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.
Bibliographical noteFunding Information:
The study has been awarded a governmental grant after undergoing peer-review. ADOPT Online is funded by the German Federal Ministry of Education and Research (BMBF) Grant 01GL1741D. ADOPT Treatment is funded by the German Federal Ministry of Education and Research (BMBF) Grant 01GL1741E. ADOPT Institution is funded by the German Federal Ministry of Education and Research (BMBF) Grant 01GL1741F. Trial sponsor of ADOPT Online as well as ADOPT Treatment is the University of Cologne, Albertus-Magnus-Platz, 50923 Cologne. Trial sponsor of ADOPT Institution is the University Hospital Ulm, 89070 Ulm. The funding source or the trial sponsors had no role in the design of this study and will not have any role during its execution, analyses, interpretation of the data, or decision to submit results.
AGD and MD receive royalties from publishing companies as authors of books and treatment manuals on child behavioral therapy, and of assessment manuals, including the treatment manuals which are evaluated in this trial. CH receives royalties from a publishing company as the author of a treatment manual. Over the last 5 years, JMF has received research funding from the EU, DFG (German Research Foundation), BMG (Federal Ministry of Health), BMBF (Federal Ministry of Education and Research), BMFSFJ (Federal Ministry of Family, Senior Citizens, Women and Youth), BMVg (Federal Ministry of Defence), several state ministries of social affairs, State Foundation Baden Württemberg, the UBS Foundation, Pontifical Gregorian University, Caritas, Diocese of Rottenburg-Stuttgart. Moreover, he received travel grants, honoraria and sponsorship for conferences and medical educational purposes from DFG, AACAP, NIMH/NIH, EU, Pro Helvetia, Janssen-Cilag (J&J), Shire, several universities, professional associations, political foundations and German Federal and state ministries. Every grant and every honorarium was declared to the law office of the University Hospital Ulm. MK receives royalties from publishing companies as an author of books. He served as PI or CI in clinical trials of Lundbeck, Pascoe and Janssen-Cilag. He received grants from the BMBF, BMFSFJ, BZgA and Bundeswehr. The present work is unrelated to the above grants and relationships. TB served in an advisory or consultancy role for Lundbeck, Medice, Neurim Pharmaceuticals, Oberberg GmbH, Shire. He received conference support or speaker’s fees from Lilly, Medice, Novartis and Shire. He has been involved in clinical trials conducted by Shire and Vifor Pharma. He received royalties from Hogrefe, Kohlhammer, CIP Medien, and Oxford University Press. The present work is unrelated to the above grants and relationships. JK, AR, AT, MH, VR, and URS declare no conflict of interest.
This trial is supported by the Clinical Trials Centre Cologne (CTCC), Medical Faculty, University of Cologne by performing the monitoring. Other members of the ADOPT Consortium: Aggensteiner Pascal, Bernheim Dorothee, Bienioschek Stefanie, Brandeis Daniel, Breier Maurice, Dobler Veronika, Frenk Franziska, Giller Franziska, Ginsberg Claudia, Groh Monja, Heintz Stefan, Hohmann Sarah, Igel Christine, Junghänel Michaela, Kaiser Anna, Katmer-Amet Betül, Koppisch Katrin, Kuhnke Kristin, Millenet Sabina, Mücke Kristina, Nickel Theresa, Otto Christiane, Rodova-Ghasemi Elisaveta, Samaras Angelina, Schreiner Anne, Schroth Jennifer, Schüller Anne, Steiner Marie, Steiner Marion, Steinhauser Susanne, Winkler Matthias, Wüstner Anne, Zaplana Sara.
© 2019 The Author(s).
- Affective dysregulation; disruptive mood dysregulation disorder
- Cognitive behavioral therapy
- Out-of-home care
- Parent management training