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. 2019 Sep 2;19(1):264.
doi: 10.1186/s12888-019-2239-8.

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

Manfred Döpfner  1   2 , Josepha Katzmann  3   4 , Charlotte Hanisch  5 , Jörg M Fegert  6 , Michael Kölch  6   7   8 , Anne Ritschel  5 , Anne-Katrin Treier  3   4 , Martin Hellmich  9 , Veit Roessner  10 , Ulrike Ravens-Sieberer  11 , Tobias Banaschewski  12 , Anja Görtz-Dorten  3   4 ; ADOPT Consortium
Collaborators, Affiliations

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

Manfred Döpfner et al. BMC Psychiatry. .

Abstract

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.

Keywords: Affective dysregulation; disruptive mood dysregulation disorder; Cognitive behavioral therapy; Irritability; Out-of-home care; Parent management training.

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Conflict of interest statement

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.

Figures

Fig. 1
Fig. 1
Study design of the ADOPT consortium including ADOPT Epidemiology, ADOPT Online, ADOPT Treatment, ADOPT Institution as well as ADOPT Neurobiology. Percentages indicate expected proportions of children with or without affective dysregulation. Dotted boxes indicate subsamples used in ADOPT Neurobiology. T1 to T4 = assessment points; R = randomisation; AD = affective dysregulation; ONLINE = web-based parent training; TAU = treatment as usual; TREATMENT = individualized cognitive behavioural psychotherapy of child, parents, teachers; n = planned/estimated sample size. 1 Patients / Families can choose between continuation of TAU and participation in Online
See this image and copyright information in PMC

References

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