Assessment of Daily Stressors in Children With Depressive Symptoms for the Development of a Gamified Emotion Regulation App

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age8-12
SponsorLudwig-Maximilians - University of Munich

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 volunteers

Qualifiers

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

Design model

Case-only

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

15 Participants
are grouped into 2 trial groups
Group A: children aged 8-12 years with increased depressive symptoms
Group B: parents of children aged 8-12 years with increased depressive symptoms

Trial outcomes

Primary outcomes

1

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.

Time frame
Start of appointment, after questionnaire on depressive symptoms

Secondary outcomes

1

Daily Hassles (Child-Report)

Assessed with the German translation of the Daily life stressors Scale (Kearney et al., 1993)

Time frame
During the Appointment, after semi-structured interview
2

Perceived Stress (Child-Report)

Assessed with the German translation of the Perceived stress scale - children (White, 2014)

Time frame
During the Appointment, after semi-structured interview
3

Emotion regulation strategies (Child-Report)

Assessed with the Process-Oriented Emotion Regulation Questionnaire for Children and Adolescents (Rüth \& Lohaus, 2023)

Time frame
During the Appointment, after semi-structured interview
4

Regulatory parenting skills (parental report)

German translation of the Parental Assistance with Child Emotion Regulation (Cohodes et al., 2022)

Time frame
During the Appointment, after focus group

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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