4-point Likert severity/frequency format. Each scale contains 14 items, subdivided into 2-5 item subscales containing the same contents.
Time Frame
Assessment at baseline (after screening), 8th week after baseline (2 months), 16th week after baseline (4 months). The purpose of the outcome measure is to estimate the change from baseline assessment to follow-up.
Title
Stroop Test
Description
The Stroop Color Test assesses the ability to prevent cognitive interference, which occurs while processing the stimulus feature affects the simultaneous processing of another attribute of the same stimulus.
Time Frame
Assessment at baseline (after screening), 8th week after baseline (2 months), 16th week after baseline (4 months). The purpose of the outcome measure is to estimate the change from baseline assessment to follow-up.
Title
Self-Efficacy scale
Description
It is a 4-point Likert-type scale consisting of 10 items, and measures are taken in response from strongly disagree to strongly agree.
Time Frame
Assessment at baseline (after screening), 8th week after baseline (2 months), 16th week after baseline (4 months). The purpose of the outcome measure is to estimate the change from baseline assessment to follow-up.
Title
Religious commitment inventory (RCI-10)
Description
This scale consists of 10 items. The responses are made in a 5 - point Likert format from Not at all to Totally true of me.
Time Frame
Assessment at baseline (after screening), 8th week after baseline (2 months), 16th week after baseline (4 months). The purpose of the outcome measure is to estimate the change from baseline assessment to follow-up.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Higher Secondary School Students
Young people at risk of suicide: those who are impulsive and have suicidal thoughts.
Exclusion Criteria:
Who has a history of suicide attempts
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abdullah
Phone
03459149029
Email
mkhankhalil@ymail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Muhammad T Khalily
Phone
03475710446
Email
dr.khalily@iiu.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Muhammad T Khalily
Organizational Affiliation
Department of Psychology, IIUI
Official's Role
Study Chair
Facility Information:
Facility Name
International Islamic University
City
Islamabad
State/Province
Islamabad (CapitalTerritory)
ZIP/Postal Code
44000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muhammad T Khalily, PhD
12. IPD Sharing Statement
Citations:
PubMed Identifier
7570788
Citation
Eggert LL, Thompson EA, Herting JR, Nicholas LJ. Reducing suicide potential among high-risk youth: tests of a school-based prevention program. Suicide Life Threat Behav. 1995 Summer;25(2):276-96. Erratum In: Suicide Life Threat Behav 1999 Spring;29(1):96.
Results Reference
result
PubMed Identifier
14998812
Citation
Aseltine RH Jr, DeMartino R. An outcome evaluation of the SOS Suicide Prevention Program. Am J Public Health. 2004 Mar;94(3):446-51. doi: 10.2105/ajph.94.3.446.
Results Reference
result
PubMed Identifier
11326768
Citation
Randell BP, Eggert LL, Pike KC. Immediate post intervention effects of two brief youth suicide prevention interventions. Suicide Life Threat Behav. 2001 Spring;31(1):41-61. doi: 10.1521/suli.31.1.41.21308.
Results Reference
result
Learn more about this trial
Title: "Intervention Based on Didactic Model for Suicidal Behavior in the Framework of Impulsivity and Ideations."
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