The coronavirus disease 2019 health crisis is strongly affecting the psychological well-being of the general population. According to a very recent literature, the imposed lockdown and social distancing measures have generated a series of negative outcomes, including fear of the future, anxiety, and somatization symptoms. Few studies have investigated the impact of the COVID-19 pandemic on the well-being of parents and children, and still fewer studies have assessed the relationship between the psychological health of parents and children. The present study (...) aimed at understanding the effect of parents’ psychological distress and verbal aggression on behavioral and emotional symptoms of children during the COVID-19 lockdown. Using an online survey administered in the first weeks of the lockdown in Italy, we explored the mediating effects of parent verbal hostility and child emotional symptoms on the relationship between parent distress and child hyperactivity/inattention in a sample of 878 Italian parents. Two hypotheses were proposed: parent distress would significantly predict child hyperactivity/inattention, and parent verbal hostility and child emotional symptoms would mediate the association between parent distress and child hyperactivity/inattention. The serial mediated model confirmed both hypotheses, suggesting that higher rates of psychological distress in parents were associated with higher levels of hyperactivity/inattention in children. Parent verbal hostility and child emotional problems were also found to positively mediate this relation. Our results may be used to improve sociopsychological interventions in the general population in the near future. They may also contribute to the clinical definition of therapeutic paths for parents and families. (shrink)

The authors report the first Italian experience of a research ethics committee (REC) audit focused on the evaluation of the REC’s compliance with standard operating procedures, requirements in insurance coverage, informed consent, protection of privacy and confidentiality, predictable risks/harms, selection of subjects, withdrawal criteria and other issues, such as advertisement details and justification of placebo. The internal audit was conducted over a two-year period (March 2009–February 2011) divided into quarters to better value the influence of the new insurance coverage regulation (...) that came into effect in March 2010 (Ministerial Decree of 14 July, 2009) and expand the requirements to safeguard participants in clinical drug trials including other critical items as information and consent and the risks to benefits ratio. Out of a total of 639 REC’s opinions and research studies, 316 were reviewed. Regarding the insurance policy requirements, Auditor/REC non-compliance occurred only in one case. The highest number of Auditor/REC non-compliance was in regard to information and consent, which should have incurred a suspended decision rather than a favorable opinion. This internal audit shows the importance and the difficulty of the review process. For this reason, specific courses for members of the research ethics committee and for those who aspire to become auditors will be provided. There may also be efforts to improve the standard operating procedures already in place. (shrink)