Anxiety DisordersNCT00553085
Anxiety Disorders in Children - Association With Neurodevelopmental Delay/Disorder
An observational study of Anxiety Disorders, run by Regionsenter for barn og unges psykiske helse at 2 sites in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorders
- How many people
- 141 participants
- Where
- 2 sitesNorway
- Study dates
- Sep 2007to Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Consecutive patient sampling
Who may be able to join
- Clinical diagnosis of anxiety disorder or ADHD or no diagnosis
Who cannot join
- Clinical diagnosis of PDD
- mental retardation
- children whose both parents do not speak Norwegian
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Akershus University Hospital
Lorenskog, Akershus, 1478
Lovisenberg Hospital
Oslo, Oslo, 0440
About this study
Official title: 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.
Read the 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.
- Conditions
- Anxiety Disorders
- Keywords
- anxiety disorders, children, neurodevelopmental disorder, neurodevelopmental delay, temperament
- Medical subject headings
- Anxiety Disorders, Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Anx group | Not described | |
| ADHD group | Not described | |
| Nonanx/nonadhd group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of anxiety disorder
Measured: 5 years
Secondary outcomes (1)
Children's global assessment scale (CGAS)
The CGAS represents an assessment of the child's overall severity of disturbance with scores ranging from 1 (lowest functioning) to 100 (excellent functioning)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2007 (estimated)
- Study startSep 2007
- Primary completionDec 2009
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regionsenter for barn og unges psykiske helse
- Sponsor type
- University, hospital or other
- Collaborators
- The Research Council of Norway, University Hospital, Akershus, Lovisenberg Diakonale Hospital, The Hospital for Sick Children
- Responsible party
- Principal investigator, Hanne Kristensen, Regionsenter for barn og unges psykiske helse
- Investigators
- Hanne Kristensen, Ph.D., Principal investigator, Regionsenter for barn og unges psykiske helse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00553085
- Sponsor's protocol ID
- 1.2006.2943
- Other IDs
- 181877/V50
- Status last verified
- Jun 2014
- First submitted
- 2 Nov 2007
- Last updated
- 20 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anxiety Disorders in Children - Association With Neurodevelopmental Delay/Disorder and Temperament/Personality. A Clinical Case-control Study
- ClinicalTrials.gov ID
- NCT00553085
- Acronym / sponsor ID
- 1.2006.2943
- Conditions
- Anxiety Disorders
- Keywords
- anxiety disorders, children, neurodevelopmental disorder, neurodevelopmental delay, temperament
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Regionsenter for barn og unges psykiske helseUniversity, hospital or other
- Collaborators
- The Research Council of Norway, University Hospital, Akershus, Lovisenberg Diakonale Hospital, The Hospital for Sick Children
- Study start
- Sep 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 5 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anx group | – | – |
| ADHD group | – | – |
| Nonanx/nonadhd group | – | – |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Consecutive patient sampling
Key inclusion criteria (1 listed)
- Clinical diagnosis of anxiety disorder or ADHD or no diagnosis
Key exclusion criteria (3 listed)
- Clinical diagnosis of PDD
- mental retardation
- children whose both parents do not speak Norwegian
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnosis of anxiety disorder
Time frame: 5 years
1 secondary outcome
Children's global assessment scale (CGAS)
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanne Kristensen, Ph.D. principal investigator
Regionsenter for barn og unges psykiske helse
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety Disorders, run by Regionsenter for barn og unges psykiske helse at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of anxiety disorder (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2014.