Psychological DistressNCT07375784
UP-GRADE: Assessment Pathways for Psychopathological Aspects and Psychological Support in the Adolescent Population
An observational study of Psychological Distress, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 17 years
- Conditions the study is for
- Psychological Distress
- What is being tested?
- Q-PAD questionnaire
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 12 Sep 2023to 22 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 17 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- Age between 14 and 17 years
- Access to hospital services
- Manifestation of psychological distress
- Understanding the Italian language
- Signing of informed consent
Who cannot join
- Age <14 years or ≥18 years at enrollment
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione IRCCS Policlinico San Matteo, SC Pediatria
Pavia, Pavia, 27100
About this study
Official 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.
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.
Read the 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
- Psychological Distress
- Being tested
- Q-PAD questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Q-PAD questionnaireOther
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start12 Sep 2023
- Primary completion22 Feb 2025
- Study completion22 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological DistressStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amelia Licari, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07375784
- Sponsor's protocol ID
- UP-GRADE
- Status last verified
- Feb 2025
- First submitted
- 31 Dec 2025
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT07375784
- Acronym / sponsor ID
- UP-GRADE
- Conditions
- Psychological Distress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 12 Sep 2023 (actual)
- Primary completion
- 22 Feb 2025 (actual)
- Study completion
- 22 Aug 2025 (actual)
- First posted
- 29 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (5 listed)
- Age between 14 and 17 years
- Access to hospital services
- Manifestation of psychological distress
- Understanding the Italian language
- Signing of informed consent
Key exclusion criteria (1 listed)
- Age <14 years or ≥18 years at enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Q-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). | Other | – |
Primary outcome
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.
1 secondary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychological Distress, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.