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

NCT07159347 | Recruiting

• 1 other identifier: 25-0508
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Disorder; Depression in Children; Depressive Symptoms

Keywords

depression; daily hassles; qualitative interviews; focus groups; serious gaming; gamification; participatory needs assessment; emotion regulation skills

Outcome Measures

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.

  Start of appointment, after questionnaire on depressive symptoms

Secondary Outcomes (4)

• Daily Hassles (Child-Report)

  During the Appointment, after semi-structured interview

• Perceived Stress (Child-Report)

  During the Appointment, after semi-structured interview

• Emotion regulation strategies (Child-Report)

  During the Appointment, after semi-structured interview

• Regulatory parenting skills (parental report)

  During the Appointment, after focus group

Study Arms (2)

children aged 8-12 years with increased depressive symptoms

This cohort includes children aged 8-12 years who report increased depressive symptoms based on a questionnaire. Participation involves a semi-structured interview on daily hassles and self-report questionnaires on stress perception and emotion regulation. No intervention is provided.

parents of children aged 8-12 years with increased depressive symptoms

This cohort includes parents of children with increased depressive symptoms aged 8-12. Parents take part in a focus group to discuss their child's exposure to daily hassles, coping strategies and ways their child can be supported. They also complete self-report questionnaires. No intervention is provided.

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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).

You may not qualify if:

• Insufficient German language skills
• Acute suicidality
• Schizophrenic disorder
• Severe developmental disorder
• Mental and behavioral disorders due to psychotropic substances

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead
• 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

Study Sites (1)

Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, LMU University Hospital

München, Bavaria, 80336, Germany

RECRUITING

MeSH Terms

Conditions

Depressive Disorder; Depression

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Gerd Schulte-Körne, Prof. Dr.

  Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, LMU University Hospital

  PRINCIPAL INVESTIGATOR

• Ellen Greimel, Prof. Dr.

  Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, LMU University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Feldmann, Dr.

CONTACT

+49 (0)89 4400 56920; Lisa.Feldmann@med.uni-muenchen.de

Laura Schäffler

CONTACT

+49 (0)89 4400 56931; Laura.Schaeffler@med.uni-muenchen.de

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: September 8, 2025
• Study Start: September 2, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)