- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01767207
Mental Health and Cognitive Dysfunction: A Multicenter Study at Pediatric Rehabilitation Clinics in North Norway
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Hammerfest, Norway, 9600
- Finnmarkssykehuset (The Finnmark Hospital Trust)
-
Tromsø, Norway, N-9019
- University Hospital of North Norway
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age from 4 years to 18 years
- Written informed consent to participate
- Fluent in Norwegian
Normal or corrected to normal vision and hearing
-
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
screening for mental disorders
|
mental disorders
screening for mental disorders
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
Within the first or second day the patient is undergoing an assessment at the hospital
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prevalence of mental disorders
Time Frame: within 6 months after the initial assessment
|
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)
|
within 6 months after the initial assessment
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prevalence of maladaptive behavior
Time Frame: Within the first or second day the patient is undergoing an assessment at the hospital
|
Aberrant Behavior Checklist
|
Within the first or second day the patient is undergoing an assessment at the hospital
|
|
Current mental health status
Time Frame: Within the first or second day the patient is undergoing an assessment at the hospital
|
Health of the Nation Outcome Scales for Children and Adolescents
|
Within the first or second day the patient is undergoing an assessment at the hospital
|
|
General functioning of children
Time Frame: Within the first or second day the patient is undergoing an assessment at the hospital
|
Children's Global Assessment
|
Within the first or second day the patient is undergoing an assessment at the hospital
|
|
Prevalence of social impairment
Time Frame: Within the first or second day the patient is undergoing an assessment at the hospital
|
Social Responsiveness Scale
|
Within the first or second day the patient is undergoing an assessment at the hospital
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Marianne Halvorsen, PhD, University Hospital of North Norway
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012/1009 (Rek)
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