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It can usually be diagnosed reliably at preschool age. Early detection of children with ADHD symptoms and an early, age-appropriate treatment are needed in order to reduce symptoms, prevent secondary problems and enable a better school start. Despite existing ADHD treatment research and guideline recommendations for the treatment of ADHD in preschool children, there is still a need to optimise individualised treatment strategies in order to improve outcomes. Therefore, the ESCApreschool study (Evidence-Based, Stepped Care of ADHD in Preschool Children aged 3\u2009years and 0\u2009months to 6\u2009years and 11\u2009months of age (3;0 to 6;11\u2009years) addresses the treatment of 3\u20136-year-old preschool children with elevated ADHD symptoms within a large multicentre trial. The study aims to investigate the efficacy of an individualised stepwise-intensifying treatment programme.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>The target sample size of ESCApreschool is 200 children (boys and girls) aged 3;0 to 6;11\u2009years with an ADHD diagnosis according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) or a diagnosis of oppositional defiant disorder (ODD) plus additional substantial ADHD symptoms. The first step of the adaptive, stepped care design used in ESCApreschool consists of a telephone-assisted self-help (TASH) intervention for parents. Participants are randomised to either the TASH group or a waiting control group. The treatment in step 2 depends on the outcome of step 1: TASH responders without significant residual ADHD\/ODD symptoms receive booster sessions of TASH. Partial or non-responders of step 1 are randomised again to either parent management and preschool teacher training or treatment as usual.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Discussion<\/jats:title>\n                <jats:p>The ESCApreschool trial aims to improve knowledge about individualised treatment strategies for preschool children with ADHD following an adaptive stepped care approach, and to provide a scientific basis for individualised medicine for preschool children with ADHD in routine clinical care.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p>The trial was registered at the German Clinical Trials Register (DRKS) as a Current Controlled Trial under <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.drks.de\/drks_web\/navigate.do?navigationId=trial.HTML&amp;TRIAL_ID=DRKS00008971\">DRKS00008971<\/jats:ext-link> on 1 October 2015. This manuscript is based on protocol version 3 (14 October 2016).<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s13063-019-3872-8","type":"journal-article","created":{"date-parts":[[2020,1,9]],"date-time":"2020-01-09T15:02:57Z","timestamp":1578582177000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":11,"title":["Individualised stepwise adaptive treatment for 3\u20136-year-old preschool children impaired by attention-deficit\/hyperactivity disorder (ESCApreschool): study protocol of an adaptive intervention study including two randomised controlled trials within the consortium ESCAlife"],"prefix":"10.1186","volume":"21","author":[{"given":"Katja","family":"Becker","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tobias","family":"Banaschewski","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Brandeis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christina","family":"Dose","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher","family":"Hautmann","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martin","family":"Holtmann","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Jans","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lea","family":"Jendreizik","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carolin","family":"Jenkner","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katja","family":"John","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Johanna","family":"Ketter","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sabina","family":"Millenet","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ursula","family":"Pauli-Pott","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tobias","family":"Renner","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marcel","family":"Romanos","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne-Katrin","family":"Treier","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elena","family":"von Wirth","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne-Kathrin","family":"Wermter","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manfred","family":"D\u00f6pfner","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2020,1,9]]},"reference":[{"issue":"9","key":"3872_CR1","first-page":"149","volume":"114","author":"T Banaschewski","year":"2017","unstructured":"Banaschewski T, Becker K, D\u00f6pfner M, Holtmann M, Rosler M, Romanos M. 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Additionally, it has been approved by all local Ethics Committees of the participating centres in Germany: Faculty of Medicine of the Ruhr-University Bochum (No. 15\u20135523), the Medical Faculty of the University of Cologne (No. 15\u2013335), the Ethics Committee of the State Chamber of Medicine (Landes\u00e4rztekammer) Baden-W\u00fcrttemberg (No. B-F-2015-080), the Medical Faculty of the University of W\u00fcrzburg (No. 254\/15_z), the Faculty of Medicine of the Eberhard Karls University T\u00fcbingen (No. 728\/2015BO2), the Medical Faculty of the University Aachen (No. EK 204\/17), the Medical Faculty of the University G\u00f6ttingen (No. 4\/3\/17) and the Brandenburg Medical School Theodor Fontane.In order to participate in the study, both parents\/guardians are informed about the study procedures and goals and give their written informed consent. The preschool child has additionally to give his\/her assent for participation.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"KB has been involved in research\/clinical trials with Eli Lilly (\u2264 2011) and Shire (\u2264 2010), was on the Advisory Board of Eli Lilly\/Germany (\u2264 2014), a member of the Scientific Committee of Shire (\u2264 2012) and was paid for public speaking by Eli Lilly (<\u20092011) and Shire (2015). These activities do not bias the objectivity of this manuscript (in her opinion), but are mentioned for the sake of completeness.TB served in an advisory or consultancy role for Lundbeck, Medice, Neurim Pharmaceuticals, Oberberg GmbH, Shire, and Infectopharm. He received conference support or speaker\u2019s fees from Lilly, Medice, and Shire. He received royalties from Hogrefe, Kohlhammer, CIP Medien, and Oxford University Press.DB served as an unpaid scientific advisor for an EU-funded neurofeedback trial unrelated to the present work.CD and MD were involved in the development of the materials used in the TASH intervention and will receive royalties after publication of the materials.MH served in an advisory or consultancy role for Lilly, Shire, and Medice, and received conference attendance support or was paid for public speaking by Medice, Neuroconn, and Shire.MD received consulting income and research support from Lilly, Medice, Shire, Janssen Cilag, Novartis, and Vifor. He received income as Head of the School for Child and Adolescent Behaviour Therapy at the University of Cologne and royalties from treatment manuals, books and psychological tests published by Guilford, Hogrefe, Enke, Beltz, and Huber, including the materials used in the PMPTT intervention.CH, TJ, LJ, CJ, KJ, JK, SM, UPP, TR, MR, AKT, EvW, and AKW are not aware of any biases that might be perceived as affecting the objectivity of this manuscript and declare that they have no competing interests.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"56"}}