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A Scalable Trans Diagnostic Intervention Targeting Adolescent Agency Supported by Conversational AI (AGENCIA) (AGENCIA)

23 aprile 2026 aggiornato da: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

A Randomized Controlled Trial Protocol of a Scalable Trans Diagnostic Intervention Targeting Adolescent Agency Supported by Conversational AI

The aim of this clinical trial is to evaluate whether AGENCIA, a brief psychological program supported by digital technology and artificial intelligence, can help reduce emotional and behavioral difficulties in adolescents aged 12 to 18. These difficulties may include irritability, impulsive behaviors, conflicts at home or at school, or difficulties in managing intense emotions. The study also aims to determine whether the effects are similar across adolescents with different symptom profiles or neurodevelopmental characteristics.

Participants will be randomly assigned to one of three groups:

AGENCIA Digital: a self-guided online version completed at home. AGENCIA in-person with a digital assistant: a clinician-delivered version supported by an interactive digital assistant to guide the exercises.

Digital psychoeducation (control): a self-guided online program providing general information about adolescent well-being.

The main research questions are:

Does AGENCIA reduce overall emotional and behavioral difficulties? Does the program improve functioning, family accommodation, and personal agency (a young person's sense of being able to act and make changes)? Are the effects similar across adolescents with different profiles or neurodevelopmental characteristics?

Participants will:

  • Complete three structured sessions depending on their assigned group.
  • Complete brief online questionnaires at baseline (T0), immediately after the sessions (T1), and at 1-month (T2) and 6-month (T3) follow-ups.
  • Receive brief phone calls during follow-ups to support questionnaire completion.

A total of 465 adolescents will take part in the study. Participation is voluntary and does not replace usual clinical care. The study does not involve medication or invasive procedures, and all digital tools operate within secure institutional systems.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This study is situated at the intersection of mental health, technological innovation, and artificial intelligence, incorporating advanced digital tools and conversational systems as supportive elements for psychological assessment and intervention in clinical settings. Within this framework, the project explores how technology can facilitate the delivery of brief, scalable, and more personalized interventions in child and adolescent mental health.

This study is a three-arm randomized clinical trial designed to evaluate the effectiveness of AGENCIA, a brief, mechanism-focused psychological intervention for adolescents aged 12 to 18 receiving care in routine mental health services. Adolescents in this age range often experience emotional and behavioral difficulties that affect daily functioning at home, school, and in social contexts. These difficulties may include irritability, impulsivity, conflicts with caregivers, or challenges in managing strong emotions, and they may occur with or without a formal neurodevelopmental diagnosis.

AGENCIA is a structured psychological program delivered in three sessions. It aims to strengthen personal agency, improve emotional regulation and self-compassion, support action toward meaningful goals, and help families reduce accommodation behaviors that may limit adolescents' autonomy. The study evaluates two delivery formats: a self-guided digital version and a clinician-delivered in-person version supported by an interactive conversational assistant. A third group receives digital psychoeducation, which provides general information about adolescent well-being without active therapeutic components.

The trial will recruit 465 participants, who will be randomly assigned in a 1:1:1 ratio to one of the study groups. The design is trans diagnostic and dimensional, including adolescents with emotional or behavioral difficulties that interfere with daily functioning, regardless of diagnostic status. Recruitment takes place across child and adolescent mental health services and primary care settings in Spain.

Assessments are conducted at baseline (T0), immediately post-intervention (T1), at 1-month follow-up (T2), and at 6-month follow-up (T3). All assessments are digital and include measures of emotional and behavioral difficulties, functioning, quality of life, family accommodation, and personal agency.

The primary outcome is the change in the Strengths and Difficulties Questionnaire (SDQ-Total Difficulties Score) from baseline to the 1-month follow-up. Secondary outcomes include symptom subscales, emotional dysregulation, functioning, interference in daily life, quality of life, family accommodation, and personal agency. Exploratory analyses will examine whether early changes in personal agency or family accommodation predict later improvement, and whether treatment effects differ across clinical profiles or neurodevelopmental traits.

The study is considered low-risk. It does not involve medication, invasive procedures, or unsupervised generative AI tools. Digital components run on secure institutional servers. Safety monitoring includes routine screening for acute clinical risk at multiple time points, with established referral procedures within the mental health system.

Participation is voluntary, and adolescents continue to receive their usual clinical care during the study. Data are de-identified, securely stored, and may be shared upon reasonable request and ethical approval.

