- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07422324
Multidimensional Assessment of Mental Health in Adolescence.
Multidimensional Assessment of Mental Health in Adolescence: Cross-sectional Study Using Self-report and Parent-report Questionnaires.
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Francesca Cucinotta
- Phone Number: 09060128256
- Email: francesca.cucinotta@irccsme.it
Study Locations
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Messina, Italy
- Recruiting
- IRCCS Neurolesi Bonino Pulejo, Messina, Messina 98124
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Contact:
- IRCCS Neurolesi Bonino Pulejo, Messina, Messina 98124
- Phone Number: +3909060128256
- Email: francesca.cucinotta@irccsme.it
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Adolescent Self-Assessment Using the Conners Adolescent Self-Report (CAS)
Time Frame: baseline (T0)
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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. |
baseline (T0)
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Columbia- Suicide Severity Rating Scale (C-SSRS)
Time Frame: baseline (T0)
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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. |
baseline (T0)
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Youth Self-Report (YSR) - Behavioral and Emotional Problems
Time Frame: baseline (T0)
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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. |
baseline (T0)
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EGO Resiliency Scale (ERS)
Time Frame: baseline(T0)
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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). |
baseline(T0)
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Emotional Intelligence Assessed by the Emotional Quotient Inventory: Youth Version (EQ-i: YV)
Time Frame: baseline (T0)
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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. |
baseline (T0)
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Personality Traits Assessed by the PID (Personality Inventory for DSM-5 - Adolescent Version)
Time Frame: baseline (T0)
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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. |
baseline (T0)
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Behavioral and Emotional Problems Assessed by the Child Behavior Checklist (CBCL) - Parent Version
Time Frame: baseline (T0)
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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. |
baseline (T0)
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Parent-Rated ADHD and Behavioral Symptoms Assessed by the Conners' Parent Rating Scale (CPRS)
Time Frame: baseline (T0)
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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. |
baseline (T0)
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Social Responsiveness Assessed by the Social Responsiveness Scale (SRS)
Time Frame: baseline (T0)
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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). |
baseline (T0)
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Aberrant Behavior Assessment Using the Aberrant Behavior Checklist (ABC) - Parent Version
Time Frame: baseline (T0)
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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. |
baseline (T0)
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Parent-Reported Strengths and Difficulties Assessed by the Strengths and Difficulties Questionnaire (SDQ) - Parent Version
Time Frame: Baseline (T0)
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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. |
Baseline (T0)
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Parent-Reported Developmental Risk Assessed by the Social Dominance Orientation 7 (SDO7) Questionnaire
Time Frame: Baseline (T0)
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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. |
Baseline (T0)
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Parent-Reported Quality of Life Assessed by the WHOQOL-BREF (Parent Version)
Time Frame: Baseline (T0)
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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. |
Baseline (T0)
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Repetitive Behaviors Assessed by the Repetitive Behavior Scale - Revised (RBS-R)
Time Frame: baseline (T0)
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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). |
baseline (T0)
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Collaborators and Investigators
Publications and helpful links
General Publications
- De Los Reyes A, Augenstein TM, Wang M, Thomas SA, Drabick DAG, Burgers DE, Rabinowitz J. The validity of the multi-informant approach to assessing child and adolescent mental health. Psychol Bull. 2015 Jul;141(4):858-900. doi: 10.1037/a0038498. Epub 2015 Apr 27.
- Johnson SB, Wang C. Why do adolescents say they are less healthy than their parents think they are? The importance of mental health varies by social class in a nationally representative sample. Pediatrics. 2008 Feb;121(2):e307-13. doi: 10.1542/peds.2007-0881.
- Gregory T, Sincovich A, Brushe M, Finlay-Jones A, Collier LR, Grace B, Sechague Monroy N, Brinkman SA. Basic epidemiology of wellbeing among children and adolescents: A cross-sectional population level study. SSM Popul Health. 2021 Aug 26;15:100907. doi: 10.1016/j.ssmph.2021.100907. eCollection 2021 Sep.
- Evans SC, Corteselli KA, Edelman A, Scott H, Weisz JR. Is Irritability a Top Problem in Youth Mental Health Care? A Multi-informant, Multi-method Investigation. Child Psychiatry Hum Dev. 2023 Aug;54(4):1027-1041. doi: 10.1007/s10578-021-01301-8. Epub 2022 Jan 22.
- De Los Reyes A, Talbott E, Power TJ, Michel JJ, Cook CR, Racz SJ, Fitzpatrick O. The Needs-to-Goals Gap: How informant discrepancies in youth mental health assessments impact service delivery. Clin Psychol Rev. 2022 Mar;92:102114. doi: 10.1016/j.cpr.2021.102114. Epub 2021 Dec 21.
- Caqueo-Urizar A, Urzua A, Villalonga-Olives E, Atencio-Quevedo D, Irarrazaval M, Flores J, Ramirez C. Children's Mental Health: Discrepancy between Child Self-Reporting and Parental Reporting. Behav Sci (Basel). 2022 Oct 19;12(10):401. doi: 10.3390/bs12100401.
- Aitken M, Plamondon A, Krzeczkowski J, Kil H, Andrade BF. Systematic Integration of Multi-Informant Externalizing Ratings in Clinical Settings. Res Child Adolesc Psychopathol. 2024 Apr;52(4):635-644. doi: 10.1007/s10802-023-01119-z. Epub 2023 Oct 3.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ADOLESCENT25
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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