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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02707848
Other study ID # 201411056RIN
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2014
Est. completion date December 31, 2016

Study information

Verified date September 2021
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This 3-year school-based epidemiological study on child and adolescent mental disorders aims to obtain the prevalence rate and identify the psychosocial, individual, environmental, and familial risk factors for mental disorders including learning disability, autism spectrum disorder, attention-deficit hyperactivity disorder, oppositional defiant disorder, conduct disorder, mood disorders (major depression, dysthymia, bipolar disorder), anxiety disorders, phobia, obsessive compulsive disorder, sleep disorders, eating disorders, and substance use disorders in Taiwan.


Description:

Despite several waves of epidemiological studies in adult and elderly mental disorders in the past decades, revealing inconsistent results, little is known about the prevalence of mental disorders in the child and young adolescent population in Taiwan. However, there is an increasing trend of child and adolescent mental disorders over the past decades consistently reported across countries. With the revision of the Diagnostic and Statistical Manual of Mental Disorders to the current version-5th edition (DSM-5), there has been no epidemiological study using DSM-5 in youth population in the world. The DSM-5 was published in October 2014. It warrants an epidemiological study on child and adolescent mental disorders using the DSM-5 as diagnostic criteria in Taiwan. This is a two-stage design to conduct screening for mental disorders including autism and all neuropsychological studies in addition to questionnaires. Moreover, clinical assessment will be conducted among urban students (n = 3000) and rural students (n = 1500) from a three-stage cluster sampling. All the screen positive (estimated n = 900) and 10% of screen negative (estimated n = 360) will receive the full diagnostic interview (K-SADS-E to obtain the pregnancy, developmental and medical history. For students who leave of absence, we will visit them at home to complete all the assessments. The investigators anticipate this study will provide the prevalence of a wide range of developmental and psychiatric disorders in children and our results will also provide a comprehensive risk factors for each psychiatric disorder identified in this study, including neurocognitive, developmental, familiar, and environmental factors. The individual, combined, and interactive effects of these predictors can be identified in this study. This study will definitely provide precious data for the government to develop a preventive program for mental disorders and a promotion program for mental health and well-being.


Recruitment information / eligibility

Status Completed
Enrollment 4500
Est. completion date December 31, 2016
Est. primary completion date December 31, 2016
Accepts healthy volunteers No
Gender All
Age group 8 Years to 14 Years
Eligibility Inclusion Criteria: - urban students (n = 3000) and rural students (n = 1500) from a three-stage cluster sampling Exclusion Criteria: -

Study Design


Related Conditions & MeSH terms


Intervention

Other:
No intervention


Locations

Country Name City State
Taiwan National Taiwan Univeristy Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Screening for mental disorders Schedule for affective disorders and schizophrenia for school-age children revision (K-SADS-E), Autism Diagnostic Observation Schedule (ADOS) 2 hours
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