Anxiety Disorders in Children - Association With Neurodevelopmental Delay/Disorder

This study is ongoing, but not recruiting participants.

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: August 26, 2011

Last verified: August 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

November 2, 2007

Last Updated Date

August 26, 2011

Start Date ^ICMJE

September 2007

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Diagnosis of anxiety disorder [ Time Frame: 5 years ]

Change History

Complete list of historical versions of study NCT00553085 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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)

Original Secondary Outcome Measures ^ICMJE

CGAS [ Time Frame: 5 years ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Anxiety Disorders in Children - Association With Neurodevelopmental Delay/Disorder

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case Control
Time Perspective: Cross-Sectional

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples Without DNA

Description:

Saliva for measuring Cortisol

Sampling Method

Probability Sample

Study Population

Consecutive patient sampling

Condition ^ICMJE

Anxiety Disorders

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Anx group
ADHD group
Nonanx/nonadhd group

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

141

Estimated Completion Date

March 2014

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

7 Years to 13 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Norway

Administrative Information

NCT Number ^ICMJE

NCT00553085

Other Study ID Numbers ^ICMJE

1.2006.2943, 181877/V50

Has Data Monitoring Committee

Responsible Party

Hanne Kristensen, Regionsenter for barn og unges psykiske helse

Study Sponsor ^ICMJE

Regionsenter for barn og unges psykiske helse

Collaborators ^ICMJE

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

Investigators ^ICMJE

Principal Investigator:

Hanne Kristensen, Ph.D.

Regionsenter for barn og unges psykiske helse

Information Provided By

Regionsenter for barn og unges psykiske helse

Verification Date

August 2011

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

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