Psychopathology in Adolescence

NCT07259109 | Enrolling By Invitation

• 1 other identifier: PSY25
• Study Type: observational
• Target: 192
• Locations: 1 country
• Sites: 1

Brief Summary

This observational study aims to evaluate the effectiveness of two different psychotherapy approaches-Cognitive Behavioral Therapy (CBT) and Brief Strategic Therapy (BST)-in treating adolescents with psychological disorders. The study will follow adolescents aged 12 to 20 who are receiving psychotherapy as part of their routine clinical care at the IRCCS Centro Neurolesi "Bonino-Pulejo" in Messina, Italy. Participants will not be randomly assigned to a treatment; instead, their natural clinical path will be observed. Data will be collected through standardized psychological assessments at the beginning, during, and after the therapy, as well as at follow-ups at 3 and 9 months. The goal is to understand which therapeutic model is more effective in improving symptoms, quality of life, and self-esteem in adolescents, and how individual and family factors influence treatment outcomes.

Conditions

Anxiety Disorders; Depressive Disorder; Obsessive-Compulsive Disorder; Mental Health; Adolescent - Emotional Problem; Psychoterapy

Outcome Measures

Primary Outcomes (7)

• Child Behavior Checklist (CBCL)

  The Child Behavior Checklist (CBCL) is a standardized parent-report questionnaire used to assess a wide range of emotional and behavioral problems in children. Higher scores indicate greater levels of emotional and behavioral difficulties.

  Baseline, Month 3, Month 6, Month 9, and Month 12

• SAFA General Screening Scales

  The SAFA (Self Administrated Psychiatric Scales for Youths and Adolescents) is a comprehensive set of standardized self-report questionnaires used to assess emotional and psychiatric symptoms in children and adolescents aged 8 to 18 years. The full battery includes six scales: * SAFA-A (Anxiety) * SAFA-D (Depression) * SAFA-O (Obsessive-Compulsive Symptoms) * SAFA-S (Somatic Complaints) * SAFA-P (Psychogenic Psychotic Symptoms) * SAFA-F (Eating Disorders) Each scale produces a raw score, which is then converted into a standardized score. Total scores for each domain range approximately from 0 to 100, although precise ranges vary slightly by scale and age group. Higher scores reflect more severe emotional or psychological difficulties, i.e., a worse outcome.

  Baseline, Month 3, Month 6, Month 9, and Month 12

• Personality Inventory for DSM (PID)

  The Personality Inventory for DSM-5 (PID-5) is a standardized self-report instrument developed to assess maladaptive personality traits aligned with the DSM-5 alternative model for personality disorders. It includes 220 items, rated on a 4-point Likert scale (0 = Very False or Often False; 3 = Very True or Often True), and provides scores on five broad domains: * Negative Affectivity * Detachment * Antagonism * Disinhibition * Psychoticism Scores range from 0 to 660 (sum of all item scores), although domain and facet scores are typically reported separately. Higher scores reflect more severe or dysfunctional personality traits (i.e., a worse outcome).

  Baseline, Month 3, Month 6, Month 9, and Month 12

• Columbia-Suicide Severity Rating Scale (C-SSRS)

  The Columbia-Suicide Severity Rating Scale (C-SSRS) is a structured clinical interview used to assess suicidal ideation and behavior. It includes subscales for suicidal thoughts, intent, plans, preparatory behavior, and actual suicide attempts. Each item is scored individually; for example: * Suicidal ideation severity scale: 0 (no ideation) to 5 (active ideation with specific plan and intent), * Behavior subscale: binary indicators (yes/no) of actual, aborted, or interrupted attempts. Higher scores indicate greater severity of suicide risk and behavior (i.e., a worse outcome).

