Efficacy of a Personalized Modular Outpatient Treatment of Affective Dysregulation and Coexisting Conditions in Children (ADOPT Treatment)

Not Applicable

• Conditions: Affective dysregulationDSM 5: F90.0; F91.3; F93.8; Oppositional defiant disorder; Other childhood emotional disorders; Disturbance of activity and attention

• Registration Number: DRKS00013317
• Lead Sponsor: niversität zu Köln

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-27
• Study Completion: 2022-06-07
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 159

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.