Evaluation of an App for Young People With Suicidal Thoughts

NCT07165561 | Completed

• 1 other identifier: ONZ-2024-0547
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Suicidal Behavior; Suicidal Ideation; Coping Behavior

Keywords

suicidal ideation; adolescents; suicidal behavior; Suicide-Related Coping; e-mental health

Outcome Measures

Primary Outcomes (1)

• Evaluation of App Usage and User Experience

  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.

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

Secondary Outcomes (1)

• 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)

Other Outcomes (1)

• Socio-demographic data

  At Baseline (Day 0)

Study Arms (1)

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.

Behavioral: Smartphone App

Interventions

Smartphone App BEHAVIORAL

This intervention is a mobile app co-created with adolescents who have experienced suicidal thoughts. It is specifically designed for youth aged 12-17 and includes a Safety Plan, tools such as a HopeBox, and psychoeducational content for young people, their loved ones, and care providers. Furthermore, there is a 'Help' button, offering direct access to crisis support. Unlike existing apps for adults, this app is tailored to the developmental needs and lived experiences of adolescents. Access is restricted to study participants to ensure controlled evaluation.

Intervention Group

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

Sponsors & Collaborators

• University Ghent: lead

Study Sites (1)

Flemish Centre of Expertise in Suicide Prevention, Ghent University

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Suicidal Ideation

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Gwendolyn Portzky, PhD

  University Ghent

  PRINCIPAL INVESTIGATOR

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: August 22, 2025
• First Posted: September 10, 2025
• Study Start: September 12, 2025
• Primary Completion: December 23, 2025
• Study Completion: December 23, 2025
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

BE (1)