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The FDA guideline was chosen as the most appropriate given its emphasis on patient input in order to ensure content validity of the questionnaire.Furthermore, following the FDA guidance will allow the instrument to be used as an outcome measure in clinical trials.This protocol outlines the intended development and validation of the ‘Assessment of Concerning Behaviour Scale’ (ACB).The term ‘concerning behaviour‘ was chosen for the title of the questionnaire based on feedback from patient and public involvement panels (PPI panels; including parents of individuals with ASD and individuals with ASD) who disliked the use of the other terms including ‘psychopathology’, ‘abnormal behaviour’, ‘maladaptive behaviour’, ‘symptoms’, ‘challenging behaviour’ and ‘mental health problems’.
Throughout this protocol, the term ‘concerning behaviour’ will be used to refer to any behaviours or emotions that may cause concern for individuals with ASD, their parents/carers or healthcare professionals.
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.
Ethics and dissemination This study has received ethical approval from the NHS Research Ethics Committee: London-Camden and King's Cross (ref: 15/LO/0085).
It is important that self-report measures are not overlooked when assessing individuals with ASD.
However, measures should be modified to the unique needs of individuals with ASD and should be validated in this population.