"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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 3, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 3, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 3, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 18, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 26, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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