NCT06776328

Brief 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 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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2024

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

Study Start

First participant enrolled

December 12, 2024

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 15, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

January 15, 2025

Status Verified

January 1, 2025

Enrollment Period

1.3 years

First QC Date

January 9, 2025

Last Update Submit

January 9, 2025

Conditions

Keywords

co-creationparticipatory researchchildrenadolescentssuicide preventionsuicidal ideationsuicidal behavioursuicide

Outcome Measures

Primary Outcomes (1)

  • 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

    From enrolment to end of co-creation sessions (10 sessions of 1.5 hours max over the course of the study)

Study Arms (1)

Co-creation meetings

OTHER

All participants will be invited to participate in the co-creation meetings.

Other: Tools

Interventions

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.

Co-creation meetings

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Aged 10-18 years
  • Proficient in Dutch
  • Has experienced suicidal thoughts in the past

You may not qualify if:

  • Limited cognitive ability
  • Currently experiencing an acute suicidal crisis

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

Suicide PreventionSuicidal IdeationSuicide

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Gwendolyn Portzky, PhD

    Flemish Centre of Expertise in Suicide Prevention, Department of Head and Skin, UGent

    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

January 9, 2025

First Posted

January 15, 2025

Study Start

December 12, 2024

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

January 15, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations