Suicide PreventionCo-crea K&JNCT06776328
Co-creation of Tools for Children and Adolescents with Suicidal Thoughts And/or Behaviour
A study testing Tools in people with Suicide Prevention and Suicidal Ideation, run by University Ghent at 1 site in Belgium.
Trial summary
Evidence shows that there are very few evidence-based tools or interventions specifically targeting suicidality in children and adolescents. It is crucial to address suicidal thoughts in these populations, as research indicates that discussing suicidality does not increase suicidal behavior but may instead reduce the… Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Suicide Prevention, Suicidal Ideation, Suicidal Behaviors
- What is being tested?
- Tools
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 12 Dec 2024to 1 Apr 2026
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Aged 10-18 years
- Proficient in Dutch
- Has experienced suicidal thoughts in the past
Who cannot join
- Limited cognitive ability
- Currently experiencing an acute suicidal crisis
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, +32 9 332.07.75, eva.dejaegere@ugent.be
About this study
Evidence shows that there are very few evidence-based tools or interventions specifically targeting suicidality in children and adolescents. It is crucial to address suicidal thoughts in these populations, as research indicates that discussing suicidality does not increase suicidal behavior but may instead reduce the associated risk. Furthermore, the field of suicide prevention increasingly incorporates digital technologies. Studies suggest that digital interventions targeting suicidality in young people show promise in enhancing knowledge, regulating emotions, developing coping skills, and managing suicidal thoughts and behaviors.
As part of this project, we will develop the following practical tools:
Read more
- A creative methodology for professionals to engage children and adolescents in talking about their suicidal thoughts.
- A self-help app for suicidal young people and their support networks. The development process will involve co-creation, with input from children and adolescents playing a central role.
A total of 30 children and adolescents aged 10 to 18 years, who have experienced suicidal thoughts in the past, will participate in this project. The co-creation sessions will be conducted in groups of up to 10 participants. Participants can attend a minimum of 1 and a maximum of 10 sessions, each lasting up to 1.5 hours. The sessions will be facilitated by researchers from VLESP and will take place at a location convenient for participants or in Ghent (the primary location of the research team). If preferred by participants, one or more sessions may also be held online.
For participants who do not wish to join a group, individual sessions can be arranged. Each session will be attended by two researchers, with the potential involvement of professionals specializing in tool development. Several potential developers will be invited to submit proposals for creating the tools, and the selection of the developer will be based on these submissions.
During the sessions, participants will review and evaluate various prototypes of the app. However, the prototypes will not be tested for effectiveness by the young participants.
- Conditions
- Suicide Prevention, Suicidal Ideation, Suicidal Behaviors
- Being tested
- Tools
- Keywords
- co-creation, participatory research, children, adolescents, suicide prevention, suicidal ideation, suicidal behaviour, suicide
- Medical subject headings
- Suicide Prevention, Suicidal Ideation, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToolsOther
In the co-creation meetings, developed tools will be presented. Participants will be asked to provide feedback and input to tailor these tools to the needs and preferences of children and adolescents with suicidal thoughts/behavior.
| Study group | Role | What they receive |
|---|---|---|
| Co-creation meetings | Other | All participants will be invited to participate in the co-creation meetings. Receives: Other: Tools |
What is being measured
The primary outcome is the main question the study is designed to answer.
