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

NCT07375784 | Completed

• 1 other identifier: UP-GRADE
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psychological Distress

Outcome Measures

Primary Outcomes (1)

• Q-PAD questionnaire score at T0

  Estimate the proportion of subjects with altered anxiety levels (compared to the reference population) using the Q-PAD questionnaire. The assessment is at T0.

  Baseline-day 1. The term T0 refers to the baseline visit, the first visit planned in the schedule of activities.

Secondary Outcomes (1)

• Assessment of psychological distress in patients with altered values detected using the Q-PAD questionnaire

  Between T0 and T1. The term T0 refers to the baseline visit, that is, the first visit scheduled in the schedule of study activities and the term T1 refers to the last visit scheduled according to the protocol procedures (visit 10-after six months).

Interventions

Q-PAD questionnaire OTHER

The 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).

Eligibility Criteria

• Age: 14 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The sample will consist of 80 subjects under the care of the Pediatric Unit, Policlinico San Matteo, Pavia, considering the prospective recruitment of patients who meet the inclusion criteria.

You may qualify if:

• Age between 14 and 17 years
• Access to hospital services
• Manifestation of psychological distress
• Understanding the Italian language
• Signing of informed consent

You may not qualify if:

• Age \<14 years or ≥18 years at enrollment

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo, SC Pediatria

Pavia, Pavia, 27100, Italy

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 31, 2025
• First Posted: January 29, 2026
• Study Start: September 12, 2023
• Primary Completion: February 22, 2025
• Study Completion: August 22, 2025
• Last Updated: January 29, 2026

Record last verified: 2025-02

Locations

IT (1)