About this trial
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
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
Insufficient German language skills
Acute suicidality
Schizophrenic disorder
Severe developmental disorder
Trial population
In total, 15-20 participants will be included in the study, including both children aged 8-12 with increased depressive symptoms and parents of children with increased depressive symptoms. Parents will be included in the study (focus group), even if their child is not taking part in the study and vice versa. The sample size is based on the concept of data saturation, which refers to the point at which no new information emerges from additional data.
Trial design
Case-only
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Qualitative data from semi-structured child interviews and parental focus groups
Data will be collected through semi-structured individual interviews with children and focus group discussions with parents. The aim is to explore children's exposure to daily hassles, the subjective perception and emotional impact of these hassles, coping strategies, and support needs.
Secondary outcomes
Daily Hassles (Child-Report)
Assessed with the German translation of the Daily life stressors Scale (Kearney et al., 1993)
Perceived Stress (Child-Report)
Assessed with the German translation of the Perceived stress scale - children (White, 2014)
Emotion regulation strategies (Child-Report)
Assessed with the Process-Oriented Emotion Regulation Questionnaire for Children and Adolescents (Rüth \& Lohaus, 2023)
Regulatory parenting skills (parental report)
German translation of the Parental Assistance with Child Emotion Regulation (Cohodes et al., 2022)
Sponsors and contacts
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Ludwig-Maximilians - University of Munich
Lead sponsor
Technical University Darmstadt (WG Serious Games)
Collaborator
Ascora GmbH
Collaborator
smart medication eHealth Solutions GmbH
Collaborator
Pedagogical Academy Elisabethenstift gGmbH
Collaborator
University Medical Center Rostock
Collaborator
Johannes Gutenberg-University Mainz (Developmental Psychology)
Collaborator
Federal Ministry of Research, Technology and Space
Collaborator