Individualised stepwise adaptive treatment for 3–6-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
Katja Becker,
Tobias Banaschewski,
Daniel Brandeis,
Christina Dose,
Christopher Hautmann,
Martin Holtmann,
Thomas Jans,
Lea Jendreizik,
Carolin Jenkner,
Katja John,
Johanna Ketter,
Sabina Millenet,
Ursula Pauli-Pott,
Tobias Renner,
Marcel Romanos,
Anne-Katrin Treier,
Elena von Wirth,
Anne-Kathrin Wermter,
Manfred Döpfner
Affiliations
Katja Becker
Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Medical Faculty of the Philipps-University Marburg
Tobias Banaschewski
Department of Child and Adolescent Psychiatry and Psychotherapy, Central Institute of Mental Health, Heidelberg University, Medical Faculty Mannheim
Daniel Brandeis
Department of Child and Adolescent Psychiatry and Psychotherapy, Central Institute of Mental Health, Heidelberg University, Medical Faculty Mannheim
Christina Dose
Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Medical Faculty of the University of Cologne
Christopher Hautmann
Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Medical Faculty of the University of Cologne
Martin Holtmann
Department of Child and Adolescent Psychiatry and Psychotherapy, LWL-University Hospital Hamm, Ruhr-University Bochum
Thomas Jans
Centre of Mental Health, Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital of Würzburg
Lea Jendreizik
Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Medical Faculty of the University of Cologne
Carolin Jenkner
Clinical Trials Unit Freiburg, Medical Centre – University of Freiburg, Faculty of Medicine, University of Freiburg
Katja John
Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Medical Faculty of the Philipps-University Marburg
Johanna Ketter
Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Medical Faculty of the Philipps-University Marburg
Sabina Millenet
Department of Child and Adolescent Psychiatry and Psychotherapy, Central Institute of Mental Health, Heidelberg University, Medical Faculty Mannheim
Ursula Pauli-Pott
Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Medical Faculty of the Philipps-University Marburg
Tobias Renner
Department of Child and Adolescent Psychiatry and Psychotherapy, University Hospital Tübingen
Marcel Romanos
Centre of Mental Health, Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital of Würzburg
Anne-Katrin Treier
Department of Child and Adolescent Psychiatry and Psychotherapy, Central Institute of Mental Health, Heidelberg University, Medical Faculty Mannheim
Elena von Wirth
Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Medical Faculty of the University of Cologne
Anne-Kathrin Wermter
Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Medical Faculty of the Philipps-University Marburg
Manfred Döpfner
Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Medical Faculty of the University of Cologne
Abstract Background Attention-deficit/hyperactivity disorder (ADHD) is a psychosocially impairing and cost-intensive mental disorder, with first symptoms occurring in early childhood. 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 years and 0 months to 6 years and 11 months of age (3;0 to 6;11 years) addresses the treatment of 3–6-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. Methods The target sample size of ESCApreschool is 200 children (boys and girls) aged 3;0 to 6;11 years 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. Discussion 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. Trial registration The trial was registered at the German Clinical Trials Register (DRKS) as a Current Controlled Trial under DRKS00008971 on 1 October 2015. This manuscript is based on protocol version 3 (14 October 2016).
