NCT00553085

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
141

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2007

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 2, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 5, 2007

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

June 20, 2014

Status Verified

June 1, 2014

Enrollment Period

2.3 years

First QC Date

November 2, 2007

Last Update Submit

June 19, 2014

Conditions

Anxiety Disorders

Keywords

anxiety disorderschildrenneurodevelopmental disorderneurodevelopmental delaytemperament

Outcome Measures

Primary Outcomes (1)

  • Diagnosis of anxiety disorder

    5 years

Secondary Outcomes (1)

  • Children's global assessment scale (CGAS)

    5 years

Study Arms (3)

Anx group

ADHD group

Nonanx/nonadhd group

Eligibility Criteria

Age7 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Consecutive patient sampling

You may qualify if:

  • Clinical diagnosis of anxiety disorder or ADHD or no diagnosis

You may not qualify if:

  • Clinical diagnosis of PDD
  • mental retardation
  • children whose both parents do not speak Norwegian

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Akershus University Hospital

Lorenskog, Akershus, 1478, Norway

Location

Lovisenberg Hospital

Oslo, Oslo County, 0440, Norway

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Saliva for measuring Cortisol

MeSH Terms

Conditions

Anxiety DisordersNeurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Hanne Kristensen, Ph.D.

    Regionsenter for barn og unges psykiske helse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Clinical Research Section

Study Record Dates

First Submitted

November 2, 2007

First Posted

November 5, 2007

Study Start

September 1, 2007

Primary Completion

December 1, 2009

Study Completion

March 1, 2014

Last Updated

June 20, 2014

Record last verified: 2014-06

Locations

NO(2)