  Baseline, Month 3, Month 6, Month 9, and Month 12

• Toronto Alexithymia Scale (TAS-20)

  The Toronto Alexithymia Scale (TAS-20) is a standardized self-report instrument designed to assess difficulties in identifying and describing emotions, and externally oriented thinking. It consists of 20 items, each rated on a 5-point Likert scale (1 = Strongly disagree to 5 = Strongly agree). Total scores range from 20 to 100, with higher scores indicating greater levels of alexithymia (i.e., worse emotional awareness).

  Baseline, Month 3, Month 6, Month 9, and Month 12

• Barratt Impulsiveness Scale (BIS-11)

  The Barratt Impulsiveness Scale - Version 11 (BIS-11) is a widely used self-report questionnaire designed to assess impulsivity as a personality trait. It consists of 30 items, rated on a 4-point Likert scale from 1 (Rarely/Never) to 4 (Almost Always/Always). Total scores range from 30 to 120, with higher scores indicating greater impulsivity (i.e., a worse outcome).

  Baseline, Month 3, Month 6, Month 9, and Month 12

• Difficulties in Emotion Regulation Scale - Short Form (DERS-SF)

  The DERS-SF (Difficulties in Emotion Regulation Scale - Short Form) is an 18-item self-report instrument that assesses difficulties in emotion regulation. Each item is scored on a 5-point Likert scale from 1 (Almost Never) to 5 (Almost Always). Total scores range from 18 to 90. Higher scores indicate greater difficulties in emotion regulation (i.e., a worse outcome).

  Baseline, Month 3, Month 6, Month 9, and Month 12

Secondary Outcomes (4)

• Rosenberg Self-Esteem Scale (RSES)

  Baseline, Month 3, Month 6, Month 9, and Month 12

• Wechsler Intelligence Scale for Children (WISC-IV) / Raven's Progressive Matrices

  Baseline

• Depression Anxiety Stress Scales - Short Version (DASS-21)

  Baseline, Month 3, Month 6, Month 9, and Month 12

• WHO Quality of Life Questionnaire - Brief (WHOQOL-BREF)

  Baseline, Month 3, Month 6, Month 9, and Month 12

Other Outcomes (2)

• Session Rating Scale (SRS)

  Each session over 10 sessions (approximately 10 weeks)

• Outcome Rating Scale (ORS)

  Each session over 10 sessions (approximately 10 weeks)

Study Arms (2)

CBT Group

Participants receiving Cognitive Behavioral Therapy (CBT) as part of routine clinical care for adolescent psychopathology.

BST Group

Participants receiving Brief Strategic Therapy (BST) as part of routine clinical care for adolescent psychopathology.

Eligibility Criteria

• Age: 12 Years - 20 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adolescents aged 12 to 20 years with clinically diagnosed psychiatric disorders, referred to the Child and Adolescent Psychiatry Unit at IRCCS Centro Neurolesi "Bonino-Pulejo" in Messina, Italy. All participants will be receiving psychotherapy (CBT or BST) as part of standard clinical care.

You may qualify if:

• Adolescents aged 12 to 20 years
• Clinical diagnosis of a psychiatric disorder according to DSM-5 criteria
• Intelligence Quotient (IQ) ≥ 80
• Written informed consent signed by participant and/or legal guardian

You may not qualify if:

• Comorbid diagnosis of major neuropsychiatric disorders (e.g., autism spectrum disorder, schizophrenia)
• Intelligence Quotient (IQ) ≤ 79
• Lack of signed informed consent

Sponsors & Collaborators

• IRCCS Centro Neurolesi Bonino Pulejo: lead

Study Sites (1)

IRCCS Centro Neurolesi Bonino Pulejo

Messina, Italy, 98100, Italy

Location

MeSH Terms

Conditions

Anxiety Disorders; Depressive Disorder; Obsessive-Compulsive Disorder; Psychological Well-Being

Condition Hierarchy (Ancestors)

Mental Disorders; Mood Disorders; Personal Satisfaction; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2025
• First Posted: December 2, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): March 1, 2031
• Last Updated: December 2, 2025

Record last verified: 2025-07

Locations

IT (1)