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

January 21, 2026 updated by: Amelia Licari, Fondazione IRCCS Policlinico San Matteo di Pavia

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Pavia
      • Pavia, Pavia, Italy, 27100
        • Fondazione IRCCS Policlinico San Matteo, SC Pediatria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Age <14 years or ≥18 years at enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Q-PAD questionnaire score at T0
Time Frame: Baseline-day 1. The term T0 refers to the baseline visit, the first visit planned in the schedule of activities.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of psychological distress in patients with altered values detected using the Q-PAD questionnaire
Time Frame: 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).
Estimate the proportion of subjects with distress levels (compared to the reference population) in other psychosocial areas and assess, in the group of patients with altered values in at least one subscale of the Q-PAD, the effect of a 10-session psychological support program.
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 12, 2023

Primary Completion (Actual)

February 22, 2025

Study Completion (Actual)

August 22, 2025

Study Registration Dates

First Submitted

December 31, 2025

First Submitted That Met QC Criteria

January 21, 2026

First Posted (Actual)

January 29, 2026

Study Record Updates

Last Update Posted (Actual)

January 29, 2026

Last Update Submitted That Met QC Criteria

January 21, 2026

Last Verified

February 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • UP-GRADE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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