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      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

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          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).

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          Nonpharmacological interventions for ADHD: systematic review and meta-analyses of randomized controlled trials of dietary and psychological treatments.

          Edmund Sonuga‐Barke, Daniel Brandeis, Samuele Cortese … (2013)
          Nonpharmacological treatments are available for attention deficit hyperactivity disorder (ADHD), although their efficacy remains uncertain. The authors undertook meta-analyses of the efficacy of dietary (restricted elimination diets, artificial food color exclusions, and free fatty acid supplementation) and psychological (cognitive training, neurofeedback, and behavioral interventions) ADHD treatments. Using a common systematic search and a rigorous coding and data extraction strategy across domains, the authors searched electronic databases to identify published randomized controlled trials that involved individuals who were diagnosed with ADHD (or who met a validated cutoff on a recognized rating scale) and that included an ADHD outcome. Fifty-four of the 2,904 nonduplicate screened records were included in the analyses. Two different analyses were performed. When the outcome measure was based on ADHD assessments by raters closest to the therapeutic setting, all dietary (standardized mean differences=0.21-0.48) and psychological (standardized mean differences=0.40-0.64) treatments produced statistically significant effects. However, when the best probably blinded assessment was employed, effects remained significant for free fatty acid supplementation (standardized mean difference=0.16) and artificial food color exclusion (standardized mean difference=0.42) but were substantially attenuated to nonsignificant levels for other treatments. Free fatty acid supplementation produced small but significant reductions in ADHD symptoms even with probably blinded assessments, although the clinical significance of these effects remains to be determined. Artificial food color exclusion produced larger effects but often in individuals selected for food sensitivities. Better evidence for efficacy from blinded assessments is required for behavioral interventions, neurofeedback, cognitive training, and restricted elimination diets before they can be supported as treatments for core ADHD symptoms.
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            Psychometric properties of the Depression Anxiety Stress Scales (DASS) in clinical samples

            Timothy A Brown, Bruce Chorpita, William J. Korotitsch … (1997)
            Article 0 comments Cited 292 times – based on 0 reviews     Review now
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              The Affective Reactivity Index: a concise irritability scale for clinical and research settings

              Argyris Stringaris, Robert Goodman, Sumudu Ferdinando … (2012)
              Background Irritable mood has recently become a matter of intense scientific interest. Here, we present data from two samples, one from the United States and the other from the United Kingdom, demonstrating the clinical and research utility of the parent- and self-report forms of the Affective Reactivity Index (ARI), a concise dimensional measure of irritability. Methods The US sample (n = 218) consisted of children and adolescents recruited at the National Institute of Mental Health meeting criteria for bipolar disorder (BD, n = 39), severe mood dysregulation (SMD, n = 67), children at family risk for BD (n = 35), or were healthy volunteers (n = 77). The UK sample (n = 88) was comprised of children from a generic mental health setting and healthy volunteers from primary and secondary schools. Results Parent- and self-report scales of the ARI showed excellent internal consistencies and formed a single factor in the two samples. In the US sample, the ARI showed a gradation with irritability significantly increasing from healthy volunteers through to SMD. Irritability was significantly higher in SMD than in BD by parent-report, but this did not reach significance by self-report. In the UK sample, parent-rated irritability was differentially related to emotional problems. Conclusions Irritability can be measured using a concise instrument both in a highly specialized US, as well as a general UK child mental health setting.
              Article 0 comments Cited 148 times – based on 0 reviews     Review now
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                Author and article information

