F90.0 F90.1 F90.8 F90.9 F91.3 F98.80
Conditions
Interventions
Group 1: For the 1st arm “parent training in a group setting”, a randomized, controlled between-group trial will be conducted. For this purpose, N = 50 participants will be randomized 1:1 into an inte
Sponsors
Universität zu Köln
Eligibility
Sex/Gender
All
Age
4 Years to 11 Years
Inclusion criteria
Inclusion criteria: - Confirmed diagnosis of ADHD and/or social behavior disorder with oppositional, defiant behavior (ODD) (ICD-10 diagnosis F90.x, F98.80 and/or F91.3; clinical judgment) - Child's age: 4;0-11;11 years - Child shows increased parent-reported symptom values in the DISYPS FBB-ADHS (ADHD overall) and/or in the DISYPS FBB-SSV (oppositional behavior subscale) at screening, scale value on at least one of the two scales > 1.0 - The child's symptoms must occur in the family - Sufficient reading skills and German language skills of the parent who primarily uses the app and participates in the data collection - Internet access in the family, smartphone or tablet PC with app-compatible operating system (Android, IOS) - Voluntary and informed consent of the children and their parent/legal guardians
Exclusion criteria
Exclusion criteria: - Onset, dosage change or preparation change of ADHD medication or medication for aggressive breakthroughs (e.g. neuroleptics) currently or firmly planned in the next 4 months (child; clinical judgment) - Child has another severe mental disorder which is in the foreground (e.g. autism, psychosis) - Intellectual disability of the child (IQ < 70) - Known severe mental disorder of the main caregiver (e.g. severe addiction, severe emotionally unstable personality disorder, psychosis) - (Partial) inpatient therapy planned due to mental disorder of the child - Current and continued or planned intensive behavioral therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measures are symptom reduction of the child's externalizing symptoms in the parents' rating (FBB-ADHS and sub-scale oppositional behavior of the FBB-SSV; Döpfner & Görtz-Dorten, 2017) at all measurement times (T1 to T5) and the parents' adherence and satisfaction (CSQ) with the intervention at T2, T3 and T4. Data survey in the arm “parent training in group setting” takes place at T1 (baseline), T2 (week 10), T3 (week 14), T4 (week 20) and T5 (12 weeks after the end of the intervention phase). Data survey in the arm “parent training in an individual setting” takes place at T1 (baseline), T2 (week 8), T3 (week 12), T4 (week 16) and T5 (12 weeks after the end of the intervention phase). | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical rating: - ADHD/ODD symptoms (ILF-EXTERNAL; collected at T1, T4) - Clinical global impression (CGI; collected at T4) - parental adherence (collected at T2, T3, T4) - App-usability (collected at T2, T3, T4) Parental rating: - positive and negative parenting behavior (FPNE; collected at T1 to T5) - parental stress (FSI; collected at T1 to T5) - problem situations in the familiy (EF-PF; collected at T1 to T5) - App-usability (SUS; collected at T4) In addition, the app usage behavior of parents is recorded for the entire duration of the study. | — |
Countries
Germany
Contacts
Public ContactAnja Görtz-Dorten
Ausbildungsinstitut für Kinder- und Jugendlichenpsychotherapie der Uniklinik Köln (AKiP)
Outcome results
None listed