Co-creation questions
In the co-creation sessions, participants will be asked about:
- Current app usage
- Preferences and needs regarding an app/creative methodology
- Accessibility and usability of the tools
- Privacy and confidentiality
- Social support and community engagement
- Sensitivity and language
- Seeking help and professional support
- Sustained engagement
- Feedback on tool prototypes
- Reflections on how they experienced the session
Measured: From enrolment to end of co-creation sessions (10 sessions of 1.5 hours max over the course of the study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start12 Dec 2024
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
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, Department of Head and Skin, UGent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06776328
- Sponsor's protocol ID
- ONZ-2024-0211
- Other IDs
- GE0-1GDF2JA
- Acronym
- Co-crea K&J
- Status last verified
- Jan 2025
- First submitted
- 9 Jan 2025
- Last updated
- 15 Jan 2025
- 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 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Co-creation of Tools for Children and Adolescents with Suicidal Thoughts And/or Behaviour
- ClinicalTrials.gov ID
- NCT06776328
- Acronym / sponsor ID
- Co-crea K&J / ONZ-2024-0211
- Conditions
- Suicide Prevention, Suicidal Ideation, Suicidal Behaviors
- Keywords
- co-creation, participatory research, children, adolescents, suicide prevention, suicidal ideation, suicidal behaviour, suicide
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 12 Dec 2024 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 15 Jan 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.
Evidence shows that there are very few evidence-based tools or interventions specifically targeting suicidality in children and adolescents. It is crucial to address suicidal thoughts in these populations, as research indicates that discussing suicidality does not increase suicidal behavior but may instead reduce the associated risk. Furthermore, the field of suicide prevention increasingly incorporates digital technologies. Studies suggest that digital interventions targeting suicidality in young people show promise in enhancing knowledge, regulating emotions, developing coping skills, and managing suicidal thoughts and behaviors.
As part of this project, we will develop the following practical tools:
- A creative methodology for professionals to engage children and adolescents in talking about their suicidal thoughts.
- A self-help app for suicidal young people and their support networks. The development process will involve co-creation, with input from children and adolescents playing a central role.
A total of 30 children and adolescents aged 10 to 18 years, who have experienced suicidal thoughts in the past, will participate in this project. The co-creation sessions will be conducted in groups of up to 10 participants. Participants can attend a minimum of 1 and a maximum of 10 sessions, each lasting up to 1.5 hours. The sessions will be facilitated by researchers from VLESP and will take place at a location convenient for participants or in Ghent (the primary location of the research team). If preferred by participants, one or more sessions may also be held online.
For participants who do not wish to join a group, individual sessions can be arranged. Each session will be attended by two researchers, with the potential involvement of professionals specializing in tool development. Several potential developers will be invited to submit proposals for creating the tools, and the selection of the developer will be based on these submissions.
During the sessions, participants will review and evaluate various prototypes of the app. However, the prototypes will not be tested for effectiveness by the young participants.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Co-creation meetings | Other | Other: ToolsAll participants will be invited to participate in the co-creation meetings. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Aged 10-18 years
- Proficient in Dutch
- Has experienced suicidal thoughts in the past
Key exclusion criteria (2 listed)
- Limited cognitive ability
- Currently experiencing an acute suicidal crisis
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 |
|---|---|---|
| ToolsIn the co-creation meetings, developed tools will be presented. Participants will be asked to provide feedback and input to tailor these tools to the needs and preferences of children and adolescents with suicidal thoughts/behavior. | Other | Co-creation meetings |
Primary outcome
Co-creation questions
Time frame: From enrolment to end of co-creation sessions (10 sessions of 1.5 hours max over the course of the study)
In the co-creation sessions, participants will be asked about: * Current app usage * Preferences and needs regarding an app/creative methodology * Accessibility and usability of the tools * Privacy and confidentiality * Social support and community engagement * Sensitivity and language * Seeking help and professional support * Sustained engagement * Feedback on tool prototypes * Reflections on how they experienced the session
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 15 Jan 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.
Gwendolyn Portzky, PhD principal investigator
Flemish Centre of Expertise in Suicide Prevention, Department of Head and Skin, UGent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tools in people with Suicide Prevention and 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 3 inclusion and 2 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 15 Jan 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 (+32 9 332.07.75, eva.dejaegere@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Co-creation questions (time frame: From enrolment to end of co-creation sessions (10 sessions of 1.5 hours max over the course of the study)). 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 15 Jan 2025.