Affective Dysregulation in Childhood – Optimizing Prevention and Treatment (ADOPT): Efficacy of a personalized modular outpatient treatment program to treat affective dysregulation and comorbid disorders in out-of-home care children.
Not Applicable
- Conditions
- Affective DysregulationF 34.8 (DSM-V): Disruptive mood dysregulation disorderNIMH Research Domain Criteria (RDoC) Initiative: Negative emotionality, Frustrative non-reward
- Registration Number
- DRKS00014581
- Lead Sponsor
- niversitätsklinik Ulm
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 157
Inclusion Criteria
age between 8;0 and 12;11 years; living in out-of-home care; clinician-rated AD symptoms > cut-off (OMAD)
Exclusion Criteria
IQ <80; severe mental disorder (profound developmental disorder, schizophrenia, psychosis, bipolar disorder, obsessive compulsive disorder) causing AD symptoms; insufficient language skills of child and/or caregiver; intensive psychotherapy (ongoing or planned)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AD-symptoms: To assess symptoms of affective dysregulation, a newly developed clinician-rated interview (Outcome Measure for Affective Dysregulation: OMAD) to evaluate caregiver (in this sub-project foster parents or child care workers from youth welfare institutions) information about the child will be used. The assessments will take place immediately before starting the treatment (T1) and immediately after closing it (T2), as well as 8 months after that (T3). The rating of the clinician and the assignment to treatment arms will be conducted independently (blinded rating). The interviews will be audiotaped; 10% of them will be evaluated by a second rater (interrater-reliability).
- Secondary Outcome Measures
Name Time Method Clinician-rated AD symptoms (children, caregivers, teachers; OMAD), ADHD and conduct disorders (DISYPS-III), other comorbid disorders (CBCL 6-18R; TRF 6-18R), psychological wellbeing oft he child (KIDSCREEN), clinician-rated psychosocial impairment of the child (DISYPS-III). All secondary endpoints will be assessed at T1, T2 and T3.