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ESCAlate – Adaptive treatment approach for adolescents and adults with ADHD: study protocol for a randomized controlled trial
BACKGROUND: Over the last decade, a wide range of attention-deficit/hyperactivity disorder (ADHD) treatment approaches for adults, including both pharmacological interventions and psychosocial treatments, have been proposed and observed to be efficient. In practice, individual treatment concepts are...
Autores principales: | , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5960079/ https://www.ncbi.nlm.nih.gov/pubmed/29776383 http://dx.doi.org/10.1186/s13063-018-2665-9 |
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author | Zinnow, Toivo Banaschewski, Tobias Fallgatter, Andreas J. Jenkner, Carolin Philipp-Wiegmann, Florence Philipsen, Alexandra Retz, Wolfgang Sobanski, Esther Thome, Johannes Rösler, Michael |
author_facet | Zinnow, Toivo Banaschewski, Tobias Fallgatter, Andreas J. Jenkner, Carolin Philipp-Wiegmann, Florence Philipsen, Alexandra Retz, Wolfgang Sobanski, Esther Thome, Johannes Rösler, Michael |
author_sort | Zinnow, Toivo |
collection | PubMed |
description | BACKGROUND: Over the last decade, a wide range of attention-deficit/hyperactivity disorder (ADHD) treatment approaches for adults, including both pharmacological interventions and psychosocial treatments, have been proposed and observed to be efficient. In practice, individual treatment concepts are based on results of clinical studies as well as international guidelines (NICE Guidelines) that recommend a step-by-step treatment approach. Since the evidence supporting this approach is limited, the aim of the present study is to determine an optimal intervention regarding severity levels of ADHD symptomatology conducting a randomized controlled trial. METHOD: We aim to include 279 ADHD subjects aged between 16 and 45 years. First, participants are randomized to either a face-to-face psychoeducation, telephone assisted self-help (TASH), or a waiting control group (Step 1). All participants assigned to the control group are treated using TASH after a 3-month waiting period. Participants are then allocated to one of three groups, based on their remaining severity level of ADHD symptoms, as (1) full responder, (2) partial responder, or (3) non-responder (Step 2). Full responders receive counseling, partial responders receive either counseling only or counseling and neurofeedback (NF), and non-responders receive either pharmacological treatment only or pharmacological treatment and NF, followed by a 3 month period without intervention. DISCUSSION: The naturalistic sample is one of the study’s advantages, avoiding highly selective inclusion or exclusion criteria. The efficacy of an evidence-based stepped care intervention is explored by primary (reduction of severity of ADHD symptoms) and secondary outcomes (functional outcomes, e.g., quality of life, anger management, enhancement of psychosocial well-being). Predictors of therapeutic response and non-response are being investigated at each step of intervention. Further, sex differences are also being explored. TRIAL REGISTRATION: This study is registered by the German Trial Register (reference number: DRKS00008975), 23 October 2015. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-018-2665-9) contains supplementary material, which is available to authorized users. |
format | Online Article Text |
id | pubmed-5960079 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-59600792018-05-24 ESCAlate – Adaptive treatment approach for adolescents and adults with ADHD: study protocol for a randomized controlled trial Zinnow, Toivo Banaschewski, Tobias Fallgatter, Andreas J. Jenkner, Carolin Philipp-Wiegmann, Florence Philipsen, Alexandra Retz, Wolfgang Sobanski, Esther Thome, Johannes Rösler, Michael Trials Study Protocol BACKGROUND: Over the last decade, a wide range of attention-deficit/hyperactivity disorder (ADHD) treatment approaches for adults, including both pharmacological interventions and psychosocial treatments, have been proposed and observed to be efficient. In practice, individual treatment concepts are based on results of clinical studies as well as international guidelines (NICE Guidelines) that recommend a step-by-step treatment approach. Since the evidence supporting this approach is limited, the aim of the present study is to determine an optimal intervention regarding severity levels of ADHD symptomatology conducting a randomized controlled trial. METHOD: We aim to include 279 ADHD subjects aged between 16 and 45 years. First, participants are randomized to either a face-to-face psychoeducation, telephone assisted self-help (TASH), or a waiting control group (Step 1). All participants assigned to the control group are treated using TASH after a 3-month waiting period. Participants are then allocated to one of three groups, based on their remaining severity level of ADHD symptoms, as (1) full responder, (2) partial responder, or (3) non-responder (Step 2). Full responders receive counseling, partial responders receive either counseling only or counseling and neurofeedback (NF), and non-responders receive either pharmacological treatment only or pharmacological treatment and NF, followed by a 3 month period without intervention. DISCUSSION: The naturalistic sample is one of the study’s advantages, avoiding highly selective inclusion or exclusion criteria. The efficacy of an evidence-based stepped care intervention is explored by primary (reduction of severity of ADHD symptoms) and secondary outcomes (functional outcomes, e.g., quality of life, anger management, enhancement of psychosocial well-being). Predictors of therapeutic response and non-response are being investigated at each step of intervention. Further, sex differences are also being explored. TRIAL REGISTRATION: This study is registered by the German Trial Register (reference number: DRKS00008975), 23 October 2015. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-018-2665-9) contains supplementary material, which is available to authorized users. BioMed Central 2018-05-18 /pmc/articles/PMC5960079/ /pubmed/29776383 http://dx.doi.org/10.1186/s13063-018-2665-9 Text en © 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. |
spellingShingle | Study Protocol Zinnow, Toivo Banaschewski, Tobias Fallgatter, Andreas J. Jenkner, Carolin Philipp-Wiegmann, Florence Philipsen, Alexandra Retz, Wolfgang Sobanski, Esther Thome, Johannes Rösler, Michael ESCAlate – Adaptive treatment approach for adolescents and adults with ADHD: study protocol for a randomized controlled trial |
title | ESCAlate – Adaptive treatment approach for adolescents and adults with ADHD: study protocol for a randomized controlled trial |
title_full | ESCAlate – Adaptive treatment approach for adolescents and adults with ADHD: study protocol for a randomized controlled trial |
title_fullStr | ESCAlate – Adaptive treatment approach for adolescents and adults with ADHD: study protocol for a randomized controlled trial |
title_full_unstemmed | ESCAlate – Adaptive treatment approach for adolescents and adults with ADHD: study protocol for a randomized controlled trial |
title_short | ESCAlate – Adaptive treatment approach for adolescents and adults with ADHD: study protocol for a randomized controlled trial |
title_sort | escalate – adaptive treatment approach for adolescents and adults with adhd: study protocol for a randomized controlled trial |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5960079/ https://www.ncbi.nlm.nih.gov/pubmed/29776383 http://dx.doi.org/10.1186/s13063-018-2665-9 |
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