Impact of the 2016 Nice terrorist attack on mental health service utilization in children and adolescents: Protocol for the PEDIMPACT Study

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/43739
• EU PAS number:
  EUPAS43738
• Study ID:
  43739
• Official title and acronym:
  Impact of the 2016 Nice terrorist attack on mental health service utilization in children and adolescents: Protocol for the PEDIMPACT Study
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  Introduction: The literature on mental healthcare use after a terror attack is relatively scarce. Moreover, several studies have highlighted the complexity of variations in patterns of care and psychotropic drug use after these attacks. The main objective of the PaEDiatric IMPact of terrorist AttaCks in general populaTion (PEDIMPACT) study is to evaluate the short- and middle-term impact in children and adolescents of the terror attack in Nice on July 14th, 2016 on use of mental health resources namely 1) use of psychotropic medications and 2) mental health-related hospitalizations and 3) outpatient visits. Methods and analysis: This is a population-based retrospective cohort study using data from the French National Health Data System (Système National des Données de Santé SNDS) collected from January 1, 2012, to 31 December 2021, in the pediatric population. We will conduct a quasi-experimental study using a monthly interrupted-time series analysis (based on mean-dispersion negative binomial regression models, segmented time series models and an autoregressive integrated moving average ARIMA models) to estimate the short- and middle-term impact on mental health service use in the Nice geographic region vs. three control regions, after the Nice truck-ramming attack. Ethics and dissemination: The study protocol will be submitted to the Institutional Review Board of Toulouse University Hospital and the National Ethics and Scientific Committee for approval. Results will be reported in accordance with the REporting of studies Conducted using Observational Routinely-collected health Data statement. They will be presented in national and international conferences and submitted to peer-reviewed journals.
• Study status:
  Planned

Research institutions and networks

Institutions

Toulouse University Hospital

Pharmacologie En Population cohorteS et biobanqueS

Study timelines

Date when funding contract was signed

Planned: 01/09/2022

Study start date

Planned: 01/09/2022

Data analysis start date

Planned: 02/01/2023

Date of interim report, if expected

Planned: 01/06/2023

Date of final study report

Planned: 18/12/2023

Sources of funding

Other

More details on funding

Grant submission in process, Grant submission in process

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable