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临床试验/NCT07250074
NCT07250074尚未招募不适用

"Sentinella" Project: a Digital Registry and Education Network for Child Maltreatment Protection.

Buzzi Children's Hospital0 个研究点目标入组 30 人开始时间: 2025年12月3日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
主要终点
System Usability of the Digital Registry

研究概览

简要总结

The "Sentinella" project aims to improve the early recognition and prevention of child maltreatment by creating a digital registry and education network for healthcare professionals. The study will test a new online registry built on the REDCap platform to collect standardized, anonymous data about suspected cases of abuse or neglect. It also includes a structured training program for pediatricians and other healthcare workers to strengthen their skills in identifying and reporting maltreatment.

This observational study will assess how easy the registry is to use and whether the training improves participants' knowledge and reporting practices. The project is expected to enhance collaboration between hospitals and community services, reduce reporting delays, and create a model for regional or national systems to protect vulnerable children.

详细描述

Child maltreatment is a major public health concern that affects one billion children worldwide each year. In Italy, despite legislative progress, the detection and reporting of suspected cases remain fragmented, often due to lack of standardized systems and professional training.

The Sentinella project aims to address these gaps by integrating a digital registry for the anonymous reporting of suspected child maltreatment with a structured training program for healthcare professionals. The project combines technological innovation and education to strengthen early recognition, documentation, and reporting within the pediatric network.

The study is observational, exploratory, and monocentric, lasting 24 months. It includes two main components:

  1. Registry Phase: Development and evaluation of a secure digital registry based on the REDCap platform for standardized and anonymous data collection. Usability is measured with the System Usability Scale (SUS), where a score ≥70 indicates good usability and ≥80 excellent usability.
  2. Training Phase: A blended theoretical and practical course (approximately 20 hours) addressing clinical, psychological, and legal aspects of child abuse, communication skills, and proper use of the registry. Training effectiveness is measured through pre- and post-tests and participant satisfaction questionnaires.

The target population consists of approximately 30 healthcare professionals (pediatricians, psychologists, nurses, and social workers) who voluntarily participate, complete the training, and consent to data collection. No patient data are collected, and no clinical interventions are performed.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthcare professionals (e.g., pediatricians, psychologists, nurses, social workers) working within the regional pediatric network.
  • Voluntary participation in the Sentinella project.
  • Completion of the planned training program (theoretical and practical components).
  • Willingness to use the digital registry and complete evaluation questionnaires.
  • Provision of written informed consent.

排除标准

  • Failure to complete the full training program.
  • Partial participation in simulation or practical sessions.
  • Incomplete pre- and post-training questionnaires.
  • Refusal or withdrawal of informed consent.

结局指标

主要结局

System Usability of the Digital Registry

时间窗: At the end of the registry implementation phase (approximately 6 months after activation).

Evaluation of the usability and acceptability of the Sentinella digital registry among participating healthcare professionals, measured using the System Usability Scale (SUS). The SUS provides a standardized usability score ranging from 0 to 100; a score ≥70 indicates good usability, and ≥80 indicates excellent usability.

次要结局

未报告次要终点

研究者

发起方
Buzzi Children's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Valeria Calcaterra

Prof

Buzzi Children's Hospital

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