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      Effects of a smartphone app-augmented treatment for children with oppositional defiant disorder / conduct disorder and peer-related aggressive behavior – a pilot study

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          Abstract

          Background

          Social competence training interventions, especially child-focused ones, have proven to be effective in the treatment of children with conduct disorder. Therapy homework assignments implemented between the therapy sessions are essential for practicing strategies developed during treatment sessions and transferring them to everyday life. However, clinical experience shows that patients’ adherence regarding these assignments is often low, thus diminishing the treatment success. One obstacle in this regard is a lack of motivation. The use of smartphone apps in the context of child and adolescent psychotherapy is relatively new, and may provide novel ways to improve the transfer of coping strategies to daily life between treatment sessions. However, only a small number of high-quality studies have analyzed the systematic use of smartphone apps in therapy. The present study will therefore evaluate patients’ homework assignment adherence when using a smartphone app as compared to a paper-and-pencil method.

          Method

          The study will be conducted as a randomized controlled trial to evaluate the impact of a smartphone app on the adherence to therapy homework assignments ( n = 35) in the treatment of children with aggressive behavior aged 6–12 years compared to paper-and-pencil homework assignments ( n = 35).

          Discussion

          This trial is intended as a pilot study and aims to provide a basis for a subsequent multicenter trial. However, the results may already lead to recommendations for the development and use of mental health-related smartphone apps for children and adolescents with aggressive behavior problems.

          Trial registration

          Trial registration AUTHARK: German Clinical Trials Register (DRKS) DRKS00015625. Registered on 15th October 2019.

          Supplementary Information

          The online version contains supplementary material available at 10.1186/s13063-022-06325-6.

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          Most cited references64

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          A Guideline of Selecting and Reporting Intraclass Correlation Coefficients for Reliability Research.

          Intraclass correlation coefficient (ICC) is a widely used reliability index in test-retest, intrarater, and interrater reliability analyses. This article introduces the basic concept of ICC in the content of reliability analysis.
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            Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable

            Sample size justification is an important consideration when planning a clinical trial, not only for the main trial but also for any preliminary pilot trial. When the outcome is a continuous variable, the sample size calculation requires an accurate estimate of the standard deviation of the outcome measure. A pilot trial can be used to get an estimate of the standard deviation, which could then be used to anticipate what may be observed in the main trial. However, an important consideration is that pilot trials often estimate the standard deviation parameter imprecisely. This paper looks at how we can choose an external pilot trial sample size in order to minimise the sample size of the overall clinical trial programme, that is, the pilot and the main trial together. We produce a method of calculating the optimal solution to the required pilot trial sample size when the standardised effect size for the main trial is known. However, as it may not be possible to know the standardised effect size to be used prior to the pilot trial, approximate rules are also presented. For a main trial designed with 90% power and two-sided 5% significance, we recommend pilot trial sample sizes per treatment arm of 75, 25, 15 and 10 for standardised effect sizes that are extra small (≤0.1), small (0.2), medium (0.5) or large (0.8), respectively.
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              The size of a pilot study for a clinical trial should be calculated in relation to considerations of precision and efficiency.

              To investigate methods to determine the size of a pilot study to inform a power calculation for a randomized controlled trial (RCT) using an interval/ratio outcome measure. Calculations based on confidence intervals (CIs) for the sample standard deviation (SD). Based on CIs for the sample SD, methods are demonstrated whereby (1) the observed SD can be adjusted to secure the desired level of statistical power in the main study with a specified level of confidence; (2) the sample for the main study, if calculated using the observed SD, can be adjusted, again to obtain the desired level of statistical power in the main study; (3) the power of the main study can be calculated for the situation in which the SD in the pilot study proves to be an underestimate of the true SD; and (4) an "efficient" pilot size can be determined to minimize the combined size of the pilot and main RCT. Trialists should calculate the appropriate size of a pilot study, just as they should the size of the main RCT, taking into account the twin needs to demonstrate efficiency in terms of recruitment and to produce precise estimates of treatment effect. Copyright © 2012 Elsevier Inc. All rights reserved.
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                Author and article information

                Contributors
                Anja.goertz-dorten@uk-koeln.de
                Marlin.frank@uk-koeln.de
                Anja.fessel@uk-koeln.de
                Leonie.hofmann@uk-koeln.de
                Manfred.doepfner@uk-koeln.de
                Journal
                Trials
                Trials
                Trials
                BioMed Central (London )
                1745-6215
                8 July 2022
                8 July 2022
                2022
                : 23
                : 554
                Affiliations
                [1 ]GRID grid.6190.e, ISNI 0000 0000 8580 3777, Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, , Faculty of Medicine and University Hospital Cologne, University of Cologne, ; Cologne, Germany
                [2 ]GRID grid.6190.e, ISNI 0000 0000 8580 3777, School of Child and Adolescent Cognitive Behavior Therapy (AKiP), , Faculty of Medicine and University Hospital Cologne, University of Cologne, ; Cologne, Germany
                Article
                6325
                10.1186/s13063-022-06325-6
                9264298
                6373e640-46b0-42a0-b7e9-1ddb419108fd
                © The Author(s) 2022

                Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. 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 in a credit line to the data.

                History
                : 9 September 2021
                : 22 April 2022
                Funding
                Funded by: Universitätsklinikum Köln (8977)
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2022

                Medicine
                smartphone app,children,aggressive behavior,cognitive behavioral therapy,therapy homework,adherence

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