Tipo di studio

Interventistico

Iscrizione (Stimato)

465

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Spagna
      • Seville, Spagna, 41013
        • Hospital Universitario Virgen del Rocio
        • Contatto:
        • Investigatore principale:
          • Nathalia Garrido Torres

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • Adolescents aged 12 to 18 years at enrollment.
  • Presence of emotional or behavioral difficulties causing functional interference (e.g., irritability, impulsivity, emotional dysregulation, conflicts at home or school, avoidance).
  • Difficulties compatible with neurodevelopmental profiles, regardless of formal diagnosis.
  • Ability to use digital materials through a personal device and basic reading skills in Spanish.
  • Availability to attend assessments and participate in the intervention and follow-up schedule.
  • Informed consent from caregivers and assent from the adolescent.

Exclusion Criteria:

  • Acute clinical risk at pre-screening or screening (e.g., imminent self-harm risk, severe agitation, aggression, disorganized behavior, or unsafe behaviors requiring immediate clinical care).
  • Score of "Severe" on any of the three HoNOSCA screening items (self-harm, substance-related problems, or bullying/social problems).
  • Uncompensated sensory, motor, or language barriers preventing valid completion of assessments or participation (e.g., severe visual or hearing impairment, significant receptive/expressive language difficulties, motor limitations preventing device use).
  • Intellectual disability defined by screening tools: ABAS-II GAC ≤ 70 or Kaufman Brief Intelligence Test Composite Intelligence Quotient ≤ 70.
  • Any condition judged by the clinical team to require immediate alternative care or that would prevent safe participation.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: AGENCIA In-person with Digital Assistant
Participants receive AGENCIA in in-person sessions delivered by a clinician and assisted by a conversational digital tool. The digital assistant guides therapeutic exercises while the clinician supervises delivery. Content is identical to the digital version.
Comportamentale: AGENCIA In-person With Digital Assistant
AGENCIA In-person With Digital Assistant is a brief, structured psychological intervention aimed at strengthening personal agency and improving emotional and behavioral functioning in adolescents. It consists of three core sessions addressing emotion regulation, self-compassion, value-based actions, meaningful goal pursuit, and the reduction of family accommodation. In the in-person format, a mental health professional delivers the intervention in person, while a conversational digital assistant guides structured exercises and presents session content. The clinician supervises and ensures safe, consistent delivery. The therapeutic ingredients and objectives of AGENCIA remain identical to those used in the self-guided format.
Sperimentale: AGENCIA Digital Self-Guided
Participants complete the AGENCIA program in a fully self-guided digital format. The intervention includes three structured online sessions with audiovisual content and experiential exercises, completed independently on a secure platform.
Comportamentale: AGENCIA Digital Self-Guided
AGENCIA Digital Self-Guided is a brief, structured psychological intervention designed to strengthen personal agency in adolescents with emotional and behavioral difficulties. The program includes three sessions focused on improving emotion regulation and self-compassion, supporting value-based actions, promoting gradual engagement with meaningful activities, and reducing family accommodation. In the self-guided digital format, participants complete the three sessions independently on a secure online platform with audiovisual materials and experiential exercises.
Nessun intervento: Control Digital Psychoeducation
Participants complete three self-guided online sessions of digital psychoeducation covering adolescent well-being topics (sleep, routines, screen use, physical activity, family communication). No mechanism-based therapeutic strategies are included.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
SDQ Total Difficulties Score
Lasso di tempo: Baseline Day 0 (T0), Within 1 week post-intervention (T1), 1-month follow-up (T2), and 6-month follow-up (T3)

Change in emotional and behavioral difficulties measured with the Strengths and Difficulties Questionnaire (SDQ) Total Difficulties Score. The scale includes 20 items assessing emotional symptoms, conduct problems, hyperactivity/inattention, and peer problems. The total score ranges from 0 to 40, with higher scores indicating greater difficulties.

