SuicideNCT06100575
Tool for Sibling and Children of Someone With Suicidal Thoughts
A study testing Website (www.mee-leven.be) in people with Suicide, run by University Ghent at 1 site in Belgium.
Trial summary
This study aims to investigate to what extent a website developed for siblings and children (16-25 years old) of someone with suicidal thoughts and/or behaviors is effective in improving perceived pressure, knowledge, attitudes, self-confidence and hopelessness. Read more about this study
- Who is it for?
- Ages 16 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Suicide
- What is being tested?
- Website (www.mee-leven.be)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteBelgium
- Study dates
- 16 Oct 2023to 29 Jan 2024
- 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 16 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Siblings and children of someone who has suicidal thoughts and/or behavior
- 16-25 years old
- Have access to internet
- Speak Dutch
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
Official title: A Tool for Siblings and Children of Someone With Suicidal Thoughts and/or Behaviors: Evaluation.
This study aims to investigate to what extent a website developed for siblings and children (16-25 years old) of someone with suicidal thoughts and/or behaviors is effective in improving perceived pressure, knowledge, attitudes, self-confidence and hopelessness. Moreover, it aims to examine how participants evaluate the website.
- Conditions
- Suicide
- Being tested
- Website (www.mee-leven.be)
- Medical subject headings
- Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Website (www.mee-leven.be)Behavioural
The tool is a website aimed siblings and children of someone who has suicidal thoughts and/or behaviors. The intended objectives of the tool are 1) to contribute to knowledge about suicide and health care options, 2) to increase perceived competences in dealing with suicidality of a family member, 3) to reduce perceived pressure and negative feelings such as hopelessness and 4) to be accessible and user-friendly.
These objectives are achieved by providing the following content: 1) concerning the sibling/child themselves (primary objective) : information about the potential impact of having a suicidal family member, own needs, informal and formal (self) care, dealing with the suicidal family member, dealing with other family members 2) concerning the suicidal family member (Secondary objective): information about the suicidal process, signal recognition, how to provide support/create a safe environment for suicidal loved ones , help available for suicidal relatives
| Study group | Role | What they receive |
|---|---|---|
| Website (www.mee-leven.be) | Experimental | Participants in this group (all participants) are asked to complete a questionnaire and then receive access to the website during three days, after which they were asked to complete another questionnaire. Receives: Behavioral: Website (www.mee-leven.be) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in self-efficacy: Gatekeeper Self-Efficacy Scale (Takahashi et al., 2020)
The Gatekeeper Self-Efficacy Scale is a 9-item self-report scale to be scored on a 7-point Likert scale (1= not at all to 5 = Extremely) to measure participants' self efficacy in dealing with suicidal individuals. Higher scores indicate higher self-efficacy.
Measured: Change from Baseline (before intervention) to post-test (after 3 days of access to website)
Secondary outcomes (5)
Changes in perceived pressure: Perceived pressure informal care ('Ervaren druk informele zorg', Pot et al., 1995)
The Perceived pressure informal care ('Ervaren druk informele zorg', Pot et al., 1995) scale is a 9-item self-report scale. Participants rate items to be applicable to them with the options: 'No!', 'No', 'More or less', 'Yes', 'Yes!', where 'No' and 'No!' are scored as 0 and the other options as 1. Total scores of 0-3 indicate little pressure, 4-6 moderate and 7-9 a lot.
Measured: Change from Baseline (before intervention) to post-test (after 3 days of access to website)
Changes in attitudes: 5 subscales of Attitudes Towards Suicide Scale (Rensberg & Jacobson, 2003; De Clerck et al., 2006)
The ATTS is a 37-item to be scored on a 5-point Likert scale (1= disagree completely to 5 = agree completely) to measure participants' attitudes towards suicide. The included subscales in this study are: incomprehensibility, non-communication, preventability, tabooing, preparedness to prevent
Measured: Change from Baseline (before intervention) to post-test (after 3 days of access to website)
Changes in hopelessness: Beck Hopelessness Scale (4-item version; Beck et al., 1974; Aish & Wasserman, 2001) and self-developed questionnaire
The BHS A 4-item self-report questionnaire to measure hopelessness in adolescents and adults. Each item is rated as 'true' (score = 1) or 'false' (score = 0) for them over the past week, resulting in a total score ranging from 0 to 4, with higher scores indicating higher levels of hopelessness.
Self-developed questionnaire: 4-item self-report questionnaire to measure hopelessness in relation to the loved one, based on the BHS 4-item version. Each item is rated as 'true' (score = 1) or 'false' (score = 0) for them over the past week, resulting in a total score ranging from 0 to 4, with higher scores indicating higher levels of hopelessness in relation to the loved one.
Measured: Change from Baseline (before intervention) to post-test (after 3 days of access to website)
Changes in self-care and awareness
Self-developed questionnaire consisting of 5 statements to be rated on a 5-point Likert scale, with 1=strongly disagree and 5=strongly agree. Higher scores indicate higher levels of self-care and awareness.
Measured: Change from Baseline (before intervention) to post-test (after 3 days of access to website)
Evaluation of the website
18 statements about the content, structure and effect of the website to be rated on a 5-point Likert scale (1= strongly disagree, 5= strongly agree) 4 open questions: "Which part of the website benefited you the most and why?"; "Which part of the website benefited you the least and why?"; "What can be improved on the website?" "Would you like to say anything else about the website?" Participants were asked to rate the website on a scale of 1-10
Measured: post-test (after 3 days of access to website)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start16 Oct 2023
- Primary completion24 Jan 2024
- Study completion29 Jan 2024
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gwendolyn Portzky, Phd, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06100575
- Sponsor's protocol ID
- B6702023000493 - ONZ-2023-0335
- Status last verified
- Feb 2024
- First submitted
- 20 Oct 2023
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Tool for Siblings and Children of Someone With Suicidal Thoughts and/or Behaviors: Evaluation.
- ClinicalTrials.gov ID
- NCT06100575
- Acronym / sponsor ID
- B6702023000493 - ONZ-2023-0335
- Conditions
- Suicide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 24 Jan 2024 (actual)
- Study completion
- 29 Jan 2024 (actual)
- First posted
- 25 Oct 2023 (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.
This study aims to investigate to what extent a website developed for siblings and children (16-25 years old) of someone with suicidal thoughts and/or behaviors is effective in improving perceived pressure, knowledge, attitudes, self-confidence and hopelessness. Moreover, it aims to examine how participants evaluate the website.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Website (www.mee-leven.be) | Experimental | Behavioral: Website (www.mee-leven.be)Participants in this group (all participants) are asked to complete a questionnaire and then receive access to the website during three days, after which they were asked to complete another questionnaire. |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Siblings and children of someone who has suicidal thoughts and/or behavior
- 16-25 years old
- Have access to internet
- Speak Dutch
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 |
|---|---|---|
| Website (www.mee-leven.be)The tool is a website aimed siblings and children of someone who has suicidal thoughts and/or behaviors. The intended objectives of the tool are 1) to contribute to knowledge about suicide and health care options, 2) to increase perceived competences in dealing with suicidality of a family member, 3) to reduce perceived pressure and negative feelings such as hopelessness and 4) to be accessible and user-friendly. These objectives are achieved by providing the following content: 1) concerning the sibling/child themselves (primary objective) : information about the potential impact of having a suicidal family member, own needs, informal and formal (self) care, dealing with the suicidal family member, dealing with other family members 2) concerning the suicidal family member (Secondary objective): information about the suicidal process, signal recognition, how to provide support/create a safe environment for suicidal loved ones , help available for suicidal relatives | Behavioural | Website (www.mee-leven.be) |
Primary outcome
Changes in self-efficacy: Gatekeeper Self-Efficacy Scale (Takahashi et al., 2020)
Time frame: Change from Baseline (before intervention) to post-test (after 3 days of access to website)
The Gatekeeper Self-Efficacy Scale is a 9-item self-report scale to be scored on a 7-point Likert scale (1= not at all to 5 = Extremely) to measure participants' self efficacy in dealing with suicidal individuals. Higher scores indicate higher self-efficacy.
5 secondary outcomes
Changes in perceived pressure: Perceived pressure informal care ('Ervaren druk informele zorg', Pot et al., 1995)
Time frame: Change from Baseline (before intervention) to post-test (after 3 days of access to website)
Changes in attitudes: 5 subscales of Attitudes Towards Suicide Scale (Rensberg & Jacobson, 2003; De Clerck et al., 2006)
Time frame: Change from Baseline (before intervention) to post-test (after 3 days of access to website)
Changes in hopelessness: Beck Hopelessness Scale (4-item version; Beck et al., 1974; Aish & Wasserman, 2001) and self-developed questionnaire
Time frame: Change from Baseline (before intervention) to post-test (after 3 days of access to website)
Changes in self-care and awareness
Time frame: Change from Baseline (before intervention) to post-test (after 3 days of access to website)
Evaluation of the website
Time frame: post-test (after 3 days of access to website)
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 6 Feb 2024.
- 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
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Website (www.mee-leven.be) in people with Suicide, 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 6 Feb 2024. 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?
Changes in self-efficacy: Gatekeeper Self-Efficacy Scale (Takahashi et al., 2020) (time frame: Change from Baseline (before intervention) to post-test (after 3 days of access to website)). 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 6 Feb 2024.