F90
Conditions
Interventions
Group 1: Step 1, severe ADHD, non-randomized group allocation: Psycho-education and ADHD medication treatment for 3 months (assessment T1 to T2a)
Group 2: Step 1, mild to moderate ADHD, randomized gr
Sponsors
Universitätsklinikum Köln
Eligibility
Sex/Gender
All
Age
6 Years to 11 Years
Inclusion criteria
Inclusion criteria: Attending of school (including special schools); Meeting criteria for ADHD according to DSM-5; Informed consent of guardians and child assent
Exclusion criteria
Exclusion criteria: IQ below average (IQ<80), diagnosis of pervasive developmental disorder, schizophrenia, bipolar disorder, severe depressive episode, epilepsy, heart disease, current or planned intensive behavioural therapy for ADHD or oppositional behavior on a weekly basis, for children with severe ADHD known non-response to all standard ADHD medication (methylphenidate,dexamphenidate, atomoxetine) psychotropic medication (other than for ADHD) or neuroleptic medication (other than for the treatment of disturbance of impulse control), insufficent German language and reading skills of participating parent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome is the blinded clinician-rated total score of the ADHD-Checklist (DCL-ADHS) based on parent interview. For children with mild to moderate ADHD analysis of the randomized between-group comparison in step 1 (arm 2 vs. arm 3 with the assessments T1 and T2b/T2c1). For children with severe ADHD and partial response to treatment in step 1 analysis of the randomized between-group comparison of corresponding interventions in step 2 (arm 5 vs. arm 6 vs. arm 7 with the assessments T2a and T3b/T3c/T3d). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are: - Blinded clinician-rated symptoms of conduct disorder and impairment due to these symptoms (DCL-SSV, based on parent interview) - Clinical global impression (CGI, clinician-rated) - Symptoms of ADHD (FBB-ADHS, parent- and teacher-rated) - Symptoms of conduct disorder (FBB-SSV, parent- and teacher-rated) - Behavioural and emotional problems of child (CBCL/6-18R, parent-rated) - Functional impairment (WFIRS, parent-rated) - Quality of life of patients (KIDSCREEN, parent-rated) - Perceived parenting sense of competency (VER, parent-rated) - Parenting behaviour (FZEV, short version of negative scale of FPNE, parent-rated) - Treatment satisfaction - electrical brain activity (electroencephalogram) - Safety parameters The secondary outcome will will be analysed the same way as the primary outcome. Furthermore, the following analyses will be conducted (primary outcome included). For children with severe ADHD and full or no response in step 1 treatment effects of the corresponding interventions from step 2 (arm 4, arm 8) will be contrasted each with treatment effects of step 1 (arm 1) intervention (arm 1 vs. arm 4 with the assessments T1, T2a and T3a; arm 1 vs. arm 8 with the assessments T1, T2a and T3e). For children with mild to moderate ADHD and full response, partial response or no response in step 1, treatment effects of corresponding interventions from step 2 (arm 9, arm 10, arm 11) will be contrasted each with treatment effects of step 1 intervention (arm 2, arm 3) (e.g., arm 2 vs. arm 9 with the assessments T1, T2b and T3f). For analyses all secondary outcome measures and blinded clinician-rated ADHD-Checklist (DCL-ADHS) based on parent interview will be considered. | — |
Countries
Germany
Contacts
Public ContactLea Teresa Jendreizik
Ausbildungsinstitut für Kinder- und Jugendlichenpsychotherapie an der Uniklinik Köln (AKiP)
Outcome results
None listed