"Sentinella": Registry and Training for Child Protection (Sentinella)

November 18, 2025 updated by: Valeria Calcaterra, Buzzi Children's Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

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.

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
System Usability of the Digital Registry
Time Frame: 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.
At the end of the registry implementation phase (approximately 6 months after activation).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Buzzi Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 3, 2025

Primary Completion (Estimated)

May 3, 2026

Study Completion (Estimated)

November 3, 2027

Study Registration Dates

First Submitted

November 18, 2025

First Submitted That Met QC Criteria

November 18, 2025

First Posted (Actual)

November 26, 2025

Study Record Updates

Last Update Posted (Actual)

November 26, 2025

Last Update Submitted That Met QC Criteria

November 18, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • Buzzi021125

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Child Abuse

Clinical Trials on Integrated Digital Registry and Education Intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Australia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe