Suicidal IdeationNCT07043231
Evaluation of Creative Materials Supporting Healthcare Professionals in Discussing Suicidality in Children and Adolescents
A study testing Creative materials in people with Suicidal Ideation, run by University Ghent at 1 site in Belgium.
Trial summary
Preliminary research clearly indicates a significant shortage of evidence-based tools and interventions specifically targeting suicidality among children and adolescents. The need for such methodologies is substantial, as suicidal ideation and suicide attempts are relatively common within this age group. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Suicidal Ideation
- What is being tested?
- Creative materials
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 2 Jun 2025to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must be healthcare professionals (e.g., general practitioners, psychiatrists, psychologists, psychotherapists, or nurses) working in mental health care.
- Participants must work with children or adolescents who may be experiencing suicidality.
- Participants must be 18 years of age or older.
- Participants must have internet access and sufficient proficiency in Dutch.
Who cannot join
- Individuals who do not meet the inclusion criteria.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Flemish Centre of Expertise in Suicide Prevention, Ghent University
Ghent, 9000
Eva De Jaegere, PhD, +3293320775, eva.dejaegere@ugent.be
About this study
Preliminary research clearly indicates a significant shortage of evidence-based tools and interventions specifically targeting suicidality among children and adolescents. The need for such methodologies is substantial, as suicidal ideation and suicide attempts are relatively common within this age group. According to the 2022 Health Behaviour in School-aged Children (HBSC) study, 16% of boys and 28% of girls aged 13 to 18 reported having had suicidal thoughts on two or more occasions in their lifetime (Schrijvers et al., 2023). Compared to the previous HBSC study conducted in 2018, this represents a negative trend, as 13% of boys and 22% of girls reported suicidal thoughts at that time (Dierckens et al., 2019).
Facilitating open discussions about suicidal thoughts is therefore of critical importance. Research has shown that discussing suicidality does not increase suicidal behavior; rather, it can contribute to a reduction in risk (Blades et al., 2018; Dazzi et al., 2014; DeCou \& Schumann, 2018; Polihronis et al., 2022). Breaking the taboo around suicidality and attuning to the emotional experiences of children and adolescents may serve as an initial step toward providing effective support. Such openness can help reduce feelings of loneliness and isolation by fostering a safe environment in which young people feel heard and understood. Moreover, the act of speaking openly about suicidality is associated with increased social support-an important protective factor (Batty et al., 2018; Calati et al., 2019).
Read more
In 2023, a project was launched aimed at developing creative materials to support professionals in initiating conversations about suicidality with children and adolescents. This material is being developed through a co-creative process (EC code: ONZ-2024-0211), in collaboration with youth care professionals, method developers, and young individuals with lived experience of suicidal thoughts. These young people provide essential contributions to ensure that the materials are aligned with their needs and expectations for support. This co-creative approach aims not only to produce a theoretically grounded methodology, but also to yield a practically applicable tool that effectively addresses the real-world challenges faced by both professionals and youth. The creative materials are currently under development and are designed to facilitate exploration and discussion of suicidality, ultimately supporting professionals in formulating a risk assessment and developing a Safety Plan. This approach aligns with the recommendations outlined in the guideline "Detection and Interventions for Suicidal Thoughts and Behaviors in Children and Adolescents" (Dumon et al., 2023).
The next phase of the project focuses on evaluating the creative materials. The evaluation aims to gain insight into their usability and applicability in professional practice. This will be conducted through an evaluation study. Professionals working in Flanders will be recruited via calls on www.zelfmoord1813.be, relevant partner organizations, social media, and newsletters from VLESP and other partners. Additionally, professionals may be invited via email. Those who have used the materials over a three-month period will be asked to retrospectively share their experiences. The study consists of the following steps:
Registration: Eligible professionals complete a short registration form (duration: approximately 5 minutes).
Use of the creative materials: Participants use the materials in their professional context over a period of three months.
Post-assessment: At the end of the three-month period, participants complete a questionnaire regarding their experiences with the materials (duration: approximately 10-15 minutes).
The post-assessment focuses on evaluating user-friendliness, practical applicability, and the potential of the creative materials to facilitate conversations about suicidality. Collected feedback will be used to further refine and optimize the materials. If participants do not complete the post-assessment promptly, they will receive reminder emails after 2 and 4 days. The target sample size for the study is 40 participants.
