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      Individualised short-term therapy for adolescents impaired by attention-deficit/hyperactivity disorder despite previous routine care treatment (ESCAadol)—Study protocol of a randomised controlled trial within the consortium ESCAlife

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          Abstract

          Background

          Despite the high persistence rate of attention-deficit/hyperactivity disorder (ADHD) throughout the lifespan, there is a considerable gap in knowledge regarding effective treatment strategies for adolescents with ADHD. This group in particular often shows substantial psychosocial impairment, low compliance and insufficient response to psychopharmacological interventions. Effective and feasible treatments should further consider the developmental shift in ADHD symptoms, comorbidity and psychosocial adversity as well as family dysfunction. Thus, individualised interventions for adolescent ADHD should comprise a multimodal treatment strategy. The randomised controlled ESCAadol study addresses the needs of this patient group and compares the outcome of short-term cognitive behavioural therapy with parent-based telephone-assisted self-help.

          Methods/design

          In step 1, 160 adolescents aged 12 to 17 years with a diagnosis of ADHD will undergo a treatment as usual (TAU) observation phase of 1 month. In step 2, those still severely affected are randomised to the intervention group with an Individualised Modular Treatment Programme (IMTP) or a telephone-assisted self-help programme for parents (TASH) as an active control condition. The IMTP was specifically designed for the needs of adolescent ADHD. It comprises 10 sessions of individual cognitive behavioural therapy with the adolescents and/or the parents, for which participants choose three out of 10 available focus modules (e.g. organisational skills and planning, emotion regulation, problem solving and stress management, dysfunctional family communication). TASH combines a bibliotherapeutic component with 10 counselling sessions for the parents via telephone. Primary outcome is the change in ADHD symptoms in a clinician-rated diagnostic interview. Outcomes are assessed at inclusion into the study, after the TAU phase, after the intervention phase and after a further 12-week follow-up period. The primary statistical analysis will be by intention-to-treat, using linear regression models. Additionally, we will analyse psychometric and biological predictors and moderators of treatment response.

          Discussion

          ESCAadol compares two short-term non-pharmacological interventions as cost-efficient and feasible treatment options for adolescent ADHD, addressing the specific needs and obstacles to treatment success in this group. We aim to contribute to personalised medicine for adolescent ADHD intended to be implemented in routine clinical care.

          Trial registration

          German Clinical Trials Register (DRKS), Current Controlled Trial DRKS00008974, http://apps.who.int/trialsearch/Trial2.aspx?TrialID=DRKS00008974; http://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00008974; Registered on 28 December 2015.

          Electronic supplementary material

          The online version of this article (10.1186/s13063-018-2635-2) contains supplementary material, which is available to authorized users.

          Related collections

          Most cited references 62

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          The age-dependent decline of attention deficit hyperactivity disorder: a meta-analysis of follow-up studies.

          This study examined the persistence of attention deficit hyperactivity disorder (ADHD) into adulthood. We analyzed data from published follow-up studies of ADHD. To be included in the analysis, these additional studies had to meet the following criteria: the study included a control group and it was clear from the methods if the diagnosis of ADHD included subjects who did not meet full criteria but showed residual and impairing signs of the disorder. We used a meta-analysis regression model to separately assess the syndromatic and symptomatic persistence of ADHD. When we define only those meeting full criteria for ADHD as having 'persistent ADHD', the rate of persistence is low, approximately 15% at age 25 years. But when we include cases consistent with DSM-IV's definition of ADHD in partial remission, the rate of persistence is much higher, approximately 65%. Our results show that estimates of ADHD's persistence rely heavily on how one defines persistence. Yet, regardless of definition, our analyses show that evidence for ADHD lessens with age. More work is needed to determine if this reflects true remission of ADHD symptoms or is due to the developmental insensitivity of diagnostic criteria for the disorder.
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            A continuous performance test of brain damage.

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

              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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                Author and article information

                Contributors
                +49 931 201-78710 , Geissler_J@ukw.de
                Jans_T@ukw.de
                Tobias.banaschewski@zi-mannheim.de
                Katja.Becker@med.uni-marburg.de
                Tobias.Renner@med.uni-tuebingen.de
                Daniel.Brandeis@zi-mannheim.de
                Manfred.Doepfner@uk-koeln.de
                Christina.Dose@uk-koeln.de
                Christopher.Hautmann@uk-koeln.de
                Martin.Holtmann@lwl.org
                Carolin.Jenkner@uniklinik-freiburg.de
                Sabina.Millenet@zi-mannheim.de
                Romanos_M@ukw.de
                Journal
                Trials
                Trials
                Trials
                BioMed Central (London )
                1745-6215
                27 April 2018
                27 April 2018
                2018
                : 19
                Affiliations
                [1 ]ISNI 0000 0001 1378 7891, GRID grid.411760.5, Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, , University Hospital of Würzburg, Center of Mental Health, ; Margarete-Höppel-Platz 1, 97080 Würzburg, Germany
                [2 ]ISNI 0000 0001 2190 4373, GRID grid.7700.0, Department of Child and Adolescent Psychiatry and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim, , University of Heidelberg, ; Mannheim, Germany
                [3 ]Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Medical Faculty of the Philipps-University Marburg and the University Hospital Marburg, Marburg, Germany
                [4 ]ISNI 0000 0001 0196 8249, GRID grid.411544.1, Department of Child and Adolescent Psychiatry and Psychotherapy, , University Hospital Tübingen, ; Tübingen, Germany
                [5 ]ISNI 0000 0004 1937 0650, GRID grid.7400.3, Department of Child and Adolescent Psychiatry and Psychotherapy, Psychiatric Hospital, , University of Zürich, ; Zurich, Switzerland
                [6 ]ISNI 0000 0004 1937 0650, GRID grid.7400.3, Zurich Center for Integrative Human Physiology, , University of Zürich, ; Zurich, Switzerland
                [7 ]ISNI 0000 0001 2156 2780, GRID grid.5801.c, Neuroscience Center Zurich, , University and ETH Zürich, ; Zurich, Switzerland
                [8 ]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
                [9 ]ISNI 0000 0000 8852 305X, GRID grid.411097.a, School of Child and Adolescent Cognitive Behaviour Therapy (AKiP), , University Hospital of Cologne, ; Cologne, Germany
                [10 ]ISNI 0000 0004 0490 981X, GRID grid.5570.7, LWL-University Hospital Hamm, , Ruhr-University Bochum, ; Hamm, Germany
                [11 ]ISNI 0000 0000 9428 7911, GRID grid.7708.8, Clinical Trails Unit at University Medical Center Freiburg, ; Freiburg, Germany
                Article
                2635
                10.1186/s13063-018-2635-2
                5921777
                29703226
                © The Author(s). 2018

                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.

                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/501100002347, Bundesministerium für Bildung und Forschung;
                Award ID: 01EE1408C
                Award Recipient :
                Categories
                Study Protocol
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                © The Author(s) 2018

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