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NCT Number: NCT07159347

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

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.

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Key information

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

München, Bavaria, 80336, Germany

Location status: Recruiting

Location contact

Ellen Greimel, Prof. Dr.

PRINCIPAL_INVESTIGATOR

Gerd Schulte-Körne, Prof. Dr.

PRINCIPAL_INVESTIGATOR

Laura Schäffler

CONTACT

[email protected]

+4989440056931

Lisa Feldmann, Dr.

CONTACT

[email protected]

089440056920

About this study

Depressive disorders are among the most common psychiatric disorders in youth. Early depression can have serious effects on psychosocial development and long-term life outcomes. Despite the high demand for early intervention, substantial barriers to care persist, including long waiting times for therapy and administrative obstacles. As a result, low-threshold, location-independent interventions play an increasingly important role in improving access to care. In recent years, digital interventions such as serious games have gained increasing recognition in this context. These purposefully designed digital games go beyond mere entertainment by delivering targeted health-promoting, therapeutic, or psychoeducational content.

An important therapeutic focus in childhood depression is the improvement of emotion regulation - an ability strongly linked to mental health and resilience. The overarching goal of the present BMFTR-funded research project (SG4ChildD) is the development of a gamified app aimed at strengthening emotion regulation skills in children aged 8 to 12 with increased depressive symptoms or depressive disorders, serving as an add-on to professional treatment. In the current subproject, a participatory needs assessment with the app's target group (children with increased depressive symptoms/depressive disorders) and their parents will be conducted prior to the development of the app.The subproject aims to gain a deeper understanding of (1) everyday stressors experienced by children with depressive symptoms, (2) the subjective perception and emotional impact of these stressors, (3) the coping strategies children apply, and (4) the parental perspective on children's emotional challenges and supportive needs.

For this purpose, a primarily qualitative approach is chosen. Following an initial screening questionnaire to assess eligibility, participating children will take part in a semi-structured interview focusing on their subjective experience of emotional stress in everyday life (daily hassles). The interview will e.g. explore situations that trigger sadness or frustration and examine how children attempt to manage these feelings. This will be supplemented by standardized questionnaires on daily hassles, stress exposure and emotion regulation. In parallel, focus groups will be conducted with parents to explore their observations regarding children's exposure to daily hassles, coping strategies and what kind of support they and their children might need. Additionally, parents will complete questionnaires assessing their own regulatory parenting skills (i.e., the degree to which parents assist their children in the use of different regulation strategies) and parental report of the child´s depressive symptoms.

The insights gained through this needs assessment will directly inform the development of the app, and particularly the selection of game-based scenarios that reflect children's real-world challenges. By involving children and parents at an early stage of development, the project aims to maximize usability, acceptance, and clinical relevance of the digital intervention.

Participants will be recruited based on predefined inclusion criteria (e.g., elevated depressive symptoms in children). Recruitment will primarily take place via the Department of Child and Adolescent Psychiatry, Psychosomatics, and Psychotherapy at the LMU University Hospital Munich. Additional recruitment may be supported by collaborating child and adolescent psychiatric clinics in the Munich area and by licensed outpatient therapists.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Qualitative data from semi-structured child interviews and parental focus groups

    Time frame: Start of appointment, after questionnaire on depressive symptoms

    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

  1. Daily Hassles (Child-Report)

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

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

  2. Perceived Stress (Child-Report)

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

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

  3. Emotion regulation strategies (Child-Report)

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

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

  4. Regulatory parenting skills (parental report)

    Time frame: During the Appointment, after focus group

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

Study contacts

Contact information is provided by the study sponsor or research team.

Laura Schäffler

CONTACT

[email protected]

+49 (0)89 4400 56931

Lisa Feldmann, Dr.

CONTACT

[email protected]

+49 (0)89 4400 56920

Sponsors and collaborators

Lead sponsor

Ludwig-Maximilians - University of Munich

Other

Collaborators

  • Ascora GmbH
  • Federal Ministry of Research, Technology and Space
  • Johannes Gutenberg-University Mainz (Developmental Psychology)
  • Pedagogical Academy Elisabethenstift gGmbH
  • Technical University Darmstadt (WG Serious Games)
  • University Medical Center Rostock
  • smart medication eHealth Solutions GmbH

Registry information

Official study title

Assessment of Stressors in Children With Depressive Symptoms for the Development of an App to Strengthen Emotional Competences Using Serious Games and Gamification.

Acronym: SG4ChildD

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 8, 2025
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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