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.

Autor: Becker K; Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Medical Faculty of the Philipps-University Marburg, Hans-Sachs-Str. 6, 35039, Marburg, Germany. katja.becker@uni-marburg.de.; Center for Mind, Brain and Behavior (CMBB), University of Marburg and Justus Liebig University Giessen, Marburg, Germany. katja.becker@uni-marburg.de., Banaschewski T; Department of Child and Adolescent Psychiatry and Psychotherapy, Central Institute of Mental Health, Heidelberg University, Medical Faculty Mannheim, Mannheim, Germany., Brandeis D; Department of Child and Adolescent Psychiatry and Psychotherapy, Central Institute of Mental Health, Heidelberg University, Medical Faculty Mannheim, Mannheim, Germany., Dose C; Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Medical Faculty of the University of Cologne, Cologne, Germany.; School of Child and Adolescent Cognitive Behaviour Therapy (AKiP), University Hospital of Cologne, Cologne, Germany., Hautmann C; Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Medical Faculty of the University of Cologne, Cologne, Germany.; School of Child and Adolescent Cognitive Behaviour Therapy (AKiP), University Hospital of Cologne, Cologne, Germany., Holtmann M; Department of Child and Adolescent Psychiatry and Psychotherapy, LWL-University Hospital Hamm, Ruhr-University Bochum, Hamm, Germany., Jans T; Centre of Mental Health, Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital of Würzburg, Würzburg, Germany., Jendreizik L; Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Medical Faculty of the University of Cologne, Cologne, Germany., Jenkner C; Clinical Trials Unit Freiburg, Medical Centre - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany., John K; Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Medical Faculty of the Philipps-University Marburg, Hans-Sachs-Str. 6, 35039, Marburg, Germany., Ketter J; Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Medical Faculty of the Philipps-University Marburg, Hans-Sachs-Str. 6, 35039, Marburg, Germany., Millenet S; Department of Child and Adolescent Psychiatry and Psychotherapy, Central Institute of Mental Health, Heidelberg University, Medical Faculty Mannheim, Mannheim, Germany., Pauli-Pott U; Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Medical Faculty of the Philipps-University Marburg, Hans-Sachs-Str. 6, 35039, Marburg, Germany.; Center for Mind, Brain and Behavior (CMBB), University of Marburg and Justus Liebig University Giessen, Marburg, Germany., Renner T; Department of Child and Adolescent Psychiatry and Psychotherapy, University Hospital Tübingen, Tübingen, Germany., Romanos M; Centre of Mental Health, Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital of Würzburg, Würzburg, Germany., Treier AK; Department of Child and Adolescent Psychiatry and Psychotherapy, Central Institute of Mental Health, Heidelberg University, Medical Faculty Mannheim, Mannheim, Germany., von Wirth E; Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Medical Faculty of the University of Cologne, Cologne, Germany.; School of Child and Adolescent Cognitive Behaviour Therapy (AKiP), University Hospital of Cologne, Cologne, Germany., Wermter AK; Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Medical Faculty of the Philipps-University Marburg, Hans-Sachs-Str. 6, 35039, Marburg, Germany.; Center for Mind, Brain and Behavior (CMBB), University of Marburg and Justus Liebig University Giessen, Marburg, Germany., Döpfner M; Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Medical Faculty of the University of Cologne, Cologne, Germany.; School of Child and Adolescent Cognitive Behaviour Therapy (AKiP), University Hospital of Cologne, Cologne, Germany.
Jazyk: angličtina
Zdroj: Trials [Trials] 2020 Jan 09; Vol. 21 (1), pp. 56. Date of Electronic Publication: 2020 Jan 09.
DOI: 10.1186/s13063-019-3872-8
Abstrakt: 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).
Databáze: MEDLINE
Externí odkaz:
Nepřihlášeným uživatelům se plný text nezobrazuje