title: Protocol for the development and validation of a questionnaire to assess concerning behaviours and mental health in individuals with autism spectrum disorders: the Assessment of Concerning Behaviour (ACB) scale.
abstract: BACKGROUND
  Co-occurring psychiatric conditions and concerning behaviours are prevalent in individuals with autism spectrum disorders (ASD), and are likely to be detrimental to functioning and long-term outcomes. The cognitive rigidity and deficits in emotional literacy and verbal behaviour that commonly occur in ASD can adversely affect clinicians' confidence to identify concerning behaviours and mental health problems. There is a need to develop a measure that is tailored towards individuals with ASD, and differentiates between symptoms of psychopathology and core ASD symptoms. Furthermore, it should be modified to capture internalising symptoms that individuals with ASD may find difficult or be unable to verbalise. This protocol describes the intended development and validation of the Assessment of Concerning Behaviour (ACB) scale. The ACB will aim to be a multidimensional measure of concerning behaviours in ASD incorporating self-report, parent/carer, teacher/employer and clinician report versions that can be used across the lifespan and spectrum of intellectual ability.
  
  
  METHODS
  This study will be guided by the methods described in the US Food and Drug Administration Guidance for Industry Patient-reported Outcome Measures. A literature review, cognitive interviews and focus groups with individuals who have experience of working or living with ASDs will be used for item generation. A sample of children and adults with ASD will complete the ACB, in addition to other gold standard measures of concerning behaviour in order to establish the initial psychometric properties of the scale.
  
  
  BACKGROUND
  This study has received ethical approval from the NHS Research Ethics Committee: London-Camden and King's Cross (ref: 15/LO/0085). Study findings will be disseminated to healthcare professionals and scientists in the field through publication in peer-reviewed journals and conference presentations.
authors.affiliation: Department of Child & Adolescent Psychiatry, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK Centre for Interventional Paediatric Psychopharmacology and Rare Diseases (CIPPRD), Michael Rutter Centre, Maudsley Hospital, London, UK.
authors.forename: Paramala
authors.initials: P
authors.lastname: Santosh
authors.affiliation: Department of Child & Adolescent Psychiatry, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
authors.forename: Joanne
authors.initials: J
authors.lastname: Tarver
authors.affiliation: Department of Child & Adolescent Psychiatry, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
authors.forename: Felicity
authors.initials: F
authors.lastname: Gibbons
authors.affiliation: Department of Biostatistics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
authors.forename: Silia
authors.initials: S
authors.lastname: Vitoratou
authors.affiliation: Department of Child & Adolescent Psychiatry, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
authors.forename: Emily
authors.initials: E
authors.lastname: Simonoff
mesh_terms: D000293:Adolescent; D000328:Adult; D000067877:Autism Spectrum Disorder / Q000523:psychology*; D000067290:Behavior Rating Scale / Q000592:standards*; D002648:Child; D060825:Cognitive Dysfunction / Q000175:diagnosis*; D004644:Emotions; D005260:Female; D017144:Focus Groups; D006801:Humans; D007406:Interview, Psychological; D008131:London; D008297:Male; D008603:Mental Health / Q000592:standards*; D011594:Psychometrics; D015203:Reproducibility of Results; D012107:Research Design; D057566:Self Report; D011795:Surveys and Questionnaires; D055815:Young Adult
keywords: Assessment; Autism Spectrum Disorder; Comorbidity