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
  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

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

Resource links provided by NLM:


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:
  • 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)


Biospecimen Retention:   Samples Without DNA

Saliva for measuring Cortisol


Enrollment: 141
Study Start Date: September 2007
Study Completion Date: March 2014
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
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 13 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Norway
Akershus University Hospital
Lorenskog, Akershus, Norway, 1478
Lovisenberg Hospital
Oslo, Norway, 0440
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

No publications provided

Responsible Party: Hanne Kristensen, Director, Clinical Research Section, Regionsenter for barn og unges psykiske helse
ClinicalTrials.gov Identifier: NCT00553085     History of Changes
Other Study ID Numbers: 1.2006.2943, 181877/V50
Study First Received: November 2, 2007
Last Updated: June 19, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics

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

Additional relevant MeSH terms:
Anxiety Disorders
Disease
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014