Suicide PreventionNCT06611956
Needs Assessment Among Carers of Someone With Suicidal Thoughts
An observational study of Suicide Prevention and Informal Caregivers, run by University Ghent at 1 site in Belgium.
Trial summary
With this study the investigators would like to gain insight into the experienced needs carers of individuals with suicidal thoughts, who attempted suicide or who died by suicide. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Suicide Prevention, Informal Caregivers
- How many people
- 2,255 participants
- Where
- 1 siteBelgium
- Study dates
- 29 Nov 2024to 12 May 2025
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants are inidividuals (16 years or older) who know someone close to them with suicidal thoughts and/or behaviors in the past three years.
Who may be able to join
- 16 years or older
- Someone close to them has experienced suicidal thoughts, attempted suicide or died by suicide in the past three years
- Access to internet
- Understand sufficient Dutch (to complete the questionnaire)
Who cannot join
- /
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Flemish Centre of Expertise in Suicide Prevention, Ghent University
Ghent, 9000
About this study
With this study the investigators would like to gain insight into the experienced needs carers of individuals with suicidal thoughts, who attempted suicide or who died by suicide. By carers the investigators mean everyone who knows/knew someone close to them who is thinking about suicide, attempted suicide or died by suicide. By mapping out these needs, the investigators hope to better support carers and develop/improve initiatives and tools.
The investigators examine this by means of an online one-time questionnaire. In this questionnaire the investigators ask the participants questions about what it is like to be a carer and what are some of the experienced needs, as well as experiences with existing initiatives/tools.
- Conditions
- Suicide Prevention, Informal Caregivers
- Being tested
- No intervention (observational study)
- Keywords
- needs assessment, informal caregivers, suicide
- Medical subject headings
- Suicide Prevention, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention (observational study)Other
No intervention (observational study)
What is being measured
The primary outcome is the main question the study is designed to answer.
Background information: information on the participant
Personal information (self-developed questionnaire): age, gender identity, education, cultural background, work status, recruitment type
Measured: Baseline. Completing the questionnaire will take about 15-20 minutes
Background information: information on the suicidal person
Information on the suicidal person (self-developed questionnaire): relationship with the person, age, gender identity, suicidality, degree of contact
Measured: Baseline. Completing the questionnaire will take about 15-20 minutes
Experienced burden: suicidality
based on national health survey (Sciensano, 2018)
Measured: Baseline. Completing the questionnaire will take about 15-20 minutes
Experienced burden when supporting the individual with suicdial thoughts
self-developed questionnaire on the role of the carer and current degree of care
Measured: Baseline. Completing the questionnaire will take about 15-20 minutes
Experienced burden when supporting the individual with suicdial thoughts
Zarit Caregiver Burden 4-item questionnaire (Zarit et al., 1985; Higginson et al., 2010)
Measured: Baseline. Completing the questionnaire will take about 15-20 minutes
Experienced burden: psychological stress
Kessler Psychological Distress Scale , 6-item (Kessler et al., 2002, 2003)
Measured: Baseline. Completing the questionnaire will take about 15-20 minutes
Experienced needs
Self-developed questionnaire examining the need for information, need for support and needs with regards to health care
Measured: Baseline. Completing the questionnaire will take about 15-20 minutes
Experience with existing initiatives and tools
Self-developed questionnaire about the experience of participants with existing initiatives and tools
Measured: Baseline. Completing the questionnaire will take about 15-20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start29 Nov 2024
- Primary completion12 May 2025
- Study completion12 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicide PreventionStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 2,255 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gwendolyn Portzky, PhD, Principal investigator, Flemish Centre of Expertise in Suicide Prevention (Ghent University)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06611956
- Sponsor's protocol ID
- ONZ-2024-0404
- Status last verified
- Aug 2025
- First submitted
- 4 Sep 2024
- Last updated
- 5 Sep 2025
- 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 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Needs Assessment Among Carers of Someone With Suicidal Thoughts
- ClinicalTrials.gov ID
- NCT06611956
- Acronym / sponsor ID
- ONZ-2024-0404
- Conditions
- Suicide Prevention, Informal Caregivers
- Keywords
- needs assessment, informal caregivers, suicide
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,255 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 29 Nov 2024 (actual)
- Primary completion
- 12 May 2025 (actual)
- Study completion
- 12 May 2025 (actual)
- First posted
- 25 Sep 2024 (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.
With this study the investigators would like to gain insight into the experienced needs carers of individuals with suicidal thoughts, who attempted suicide or who died by suicide. By carers the investigators mean everyone who knows/knew someone close to them who is thinking about suicide, attempted suicide or died by suicide. By mapping out these needs, the investigators hope to better support carers and develop/improve initiatives and tools.
The investigators examine this by means of an online one-time questionnaire. In this questionnaire the investigators ask the participants questions about what it is like to be a carer and what are some of the experienced needs, as well as experiences with existing initiatives/tools.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants are inidividuals (16 years or older) who know someone close to them with suicidal thoughts and/or behaviors in the past three years.
Key inclusion criteria (4 listed)
- 16 years or older
- Someone close to them has experienced suicidal thoughts, attempted suicide or died by suicide in the past three years
- Access to internet
- Understand sufficient Dutch (to complete the questionnaire)
Key exclusion criteria (1 listed)
- /
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 |
|---|---|---|
| No intervention (observational study)No intervention (observational study) | Other | – |
Primary outcome
Background information: information on the participant
Time frame: Baseline. Completing the questionnaire will take about 15-20 minutes
Personal information (self-developed questionnaire): age, gender identity, education, cultural background, work status, recruitment type
Background information: information on the suicidal person
Time frame: Baseline. Completing the questionnaire will take about 15-20 minutes
Information on the suicidal person (self-developed questionnaire): relationship with the person, age, gender identity, suicidality, degree of contact
Experienced burden: suicidality
Time frame: Baseline. Completing the questionnaire will take about 15-20 minutes
based on national health survey (Sciensano, 2018)
Experienced burden when supporting the individual with suicdial thoughts
Time frame: Baseline. Completing the questionnaire will take about 15-20 minutes
self-developed questionnaire on the role of the carer and current degree of care
Experienced burden when supporting the individual with suicdial thoughts
Time frame: Baseline. Completing the questionnaire will take about 15-20 minutes
Zarit Caregiver Burden 4-item questionnaire (Zarit et al., 1985; Higginson et al., 2010)
Experienced burden: psychological stress
Time frame: Baseline. Completing the questionnaire will take about 15-20 minutes
Kessler Psychological Distress Scale , 6-item (Kessler et al., 2002, 2003)
Experienced needs
Time frame: Baseline. Completing the questionnaire will take about 15-20 minutes
Self-developed questionnaire examining the need for information, need for support and needs with regards to health care
Experience with existing initiatives and tools
Time frame: Baseline. Completing the questionnaire will take about 15-20 minutes
Self-developed questionnaire about the experience of participants with existing initiatives and tools
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- 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.
Gwendolyn Portzky, PhD principal investigator
Flemish Centre of Expertise in Suicide Prevention (Ghent University)
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 Prevention and Informal Caregivers, run by University Ghent at 1 site in Belgium.
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 4 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: finished, as of the sponsor's last update on 5 Sep 2025. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Background information: information on the participant (time frame: Baseline. Completing the questionnaire will take about 15-20 minutes). The study lists 8 primary outcomes in all. 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 5 Sep 2025.