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Completed

NCT Number: NCT00553085

Anxiety Disorders in Children - Association With Neurodevelopmental Delay/Disorder

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

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Key information

Age range

7 year–13 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Akershus University Hospital, Lorenskog, Akershus, Norway

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Diagnosis of anxiety disorder

    Time frame: 5 years

Secondary outcomes

  1. Children's global assessment scale (CGAS)

    Time frame: 5 years

    The CGAS represents an assessment of the child's overall severity of disturbance with scores ranging from 1 (lowest functioning) to 100 (excellent functioning)

Sponsors and collaborators

Lead sponsor

Regionsenter for barn og unges psykiske helse

Other

Collaborators

  • Lovisenberg Diakonale Hospital
  • The Hospital for Sick Children
  • The Research Council of Norway
  • University Hospital, Akershus

Registry information

Official study title

Anxiety Disorders in Children - Association With Neurodevelopmental Delay/Disorder and Temperament/Personality. A Clinical Case-control Study

Important dates

Study start
2007
Primary completion
2009
Study completion
2014
First posted
Nov 5, 2007
Registry last updated
Jun 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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