NCT07159347 Assessment of Daily Stressors in Children With Depressive Symptoms for the Development of a Gamified Emotion Regulation App
| NCT ID | NCT07159347 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ludwig-Maximilians - University of Munich |
| Condition | Depressive Disorder |
| Study Type | OBSERVATIONAL |
| Enrollment | 15 participants |
| Start Date | 2025-09-02 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 15 participants in total. It began in 2025-09-02 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Digital interventions, such as serious games, are becoming increasingly important in the context of prevention and treatment approaches of mental disorders. A project (SG4ChildD) funded by the Federal Ministry of Research, Technology and Space (BMFTR) aims to develop a gamified app to promote emotion regulation in children aged 8 to 12 with increased depressive symptoms or a manifest diagnosis of depression. The app intends to train emotion regulation skills through playful and everyday-relevant scenarios. To ensure that the app meets the needs of the target group, a participatory needs assessment will be conducted that involves both children and their parents. Based on interviews with children and focus groups with parents and complemented by questionnaires, it will be assessed which everyday stressors children experience, how they cope with them, and what kind of support they and their parents find helpful.
Eligibility Criteria
Inclusion Criteria (Children): * increased depressive symptoms indicated by either (1) self report assessed with Beck Depression Inventory for Youth 2 (Beck et al., 2019; T-score \> 60) , or (2) parental report assessed with DISYPS-III - external rating scale for depressive disorders (FBB-DES; Döpfner et al., 2017; applying gender- and age-normed Stanine scores ≥ 7). Exclusion Criteria (Children): * Insufficient German language skills * Acute suicidality * Schizophrenic disorder * Severe developmental disorder * Mental and behavioral disorders due to psychotropic substances Inclusion Criteria (Parents): Parent of a child meeting the above inclusion criteria
Contact & Investigator
Gerd Schulte-Körne, Prof. Dr.
PRINCIPAL INVESTIGATOR
Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, LMU University Hospital
Frequently Asked Questions
Who can join the NCT07159347 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 12 Years, studying Depressive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07159347 currently recruiting?
Yes, NCT07159347 is actively recruiting participants. Contact the research team at Lisa.Feldmann@med.uni-muenchen.de for enrollment information.
Where is the NCT07159347 trial being conducted?
This trial is being conducted at München, Germany.
Who is sponsoring the NCT07159347 clinical trial?
NCT07159347 is sponsored by Ludwig-Maximilians - University of Munich. The principal investigator is Gerd Schulte-Körne, Prof. Dr. at Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, LMU University Hospital. The trial plans to enroll 15 participants.