Psychotherapy and Psychopathology in Adolescence: an Observational Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- Child Behavior Checklist (CBCL)
研究概览
简要总结
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.
详细描述
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.
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
- 12 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Comorbid diagnosis of major neuropsychiatric disorders (e.g., autism spectrum disorder, schizophrenia)
- •Intelligence Quotient (IQ) ≤ 79
- •Lack of signed informed consent
结局指标
主要结局
Child Behavior Checklist (CBCL)
时间窗: 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.
Personality Inventory for DSM (PID)
时间窗: 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).
SAFA General Screening Scales
时间窗: 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.
Columbia-Suicide Severity Rating Scale (C-SSRS)
时间窗: 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).
Toronto Alexithymia Scale (TAS-20)
时间窗: 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).
Barratt Impulsiveness Scale (BIS-11)
时间窗: 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).
Difficulties in Emotion Regulation Scale - Short Form (DERS-SF)
时间窗: 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).
次要结局
- 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)