Mental DisordersNCT01767207
Mental Health and Cognitive Dysfunction: A Multicenter Study at Pediatric Rehabilitation Clinics in North Norway
An observational study of Mental Disorders, run by University Hospital of North Norway at 2 sites in Norway.
Trial summary
Patients referred to pediatric rehabilitation services have often cognitive deficits/intellectual disabilities.Neurocognitive assessment is, hence, important when designing treatment plans. Read more about this study
- Who is it for?
- Ages 4 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Disorders
- What is being tested?
- mental disorders and screening for mental disorders
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 365 participants
- Where
- 2 sitesNorway
- Study dates
- Oct 2012to Jun 2016
- 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 4 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Patients referred to pediatric rehabilitation outpatient clinic
Who may be able to join
- Age from 4 years to 18 years
- Written informed consent to participate
- Fluent in Norwegian
- Normal or corrected to normal vision and hearing
- -
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Finnmarkssykehuset (The Finnmark Hospital Trust)
Hammerfest, 9600
University Hospital of North Norway
Tromsø, N-9019
About this study
Patients referred to pediatric rehabilitation services have often cognitive deficits/intellectual disabilities.Neurocognitive assessment is, hence, important when designing treatment plans.
Children and adolescents with cognitive deficits and intellectual disabilities (ID) have a high risk of developing mental health problems. There is lack of knowledge about such comorbid mental disorders in the health service. There are also few validated instruments for assessing mental disorders among children and adolescents with cognitive deficits and ID both in Norway and abroad.
Read more
The main aims of the current multicentre study are to:
Investigate psychometric properties of different psychiatric instruments for children and adolescents. Investigate change and stability of symptoms over time. Investigate user satisfaction. The study will include Pediatric Rehabilitation Services at hospitals in Tromsø, Hammerfest and Bodø and will include in total 320 patients aged 4 to 18. We will use information from parents, teachers and patients, in addition to clinician-rated measures. Patients will be assessed at intake and after six months. We have conducted a pilot study in the period from 2012 to 2013.
Read the detailed description
- Investigate psychometric properties of a structured psychiatric interview (DAWBA) and a symptom measure (SDQ) in clinical samples of children and adolescents with cognitive deficits and intellectual disabilities. We will investigate the instruments' reliability and convergent validity with the Aberrant Behavior checklist (ABC), the DBC and the Social Responsiveness Scale (SRS), in addition to the clinician-rated severity of children's mental health problems measured with the CGAS and HoNOSCA.
- The psychiatric instruments will be administrated at intake and after six months. We will investigate prevalence rates and indicators of disorder severity (comorbidity and persistence), including risk factors (socioeconomic status, parenting styles).
- Investigate user satisfaction with the health service, i.e., the Pediatric
Rehabilitation Services.
- Conditions
- Mental Disorders
- Being tested
- mental disorders, screening for mental disorders
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mental disordersOther
mental disorders
screening for mental disordersBehavioural
screening for mental disorders
| Study group | Role | What they receive |
|---|---|---|
| screening for mental disorders | screening for mental disorders Receives: Other: mental disorders; Behavioral: screening for mental disorders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of mental disorders
The Development and Well Being Assessment (DAWBA) is a package of interviews, questionnaires and rating techniques designed to generate psychiatric diagnoses on 5-17 year old according to the International Statistical Classification of Diseases and Related Health Problems (ICD-10) and Diagnostic and Statistical Manual of Mental Disorders(DSM-IV).
Measured: Within the first or second day the patient is undergoing an assessment at the hospital
Secondary outcomes (1)
Prevalence of mental disorders
The Development and Well Being Assessment short-version is re-administered 6 months after taking part in the study (i.e., the basic outcome measure)
Measured: within 6 months after the initial assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2013 (estimated)
- Study startOct 2012
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental 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 only
- Time perspective
- Prospective
- Enrolment
- 365 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- University of Tromso
- Responsible party
- Sponsor
- Investigators
- Marianne Halvorsen, PhD, Principal investigator, University Hospital of North Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01767207
- Sponsor's protocol ID
- 2012/1009 (Rek)
- Status last verified
- Jul 2017
- First submitted
- 10 Jan 2013
- Last updated
- 14 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mental Health and Cognitive Dysfunction: A Multicenter Study at Pediatric Rehabilitation Clinics in North Norway
- ClinicalTrials.gov ID
- NCT01767207
- Acronym / sponsor ID
- 2012/1009 (Rek)
- Conditions
- Mental Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 365 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- University of Tromso
- Study start
- Oct 2012 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 14 Jan 2013 (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.
Patients referred to pediatric rehabilitation services have often cognitive deficits/intellectual disabilities.Neurocognitive assessment is, hence, important when designing treatment plans.
Children and adolescents with cognitive deficits and intellectual disabilities (ID) have a high risk of developing mental health problems. There is lack of knowledge about such comorbid mental disorders in the health service. There are also few validated instruments for assessing mental disorders among children and adolescents with cognitive deficits and ID both in Norway and abroad.
The main aims of the current multicentre study are to:
Investigate psychometric properties of different psychiatric instruments for children and adolescents. Investigate change and stability of symptoms over time. Investigate user satisfaction. The study will include Pediatric Rehabilitation Services at hospitals in Tromsø, Hammerfest and Bodø and will include in total 320 patients aged 4 to 18. We will use information from parents, teachers and patients, in addition to clinician-rated measures. Patients will be assessed at intake and after six months. We have conducted a pilot study in the period from 2012 to 2013.
Detailed description
- Investigate psychometric properties of a structured psychiatric interview (DAWBA) and a symptom measure (SDQ) in clinical samples of children and adolescents with cognitive deficits and intellectual disabilities. We will investigate the instruments' reliability and convergent validity with the Aberrant Behavior checklist (ABC), the DBC and the Social Responsiveness Scale (SRS), in addition to the clinician-rated severity of children's mental health problems measured with the CGAS and HoNOSCA.
- The psychiatric instruments will be administrated at intake and after six months. We will investigate prevalence rates and indicators of disorder severity (comorbidity and persistence), including risk factors (socioeconomic status, parenting styles).
- Investigate user satisfaction with the health service, i.e., the Pediatric
Rehabilitation Services.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| screening for mental disorders | – | Other: mental disorders, Behavioral: screening for mental disordersscreening for mental disorders |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patients referred to pediatric rehabilitation outpatient clinic
Key inclusion criteria (5 listed)
- Age from 4 years to 18 years
- Written informed consent to participate
- Fluent in Norwegian
- Normal or corrected to normal vision and hearing
- -
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mental disordersmental disorders | Other | screening for mental disorders |
| screening for mental disordersscreening for mental disorders | Behavioural | screening for mental disorders |
Primary outcome
Prevalence of mental disorders
Time frame: Within the first or second day the patient is undergoing an assessment at the hospital
The Development and Well Being Assessment (DAWBA) is a package of interviews, questionnaires and rating techniques designed to generate psychiatric diagnoses on 5-17 year old according to the International Statistical Classification of Diseases and Related Health Problems (ICD-10) and Diagnostic and Statistical Manual of Mental Disorders(DSM-IV).
1 secondary outcome
Prevalence of mental disorders
Time frame: within 6 months after the initial assessment
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 14 Jul 2017.
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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.
Marianne Halvorsen, PhD principal investigator
University Hospital of North Norway
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 Mental Disorders, run by University Hospital of North Norway 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 5 inclusion and 1 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 14 Jul 2017. 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?
Prevalence of mental disorders (time frame: Within the first or second day the patient is undergoing an assessment at the hospital). 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 14 Jul 2017.