Suicidal Ideation and BehaviorNCT05324670
Title: "Intervention Based on Didactic Model for Suicidal Behavior in the Framework of Impulsivity and Ideations."
A study testing Didactic model for suicidal behavior in the framework of impulsivity and ideations in people with Suicidal Ideation and Behavior and Impulsivity, run by International Islamic University, Islamabad at 1 site in Pakistan.
Trial 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). Read more about this study
- Who is it for?
- Ages 12 to 25 years, men only
- Conditions the study is for
- Suicidal Ideation and Behavior, Impulsivity
- What is being tested?
- Didactic model for suicidal behavior in the framework of impulsivity and ideations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2021to 1 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 25 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Higher Secondary School Students
- Young people at risk of suicide: those who are impulsive and have suicidal thoughts.
Who cannot join
- Who has a history of suicide attempts
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
International Islamic University
Islamabad, Islamabad (CapitalTerritory), 44000
Muhammad T Khalily, PhD
About this study
Official title: Intervention Based on Didactic Model for Suicidal Behavior in the Framework of Impulsivity and Ideations.
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.
Read the 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.
- Conditions
- Suicidal Ideation and Behavior, Impulsivity
- Being tested
- Didactic model for suicidal behavior in the framework of impulsivity and ideations
- Medical subject headings
- Suicidal Ideation, Behavior, Impulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Didactic model for suicidal behavior in the framework of impulsivity and ideationsOther
Also called Prophylactic Strategy Known as Didactic intervention
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental condition | Experimental | 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. Receives: Other: Didactic model for suicidal behavior in the framework of impulsivity and ideations |
| Control condition | Other | 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). Receives: Other: Didactic model for suicidal behavior in the framework of impulsivity and ideations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Beck Scale for Suicidal Ideation
This scale entails of 19 items and measures 3 responses from Least severe= 0 to Most severe= 2
Measured: 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 outcomes (4)
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start1 Aug 2021
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Suicidal Ideation and BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Islamic University, Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mudassar Abdullah, International Islamic University, Islamabad
- Investigators
- Dr. Muhammad T Khalily, Study chair, Department of Psychology, IIUI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05324670
- Sponsor's protocol ID
- HSSSP
- Status last verified
- Apr 2022
- First submitted
- 3 Apr 2022
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 7570788Aseltine 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.
PubMed 14998812Randell 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.
PubMed 11326768Abdullah M, Khalily MT, Hallahan B. A randomised controlled trial of a culturally adapted didactic strategy for suicidal ideation (CADS-S) in young male students in Pakistan. Ir J Psychol Med. 2026 Mar 3:1-7. doi: 10.1017/ipm.2026.10172. Online ahead of print.
PubMed 41772830
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention Based on Didactic Model for Suicidal Behavior in the Framework of Impulsivity and Ideations.
- ClinicalTrials.gov ID
- NCT05324670
- Acronym / sponsor ID
- HSSSP
- Conditions
- Suicidal Ideation and Behavior, Impulsivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- International Islamic University, IslamabadUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 12 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Experimental condition | Experimental | Other: Didactic model for suicidal behavior in the framework of impulsivity and ideationsDidactic 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. |
| Control condition | Other | Other: Didactic model for suicidal behavior in the framework of impulsivity and ideationsThey 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). |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Higher Secondary School Students
- Young people at risk of suicide: those who are impulsive and have suicidal thoughts.
Key exclusion criteria (1 listed)
- Who has a history of suicide attempts
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Didactic model for suicidal behavior in the framework of impulsivity and ideationsAlso: Prophylactic Strategy Known as Didactic interventionIt 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. | Other | Control condition, Experimental condition |
Primary outcome
Barratt Impulsiveness scale
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.
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
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.
This scale entails of 19 items and measures 3 responses from Least severe= 0 to Most severe= 2
4 secondary outcomes
Depression Anxiety Stress Scale (DASS)
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.
Stroop Test
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.
Self-Efficacy scale
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.
Religious commitment inventory (RCI-10)
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
- Results publication: PubMed 7570788Eggert 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.
- Results publication: PubMed 14998812Aseltine 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 publication: PubMed 11326768Randell 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.
- Derived from this study: PubMed 41772830Abdullah M, Khalily MT, Hallahan B. A randomised controlled trial of a culturally adapted didactic strategy for suicidal ideation (CADS-S) in young male students in Pakistan. Ir J Psychol Med. 2026 Mar 3:1-7. doi: 10.1017/ipm.2026.10172. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Muhammad T Khalily study chair
Department of Psychology, IIUI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Didactic model for suicidal behavior in the framework of impulsivity and ideations in people with Suicidal Ideation and Behavior and Impulsivity, run by International Islamic University, Islamabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abdullah (03459149029, mkhankhalil@ymail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Barratt Impulsiveness scale (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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05324670, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2022.