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NCT Number: NCT07375784

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

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.

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Key information

Conditions

Psychological Distress

Age range

14 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione IRCCS Policlinico San Matteo, SC Pediatria

Pavia, 27100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Registry information

Official study title

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.

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 29, 2026
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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