Mental illness in childhood
Conditions
Interventions
Group 1: All 30 participating families receive the EnTree intervention over eight weeks. The intervention comprises an interactive digital picture-book app with five chapters, based on the Unified Pro
Sponsors
Universitätsklinikum Hamburg-Eppendorf (UKE)
Eligibility
Sex/Gender
All
Age
6 Years to 11 Years
Inclusion criteria
Inclusion criteria: Children: - Aged 6–11 years (inclusive) at the time of consent - receiving treatment or undergoing diagnostic assessment at the Department of Child and Adolescent Psychiatry and Psychotherapy (KJP) - Sufficient German language proficiency - Ability to comply with the study protocol as assessed by the treating clinician - Ability to provide consent Caregivers: - Legal caregiver of a child receiving treatment or undergoing diagnostic assessment at the Department of Child and Adolescent Psychiatry and Psychotherapy (KJP) - Sufficient German language proficiency - Ability to comply with the study protocol - Ability to provide informed consent (for themselves and the child)
Exclusion criteria
Exclusion criteria: Children: - Acute risk of harm to self or others - Medical or psychiatric contraindications as assessed by the treating clinician - Insufficient German language proficiency - Cognitive contraindications precluding the provision of informed consent Caregivers: - Acute risk of harm to self or others - Medical or psychiatric contraindications as assessed by the treating clinician - Insufficient German language proficiency - Cognitive contraindications precluding the provision of informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the feasibility of developing, implementing, and delivering the EnTree intervention, operationalized by the following criteria: - Recruitment rate: Number of families consenting to participate over the course of the study. - Dropout rate: Proportion of consented families not completing the full study process including follow-up (target: = 20%, equivalent to = 6 families). - Retention rate: Proportion of consented families completing the entire study process including follow-up at week 12 (target: = 80%). - Recruitment effort: Total number of recruitment attempts required to enroll 30 participating families. - Technical feasibility: Development and implementation of a stable, functional demonstrator; technical success is defined as the absence of system crashes or interruptions in the data-protection-compliant data flow between the digital picture-book app, the online portal, and the database. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are assessed at baseline (week 0), post-intervention (week 8), and follow-up (week 12). The following variables are investigated: For children: - Emotion regulation: Emotion Regulation Questionnaire for Children and Adolescents (ERQ-CA, child self-report from age 8 years); Parent-rated Emotion Regulation Questionnaire (P-ERQ, caregiver report from age 6 years). - General psychopathology: Strengths and Difficulties Questionnaire (SDQ, caregiver report). - Mood: caregiver-report items; 5-point facial Likert scale (Smileys) within the app during each usage session. - Sleep: caregiver-report items. - Nature connectedness: Connectedness to Nature Index (CNI, child self-report). - Nature-related knowledge: nature-related knowledge test (child self-report). - Safety and burden: caregiver-report items. - Task fatigue: Stage Fatigue Scale (child self-report). For caregivers: - Psychological distress: Patient Health Questionnaire-4 (PHQ-4). - Family functioning: Family Adaptation, Partnership, Growth, Affection, and Resolve (APGAR). | — |
Countries
Germany
Contacts
Public ContactSarah Hohmann
Universitätsklinikum Hamburg-Eppendorf (UKE)
Outcome results
None listed