- Conditions
- Suicidal Ideation
- Being tested
- Creative materials
- Medical subject headings
- Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creative materialsOther
This intervention provides professionals with co-created creative materials specifically designed to facilitate structured, safe conversations about suicidality with children and adolescents. Unlike standard tools, it offers three flexible pathways-Conversation, Drawing, and Walking-allowing a personalized approach tailored to the young person's preferences and context. The materials guide professionals through the assessment of suicidal intent, risk and protective factors, and help formulate a risk assessment and Safety Plan. The content is aligned with national clinical guidelines but uniquely integrates experiential insights from youth with lived experience, ensuring both theoretical grounding and practical applicability.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Not described Receives: Other: Creative materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability of Creative Materials for Discussing Suicidality
This is self-developed questionnaire regarding the usability of the creative materials.
Measured: Three months after enrollment
Secondary outcomes (6)
Efficacy of Creative Materials for Discussing Suicidality
This is a self-developed questionnaire regarding the efficacy of the creative materials.
Measured: Three months after enrollment
Applicability of the creative materials for Discussing Suicidality
This is a self-developed questionnaire regarding the applicability of the creative materials.
Measured: Three months after enrollment
Acceptability of Intervention Measure (AIM)
This is a psychometrically validated tool developed by Weiner et al. (2017) which assesses the perceived acceptability of an intervention by stakeholders. The measure consists of 4 items, rated on a Likert scale (typically 1 = completely disagree to 5 = completely agree).
Measured: Three months after enrollment
Intervention Appropriateness Measure (IAM)
This is a psychometrically validated tool developed by Weiner et al. (2017) which evaluates the perceived relevance or suitability of the intervention for a given setting or problem. The measure consists of 4 items, rated on a Likert scale (typically 1 = completely disagree to 5 = completely agree).
Measured: Three months after enrollment
Feasibility of Intervention Measure (FIM)
This is a psychometrically validated tool developed by Weiner et al. (2017) which measures the extent to which an intervention can be successfully used or carried out within a setting. The measure consists of 4 items, rated on a Likert scale (typically 1 = completely disagree to 5 = completely agree).
Measured: Three months after enrollment
Implementation of the creative materials for Discussing Suicidality
This is a self-developed questionnaire regarding the implementation of the creative materials.
Measured: Three months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start2 Jun 2025
- Primary completionNov 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicidal IdeationStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Flemish Minister for Welfare, Public Health and Family, Belgium
- Responsible party
- Sponsor
- Investigators
- Gwendolyn Portzky, PhD, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07043231
- Sponsor's protocol ID
- ONZ-2024-0593
- Status last verified
- Jun 2025
- First submitted
- 27 May 2025
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Creative Materials Supporting Healthcare Professionals in Discussing Suicidality in Children and Adolescents
- ClinicalTrials.gov ID
- NCT07043231
- Acronym / sponsor ID
- ONZ-2024-0593
- Conditions
- Suicidal Ideation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- Flemish Minister for Welfare, Public Health and Family, Belgium
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 29 Jun 2025 (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.
Preliminary research clearly indicates a significant shortage of evidence-based tools and interventions specifically targeting suicidality among children and adolescents. The need for such methodologies is substantial, as suicidal ideation and suicide attempts are relatively common within this age group. According to the 2022 Health Behaviour in School-aged Children (HBSC) study, 16% of boys and 28% of girls aged 13 to 18 reported having had suicidal thoughts on two or more occasions in their lifetime (Schrijvers et al., 2023). Compared to the previous HBSC study conducted in 2018, this represents a negative trend, as 13% of boys and 22% of girls reported suicidal thoughts at that time (Dierckens et al., 2019).
Facilitating open discussions about suicidal thoughts is therefore of critical importance. Research has shown that discussing suicidality does not increase suicidal behavior; rather, it can contribute to a reduction in risk (Blades et al., 2018; Dazzi et al., 2014; DeCou \& Schumann, 2018; Polihronis et al., 2022). Breaking the taboo around suicidality and attuning to the emotional experiences of children and adolescents may serve as an initial step toward providing effective support. Such openness can help reduce feelings of loneliness and isolation by fostering a safe environment in which young people feel heard and understood. Moreover, the act of speaking openly about suicidality is associated with increased social support-an important protective factor (Batty et al., 2018; Calati et al., 2019).
