Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT06757205
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-12
First Post:
2024-12-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Analysis of the Personality Characteristics and Lifestyle of Young People Who Access Psychiatric Outpatient Clinics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 115}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2027-01-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-11', 'studyFirstSubmitDate': '2024-12-23', 'studyFirstSubmitQcDate': '2025-01-02', 'lastUpdatePostDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Collect useful information to improve the effectiveness and variety of therapeutic paths to be offered to adolescents who consult the clinic and their parents.', 'timeFrame': 'one year', 'description': "Administration of psychometric scales:\n\n* 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.\n* 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."}], 'primaryOutcomes': [{'measure': 'Analyze the characteristics of adolescents who access the clinic, both with respect to the discomfort presented and the resources available to them', 'timeFrame': 'one year', 'description': 'Data analysis through qualitative methods to identify recurring trends and patterns.'}], 'secondaryOutcomes': [{'measure': 'Relate these characteristics to the ways of relating within the family, through meetings that also involve their parents', 'timeFrame': 'one year', 'description': "Administration of psychometric scales:\n\n* 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.\n* 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."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Personality', 'Life Style']}, 'descriptionModule': {'briefSummary': '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.\n\nReasons:\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '13 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study involves the enrollment of 115 adolescents aged between 13-21 years treated at the psychiatric clinic.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n\\- Participants will be selected based on their age between 13 and 21, their availability to sign the informed consent.\n\nExclusion criteria:\n\n* Patients who do not give their consent are excluded from the study.\n* 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.'}, 'identificationModule': {'nctId': 'NCT06757205', 'acronym': 'APGP', 'briefTitle': 'Analysis of the Personality Characteristics and Lifestyle of Young People Who Access Psychiatric Outpatient Clinics', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Analysis of the Personality Characteristics and Lifestyle of Young People Who Access Psychiatric Outpatient Clinics: a Qualitative Study', 'orgStudyIdInfo': {'id': '7088'}}, 'armsInterventionsModule': {'interventions': [{'name': "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", 'type': 'DIAGNOSTIC_TEST', 'description': "Using a structured questionnaire to collect quantitative and qualitative data on adolescents' experiences and perceptions.\n\n* 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.\n* 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."}]}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Rome', 'state': 'ROMA', 'country': 'Italy', 'contacts': [{'name': 'Marianna Mazza', 'role': 'CONTACT', 'email': 'mariannamazza@hotmail.com', 'phone': '+390630156196'}, {'name': 'Marianna Mazza', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fondazione Policlinico Universitario A.Gemelli IRCCS', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'centralContacts': [{'name': 'Marianna Mazza', 'role': 'CONTACT', 'email': 'mariannamazza@hotmail.com', 'phone': '+390630154122'}], 'overallOfficials': [{'name': 'Marianna Mazza', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondazione Policlinico Universitario A. Gemelli, IRCCS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}