Affective dysregulation in childhood - optimizing prevention and treatment: protocol of three randomized controlled trials in the ADOPT study

BACKGROUND: The terms affective dysregulation (AD) and irritability describe transdiagnostic dimensions and are characterized by an excessive reactivity to negative emotional stimuli with an affective (anger) and a behavioral component (aggression). Due to early onset, high prevalence and persistence, as well as developmental comorbidity, AD in childhood is one of the most psychosocially impairing and cost-intensive mental health conditions. AD is especially prevalent in children in the youth welfare service. Despite continuous research, there remains a substantial need for diagnostic approaches and optimization of individualized treatment strategies in order to improve outcomes and reduce the subjective and economic burden.

METHODS: The ADOPT (Affective Dysregulation - Optimizing Prevention and Treatment) Consortium integrates internationally established, highly experienced and interdisciplinary research groups. The work program encompasses (a) epidemiology, including prevalence of symptoms and disorders, (b) development and evaluation of screening and assessment tools, (c) stepped care approaches for clinically useful personalized medicine, (d) evaluation of an easily accessible and cost-effective online intervention as indicated prevention (treatment effects, moderation/mediation analysis), and (e) evaluation of an intensive personalized modular outpatient treatment in a cohort of children with AD who live with their parents and in a cohort of children with AD who live in out-of-home care (treatment effects, moderation/mediation analysis).

DISCUSSION: The results will lead to significant recommendations for improving treatment within routine clinical care in two cohorts of children with AD and coexisting conditions, especially oppositional-defiant disorder, conduct disorder and disruptive mood dysregulation disorder.

TRIAL REGISTRATION: Trial registration ADOPT Online: German Clinical Trials Register (DRKS) DRKS00014963 . Registered 27 June 2018. Trial registration ADOPT Treatment: German Clinical Trials Register (DRKS) DRKS00013317 . Registered 27 September 2018. Trial registration ADOPT Institution: German Clinical Trials Register (DRKS) DRKS00014581 . Registered 04 July 2018.