Anxiety Disorders in Children - Association With Neurodevelopmental Delay/Disorder

June 19, 2014 updated by: Hanne Kristensen, Regionsenter for barn og unges psykiske helse

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.

Study Overview

Status

Completed

Conditions

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

Observational

Enrollment (Actual)

141

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 13 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Consecutive patient sampling

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
ADHD group
Anx group
Nonanx/nonadhd group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Diagnosis of anxiety disorder
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Hanne Kristensen, Ph.D., Regionsenter for barn og unges psykiske helse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

November 2, 2007

First Submitted That Met QC Criteria

November 2, 2007

First Posted (Estimate)

November 4, 2007

Study Record Updates

Last Update Posted (Estimate)

June 20, 2014

Last Update Submitted That Met QC Criteria

June 19, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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