NCT06757205

Brief Summary

Considering the growing importance of services psychiatric and psychological for adolescence and adulthood incidence of discomfort expressed in this age group, comes assessed the need to provide adequate and targeted services. Reasons: The study aims to evaluate the characteristics and trends of adolescents who access the service, in order to frame the type of discomfort expressed and the expectations with respect to access to the service and the resource base on which it can the therapeutic intervention must be thought out and organised. Furthermore, the study aims to identify the factors that influence the request for help and evaluate the quality of the assistance received, with the aim of improving it effectiveness.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
115

participants targeted

Target at P50-P75 for all trials

Timeline
8mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

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 Progress48%
Sep 2025Jan 2027

First Submitted

Initial submission to the registry

December 23, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 3, 2025

Completed
9 months until next milestone

Study Start

First participant enrolled

September 15, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2027

Expected
Last Updated

August 12, 2025

Status Verified

December 1, 2024

Enrollment Period

4 months

First QC Date

December 23, 2024

Last Update Submit

August 11, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Analyze the characteristics of adolescents who access the clinic, both with respect to the discomfort presented and the resources available to them

    Data analysis through qualitative methods to identify recurring trends and patterns.

    one year

Secondary Outcomes (1)

  • Relate these characteristics to the ways of relating within the family, through meetings that also involve their parents

    one year

Other Outcomes (1)

  • Collect useful information to improve the effectiveness and variety of therapeutic paths to be offered to adolescents who consult the clinic and their parents.

    one year

Interventions

Using a structured questionnaire to collect quantitative and qualitative data on adolescents' experiences and perceptions. * The Italian version of the Mentalization Questionnaire (MZQ) was developed as a self-rated instrument to assess mentalization. It consists of 15 items with responses ranging from 1 = 'no agreement at all' to 5 = 'total agreement' on a 5-point Likert scale. Calculated sum scores for the total scale range from 15 to 75 with higher scores indicating lower mentalization capacities. * The Toronto Alexithymia Scale (TAS) is a measure of deficiency in understanding, processing, or describing emotions (alexithymia). It has twenty statements rated on a five-point Likert scale. The total score ranges from 40 to 200 and the higher score indicates a greater level of alexithymia.

Eligibility Criteria

Age13 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

The study involves the enrollment of 115 adolescents aged between 13-21 years treated at the psychiatric clinic.

You may qualify if:

  • \- Participants will be selected based on their age between 13 and 21, their availability to sign the informed consent.

You may not qualify if:

  • Patients who do not give their consent are excluded from the study.
  • Patients who do not speak fluent Italian or those who due to cognitive and/or thinking characteristics would not be able to understand or complete the questionnaire are also excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Universitario A.Gemelli IRCCS

Rome, ROMA, 00168, Italy

Location

Study Officials

  • Marianna Mazza

    Fondazione Policlinico Universitario A. Gemelli, IRCCS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2024

First Posted

January 3, 2025

Study Start

September 15, 2025

Primary Completion

January 15, 2026

Study Completion (Estimated)

January 15, 2027

Last Updated

August 12, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations