title: START NOW - a comprehensive skills training programme for female adolescents with oppositional defiant and conduct disorders: study protocol for a cluster-randomised controlled trial.
abstract: 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'.
  
  
  
  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.
  
  
  
  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.
  
  
  
  German Clinical Trials Register (DRKS) identifier: DRKS00007524 . Registered on 18 December 2015 and with the World Health Organisation International Clinical Trials Registry Platform.
authors.affiliation: Department of Child and Adolescent Psychiatry/Department of Psychology, University Psychiatry Clinics Basel/University of Basel, Basel, Switzerland. linda.kersten@upkbs.ch.
authors.forename: Linda
authors.identifier: 0000-0001-7883-6236
authors.initials: L
authors.lastname: Kersten
authors.affiliation: Department of Child and Adolescent Psychiatry/Department of Psychology, University Psychiatry Clinics Basel/University of Basel, Basel, Switzerland.
authors.forename: Martin
authors.initials: M
authors.lastname: Prätzlich
authors.affiliation: Department of Child and Adolescent Psychiatry/Department of Psychology, University Psychiatry Clinics Basel/University of Basel, Basel, Switzerland.
authors.forename: Sandra
authors.initials: S
authors.lastname: Mannstadt
authors.affiliation: Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital Frankfurt, Goethe-Universität, Frankfurt am Main, Germany.
authors.forename: Katharina
authors.initials: K
authors.lastname: Ackermann
authors.affiliation: Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, RWTH Aachen University, Aachen, Germany.
authors.forename: Gregor
authors.initials: G
authors.lastname: Kohls
authors.affiliation: Department of Child and Adolescent Psychiatry, de Bascule, University of Amsterdam/VUmc, Amsterdam, The Netherlands.
authors.forename: Helena
authors.initials: H
authors.lastname: Oldenhof
authors.affiliation: Institute of Medical Biometry and Informatics, Department Medical Biometry, University of Heidelberg, Heidelberg, Germany.
authors.forename: Daniel
authors.initials: D
authors.lastname: Saure
authors.affiliation: Coordination Centre for Clinical Trials, University Hospital Heidelberg, Heidelberg, Germany.
authors.forename: Katrin
authors.initials: K
authors.lastname: Krieger
authors.affiliation: Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, RWTH Aachen University, Aachen, Germany.
authors.forename: Beate
authors.initials: B
authors.lastname: Herpertz-Dahlmann
authors.affiliation: Department of Child and Adolescent Psychiatry, de Bascule, University of Amsterdam/VUmc, Amsterdam, The Netherlands.
authors.forename: Arne
authors.initials: A
authors.lastname: Popma
authors.affiliation: Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital Frankfurt, Goethe-Universität, Frankfurt am Main, Germany.
authors.forename: Christine M
authors.initials: CM
authors.lastname: Freitag
authors.affiliation: Correctional Managed Health Care, UConn Health, Farmington, CT, USA.
authors.forename: Robert L
authors.initials: RL
authors.lastname: Trestman
authors.affiliation: Department of Child and Adolescent Psychiatry/Department of Psychology, University Psychiatry Clinics Basel/University of Basel, Basel, Switzerland.
authors.forename: Christina
authors.initials: C
authors.lastname: Stadler
mesh_terms: D000293:Adolescent; D019958:Attention Deficit and Disruptive Behavior Disorders / Q000523:psychology / Q000628:therapy*; D002985:Clinical Protocols; D015928:Cognitive Behavioral Therapy; D019955:Conduct Disorder / Q000523:psychology / Q000628:therapy*; D005260:Female; D006801:Humans; D009042:Motivation; D011446:Prospective Studies
keywords: Adolescents; Conduct disorder; Emotion regulation; Females; Oppositional defiant disorder; Randomised controlled trial; Residential care; Skills training; Treatment