NCT07043231

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

June 2, 2025

Completed
27 days until next milestone

First Posted

Study publicly available on registry

June 29, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

June 29, 2025

Status Verified

June 1, 2025

Enrollment Period

5 months

First QC Date

May 27, 2025

Last Update Submit

June 20, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Usability of Creative Materials for Discussing Suicidality

    This is self-developed questionnaire regarding the usability of the creative materials.

    Three months after enrollment

Secondary Outcomes (6)

  • Efficacy of Creative Materials for Discussing Suicidality

    Three months after enrollment

  • Applicability of the creative materials for Discussing Suicidality

    Three months after enrollment

  • Acceptability of Intervention Measure (AIM)

    Three months after enrollment

  • Intervention Appropriateness Measure (IAM)

    Three months after enrollment

  • Feasibility of Intervention Measure (FIM)

    Three months after enrollment

  • +1 more secondary outcomes

Study Arms (1)

Study group

EXPERIMENTAL
Other: Creative materials

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Flemish Centre of Expertise in Suicide Prevention, Ghent University

Ghent, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Suicidal Ideation

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Gwendolyn Portzky, PhD

    University Ghent

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva De Jaegere, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2025

First Posted

June 29, 2025

Study Start

June 2, 2025

Primary Completion

November 1, 2025

Study Completion

December 1, 2025

Last Updated

June 29, 2025

Record last verified: 2025-06

Locations