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临床试验/NCT07375784
NCT07375784已完成不适用

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.

Fondazione IRCCS Policlinico San Matteo di Pavia1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年9月12日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
Q-PAD questionnaire score at T0

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
14 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Age <14 years or ≥18 years at enrollment

结局指标

主要结局

Q-PAD questionnaire score at T0

时间窗: 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.

次要结局

  • 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).)

研究者

发起方
Fondazione IRCCS Policlinico San Matteo di Pavia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Amelia Licari

MD

Fondazione IRCCS Policlinico San Matteo di Pavia

研究点 (1)

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