F40 F41 F93 F92.8 F94.0
Conditions
Interventions
Group 1: The cognitive-behavioral therapy based, anxiety-specific tablet app “KIKAN” is used both as a gamification-based intervention and as a data-collection tool alongside therapy for approximately
physiological EMA data are collected only for the children) on a daily basis for 14 days at each of the measurement points specified below (excluding the follow up), as well as game related data.
Ps
Sponsors
Universität Osnabrück, Institut für Psychologie, Fachgebiet Klinische Psychologie und Psychotherapie des Kindes- und Jugendalters
Eligibility
Sex/Gender
All
Age
6 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1) Child’s age = 6 and = 12 years. 2) Sufficient German language skills of both the child and the parent/legal guardian(s). 3) Mental disroder in which anxiety symptoms are predominant (e.g., anxiety disorder of childhood-adolescence or emotional disorder of childhood; see ICD-10 codes F40, F41, F93, F92.8, F94.0). 4) Written informed consent from all parent(s) or legal guardian(s). 5) The child is affiliated with the outpatient psychotherapy clinic at Osnabrück University.
Exclusion criteria
Exclusion criteria: 1) The child has a neurological or other somatic disorder that affects the nervous system. 2) The child has a comorbid disorder of any of the following types: Eating disorders (ICD-10 F50) Mental and behavioural disorders due to psycho-active substances (ICD-10 F10–F19) Internet-use disorder (according to DSM-5 research criteria) Schizophrenia, schizotypal and delusional disorders (ICD-10 F20–F29) Manic episode (ICD-10 F30) Bipolar affective disorder (ICD-10 F31) Dissociative disorders (ICD-10 F44) Intellectual disability (ICD-10 F70–F79) Pervasive developmental disorders (ICD-10 F84) 3) Acute suicidality (suicidal ideation or intent). 4) Inability to play the game (e.g., severe visual impairment).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint 1a: Overall symptomatology of the children from the caregiver’s perspective, assessed with the German version of the Child Behavior Checklist (CBCL/6-18R; Döpfner et al., 2014) “Total Problems” scale (caregiver report), measured at BL, T1, T3, and FU. Primary endpoint 1b: Internalizing symptomatology of the children from the caregiver’s perspective, assessed with the German version of the CBCL/6 18R “Internal Problems” scale (caregiver report), measured at BL, T1, T3, and FU. Within the intervention group, pre-post comparisons (T1 vs. T3) of these primary endpoints are planned. In additional exploratory analyses, the primary endpoints will be examined for associations with other outcome and process variables, acceptance and feasibility indicators, EMA measures, and variables concerning the gamification-based intervention. Furthermore, the primary endpoints measured at T1 and T3 will be compared with a historical control group as a benchmark. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoint 1: Anxiety symptomatology of the children, assessed with the German version of the Screen for Child Anxiety Related Disorders – Parent version (FAS-E; German adaptation by Steinhausen, 2005, based on Birmaher et al.,1995), measured at BL, T1, T3, and FU. Secondary endpoint 2: Anxiety symptomatology of the children, assessed with the German version of the Screen for Child Anxiety Related Disorders – Child version (FAS-K; Steinhausen, 2005), measured at BL, T1, T3, and FU. Secondary endpoint 3: Quality of life of the children from the caregiver’s perspective, assessed with the Inventar zur Erfassung der Lebensqualität bei Kindern und Jugendlichen [Inventory for the Assessment of Quality of Life in Children and Adolescents] (ILK; Mattejat & Remschmidt, 2006; caregiver report), measured at BL, T1, T2, T3, and FU. Secondary endpoint 4: Self-rated quality of life of the children, assessed with the ILK (self-report), measured at BL, T1, T2, T3, and FU. Similarly to the primary endpoints, pre-post comparisons (T1 vs. T3) and exploratory analyses will be performed for the secondary outcomes. In addition, secondary endpoints 3 and 4 from the intervention group at T1 and T3 will be compared with a historical control group as a benchmark. | — |
Countries
Germany
Outcome results
None listed