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Anxiety Disorders in Children - Association With Neurodevelopmental Delay/Disorder (NDD)

This study is currently recruiting participants.
Verified by Regionsenter for barn og unges psykiske helse, June 2008

Sponsors and Collaborators: Regionsenter for barn og unges psykiske helse
The Research Council of Norway
University Hospital, Akershus
Lovisenberg Diakonale Hospital
The Hospital for Sick Children
Information provided by: Regionsenter for barn og unges psykiske helse
ClinicalTrials.gov Identifier: NCT00553085
  Purpose

The main objective of the study is to examine the relationship between anxiety disorders and neurodevelopmental disorder/delay in children aged 7- 13 years


Condition
Anxiety Disorders

MedlinePlus related topics:   Anxiety   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Case Control, Cross-Sectional
Official Title:   Anxiety Disorders in Children - Association With Neurodevelopmental Delay/Disorder and Temperament/Personality. A Clinical Case-Control Study

Further study details as provided by Regionsenter for barn og unges psykiske helse:

Primary Outcome Measures:
  • Diagnosis of anxiety disorder [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CGAS [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Biospecimen Description:

Saliva for measuring Cortisol


Estimated Enrollment:   240
Study Start Date:   September 2007
Estimated Study Completion Date:   March 2014

Groups/Cohorts
Anx group
ADHD group
Nonanx/nonadhd group

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.

  Eligibility
Ages Eligible for Study:   7 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample

Study Population

Consecutive patient sampling


Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00553085

Contacts
Contact: Hanne Kristensen, M.D.     +47 22586000     hanne.kristensen@r-bup.no    

Locations
Norway
Lovisenberg Hospital     Recruiting
      Oslo, Norway, 0440
      Contact: Benedicte Skirbekk, MD     22028800 ext +47     benedicte.skirbekk@r-bup.no    
Norway, Akershus
Akershus University Hospital     Recruiting
      Lorenskog, Akershus, Norway, 1478
      Contact: Berit H Hansen, MD     67912400 ext +47     Berit.Hjelde.Hansen@r-bup.no    

Sponsors and Collaborators
Regionsenter for barn og unges psykiske helse
The Research Council of Norway
University Hospital, Akershus
Lovisenberg Diakonale Hospital
The Hospital for Sick Children

Investigators
Principal Investigator:     Hanne Kristensen, Ph.D.     Regionsenter for barn og unges psykiske helse    
  More Information


Responsible Party:   Regionsenter for barn og unges psykiske helse ( Hanne Kristensen, M, Phd )
Study ID Numbers:   1.2006.2943, 181877/V50
First Received:   November 2, 2007
Last Updated:   July 1, 2008
ClinicalTrials.gov Identifier:   NCT00553085
Health Authority:   Norway: The National Committees for Research Ethics in Norway

Keywords provided by Regionsenter for barn og unges psykiske helse:
anxiety disorders  
children  
neurodevelopmental disorder  
neurodevelopmental delay  
temperament  

Study placed in the following topic categories:
Anxiety Disorders
Mental Disorders

Additional relevant MeSH terms:
Pathologic Processes
Disease

ClinicalTrials.gov processed this record on October 07, 2008




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