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Trials / Completed

CompletedNCT07375784

UP-GRADE: Assessment Pathways for Psychopathological Aspects and Psychological Support in the Adolescent Population

UP-GRADE: Assessment Pathways for Psychopathological Aspects and Psychological Support in the Adolescent Population (UG) A Prospective, Single-center, Longitudinal Study of Pediatric Patients Aged 14 to 17 Years With Psycho-relational Distress Treated at the Pediatric Department of the Policlinico San Matteo in Pavia.

Status
Completed
Phase
Study type
Observational
Enrollment
80 (actual)
Sponsor
Fondazione IRCCS Policlinico San Matteo di Pavia · Academic / Other
Sex
All
Age
14 Years – 17 Years
Healthy volunteers
Not accepted

Summary

The objective of the observational study "UP-GRADE: Assessment of Psychopathological Aspects and Psychological Support in the Adolescent Age Group of the Population. A Monocentric Longitudinal Interventional Study with Prospective Enrollment of Pediatric Patients Aged 14-17 with Psychosocial Distress in the Pediatric Department of the Policlinico San Matteo in Pavia" is to explore the psycho-emotional state of a sample of adolescents aged 14-17 in a population of patients under the care of the Pediatric Unit, at the Fondazione IRCCS Policlinico San Matteo. The study aims to estimate the proportion of subjects with altered anxiety levels (compared to the reference population). A secondary objective is to estimate the proportion of subjects with distress levels (compared to the reference population) in other psychosocial areas, based on the Q-PAD questionnaire score. Additionally, for patients with altered scores in at least one subscale of the Q-PAD, the study will assess the effect of a psychological support program consisting of 10 counseling sessions. The subjects involved in the study must meet the following inclusion criteria: being aged between 14 and 17 at the time of enrollment, having access to hospital services, having exhibited psychosocial distress, understanding the Italian language, and signing informed consent. Finally, it is specified that the study does not involve any interventions or potentially invasive instrumental investigations.

Detailed description

The protocol is structured in two phases: an initial screening meeting and the follow-up of each participant through 10 psychological support sessions.The follow-up will consist of 10 psychological support sessions, each lasting 1 hour, at a biweekly interval. It is specified that during the second meeting, the Q-PAD questionnaire-used for the evaluation of psychopathology in adolescence-will be administered. Finally, a retest with the same questionnaire will be conducted at the end of the last psychological support session.

Conditions

Interventions

TypeNameDescription
OTHERQ-PAD questionnaireThe Q-PAD is a questionnaire designed to assess psychopathology in adolescence, measure the level of adjustment, and evaluate overall well-being. The minor will be presented with statements and asked to indicate their response using a scale from 1 (the statement is false/does not describe my situation or opinion at all) to 4 (the statement is true/accurately describes my situation or opinion). This questionnaire has been validated on a sample of 1,454 individuals aged between 14 and 19 years and is used to investigate anxiety, depression, body dissatisfaction, substance abuse, interpersonal conflicts, family problems, uncertainty about the future, psychosocial risk, self-esteem, and well-being. The questionnaire is evaluated at 3 different time points during the study: at T0 and at T1 (+6 months).

Timeline

Start date
2023-09-12
Primary completion
2025-02-22
Completion
2025-08-22
First posted
2026-01-29
Last updated
2026-01-29

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT07375784. Inclusion in this directory is not an endorsement.