Suicidality Treatment Occurring in Paediatrics (STOP) Medication Suicidality Side Effects Scale in young people in two cohorts across Europe
David Coghill,
Jatinder Singh,
Federico Fiori,
Paramala Santosh,
Kate Lievesley,
Diane Purper-Ouakil,
Ulrike Schulze,
Pieter J Hoekstra,
Alessandro Zuddas,
Ralf W Dittmann,
Jan K Buitelaar,
Celso Arango,
Mohapradeep Mohan,
Nathan Parnell,
Regina Sala,
Josefina Castro-Fornieles,
Itziar Flamarique,
Cloe Llorente
Affiliations
David Coghill
Murdoch Children’s Research Institute, Melbourne, Victoria, Australia
Jatinder Singh
Department of Child and Adolescent Psychiatry, Institute of Psychiatry, Psychology and Neuroscience, King`s College London, London, UK
Federico Fiori
Department of Child and Adolescent Psychiatry, Institute of Psychiatry, Psychology and Neuroscience, King`s College London, London, UK
Paramala Santosh
Department of Child and Adolescent Psychiatry, Institute of Psychiatry, Psychology and Neuroscience, King`s College London, London, UK
Kate Lievesley
Department of Child and Adolescent Psychiatry, Institute of Psychiatry, Psychology and Neuroscience, King`s College London, London, UK
Diane Purper-Ouakil
Hôpital Saint Eloi, Médecine Psychologique de l’Enfant et de l’Adolescent, Centre Hospitalier Regional Universitaire de Montpellier, Montpellier, Languedoc-Roussillon, France
Ulrike Schulze
Department of Child and Adolescent Psychiatry/Psychotherapy, Universitatsklinikum Ulm, Ulm, Baden-Württemberg, Germany
Pieter J Hoekstra
Department of Child and Adolescent Psychiatry & Accare Child Study Center, University of Groningen, Groningen, The Netherlands
Alessandro Zuddas
Child and Adolescent Neuropsychiatry Unit, Department of Biomedical Science, University of Cagliari, Cagliari, Italy
Ralf W Dittmann
Dept. of Child & Adolescent Psychiatry and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany
Jan K Buitelaar
Department of Cognitive Neuroscience, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Centre, Nijmegen, The Netherlands
Celso Arango
Child and Adolescent Psychiatry Department, Institute of Psychiatry and Mental Health, Hospital General Universitario Gregorio Marañón, Madrid, Spain
Mohapradeep Mohan
Department of Child and Adolescent Psychiatry, Institute of Psychiatry, Psychology and Neuroscience, King`s College London, London, UK
Nathan Parnell
Department of Child and Adolescent Psychiatry, Institute of Psychiatry, Psychology and Neuroscience, King`s College London, London, UK
Regina Sala
Centre for Psychiatry, Wolfson Institute, Barts & The London School of Medicine & Dentistry Queen Mary University of London, London, UK
Josefina Castro-Fornieles
Child and Adolescent Psychiatry and Psychology Department, Hospital Clinic de Barcelona, Barcelona, Catalunya, Spain
Itziar Flamarique
Child and Adolescent Psychiatry and Psychology Department, Hospital Clinic de Barcelona, Barcelona, Catalunya, Spain
Cloe Llorente
Child and Adolescent Psychiatry Department, Institute of Psychiatry and Mental Health, Hospital General Universitario Gregorio Marañón, Madrid, Spain
Objectives As part of the ‘Suicidality: Treatment Occurring in Paediatrics (STOP)’ study, we developed and performed psychometric validation of an electronic-clinical-outcome-assessment (eCOA), which included a patient-reported-outcome (ePRO), an observer-rated-outcome (eObsRO) for parents/carers and a clinician-reported-outcome (eClinRO) that allows identification and monitoring of medication-related suicidality (MRS) in adolescents.Design STOP: Prospective study: A two phase validation study to assess the impact of medication on suicidal ideations.Setting Six participating countries: Netherlands, UK, Germany, France, Spain and Italy that were part of the Community’s Seventh Framework Programme (FP7/2007-2013) under grant agreement no. 261411.Participants Cohort 1 consisted of 41 adolescent-completions, 50 parent-completions and 56 clinician-completions. Cohort 2 consisted of 244 adolescent-completions, 198 parent-completions and 240 clinician-completions from across the six countries. The scale was administered only to participants who have screened positive for the STOP-Suicidality Assessment Scale (STOP-SAS).Results A total of 24 items for the development of the STOP-Medication Suicidality Side Effects Scale (STOP-MS3) were identified and three versions (for patients, parents and clinicians) of the STOP-MS3 were developed and validated in two separate study cohorts comprising of adolescents, their parents and clinicians. Cronbach’s α coefficients were above 0.85 for all domains. The inter-rater reliability of the STOP-MS3 was good and significant for the adolescent (ePRO), clinician (eClinRO) (r=0.613), parent (eObsRO) versions of the scale (r=0.394) and parent and clinician (r=0.347). Exploratory factor analysis identified a 3-factor model across 24 items for the adolescent and parent version of the scale: (1) Emotional Dysregulation, (2) Somatic Dysregulation and (3) Behavioural Dysregulation. For the clinician version, a 4-factor model defined the scale structure: (1) Somatic Dysregulation, (2) Emotional Dysregulation, (3) Behavioural Dysregulation and (4) Mood Dysregulation.Conclusion These findings suggest that the STOP-MS3 scale, a web-based eCOA, allows identification and monitoring of MRS in the adolescent population and shows good reliability and validity.