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Clinical Trials/NCT07165561
NCT07165561CompletedNot Applicable

Evaluation of an App for Young People With Suicidal Thoughts

University Ghent2 sites in 1 country32 target enrollmentStarted: September 12, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
32
Locations
2
Primary Endpoint
Evaluation of App Usage and User Experience

Study Overview

Brief Summary

There are currently very few evidence-based tools specifically designed to support children and adolescents experiencing suicidal thoughts. Digital interventions are increasingly used in suicide prevention and show promise in helping young people improve emotional regulation, coping skills, and manage suicidal thoughts and behaviors.

In Flanders, the app BackUp was developed in 2015 by VLESP to support adults with suicidal thoughts. Research showed that while the app led to a small, non-significant reduction in suicidal thoughts after one week, 70% of users found it helpful in daily life. A key feature of the app is the Safety Plan, based on cognitive behavioral therapy, which helps individuals identify coping strategies and sources of support. This approach has proven effective in reducing suicidal behavior and is also suitable for use with children and adolescents.

Despite these developments, there is still a need for a digital tool specifically tailored to young people. In 2023, the investigators launched a project to develop a new app in collaboration with youth care professionals, app developers, and adolescents with lived experience of suicidality. Their input ensures the app meets the needs and preferences of young users.

This study aims to evaluate the effectiveness and usability of the app through a pilot study involving adolescents aged 12-17 who are currently experiencing suicidal thoughts. Participants and their parents or guardians must provide informed consent before joining the study.

The evaluation includes online questionnaires completed before and after using the app. These questionnaires collect information on demographics, coping strategies, and the severity of suicidal thoughts and behaviors. The post-assessment also includes questions about user experience and satisfaction. No interviews are conducted; all data are collected digitally.

Participants are recruited through various channels and must meet specific inclusion criteria. After completing the initial questionnaire, they receive a code to access the app, ensuring that only study participants can use it.

Detailed Description

Research clearly shows that very few evidence-based tools or interventions exist specifically targeting suicidality in children and adolescents. Within suicide prevention there is increasing use of digital technology. Studies show that digital interventions aimed at suicidality in young people seem promising in terms of knowledge promotion, emotion regulation, development of coping skills and dealing with suicidal thoughts and behavior.

In Flanders in 2015, the app BackUp was developed by VLESP for adults struggling with suicidal thoughts. Research conducted by VLESP (reference number: 2015/0306) showed that use of the app led to a small but non-significant decrease in suicidal thoughts after one week. Moreover, 70% of users found the app useful in their daily lives. A key component of the app BackUp is the Safety Plan. Based on cognitive behavioral therapy, the Safety Plan aims to prevent suicidal behavior by establishing coping strategies and support resources. Since its introduction, the Safety Plan has been an integral part of standard care for suicidal individuals. The use of a Safety Plan has been shown to be effective in reducing suicidal behavior. In addition, research shows that it appears to be effective for use with children and adolescents.

However, there is a need for an app specifically aimed at young people, which they can use when they have suicidal thoughts. In 2023, the investigators initiated a project (EC code: ONZ-2024-0211) aimed at developing a mobile application through collaboration with professionals working in youth care, app developers, and co-creation with adolescents who have experienced suicidal thoughts. Throughout this process, young individuals with lived experience of suicidality actively contributed to the development of the app. This participatory approach ensures that the app is better aligned with their needs and help-seeking behaviors.

The next phase involves conducting an evaluation of the app. This evaluation seeks to gain deeper insights into its effectiveness and usability. To achieve this, the investigators will carry out a pilot study involving pre- and post-assessments with adolescents (aged 12-17) who are currently experiencing suicidal thoughts.

TThe pre- and post-assessments consist of online questionnaires completed by participants after both they and their parent or legal guardian have provided informed consent to participate in the study. During the pre-assessment, socio-demographic data are collected, along with information regarding suicide-related coping strategies and the severity of suicidal thoughts and behaviors. The post-assessment covers the same domains, supplemented with questions about user experience and satisfaction with the app.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
12 Years to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Aged 12 through 17 years
  • Currently experiencing suicidal thoughts (defined as a score of 1 or higher on the Suicidal Ideation Attributes Scale [SIDAS; Van Spijker et al., 2014])
  • Access to the internet
  • Possession of a smartphone
  • Proficient in Dutch

Exclusion Criteria

  • Does not meet one or more of the inclusion criteria listed above

Arms & Interventions

Intervention Group

Experimental

Once the participants and their parents/guardians have given their consent online, the participants will receive the first questionnaire (pre-test). Once this questionnaire has been completed, a link to the app and the access code for the app will be provided. Participants will receive an invitation to complete the post-test after 10 days. Reminders to complete the questionnaire will follow after 2 and 4 days. All questionnaires are completed online.

Intervention: Smartphone App (Behavioral)

Outcomes

Primary Outcomes

Evaluation of App Usage and User Experience

Time Frame: At post-test (Day 10 to day 14 after baseline assessment)

The primary outcome of this study is to assess how young people use the app and their experience with its usability and perceived effectiveness. The evaluation focuses on identifying strengths and potential barriers within the target group to improve the app's accessibility and relevance. If participants have not completed the post-test questionnaire by Day 10, reminder messages are sent on Day 12 and Day 14.

Secondary Outcomes

  • Suicide-Related Coping and Severity of Suicidal Thoughts and Behaviors(At Baseline (Day 0) and at Post-test (Day 10 to day 14 after baseline assessment))

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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