SuicideNCT05097690
Case Control Psychological Autopsy of Suicide
An observational study of Suicide and Fatal Suicide, run by Tamkeen Saleem at 1 site in Pakistan.
Trial summary
Suicide is a leading cause of death worldwide, and identifying risk factors has been considered as the key initiative of suicide prevention. Considering that, the study aimed to explore the factors leading towards suicide in Pakistan through Case-Control Psychological Autopsy of Suicide. Read more about this study
- Who is it for?
- Ages 10 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Suicide, Fatal Suicide, Non Fatal Suicidal Behavior
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 14 Oct 2021to 30 Mar 2022
- Phase
- Observational
- 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 10 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Cases are those individuals who died by suicide and the controls include individuals who survive after attempting suicide.
Who may be able to join
- The age of the deceased by suicide and living controls will range from 10 to 35 years.
- The key informants will be of 18 years of age and above without any learning
- disability.
- The key informants will be a close family member or immediate friend.
- Only suicides took place in 2019 to September 2021.
Who cannot join
- If contact was deemed to pose a risk to the safety of the researcher (likely intoxication; history of or potential for violence).
- Informants who are not willing to give written informed consent will be excluded from the study.
- Informants who are taking any psychological help in the past and present will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
International Islamic University, Islamabad Pakistan
Islamabad, Capital, 44000
About this study
Official title: Psychological Autopsy: An Investigation to Explore Antecedents, Sequelae and Causes of Case Control Suicide Equivocal Behavior
Suicide is a leading cause of death worldwide, and identifying risk factors has been considered as the key initiative of suicide prevention. Considering that, the study aimed to explore the factors leading towards suicide in Pakistan through Case-Control Psychological Autopsy of Suicide. Also, the study aimed to Translate, Adapt and Validate American Association of Suicidology (AAS) Semi-Structured Interview for Psychological Autopsy (Generic Version, 2018).
- Conditions
- Suicide, Fatal Suicide, Non Fatal Suicidal Behavior
- Keywords
- Cases, Controls
- Medical subject headings
- Suicide, Suicide, Completed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Case | Case (Fatal Suicide) | |
| Control | Control (Non-Fatal Suicidal Behavior) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Semi-structured Interview for Psychological Autopsy
American Association of Suicidology Semi-Structured Interview for Psychological Autopsy
Measured: Upto 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2021
- Study start14 Oct 2021
- Primary completion25 Feb 2022 (estimated)
- Study completion30 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SuicideStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tamkeen Saleem
- Sponsor type
- University, hospital or other
- Collaborators
- University of Leicester, University of Warwick, The American Association of Suicidology
- Responsible party
- Sponsor-investigator, Tamkeen Saleem, International Islamic University, Islamabad
- Investigators
- Dr Tamkeen Saleem, PhD, Study chair, International Islamic University, Islamabad, PakistanDr Michelle O'Reilly, PhD, Study chair, University of Leicester and Leicestershire Partnership NHS TrustDr Domenico Giacco, PhD, Study chair, Warwick Medical School, University of Warwick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05097690
- Sponsor's protocol ID
- AAS-ATV-PAS
- Status last verified
- Oct 2021
- First submitted
- 25 Sep 2021
- Last updated
- 28 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Autopsy: An Investigation to Explore Antecedents, Sequelae and Causes of Case Control Suicide Equivocal Behavior
- ClinicalTrials.gov ID
- NCT05097690
- Acronym / sponsor ID
- AAS-ATV-PAS
- Conditions
- Suicide, Fatal Suicide, Non Fatal Suicidal Behavior
- Keywords
- Cases, Controls
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tamkeen SaleemUniversity, hospital or other
- Collaborators
- University of Leicester, University of Warwick, The American Association of Suicidology
- Study start
- 14 Oct 2021 (actual)
- Primary completion
- 25 Feb 2022 (estimated)
- Study completion
- 30 Mar 2022 (estimated)
- First posted
- 28 Oct 2021 (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 is a leading cause of death worldwide, and identifying risk factors has been considered as the key initiative of suicide prevention. Considering that, the study aimed to explore the factors leading towards suicide in Pakistan through Case-Control Psychological Autopsy of Suicide. Also, the study aimed to Translate, Adapt and Validate American Association of Suicidology (AAS) Semi-Structured Interview for Psychological Autopsy (Generic Version, 2018).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | –Case (Fatal Suicide) |
| Control | – | –Control (Non-Fatal Suicidal Behavior) |
Who may qualify
- Ages
- 10 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Cases are those individuals who died by suicide and the controls include individuals who survive after attempting suicide.
Key inclusion criteria (5 listed)
- The age of the deceased by suicide and living controls will range from 10 to 35 years.
- The key informants will be of 18 years of age and above without any learning
- disability.
- The key informants will be a close family member or immediate friend.
- Only suicides took place in 2019 to September 2021.
Key exclusion criteria (3 listed)
- If contact was deemed to pose a risk to the safety of the researcher (likely intoxication; history of or potential for violence).
- Informants who are not willing to give written informed consent will be excluded from the study.
- Informants who are taking any psychological help in the past and present will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The Semi-structured Interview for Psychological Autopsy
Time frame: Upto 6 months
American Association of Suicidology Semi-Structured Interview for Psychological Autopsy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2021.
- Individual participant dataSharing planned: No
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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 Tamkeen Saleem, PhD study chair
International Islamic University, Islamabad, Pakistan
Dr Michelle O'Reilly, PhD study chair
University of Leicester and Leicestershire Partnership NHS Trust
Dr Domenico Giacco, PhD study chair
Warwick Medical School, University of Warwick
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Suicide and Fatal Suicide, run by Tamkeen Saleem 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 5 inclusion and 3 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 28 Oct 2021. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Semi-structured Interview for Psychological Autopsy (time frame: Upto 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Oct 2021.