In 2023, a project was launched aimed at developing creative materials to support professionals in initiating conversations about suicidality with children and adolescents. This material is being developed through a co-creative process (EC code: ONZ-2024-0211), in collaboration with youth care professionals, method developers, and young individuals with lived experience of suicidal thoughts. These young people provide essential contributions to ensure that the materials are aligned with their needs and expectations for support. This co-creative approach aims not only to produce a theoretically grounded methodology, but also to yield a practically applicable tool that effectively addresses the real-world challenges faced by both professionals and youth. The creative materials are currently under development and are designed to facilitate exploration and discussion of suicidality, ultimately supporting professionals in formulating a risk assessment and developing a Safety Plan. This approach aligns with the recommendations outlined in the guideline "Detection and Interventions for Suicidal Thoughts and Behaviors in Children and Adolescents" (Dumon et al., 2023).
The next phase of the project focuses on evaluating the creative materials. The evaluation aims to gain insight into their usability and applicability in professional practice. This will be conducted through an evaluation study. Professionals working in Flanders will be recruited via calls on www.zelfmoord1813.be, relevant partner organizations, social media, and newsletters from VLESP and other partners. Additionally, professionals may be invited via email. Those who have used the materials over a three-month period will be asked to retrospectively share their experiences. The study consists of the following steps:
Registration: Eligible professionals complete a short registration form (duration: approximately 5 minutes).
Use of the creative materials: Participants use the materials in their professional context over a period of three months.
Post-assessment: At the end of the three-month period, participants complete a questionnaire regarding their experiences with the materials (duration: approximately 10-15 minutes).
The post-assessment focuses on evaluating user-friendliness, practical applicability, and the potential of the creative materials to facilitate conversations about suicidality. Collected feedback will be used to further refine and optimize the materials. If participants do not complete the post-assessment promptly, they will receive reminder emails after 2 and 4 days. The target sample size for the study is 40 participants.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Other: Creative materials |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants must be healthcare professionals (e.g., general practitioners, psychiatrists, psychologists, psychotherapists, or nurses) working in mental health care.
- Participants must work with children or adolescents who may be experiencing suicidality.
- Participants must be 18 years of age or older.
- Participants must have internet access and sufficient proficiency in Dutch.
Key exclusion criteria (1 listed)
- Individuals who do not meet the inclusion criteria.
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 |
|---|---|---|
| Creative materialsThis intervention provides professionals with co-created creative materials specifically designed to facilitate structured, safe conversations about suicidality with children and adolescents. Unlike standard tools, it offers three flexible pathways-Conversation, Drawing, and Walking-allowing a personalized approach tailored to the young person's preferences and context. The materials guide professionals through the assessment of suicidal intent, risk and protective factors, and help formulate a risk assessment and Safety Plan. The content is aligned with national clinical guidelines but uniquely integrates experiential insights from youth with lived experience, ensuring both theoretical grounding and practical applicability. | Other | Study group |
Primary outcome
Usability of Creative Materials for Discussing Suicidality
Time frame: Three months after enrollment
This is self-developed questionnaire regarding the usability of the creative materials.
6 secondary outcomes
Efficacy of Creative Materials for Discussing Suicidality
Time frame: Three months after enrollment
Applicability of the creative materials for Discussing Suicidality
Time frame: Three months after enrollment
Acceptability of Intervention Measure (AIM)
Time frame: Three months after enrollment
Intervention Appropriateness Measure (IAM)
Time frame: Three months after enrollment
Feasibility of Intervention Measure (FIM)
Time frame: Three months after enrollment
Implementation of the creative materials for Discussing Suicidality
Time frame: Three months after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
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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.
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 Creative materials in people with Suicidal Ideation, 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: looking for participants now, as of the sponsor's last update on 29 Jun 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eva De Jaegere, PhD (+3293320775, eva.dejaegere@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability of Creative Materials for Discussing Suicidality (time frame: Three months after enrollment). 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 29 Jun 2025.