Funding for this research was provided by:
Bundesministerium für Bildung und Forschung (01GL1741F, 01GL1741D, 01GL1741E)
Text and Data Mining valid from 2019-09-02
Received: 27 June 2019
Accepted: 14 August 2019
First Online: 2 September 2019
Ethics approval and consent to participate
: Ethical approval has been obtained for the study center Cologne from the University of Cologne (ADOPT Online: ID 18–033, ADOPT Treatment: ID 18–040, ADOPT Institution: ID 18–210), for the study center Dresden from the University Hospital Dresden (ADOPT Online: ID EK 354092018, ADOPT Treatment: ID EK 445112018, ADOPT Institution: ID EK 32082018), for the study center Mannheim from the University of Heidelberg (ADOPT Online: ID 2018-554 N-MA, ADOPT Treatment: ID 2018-639 N-MA, ADOPT Institution: ID 2018-590 N-MA), for the study center Ulm from the University Hospital Ulm (ADOPT Online: ID 297/18, ADOPT Treatment: ID 427/18, ADOPT Institution: 139/18), for the study center Neuruppin from the Medical School Brandenburg (ADOPT Institution: ID Z-01-20180618). Currently approved protocol versions of the three trials are: ADOPT Online version 04 of December 17 2018; ADOPT Treatment version 04 of January 1 2019; ADOPT Institution version 03 of December 10 2018. Important protocol modifications require a formal amendment to the protocol. Such amendment will be agreed upon by all investigators, approved by funding body, trial sponsor as well as ethics committee and noted in the trial registries.Guidelines about data protection (European data protection Directive 95/46/EC and national data protection law) will be complied with. Informed consent will be obtained both written and verbal by patients, parents or guardians, and (if applicable) teachers. For detailed information see Additional file InternalRef removed : Model written informed consent. All participants can clarify questions about the study with research staff members. For study participation, it is required that both the patient and his/her parents or guardians give their assent and informed consent. Likewise, teachers must give their informed consent for study participation. Data entry and processing will take place as soon as signed informed consent is available. The stated procedure will be carried out within each of the ADOPT trials including ADOPT Online, ADOPT Treatment, ADOPT Institution, ADOPT Epidemiology as well as ADOPT Neurobiology.
: Not applicable.
: 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.