An observational study in Child Abuse, Child Neglect and Child Maltreatment, sponsored by Buzzi Children's Hospital. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-26.
Sponsored by Buzzi Children's Hospital · Observational
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.
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:
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.
Primary outcome: Usability of the digital registry (SUS score). Secondary outcomes: Improvement in knowledge and competence, increased reporting rates, and user satisfaction.
Data will be analyzed using descriptive and inferential statistics (paired t-tests, Wilcoxon tests, Poisson or negative binomial regression models). Significance will be set at p \< 0.05.
The project complies with the Declaration of Helsinki and the EU GDPR (Reg. 2016/679). Participation is voluntary and risk-free.
Expected results: The registry is expected to achieve high usability (SUS ≥80), while the training program should lead to measurable improvement in professional knowledge and reporting behavior. Together, these components aim to enhance coordination between hospital and community services, increase early detection of abuse, and establish a sustainable "Sentinel Pediatricians" network.
Ultimately, Sentinella seeks to validate an integrated and replicable model for child protection that can evolve into an Observatory on Child Maltreatment, supporting continuous surveillance, education, and policy development.
Buzzi Children's Hospital is the lead sponsor of 6 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population consists of healthcare professionals involved in child care and protection within the regional pediatric network, including hospital and community pediatricians, psychologists, nurses, and social workers. Participants are professionals who voluntarily enroll in the Sentinella project, complete the structured training program, and participate in the evaluation of the digital registry's usability and the training's effectiveness.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The Sentinella intervention combines a secure digital registry with a structured training program for healthcare professionals to improve the early recognition and reporting of suspected child maltreatment. The digital registry, developed using the REDCap platform, enables standardized, anonymous data collection and supports communication between hospital and community services. The training component includes theoretical and practical modules focused on clinical, psychological, and legal aspects of child abuse, as well as hands-on exercises for correct use of the registry. This integrated approach-linking technology and professional education-distinguishes Sentinella from other interventions, which typically address either training or data collection separately.
System Usability of the Digital Registry
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.
Time frame: At the end of the registry implementation phase (approximately 6 months after activation).
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Dec 2025; primary completion for May 2026, 5 months later.
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This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Buzzi Children's Hospital