NCT07250074

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
18mo left

Started Dec 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress22%
Dec 2025Nov 2027

First Submitted

Initial submission to the registry

November 18, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 26, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

December 3, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2026

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2027

Expected
Last Updated

November 26, 2025

Status Verified

November 1, 2025

Enrollment Period

5 months

First QC Date

November 18, 2025

Last Update Submit

November 18, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

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

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Valeria Calcaterra, Prof

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

November 18, 2025

First Posted

November 26, 2025

Study Start

December 3, 2025

Primary Completion

May 3, 2026

Study Completion (Estimated)

November 3, 2027

Last Updated

November 26, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share