START NOW - a comprehensive skills training programme for female adolescents with oppositional defiant and conduct disorders: study protocol for a cluster-randomised controlled trial

Trials, Dec 2016

Background In Europe, the number of females exhibiting oppositional defiant disorder (ODD) and conduct disorder (CD) is growing. Many of these females live in youth welfare institutions. Consequently, there is a great need for evidence-based interventions within youth welfare settings. A recently developed approach targeting the specific needs of girls with ODD and CD in residential care is START NOW. The aim of this group-based behavioural skills training programme is to specifically enhance emotional regulation capacities to enable females with CD or ODD to appropriately deal with daily-life demands. It is intended to enhance psychosocial adjustment and well-being as well as reduce oppositional and aggressive behaviour. We present the study protocol (version 4.1; 10 February 2016) of the FemNAT-CD intervention trial titled ‘Group-Based Treatment of Adolescent Female Conduct Disorders: The Central Role of Emotion Regulation’. Methods/design The study is a prospective, confirmatory, cluster-randomised, parallel-group, multi-centre, randomised controlled trial with 128 institutionalised female adolescents who fulfil the diagnostic criteria of ODD and/or CD. Institutions/wards will be randomised either to provide the 12-week skills training as an add-on intervention or to provide treatment as usual. Once the first cycle is completed, each institution will run a second cycle with the opposite condition. Primary endpoints are the pre-post change in number of CD/ODD symptoms as assessed by a standardised, semi-structured psychiatric interview (Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children–Present and Lifetime, CD/ODD section) between baseline and the end of intervention, as well as between baseline and a 3-month follow-up point. Secondary objectives include pre-post change in CD/ODD-related outcome measures, most notably emotional regulation on a behavioural and neurobiological level after completion of START NOW compared with treatment as usual. Discussion To our knowledge, this study is the first to date to systematically investigate the effectiveness of an adapted integrative psychosocial intervention designed for female adolescents with ODD and CD in youth welfare settings. Trial registration German Clinical Trials Register (DRKS) identifier: DRKS00007524. Registered on 18 December 2015 and with the World Health Organisation International Clinical Trials Registry Platform.

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START NOW - a comprehensive skills training programme for female adolescents with oppositional defiant and conduct disorders: study protocol for a cluster-randomised controlled trial

Kersten et al. Trials START NOW - a comprehensive skills training programme for female adolescents with oppositional defiant and conduct disorders: study protocol for a cluster- randomised controlled trial Linda Kersten 0 Martin Prätzlich 0 Sandra Mannstadt 0 Katharina Ackermann 2 Gregor Kohls 1 Helena Oldenhof 6 Daniel Saure 5 Katrin Krieger 4 Beate Herpertz-Dahlmann 1 Arne Popma 6 Christine M. Freitag 2 Robert L. Trestman 3 Christina Stadler 0 0 Department of Child and Adolescent Psychiatry/Department of Psychology, University Psychiatry Clinics Basel/University of Basel , Basel , Switzerland 1 Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, RWTH Aachen University , Aachen , Germany 2 Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital Frankfurt, Goethe-Universität , Frankfurt am Main , Germany 3 Correctional Managed Health Care, UConn Health , Farmington, CT , USA 4 Coordination Centre for Clinical Trials, University Hospital Heidelberg , Heidelberg , Germany 5 Institute of Medical Biometry and Informatics, Department Medical Biometry, University of Heidelberg , Heidelberg , Germany 6 Department of Child and Adolescent Psychiatry, de Bascule, University of Amsterdam/VUmc , Amsterdam , The Netherlands Background: In Europe, the number of females exhibiting oppositional defiant disorder (ODD) and conduct disorder (CD) is growing. Many of these females live in youth welfare institutions. Consequently, there is a great need for evidence-based interventions within youth welfare settings. A recently developed approach targeting the specific needs of girls with ODD and CD in residential care is START NOW. The aim of this group-based behavioural skills training programme is to specifically enhance emotional regulation capacities to enable females with CD or ODD to appropriately deal with daily-life demands. It is intended to enhance psychosocial adjustment and well-being as well as reduce oppositional and aggressive behaviour. We present the study protocol (version 4.1; 10 February 2016) of the FemNAT-CD intervention trial titled 'Group-Based Treatment of Adolescent Female Conduct Disorders: The Central Role of Emotion Regulation'. Methods/design: The study is a prospective, confirmatory, cluster-randomised, parallel-group, multi-centre, randomised controlled trial with 128 institutionalised female adolescents who fulfil the diagnostic criteria of ODD and/or CD. Institutions/wards will be randomised either to provide the 12-week skills training as an add-on intervention or to provide treatment as usual. Once the first cycle is completed, each institution will run a second cycle with the opposite condition. Primary endpoints are the pre-post change in number of CD/ODD symptoms as assessed by a standardised, semi-structured psychiatric interview (Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime, CD/ODD section) between baseline and the end of intervention, as well as between baseline and a 3-month follow-up point. Secondary objectives include pre-post change in CD/ODD-related outcome measures, most notably emotional regulation on a behavioural and neurobiological level after completion of START NOW compared with treatment as usual. Discussion: To our knowledge, this study is the first to date to systematically investigate the effectiveness of an adapted integrative psychosocial intervention designed for female adolescents with ODD and CD in youth welfare settings. (Continued on next page) © The Author(s). 2016 Open Access This 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. - (Continued from previous page) Trial registration: German Clinical Trials Register (DRKS) identifier: DRKS00007524. Registered on 18 December 2015 and with the World Health Organisation International Clinical Trials Registry Platform. Background Across European countries, an increase in mental health problems, along with a growing rate of violence and aggression in youths, can be observed [1]. Children and adolescents with conduct problems, including aggression, represent a highly heterogeneous group. From a diagnostic perspective, aggressive and oppositional behaviour has been subsumed under the diagnoses conduct disorder (CD) and oppositional defiant disorder (ODD) [2]. The heterogeneity is reflected not only by a great variety of symptoms ranging from impulsive, hottempered quarrels or (...truncated)


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Linda Kersten, Martin Prätzlich, Sandra Mannstadt, Katharina Ackermann, Gregor Kohls, Helena Oldenhof, Daniel Saure, Katrin Krieger, Beate Herpertz-Dahlmann, Arne Popma, Christine Freitag, Robert Trestman, Christina Stadler. START NOW - a comprehensive skills training programme for female adolescents with oppositional defiant and conduct disorders: study protocol for a cluster-randomised controlled trial, Trials, 2016, pp. 568, 17, DOI: 10.1186/s13063-016-1705-6