Anxiety Disorders in Children - Association With Neurodevelopmental Delay/Disorder

This study has been completed.
Sponsor:
Collaborators:
The Research Council of Norway
University Hospital, Akershus
Lovisenberg Diakonale Hospital
The Hospital for Sick Children
Information provided by (Responsible Party):
Hanne Kristensen, Regionsenter for barn og unges psykiske helse
ClinicalTrials.gov Identifier:
NCT00553085
First received: November 2, 2007
Last updated: June 19, 2014
Last verified: June 2014

November 2, 2007
June 19, 2014
September 2007
December 2009   (final data collection date for primary outcome measure)
Diagnosis of anxiety disorder [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Diagnosis of anxiety disorder [ Time Frame: 5 years ]
Complete list of historical versions of study NCT00553085 on ClinicalTrials.gov Archive Site
Children's global assessment scale (CGAS) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
The CGAS represents an assessment of the child's overall severity of disturbance with scores ranging from 1 (lowest functioning) to 100 (excellent functioning)
CGAS [ Time Frame: 5 years ]
Not Provided
Not Provided
 
Anxiety Disorders in Children - Association With Neurodevelopmental Delay/Disorder
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.

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.

Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples Without DNA
Description:

Saliva for measuring Cortisol

Probability Sample

Consecutive patient sampling

Anxiety Disorders
Not Provided
  • Anx group
  • ADHD group
  • Nonanx/nonadhd group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
141
March 2014
December 2009   (final data collection date for primary outcome measure)

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
Both
7 Years to 13 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00553085
1.2006.2943, 181877/V50
No
Hanne Kristensen, Regionsenter for barn og unges psykiske helse
Regionsenter for barn og unges psykiske helse
  • The Research Council of Norway
  • University Hospital, Akershus
  • Lovisenberg Diakonale Hospital
  • The Hospital for Sick Children
Principal Investigator: Hanne Kristensen, Ph.D. Regionsenter for barn og unges psykiske helse
Regionsenter for barn og unges psykiske helse
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP