AzTrials
AzTrials

Mental DiseaseNCT07422324

Multidimensional Assessment of Mental Health in Adolescence.

An observational study of Mental Disease, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 11 to 18 yearsHealthy volunteers can take part
Conditions the study is for
Mental Disease
How many people
180 participants
Where
1 siteItaly
Study dates
27 Oct 2025to 31 Mar 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 11 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Study population: Adolescents aged between 11 and 18 years old and their parents or primary carers.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Italy1 site, 1 recruiting
  • IRCCS Neurolesi Bonino Pulejo, Messina, Messina 98124

    Messina

    IRCCS Neurolesi Bonino Pulejo, Messina, Messina 98124, +3909060128256, francesca.cucinotta@irccsme.it

    Recruiting

Other trials in Italy

About this study

Official title: 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.

Read more

Main objective:

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

Conditions
Mental Disease
Medical subject headings
Mental Disorders

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: baseline (T0)

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

    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.

    Measured: baseline (T0)

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

    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.

    Measured: baseline (T0)

  4. EGO Resiliency Scale (ERS)

    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).

    Measured: baseline(T0)

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

    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.

    Measured: baseline (T0)

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

    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.

    Measured: baseline (T0)

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

    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.

    Measured: baseline (T0)

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

    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.

    Measured: baseline (T0)

  9. Social Responsiveness Assessed by the Social Responsiveness Scale (SRS)

    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).

    Measured: baseline (T0)

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

    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.

    Measured: baseline (T0)

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

    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.

    Measured: Baseline (T0)

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

    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.

    Measured: Baseline (T0)

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

    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.

    Measured: Baseline (T0)

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

    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).

    Measured: baseline (T0)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2026
  2. Study start27 Oct 2025
  3. Primary completion28 Feb 2027 (estimated)
  4. Study completion31 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07422324
Sponsor's protocol ID
ADOLESCENT25
Status last verified
Feb 2026
First submitted
21 Nov 2025
Last updated
20 Feb 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 18245403
  • 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.

    PubMed 34504941
  • 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.

    PubMed 35064392
  • 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.

    PubMed 35066239
  • 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.

    PubMed 25915035
  • 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.

    PubMed 36285970
  • 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.

    PubMed 37787879

Questions about this trial

What is this clinical trial studying?

An observational study of Mental Disease, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Francesca Cucinotta (09060128256, francesca.cucinotta@irccsme.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adolescent Self-Assessment Using the Conners Adolescent Self-Report (CAS) (time frame: baseline (T0)). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07422324, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.

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