Co-creation of Tools for Children and Adolescents with Suicidal Thoughts And/or Behaviour (Co-crea K&J)

January 9, 2025 updated by: University Ghent

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • Recruiting
        • Flemish Centre of Expertise in Suicide Prevention, Ghent University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria (as assessed by the care provider):

  • Limited cognitive ability
  • Currently experiencing an acute suicidal crisis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Co-creation meetings
All participants will be invited to participate in the co-creation meetings.
Other: Tools
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From enrolment to end of co-creation sessions (10 sessions of 1.5 hours max over the course of the study)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Ghent

Investigators

  • Principal Investigator: Gwendolyn Portzky, PhD, Flemish Centre of Expertise in Suicide Prevention, Department of Head and Skin, UGent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2024

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

January 9, 2025

First Submitted That Met QC Criteria

January 9, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 9, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONZ-2024-0211
  • GE0-1GDF2JA (Other Identifier: Flemish government)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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