PersonalityAPGPNCT06757205
Analysis of the Personality Characteristics and Lifestyle of Young People Who Access Psychiatric Outpatient Clinics
An observational study of Personality and Life Style, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 21 years
- Conditions the study is for
- Personality, Life Style
- What is being tested?
- Using a structured questionnaire to collect quantitative and qualitative data on adolescents' experiences and perceptions. The Italian version of the Mentalization Questionnaire (MZQ) was develop
- How many people
- 115 participants
- Where
- 1 siteItaly
- Study dates
- 15 Sep 2025to 15 Jan 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 13 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study involves the enrollment of 115 adolescents aged between 13-21 years treated at the psychiatric clinic.
Who may be able to join
- Participants will be selected based on their age between 13 and 21, their availability to sign the informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Fondazione Policlinico Universitario A.Gemelli IRCCS
Rome, ROMA, 00168
Marianna Mazza, +390630156196, mariannamazza@hotmail.com
Marianna Mazza
About this study
Official title: Analysis of the Personality Characteristics and Lifestyle of Young People Who Access Psychiatric Outpatient Clinics: a Qualitative Study
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.
- Conditions
- Personality, Life Style
- Being tested
- Using a structured questionnaire to collect quantitative and qualitative data on adolescents' experiences and perceptions. The Italian version of the Mentalization Questionnaire (MZQ) was develop
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Using a structured questionnaire to collect quantitative and qualitative data on adolescents' experiences and perceptions. The Italian version of the Mentalization Questionnaire (MZQ) was developDiagnostic test
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
Secondary outcomes (1)
Relate these characteristics to the ways of relating within the family, through meetings that also involve their parents
Administration of psychometric scales:
- 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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start15 Sep 2025 (estimated)
- Primary completion15 Jan 2026 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PersonalityStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marianna Mazza, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06757205
- Sponsor's protocol ID
- 7088
- Acronym
- APGP
- Status last verified
- Dec 2024
- First submitted
- 23 Dec 2024
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Personality Characteristics and Lifestyle of Young People Who Access Psychiatric Outpatient Clinics: a Qualitative Study
- ClinicalTrials.gov ID
- NCT06757205
- Acronym / sponsor ID
- APGP / 7088
- Conditions
- Personality, Life Style
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 15 Jan 2026 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 3 Jan 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 13 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study involves the enrollment of 115 adolescents aged between 13-21 years treated at the psychiatric clinic.
Key inclusion criteria (1 listed)
- Participants will be selected based on their age between 13 and 21, their availability to sign the informed consent.
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| Using a structured questionnaire to collect quantitative and qualitative data on adolescents' experiences and perceptions. The Italian version of the Mentalization Questionnaire (MZQ) was developUsing 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. | Diagnostic test | – |
Primary outcome
Analyze the characteristics of adolescents who access the clinic, both with respect to the discomfort presented and the resources available to them
Time frame: one year
Data analysis through qualitative methods to identify recurring trends and patterns.
1 secondary outcome
Relate these characteristics to the ways of relating within the family, through meetings that also involve their parents
Time frame: one year
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 12 Aug 2025.
- 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.
Marianna Mazza principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Personality and Life Style, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 1 inclusion and 2 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 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Marianna Mazza (+390630154122, mariannamazza@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analyze the characteristics of adolescents who access the clinic, both with respect to the discomfort presented and the resources available to them (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Aug 2025.