  • 0-13: Close to average
  • 14-16: Slightly raised
  • 17-19: High
  • 20-40: Very high The primary comparison is change from baseline day 0 to the 1-month follow-up.
Baseline Day 0 (T0), Within 1 week post-intervention (T1), 1-month follow-up (T2), and 6-month follow-up (T3)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
SDQ Subscale Scores (Emotional, Conduct, Hyperactivity/Inattention, Peer, Prosocial)
Lasso di tempo: Time Frame: Baseline Day 0 (T0), Within 1 week post-intervention (T1), 1-month follow-up (T2), and 6-month follow-up (T3)
Subscale scores of the Strengths and Difficulties Questionnaire (SDQ) capturing specific emotional and behavioral areas. The SDQ consists of 25 items divided into 5 subscales, each containing 5 items rated on a 3-point scale (0 = not true, 1 = somewhat true, 2 = certainly true). Each subscale score ranges from 0 to 10. For the Emotional Symptoms, Conduct Problems, Hyperactivity/Inattention, and Peer Problems subscales, higher scores indicate greater difficulties. For the Prosocial Behavior subscale, higher scores indicate better functioning.
Time Frame: Baseline Day 0 (T0), Within 1 week post-intervention (T1), 1-month follow-up (T2), and 6-month follow-up (T3)
SDQ-Impact Score (Functional Impairment)
Lasso di tempo: Time Frame: Baseline Day 0 (T0), Within 1 week post-intervention (T1), 1-month follow-up (T2), and 6-month follow-up (T3)
Index of functional impairment associated with emotional and behavioral symptoms, including impact on home life, friendships, school learning, and overall distress, measured with the Strengths and Difficulties Questionnaire Impact Supplement. The impact score ranges from 0 to 10, with higher scores indicating greater impairment.
Time Frame: Baseline Day 0 (T0), Within 1 week post-intervention (T1), 1-month follow-up (T2), and 6-month follow-up (T3)
Aberrant Behavior Checklist (ABC) Subscales
Lasso di tempo: Time Frame: Baseline Day 0 (T0), Within 1 week post-intervention (T1), 1-month follow-up (T2), and 6-month follow-up (T3)
Measures irritability, lethargy/withdrawal, stereotypy, hyperactivity/non-compliance, and inappropriate speech using the Aberrant Behavior Checklist. The ABC consists of 58 items across 5 subscales, each scored from 0 (not a problem) to 3 (severe problem). Subscale score ranges are: Irritability (0-45), Lethargy/Social Withdrawal (0-48), Stereotypic Behavior (0-21), Hyperactivity/Noncompliance (0-48), and Inappropriate Speech (0-12). Higher scores indicate more severe symptoms.
Time Frame: Baseline Day 0 (T0), Within 1 week post-intervention (T1), 1-month follow-up (T2), and 6-month follow-up (T3)
HoNOSCA-SR Total Score
Lasso di tempo: Time Frame: Baseline Day 0 (T0), Within 1 week post-intervention (T1), 1-month follow-up (T2), and 6-month follow-up (T3)
Self-reported global functioning across emotional, behavioral, social, and daily living domains measured with the Health of the Nation Outcome Scales for Children and Adolescents - Self-Rated (HoNOSCA-SR). The scale consists of 13 items, each rated from 0 to 4. The total score ranges from 0 to 52, with higher scores indicating greater impairment.
Time Frame: Baseline Day 0 (T0), Within 1 week post-intervention (T1), 1-month follow-up (T2), and 6-month follow-up (T3)
EQ-5 Dimension-5 Level Index Score (Quality of Life)
Lasso di tempo: Time Frame: Baseline Day 0 (T0), Within 1 week post-intervention (T1), 1-month follow-up (T2), and 6-
Health-related quality of life index measured with the EuroQol 5-Dimension 5-Level questionnaire, covering mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The index score is calculated using country-specific value sets and ranges from less than 0 (states worse than dead) to 1.0 (perfect health), with higher scores reflecting better health status.
Time Frame: Baseline Day 0 (T0), Within 1 week post-intervention (T1), 1-month follow-up (T2), and 6-
Family Accommodation (FASA / FASA-CR Total Score)
Lasso di tempo: Time Frame: Baseline Day 0 (T0), Within 1 week post-intervention (T1), 1-month follow-up (T2), and 6-month follow-up (T3)
Extent to which caregivers or adolescents engage in accommodation behaviors that may maintain emotional/behavioral difficulties, measured with the Family Accommodation Scale - Anxiety (FASA) for parents and FASA-Child Report (FASA-CR) for adolescents. The FASA total score ranges from 0 to 36, with higher scores indicating more accommodation.
Time Frame: Baseline Day 0 (T0), Within 1 week post-intervention (T1), 1-month follow-up (T2), and 6-month follow-up (T3)
Children's Hope Scale - Agency Subscale (CHS-Agency)
Lasso di tempo: Time Frame: Baseline Day 0 (T0), Within 1 week post-intervention (T1), 1-month follow-up (T2), and 6-month follow-up (T3)
Assesses adolescents' sense of personal agency (ability to initiate and sustain goal-directed actions) using the Children's Hope Scale - Agency Subscale. The agency subscale consists of 3 items, each rated from 1 to 6, yielding a subscale score range of 3 to 18, with higher scores indicating stronger perceived agency.
Time Frame: Baseline Day 0 (T0), Within 1 week post-intervention (T1), 1-month follow-up (T2), and 6-month follow-up (T3)
Usability, Acceptability, and Satisfaction Questionnaire
Lasso di tempo: Within 1 week post-intervention (T1)
Self-reported ratings of satisfaction with the intervention, ease of use, perceived helpfulness, and likelihood of recommending it, measured with an ad hoc Usability and Satisfaction Questionnaire developed for this study. The questionnaire includes 7 closed-ended items assessing perceived benefit, treatment planning, motivation to use strategies, likelihood of recommendation, and modality-specific usability (digital platform, in-person, or conversational AI agent). Each item is rated on a 4-point scale (0 = No, 1 = A little, 2 = Yes, 3 = Very much). Individual item scores range from 0 to 3, with higher scores indicating greater usability, acceptability, and satisfaction. The questionnaire also includes one open-ended item for qualitative feedback.
Within 1 week post-intervention (T1)
Relational Openness / Self-Disclosure
Lasso di tempo: Within 1 week post-intervention (T1)
Relational openness measured with an ad hoc 4-item self-disclosure scale developed for this study, assessing the tendency to talk about oneself, share feelings, express beliefs and opinions, and feel comfortable revealing one's true self during the intervention. Items are adapted to the intervention format (AI conversational agent, therapist-led, or web/app-based). Each item is rated on a 5-point Likert scale (1 = Strongly disagree to 5 = Strongly agree), with total scores ranging from 4 to 20. Higher scores indicate greater relational openness.
Within 1 week post-intervention (T1)
Perceived Alliance (Session Rating Scale, SRS)
Lasso di tempo: Within 1 week post-intervention (T1)
Working alliance measured with the Session Rating Scale (SRS), a 4-item visual analog scale assessing relationship bond (feeling heard, understood, and respected), agreement on goals and topics, agreement on approach or method, and overall session quality. Each item is rated on a 0-10 visual analog scale, with total scores ranging from 0 to 40. Higher scores indicate stronger perceived therapeutic alliance.
Within 1 week post-intervention (T1)

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
K-Brief Intelligence Test (Intellectual Functioning)
Lasso di tempo: Baseline Day 0 (T0)
Intellectual functioning assessed with the Kaufman Brief Intelligence Test, Second Edition, measuring verbal and non-verbal cognitive abilities. The Kaufman Brief Intelligence Test, Second Edition yields an Intelligence Quotient Composite standard score with a normative mean of 100 and standard deviation of 15. Standard scores typically range from 40 to 160, with higher scores indicating better intellectual functioning.
Baseline Day 0 (T0)
ABAS-II (Adaptive Functioning)
Lasso di tempo: Baseline Day 0 (T0)
Adaptive functioning assessed with the Adaptive Behavior Assessment System, Second Edition (ABAS-II), providing a General Adaptive Composite (GAC) and conceptual, social, and practical domain scores. The GAC is a standard score with a normative mean of 100 and standard deviation of 15. Standard scores typically range from 40 to 160, with lower scores indicating poorer adaptive functioning.
Baseline Day 0 (T0)
SRS-2 (Autistic Traits)
Lasso di tempo: Baseline Day 0 (T0)
Dimensional assessment of autistic traits measured with the Social Responsiveness Scale, Second Edition (SRS-2), used for baseline characterization and heterogeneity analyses. The SRS-2 yields T-scores with a normative mean of 50 and standard deviation of 10. T-scores range from 37 to 90+, with higher scores indicating greater severity of autistic traits. T-scores ≥76 are considered severe, 66-75 moderate, and 60-65 mild.
Baseline Day 0 (T0)
CBCL (Child Behavior Checklist)
Lasso di tempo: Baseline Day 0 (T0)
Emotional and behavioral problems assessed with the Child Behavior Checklist (CBCL), providing broadband Internalizing and Externalizing problem scores and syndrome scales. The CBCL yields T-scores with a normative mean of 50 and standard deviation of 10. T-scores range from approximately 30 to 100, with higher scores indicating greater symptom severity. T-scores ≥64 are considered clinically significant.
Baseline Day 0 (T0)
ASQ-14 (Psychosocial Stressors)
Lasso di tempo: Baseline Day 0 (T0)
Accumulated psychosocial stress measured with the Adolescent Stress Questionnaire-14 (ASQ-14), a 14-item scale assessing exposure to common adolescent stress domains. Each item is rated on a 5-point scale (1 = not at all stressful to 5 = very stressful), with total scores ranging from 14 to 70. Higher scores indicate greater stress burden.
Baseline Day 0 (T0)
Sociodemographic and Clinical Data
Lasso di tempo: Baseline Day 0 (T0)
Sociodemographic and clinical information collected for sample characterization and covariate adjustment, including: age, sex assigned at birth, gender identity, racial/ethnic self-identification (White, Black, Roma, Latin American, Arab/Moroccan, Mixed, Asian, other), recruitment source, living situation, educational level and school modality (mainstream, mainstream with support, specific classroom, or special education center), personal neuropsychiatric history (current and past diagnoses), family neuropsychiatric history (first-degree: parents, siblings; second-degree: grandparents, aunts/uncles), current and past psychopharmacological treatments (name, dose, regimen, start/end dates), and history of significant adverse drug reactions (paradoxical reactions to benzodiazepines/sedatives/anesthetics, atypical reactions to other medications). These are descriptive categorical and continuous variables; no composite score is calculated.
Baseline Day 0 (T0)
THRIVE Screener (Social Determinants of Health)
Lasso di tempo: Baseline Day 0 (T0)
Social determinants of health assessed with the THRIVE Screener (Boston Medical Center), a caregiver-reported questionnaire designed to identify social risk factors in clinical settings. The screener includes 9 items covering: housing stability (0 = stable, 1 = at risk, 2 = unstable), food security (2 items; 0 = never, 1 = sometimes, 2 = frequently), medication affordability (Yes/No), transportation access to medical appointments (Yes/No), utility payment difficulties (Yes/No), caregiving burden (Yes/No), employment status (Yes/No), and interest in further education (Yes/No). Items use mixed response formats; higher scores on housing and food security items indicate greater social risk. This measure is used for sample characterization and covariate adjustment; no composite score is calculated.
Baseline Day 0 (T0)
Anthropometric Measures
Lasso di tempo: Baseline Day 0 (T0)
Height (cm) and weight (kg) collected as general health indicators for sample characterization. These are continuous measurements reported in their respective units.
Baseline Day 0 (T0)
Physiological Biomarkers
Lasso di tempo: During intervention sessions (Days 1-21, approximately)
Electrodermal activity (skin conductance, µS) and heart rate (beats per minute) continuously recorded using an Empathic wristband device during intervention sessions as potential mechanistic correlates of emotional reactivity and autonomic stress response. These are continuous physiological measurements; mean, variability, and reactivity indices may be derived for analysis.
During intervention sessions (Days 1-21, approximately)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Collaboratori

Instituto de Salud Carlos III
Hospital Universitario Virgen del Rocio

Investigatori

  • Investigatore principale: Nathalia Garrido Torres, Andalusian Health Service

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 aprile 2026

Completamento primario (Stimato)

31 marzo 2028

Completamento dello studio (Stimato)

31 dicembre 2028

Date di iscrizione allo studio

Primo inviato

17 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

23 aprile 2026

Primo Inserito (Effettivo)

30 aprile 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

30 aprile 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

23 aprile 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • AGENCIA TEENS

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

De-identified individual participant data (IPD) will be available for sharing. Shared data may include scores from primary and secondary outcomes (SDQ, ABC, HoNOSCA-SR, EQ-5D-5L, FASA, CHS), excluding all direct identifiers. Only fully anonymized datasets will be provided. No information that could allow re-identification will be shared.

Periodo di condivisione IPD

IPD and supporting documents will be available after publication of the main study results. Data may be requested for up to 5 years after publication. Availability beyond this period will depend on institutional policies and ethical approvals.

Criteri di accesso alla condivisione IPD

Access will be granted to qualified researchers for scientific and non-commercial purposes. Requests must include a methodologically sound proposal and will require approval from the Research Ethics Committee. A Data Transfer Agreement (DTA) will be required. Only fully de-identified datasets will be shared, delivered through secure institutional channels.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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