                Contributors
                Katja Becker: katja.becker@uni-marburg.de
                Tobias Banaschewski: Tobias.banaschewski@zi-mannheim.de
                Daniel Brandeis: Daniel.Brandeis@zi-mannheim.de
                Christina Dose: Christina.Dose@uk-koeln.de
                Christopher Hautmann: Christopher.Hautmann@uk-koeln.de
                Martin Holtmann: Martin.Holtmann@lwl.org
                Thomas Jans: Jans_T@ukw.de
                Lea Jendreizik: lea.jendreizik@uk-koeln.de
                Carolin Jenkner: Carolin.Jenkner@uniklinik-freiburg.de
                Katja John: Katja.John@verwaltung.uni-marburg.de
                Johanna Ketter: johanna.ketter@med.uni-marburg.de
                Sabina Millenet: Sabina.Millenet@zi-mannheim.de
                Ursula Pauli-Pott: paulipot@med.uni-marburg.de
                Tobias Renner: Tobias.Renner@med.uni-tuebingen.de
                Marcel Romanos: Romanos_M@ukw.de
                Anne-Katrin Treier: anne-katrin.treier@uk-koeln.de
                Elena von Wirth: elena.von-wirth@uk-koeln.de
                Anne-Kathrin Wermter: Anne-Kathrin.Wermter@med.uni-marburg.de
                Manfred Döpfner: Manfred.Doepfner@uk-koeln.de
                Journal
                Journal ID (nlm-ta): Trials
                Journal ID (iso-abbrev): Trials
                Title: Trials
                Publisher: BioMed Central (London )
                ISSN (Electronic): 1745-6215
                Publication date (Electronic): 9 January 2020
                Publication date PMC-release: 9 January 2020
                Publication date Collection: 2020
                Volume: 21
                Electronic Location Identifier: 56
                Affiliations
                [1 ]ISNI 0000 0004 1936 9756, GRID grid.10253.35, Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, , Medical Faculty of the Philipps-University Marburg, ; Hans-Sachs-Str. 6, 35039 Marburg, Germany
                [2 ]ISNI 0000 0001 2165 8627, GRID grid.8664.c, Center for Mind, Brain and Behavior (CMBB), , University of Marburg and Justus Liebig University Giessen, ; Marburg, Germany
                [3 ]ISNI 0000 0001 2190 4373, GRID grid.7700.0, Department of Child and Adolescent Psychiatry and Psychotherapy, Central Institute of Mental Health, , Heidelberg University, Medical Faculty Mannheim, ; Mannheim, Germany
                [4 ]ISNI 0000 0000 8580 3777, GRID grid.6190.e, Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, , Medical Faculty of the University of Cologne, ; Cologne, Germany
                [5 ]ISNI 0000 0000 8852 305X, GRID grid.411097.a, School of Child and Adolescent Cognitive Behaviour Therapy (AKiP), , University Hospital of Cologne, ; Cologne, Germany
                [6 ]ISNI 0000 0004 0490 981X, GRID grid.5570.7, Department of Child and Adolescent Psychiatry and Psychotherapy, , LWL-University Hospital Hamm, Ruhr-University Bochum, ; Hamm, Germany
                [7 ]ISNI 0000 0001 1378 7891, GRID grid.411760.5, Centre of Mental Health, Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, , University Hospital of Würzburg, ; Würzburg, Germany
                [8 ]GRID grid.5963.9, Clinical Trials Unit Freiburg, Medical Centre – University of Freiburg, Faculty of Medicine, , University of Freiburg, ; Freiburg, Germany
                [9 ]ISNI 0000 0001 0196 8249, GRID grid.411544.1, Department of Child and Adolescent Psychiatry and Psychotherapy, , University Hospital Tübingen, ; Tübingen, Germany
                Article
                Publisher ID: 3872
                DOI: 10.1186/s13063-019-3872-8
                PMC ID: 6953462
                PubMed ID: 31918739
                SO-VID: c31d5627-82d5-43c1-bf62-c12a0894c72a
                Copyright © © The Author(s). 2020
                License:

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                Date received : 14 August 2019
                Date accepted : 31 October 2019
                Funding
                Funded by: BMBF
                Award ID: Grant 01EE1408
                Award Recipient :
                Categories
                Subject: Study Protocol
                Custom metadata
                issue-copyright-statement © The Author(s) 2020

                ScienceOpen disciplines: Medicine
                Keywords: attention-deficit/hyperactivity disorder,adhd,preschool children,stepped care,adaptive treatment,telephone-assisted self-help,behaviour therapy,kindergarten,escalife
                Data availability:
                ScienceOpen disciplines: Medicine
                Keywords: attention-deficit/hyperactivity disorder, adhd, preschool children, stepped care, adaptive treatment, telephone-assisted self-help, behaviour therapy, kindergarten, escalife

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