Child AbuseSentinellaNCT07250074
"Sentinella": Registry and Training for Child Protection
An observational study of Child Abuse and Child Neglect, run by Buzzi Children's Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Child Abuse, Child Neglect, Child Maltreatment
- What is being tested?
- Integrated Digital Registry and Education Intervention
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 3 Dec 2025to 3 Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: "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.
Read the 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:
- 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.
- 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.
- Conditions
- Child Abuse, Child Neglect, Child Maltreatment
- Being tested
- Integrated Digital Registry and Education Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Digital Registry and Education InterventionOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the end of the registry implementation phase (approximately 6 months after activation).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start3 Dec 2025 (estimated)
- Primary completion3 May 2026 (estimated)
- Study completion3 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Child AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Buzzi Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valeria Calcaterra, Buzzi Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07250074
- Sponsor's protocol ID
- Buzzi021125
- Acronym
- Sentinella
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zuccotti G, Dilillo D, Agosto A, Brazzoduro V, Marinelli EBL, Calcaterra V. A Digital Registry and Education Network for Child Maltreatment Protection: Protocol for a Pilot Observational Exploratory Intervention Study. JMIR Res Protoc. 2026 Sep 2;15:e89128. doi: 10.2196/89128.
PubMed 42684799
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Sentinella" Project: a Digital Registry and Education Network for Child Maltreatment Protection.
- ClinicalTrials.gov ID
- NCT07250074
- Acronym / sponsor ID
- Sentinella / Buzzi021125
- Conditions
- Child Abuse, Child Neglect, Child Maltreatment
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Buzzi Children's HospitalUniversity, hospital or other
- Study start
- 3 Dec 2025 (estimated)
- Primary completion
- 3 May 2026 (estimated)
- Study completion
- 3 Nov 2027 (estimated)
- First posted
- 26 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- 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 design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated Digital Registry and Education InterventionThe 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. | Other | – |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Derived from this study: PubMed 42684799Zuccotti G, Dilillo D, Agosto A, Brazzoduro V, Marinelli EBL, Calcaterra V. A Digital Registry and Education Network for Child Maltreatment Protection: Protocol for a Pilot Observational Exploratory Intervention Study. JMIR Res Protoc. 2026 Sep 2;15:e89128. doi: 10.2196/89128.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Child Abuse and Child Neglect, run by Buzzi Children's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valeria Calcaterra, Prof (02636301, valeria.calcaterra@unipv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
System Usability of the Digital Registry (time frame: At the end of the registry implementation phase (approximately 6 months after activation).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07250074, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.