Affective dysregulation DSM 5: F90.0 F91.3 F93.8
Conditions
Interventions
Group 1: Personalized modular outpatient treatment of affective dysregulation and coexisting disorders with THOPAS: THOPAS consists of 10 CBT (Cognitive Behavior Therapy) modules that include child-ba
Görtz-Dorten & Döpfner, 2010), and the Social Computer-assisted Training for Children with Aggressive Behavior Problems (ScouT
Görtz-Dorten & Döpfner, 2016) – which are adapted from evidence-based international treatment manuals, especially the Coping Power Program (Lochman, Wells, & Lenhart, 2008), the Cognitive-Behavioral T
Chorpita & Weisz, 2009). The child-centered interventions also include guidance for parents/teachers to support the behavior change of the children at home/school. The parent training interventions ar
Döpfner, Schürmann, & Frölich, 2013) which is adapted from evidence-based international treatment manuals, especially Barkleys Defiant Children (Barkley, 2013), and Helping the Non-compliant Child (Mc
C. Hanisch, Richard, Eichelberger, Greimel, & Döpfner, 2017) which is a
Sponsors
Universität zu Köln
Eligibility
Sex/Gender
All
Age
8 Years to 12 Years
Inclusion criteria
Inclusion criteria: Patients will be included if they meet following inclusion criteria: Age: 8;0 to 12;11 years (= completed 8th year of life to completed 13th year of life) at T1; resident with at least one natural parent/adoptive parent; clinician-rated AD symptoms of the child (DADYS interview) based on parent interview > cut-off at T2; willingness and ability of patient and parents to participate in the intervention; Participating parent: sufficient proficiency in German language or continuous inclusion of an interpreter for study visits and therapy.
Exclusion criteria
Exclusion criteria: Following exclusion criteria will be applied and evaluated at T1: Intelligence below average in clinical evaluation/patient attends school for intellectual disabilities; mental disorder other than CoCo is primary disorder and main cause of AD (e.g. autism spectrum disorder); current or planned intensive behavioral therapy or behavioral parent management training on a weekly/biweekly basis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy outcome is the blinded clinician-rated affective dysregulation symptom score of the child, assessed with a newly developed outcome measure for AD (DADYS interview) based on parent interview. DADYS will be developed by another subproject of the ADOPT consortium (ADOPT Epidemiology, in cooperation with ADOPT Treatment) before the start of the trial. Affective dysregulation of the child will be measured before and after treatment and after a 8-months follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints are also summary scores/scale scores of the respective items. The secondary outcomes listed below will be evaluated at T2-T4, unless otherwise noted. Secondary outcomes are (1) psychosocial impairment of the child due to AD symptoms in blinded clinical rating as well as patient-, parent-, and teacher-rating (DADYS interview/DADYS questionnaire), (2) patient-, parent-, teacher- and clinician-rated AD symptoms of the child (DADYS questionnaire, DADYS interview), (3) patient-, parent- and teacher-rated symptoms of ADHD and ODD/CD (SBB-ADHS/-SSV, FBB-ADHS/-SSV; FBB-Screen), (4) other comorbid conditions (e.g., anxiety, depression) assessed by parent-ratings and teacher-ratings (CBCL 6-18R, TRF 6-18R, FBB-BIST [only parent-rating], FBB-TBS [only parent-rating]), (5) psychological well-being in patient- and parent-rating (KIDSCREEN-10-Index, KIDSCREEN-27), and (6) satisfaction with the treatment. As predictors/moderators for treatment outcome on AD symptoms and impairment the following variables will be analyzed: (1) gender, (2) age of patients and parents, (3) chronicity of AD-Symptoms, (4) severity of AD symptoms, (5) severity of comorbid symptoms, (6) AD-symptoms and other psychopathology of the participating parent, (7) positive and negative parenting practices, (8) public assistance of the family, (9) socio-economic status of the family, (10) early childhood neglect of the patient, (11) family climate in perception of the child, (12) social support and (13) personal resources of the child. These parameters are assessed at T1 and/or at T2. Additionally, during treatment, (14) implementation of treatment modules will be assessed and analyzed as predictor for treatment outcome in the THOPAS group as well as (15) treatment adherence rated and (16) treatment fidelity, both rated by the therapist. Potential mediators are assessed at T2, at intermediate measurement T2b and at T3/T4: (1) parent reported positive and negative parenting practices | — |
Countries
Germany
Contacts
Public ContactAnja Görtz-Dorten
Ausbildungsinstitut für Kinder- und Jugendlichenpsychotherapie an der Klinik und Poliklinik für Psychiatrie, Psychosomatik und Psychotherapie des Kindes- und Jugendalters der Uniklinik Köln
Outcome results
None listed