Clinical trial NCT00553085: Anxiety Disorders in Children - Association With Neurodevelopmental Delay/Disorder
Official title: Anxiety Disorders in Children - Association With Neurodevelopmental Delay/Disorder and Temperament/Personality. A Clinical Case-control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anxiety Disorders
Keywords: anxiety disorders
children
neurodevelopmental disorder
neurodevelopmental delay
temperament
Lead sponsor: Regionsenter for barn og unges psykiske helse
Sponsor class: OTHER
Collaborators: name: The Research Council of Norway
name: University Hospital, Akershus
name: Lovisenberg Diakonale Hospital
name: The Hospital for Sick Children
First posted: 2007-11-04
Enrollment: 141
Sex: ALL
Minimum age (years): 7
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patient sampling

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

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 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

Primary outcomes:
measure: Diagnosis of anxiety disorder
timeFrame: 5 years
Secondary outcomes:
measure: Children's global assessment scale (CGAS)
timeFrame: 5 years
Other outcomes:
Locations:
city: Lorenskog
country: Norway
facility: Akershus University Hospital
state: Akershus
city: Oslo
country: Norway
facility: Lovisenberg Hospital
Study officials:
affiliation: Regionsenter for barn og unges psykiske helse
name: Hanne Kristensen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: