跳至主要内容
临床试验/NCT07422324
NCT07422324招募中不适用

Multidimensional Assessment of Mental Health in Adolescence: Cross-sectional Study Using Self-report and Parent-report Questionnaires.

IRCCS Centro Neurolesi Bonino Pulejo1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2025年10月27日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
180
试验地点
1
主要终点
Adolescent Self-Assessment Using the Conners Adolescent Self-Report (CAS)

研究概览

简要总结

Evidence indicates that many mental disorders in adulthood originate during adolescence, with a typical onset between the ages of 14 and 18, especially for anxiety, mood, and behavioral disorders. Over the past 20 years, the prevalence of psychiatric disorders among children and adolescents has increased globally, influenced by factors such as environmental stress, digital technologies, socioeconomic inequalities, and the consequences of the COVID-19 pandemic. Approximately one in seven adolescents worldwide suffers from a diagnosable mental disorder, with a growing trend, especially in high-income countries.

A multidimensional and multi-informant assessment, integrating the perspectives of adolescents and parents, is essential for the early detection of signs of psychological distress and the definition of targeted interventions.

Main objective:

To assess the mental health of adolescents (aged 11-18) using multidimensional psychometric tools to identify early signs of distress and vulnerability.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
11 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • adolescents aged between 11 and 18;
  • consent from legal guardians/parents;
  • good reading and comprehension skills, absence of sensory impairments that prevent them from completing the questionnaires independently.

排除标准

  • age not between 11-18 years;
  • failure to obtain consent from legal guardians/parents;
  • overt difficulties in reading and understanding the text, presence of sensory deficits that prevent independent completion of the questionnaires.

结局指标

主要结局

Adolescent Self-Assessment Using the Conners Adolescent Self-Report (CAS)

时间窗: baseline (T0)

Behavioral and attentional symptoms will be assessed using the Conners Adolescent Self-Report (CAS), a standardized questionnaire completed from the adolescent's perspective. The CAS evaluates symptoms related to attention disorders, mood disorders, and related behavioral issues. Scores are reported as T-scores, with a typical range of 0 to 100, where higher scores indicate more severe symptoms, reflecting a worse outcome.

Columbia- Suicide Severity Rating Scale (C-SSRS)

时间窗: baseline (T0)

Questionnaire assessing the presence, frequency, and intensity of suicidal ideation and behavior in adolescents. The total score ranges from 0 to 25, with higher scores indicating worse suicidal ideation/behavior severity.

Youth Self-Report (YSR) - Behavioral and Emotional Problems

时间窗: baseline (T0)

Behavioral and emotional problems in adolescents will be assessed using the Youth Self-Report (YSR), a standardized self-report questionnaire for youth aged 11 to 18 years. The YSR measures a range of internalizing and externalizing problems. Scores are reported as T-scores, with a typical range of 0 to 100, where higher scores indicate more severe behavioral or emotional problems, reflecting a worse outcome.

EGO Resiliency Scale (ERS)

时间窗: baseline(T0)

Assessment of the child's capacity to adapt flexibly to environmental demands and stressors. The scale consists of 14 items, each rated on a 4-point Likert scale (1-4), producing a total score range of 14 to 56. Higher scores indicate greater ego resiliency (better adaptive functioning).

Emotional Intelligence Assessed by the Emotional Quotient Inventory: Youth Version (EQ-i: YV)

时间窗: baseline (T0)

Emotional intelligence in adolescents will be assessed using the Emotional Quotient Inventory: Youth Version (EQ-i: YV), a standardized self-report questionnaire designed for youth. The EQ-i: YV evaluates emotional and social functioning, including awareness, regulation, and interpersonal skills. Scores are reported as standard scores, typically ranging from 40 to 160, where higher scores indicate better emotional intelligence, reflecting a better outcome.

Personality Traits Assessed by the PID (Personality Inventory for DSM-5 - Adolescent Version)

时间窗: baseline (T0)

Personality traits in adolescents will be assessed using the PID (Personality Inventory for DSM-5 - Adolescent Version), a standardized self-report questionnaire for youth aged 11 to 17 years. The PID evaluates a broad range of personality traits and psychopathological features relevant to DSM-5 criteria. Scores are reported as T-scores, typically ranging from 0 to 100, where higher scores indicate more pronounced personality traits or pathology, reflecting a worse outcome.

Behavioral and Emotional Problems Assessed by the Child Behavior Checklist (CBCL) - Parent Version

时间窗: baseline (T0)

Behavioral and emotional problems in children and adolescents will be assessed using the Child Behavior Checklist (CBCL) - Parent Version, a standardized questionnaire completed by the caregiver (typically the mother). The CBCL evaluates a range of internalizing and externalizing problems. Scores are reported as T-scores, typically ranging from 0 to 100, where higher scores indicate more severe behavioral or emotional problems, reflecting a worse outcome.

Parent-Rated ADHD and Behavioral Symptoms Assessed by the Conners' Parent Rating Scale (CPRS)

时间窗: baseline (T0)

ADHD symptoms and other behavioral problems in children and adolescents will be assessed using the Conners' Parent Rating Scale (CPRS), a standardized questionnaire completed by the parent or caregiver. The CPRS provides T-scores across multiple clinical scales, including inattention, hyperactivity/impulsivity, executive functioning, learning problems, aggression, and peer relations. Scores typically range from 0 to 100, where higher scores indicate more severe symptoms, reflecting a worse outcome.

Social Responsiveness Assessed by the Social Responsiveness Scale (SRS)

时间窗: baseline (T0)

Measures the presence and severity of autistic spectrum traits and social communication difficulties. The questionnaire consists of 65 items, each rated on a 4-point Likert scale (0-3), yielding a total raw score range from 0 to 195. Higher scores indicate greater severity of autism-related social impairment (worse outcome).

Aberrant Behavior Assessment Using the Aberrant Behavior Checklist (ABC) - Parent Version

时间窗: baseline (T0)

Dysfunctional behaviors in children and adolescents with atypical development will be assessed using the Aberrant Behavior Checklist (ABC) - Parent Version, a standardized questionnaire completed by the parent or caregiver. The ABC evaluates irritability, lethargy/social withdrawal, stereotypic behavior, hyperactivity/noncompliance, and inappropriate speech. Scores are reported as total scores and subscale scores, typically ranging from 0 to 158, where higher scores indicate more severe behavioral problems, reflecting a worse outcome.

Parent-Reported Strengths and Difficulties Assessed by the Strengths and Difficulties Questionnaire (SDQ) - Parent Version

时间窗: Baseline (T0)

Behavioral strengths and difficulties in children and adolescents will be assessed using the Strengths and Difficulties Questionnaire (SDQ) - Parent Version, a standardized questionnaire completed by the parent or caregiver. The SDQ evaluates emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior. Scores are reported as total difficulties scores and subscale scores, typically ranging from 0 to 40 for the total difficulties score, where higher scores indicate more behavioral difficulties, reflecting a worse outcome.

Parent-Reported Developmental Risk Assessed by the Social Dominance Orientation 7 (SDO7) Questionnaire

时间窗: Baseline (T0)

Areas of developmental risk or compromise in children and adolescents will be assessed using the Social Dominance Orientation 7 (SDO7), a standardized parent-report questionnaire. Scores are typically calculated as a total score, with a range from 0 to 28, where higher scores indicate greater developmental risk or more pronounced compromised areas, reflecting a worse outcome.

Parent-Reported Quality of Life Assessed by the WHOQOL-BREF (Parent Version)

时间窗: Baseline (T0)

Perceived quality of life in children and adolescents will be assessed using the WHOQOL-BREF - Parent Version, a standardized questionnaire completed by the parent or caregiver. The WHOQOL-BREF evaluates physical health, psychological well-being, social relationships, and environment. Scores are reported on a 0-100 scale for each domain, where higher scores indicate better perceived quality of life, reflecting a better outcome.

Repetitive Behaviors Assessed by the Repetitive Behavior Scale - Revised (RBS-R)

时间窗: baseline (T0)

Assesses the frequency and type of repetitive and stereotyped behaviors based on parent report. The scale includes 43 items, each rated on a 4-point scale (0 = behavior does not occur; 3 = behavior occurs and is severe), producing a total score range from 0 to 129. Higher scores indicate more frequent and severe repetitive behaviors (worse outcome).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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