F90 F90.0 F90.1 F90.8 F90.9 F98.80
Conditions
Interventions
Group 1: Intervention group (IG) consisting of one parent (n = 96) per affected children, with the children receiving Treatment as Usual (TAU) as part of routine care.
Parents in the IG additionally r
Sponsors
Medigital GmbH
Eligibility
Sex/Gender
All
Age
4 Years to 11 Years
Inclusion criteria
Inclusion criteria: - Child with a confirmed diagnosis of ADHD (ICD-10 diagnosis F90.x, F98.80; clinical judgment of treating health care professional ;HCP) - Child shows elevated parent-reported symptom score in the SCL-ADHD/ODD at pre-screening; score =1.0 - The child’s symptoms occur in family situations (clinical judgement) - Sufficient reading skills and German language skills of the participant (clinical judgement) - Willingness and resources of the participant to actively participate in this study (clinical judgment) - Internet connection in the family, smartphone and PC/notebook or tablet PC - Written informed consent of all custodians and oral assent of the child for participation in the study
Exclusion criteria
Exclusion criteria: - ADHD medication or medication for aggressive breakthroughs (e.g. neuroleptics) of the child currently or firmly planned in the next three months (clinical judgment) - Intensive behavioural therapy of the child due to the externalizing symptoms with usually at least 2 contacts per month or regular parent training due to the child's externalizing symptoms with usually at least 2 contacts per month within the last 12 months, currently ongoing or firmly planned in the next three months (clinical judgment) - Simultaneous, prior (last 12 months) or planned (within the next three months) regular use of another ADHD/ODD parent training app - Child has another severe mental disorder (e.g. intellectual disability, autism, psychosis; clinical judgement) - Known severe mental disorder of the participant (e.g. severe addiction, severe emotionally unstable personality disorder, psychosis; clinical judgment) - (Partial) inpatient therapy planned due to mental disorder of the child - Prior and/or current use of hiToco® - Simultaneous participation in other studies or other clinical research projects - Simultaneous participation in this study with another child
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary variable is the mean total score of the 28 items of the SCL-ADHD/ODD based on parent reports. This scale is composed of all items of the two German Fremdbeurteilungsbogen (FBB)-ADHS (Part A and B; 20 items) and FBB-SSV (Part A, 8 items) according to ICD-10 and DSM-5 diagnostic criteria. Assessment schedule: - Baseline (Pre-Screening) - T1 (Week 8) - T2 (Week 12) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Parental stress according to the Family Strain Index (FSI; parent-reported) - ADHD symptoms of the child (SCL-ADHD Part A + B; 20 items; parent reported) - ODD symptoms of the child (SCL-ODD Part A; 8 items; parent reported) - Positive/negative parenting behaviour according to the questionnaire on positive and negative parenting behaviour (FPNE; parent reported) - Functional impairment of the child (SCL-ADHD Part F, 5 Items, parent reported) - Safety (adverse events, device deficiencies) All secondary outcomes will be assessed at baseline (pre-screening / week 0), at T1 (week 8) and at T2 (week 12). | — |
Countries
Germany
Contacts
Public ContactAnja Görtz-Dorten
Centrum für Kinder- und Jugendlichenpsychotherapie der Uniklinik Köln (CEKIP)
Outcome results
None listed