CoCo20 protocol: a pilot longitudinal follow-up study about the psychiatric outcomes in a paediatric population and their families during and after the stay-at-home related to coronavirus pandemic (COVID-19).

Introduction: In the context of a viral outbreak and the stay-at-home measures, a significant increase in psychological distress, such as stress or fear behaviours, has previously been reported in adult and paediatric population. Children and adolescents seem to be particularly at risk of developing psychiatric disorders during and after the stay-at-home but evidences are lacking. The main objective of this article is to present the methodology of Coronavirus Confinement 2020 (CoCo20) Study, which aims to assess the impact of the coronavirus pandemic (COVID-19) and stay-at-home on the development of psychiatric disorders, including post-traumatic stress disorder (PTSD), in children and adolescents.

Methods And Analysis: We describe a longitudinal and multicentre study in the paediatric population during and after stay-at-home related to COVID-19 pandemic. Inclusions started on 30 March 2020 for 6 months. This study is proposed to all consecutive paediatric outpatients consulting during and after stay-at-home related to COVID-19 pandemic in medical-psychological centres and in a paediatric psychotrauma centre and/or calling the emergency COVID-19 hotline. We perform standardised and internationally validated psychiatric assessments (Diagnosis Infant and Preschool Assessment, Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime Version) together with anxiety, attention deficit hyperactivity disorder, PTSD, parenting stress and somatic symptoms scales during five visits (baseline, 1 week after baseline, 1 month after baseline, 1 week after the end of the containment and 1 month after the end of the containment) in patients and their families enrolled during the containment and during three visits in case of enrolment after the containment. The inclusion period will end in 30 November 2020.

Ethics And Dissemination: The protocol has been approved by the Ethics Committee of Cote d'Azur University « CERNI » (number 2020-59). All patients and their legal caregivers provide a written informed consent on enrolment in the study. We will submit the results of the study to relevant journals and offer national and international presentations. This study will enable better characterisation of the impact of the stay-at-home (related to COVID-19 pandemic) on the mental health of children and adolescents.

Trial Registration Number: NCT04498416.