- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00553085
Anxiety Disorders in Children - Association With Neurodevelopmental Delay/Disorder
June 19, 2014 updated by: Hanne Kristensen, Regionsenter for barn og unges psykiske helse
Anxiety Disorders in Children - Association With Neurodevelopmental Delay/Disorder and Temperament/Personality. A Clinical Case-control Study
The main objective of the study is to examine the relationship between anxiety disorders and neurodevelopmental disorder/delay in children aged 7- 13 years.
Study Overview
Status
Completed
Conditions
Detailed Description
Project summary Anxiety disorders (AD's) in childhood are common and may cause great suffering.Childhood AD's may persist into adulthood and knowledge of important risk factors for development and maintenance of these disorders is essential.The development of AD's is due to a complex interaction between biological and environmental factors.This study will examine the relationship between AD's and two biological risk factors:1.Neurodevelopmental delays/disorders (NDD'S) in motor and cognitive function and 2.Temperament/personality.To date a few studies have consistently found that motor impairment is associated with childhood anxiety and predicts persistent anxiety in adolescence.The association between AD's and NDD's in cognitive functions such as language and attention is far less studied.
In contrast, there is a huge research literature on temperament as a risk factor for AD's.The temperamental trait "behavioural inhibition" has been shown to be particularly associated with AD's.However, very few studies have examined the interplay between NDD's, temperament and anxiety.The study is a clinical case-control study of children aged 7-13 years with AD's referred to three different out-patient clinics.The participants will be assessed by diagnostic interviews, neuropsychological tests and temperament/personality instruments.Comparison groups are:1.children
with ADHD (to compare AD's with another mental disorder related to NDD's) and 2.Non-referred children without a mental disorder.
Follow-up at 6 months,1 and 5 years.A pilot study at two of the three out-patient clinics to be included,showed a sufficient sample size.Anticipated implications of the study include increased knowledge of biological risk factors and of latent neurological brain correlates,as well as treatment implications.Children with NDD's are often met with demands they cannot cope with due to their neurodevelopmental immaturity.To adjust the demands to the child's actual level of functioning is important.
Study Type
Observational
Enrollment (Actual)
141
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Oslo, Norway, 0440
- Lovisenberg Hospital
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Akershus
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Lorenskog, Akershus, Norway, 1478
- Akershus University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 13 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Consecutive patient sampling
Description
Inclusion Criteria:
- Clinical diagnosis of anxiety disorder or ADHD or no diagnosis
Exclusion Criteria:
- Clinical diagnosis of PDD
- mental retardation
- children whose both parents do not speak Norwegian
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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ADHD group
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Anx group
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Nonanx/nonadhd group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Diagnosis of anxiety disorder
Time Frame: 5 years
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5 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Children's global assessment scale (CGAS)
Time Frame: 5 years
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The CGAS represents an assessment of the child's overall severity of disturbance with scores ranging from 1 (lowest functioning) to 100 (excellent functioning)
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5 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Hanne Kristensen, Ph.D., Regionsenter for barn og unges psykiske helse
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2007
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
March 1, 2014
Study Registration Dates
First Submitted
November 2, 2007
First Submitted That Met QC Criteria
November 2, 2007
First Posted (Estimate)
November 4, 2007
Study Record Updates
Last Update Posted (Estimate)
June 20, 2014
Last Update Submitted That Met QC Criteria
June 19, 2014
Last Verified
June 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1.2006.2943
- 181877/V50
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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