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

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.

Contributors

Julia Geissler:

ORCID: http://orcid.org/0000-0003-1878-9647

[phone] , [e-mail]

Thomas Jans: [e-mail]

Tobias Banaschewski: [e-mail]

Katja Becker: [e-mail]

Tobias Renner: [e-mail]

Daniel Brandeis: [e-mail]

Manfred Döpfner: [e-mail]

Christina Dose: [e-mail]

Christopher Hautmann: [e-mail]

Martin Holtmann: [e-mail]

Carolin Jenkner: [e-mail]

Sabina Millenet: [e-mail]

Marcel Romanos: [e-mail]

Journal

Journal ID (nlm-ta): Trials

Journal ID (iso-abbrev): Trials

Title: Trials

Publisher: BioMed Central (London )

ISSN (Electronic): 1745-6215

Publication date (Electronic): 27 April 2018

Publication date PMC-release: 27 April 2018

Publication date Collection: 2018

Volume: 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

Publisher ID: 2635

DOI: 10.1186/s13063-018-2635-2

PMC ID: 5921777

PubMed ID: 29703226

Copyright statement: © The Author(s). 2018

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.

Funding

Funded by: FundRef http://dx.doi.org/10.13039/501100002347, Bundesministerium für Bildung und Forschung;

Award ID: 01EE1408C

Award Recipient : Marcel Romanos

Categories

Subject: Study Protocol

Custom metadata

issue-copyright-statement © The Author(s) 2018