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 |
Trial Parameters
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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