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NCT Number: NCT07259109

Psychopathology in Adolescence

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.

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Key information

Age range

12 year–20 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Centro Neurolesi Bonino Pulejo

Messina, Italy, 98100

About this study

This is a 5-year observational study evaluating the effectiveness and clinical characteristics of two psychotherapy approaches-Cognitive Behavioral Therapy (CBT) and Brief Strategic Therapy (BST)-in adolescents with psychiatric disorders. Patients aged 12 to 20 receiving care at the IRCCS Centro Neurolesi "Bonino-Pulejo" will be followed according to standard clinical practice, without random assignment. Psychopathological symptoms, self-esteem, and quality of life will be assessed at multiple time points (baseline, mid-treatment, end of treatment, and 3- and 9-month follow-ups) using standardized psychological tools. A propensity score matching method will be applied to reduce selection bias between treatment groups. The study also aims to identify predictors of treatment response and explore the influence of clinical and family-related factors on therapeutic outcomes. Data will be analyzed using both intra-group and inter-group statistical comparisons.

Who can participate

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

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Child Behavior Checklist (CBCL)

    Time frame: Baseline, Month 3, Month 6, Month 9, and Month 12

    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.

  2. SAFA General Screening Scales

    Time frame: Baseline, Month 3, Month 6, Month 9, and Month 12

    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.

  3. Personality Inventory for DSM (PID)

    Time frame: Baseline, Month 3, Month 6, Month 9, and Month 12

    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).

  4. Columbia-Suicide Severity Rating Scale (C-SSRS)

    Time frame: Baseline, Month 3, Month 6, Month 9, and Month 12

    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).

  5. Toronto Alexithymia Scale (TAS-20)

    Time frame: Baseline, Month 3, Month 6, Month 9, and Month 12

    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).

  6. Barratt Impulsiveness Scale (BIS-11)

    Time frame: Baseline, Month 3, Month 6, Month 9, and Month 12

    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).

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

    Time frame: Baseline, Month 3, Month 6, Month 9, and Month 12

    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).

Secondary outcomes

  1. Rosenberg Self-Esteem Scale (RSES)

    Time frame: Baseline, Month 3, Month 6, Month 9, and Month 12

    The Rosenberg Self-Esteem Scale (RSES) is a widely used 10-item self-report questionnaire designed to measure global self-esteem in adolescents and adults. Each item is rated on a 4-point Likert scale (1 = Strongly Disagree to 4 = Strongly Agree), with both positively and negatively worded items.

    Total scores range from 10 to 40, with higher scores indicating higher self-esteem (i.e., a better outcome). Scores below 15 may indicate problematic low self-esteem.

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

    Time frame: Baseline

    Cognitive functioning is assessed at baseline using one or both of the following standardized instruments:

    • The Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV), a widely used clinical tool for measuring verbal comprehension, perceptual reasoning, working memory, and processing speed. The Full Scale IQ (FSIQ) score ranges from 40 to 160, with higher scores indicating greater cognitive ability.
    • The Raven's Progressive Matrices is a non-verbal test of abstract reasoning and fluid intelligence. Standard scores range from 60 to 140, depending on the version and age norms. Higher scores indicate higher cognitive performance.

    Only participants with IQ ≥ 80 (as determined by one of the above instruments) are included in the study.

  3. Depression Anxiety Stress Scales - Short Version (DASS-21)

    Time frame: Baseline, Month 3, Month 6, Month 9, and Month 12

    The DASS-21 (Depression Anxiety Stress Scales - Short Version) is a self-report questionnaire designed to measure negative emotional states across three domains: depression, anxiety, and stress. It consists of 21 items, with 7 items per subscale. Each item is rated on a 4-point Likert scale from 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time).

    Subscale scores range from 0 to 21, and are commonly multiplied by 2 to obtain scores equivalent to the full DASS-42 (range: 0 to 42 per subscale).

    Higher scores indicate more severe symptoms (i.e., a worse outcome).)

  4. WHO Quality of Life Questionnaire - Brief (WHOQOL-BREF)

    Time frame: Baseline, Month 3, Month 6, Month 9, and Month 12

    The WHOQOL-BREF is a validated, 26-item self-report questionnaire developed by the World Health Organization to assess an individual's perceived quality of life. It includes four domains:

    • Physical Health
    • Psychological Health
    • Social Relationships
    • Environment

    Each item is rated on a 5-point Likert scale, and domain scores are transformed to a scale from 0 to 100, where higher scores indicate better quality of life (i.e., a better outcome). The WHOQOL-BREF has been used across cultures and is suitable for both clinical and general populations.

Other outcomes

  1. Session Rating Scale (SRS)

    Time frame: Each session over 10 sessions (approximately 10 weeks)

    The Session Rating Scale (SRS) is a 4-item self-report measure used to assess the therapeutic alliance at the end of each therapy session. Each item is rated on a visual analog scale from 0 to 10, yielding a total score ranging from 0 to 40.

    The four dimensions assessed are: relationship, goals and topics, approach or method, and overall alliance.

    Higher scores indicate a stronger therapeutic alliance (i.e., a better outcome). Scores below 36 may indicate a need to address ruptures in the alliance.

  2. Outcome Rating Scale (ORS)

    Time frame: Each session over 10 sessions (approximately 10 weeks)

    The Outcome Rating Scale (ORS) is a 4-item self-report tool designed to measure a client's perception of change and progress in therapy. It evaluates functioning in four areas: individual (personal well-being), interpersonal (close relationships), social (work/school), and general well-being.

    Each item is scored from 0 to 10, resulting in a total score ranging from 0 to 40.

    Higher scores reflect greater perceived well-being and positive clinical change (i.e., a better outcome).

Sponsors and collaborators

Lead sponsor

IRCCS Centro Neurolesi Bonino Pulejo

Other

Registry information

Official study title

Psychotherapy and Psychopathology in Adolescence: an Observational Study

Important dates

Study start
2025
Primary completion
2030
Study completion
2031
First posted
Dec 2, 2025
Registry last updated
Dec 2, 2025

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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