Clinical trial NCT01767207: Mental Health and Cognitive Dysfunction: A Multicenter Study at Pediatric Rehabilitation Clinics in North Norway
Official title: Mental Health and Cognitive Dysfunction: A Multicenter Study at Pediatric Rehabilitation Clinics in North Norway
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mental Disorders
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
Collaborators: name: University of Tromso
First posted: 2013-01-14
Enrollment: 365
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred to pediatric rehabilitation outpatient clinic

Brief summary: 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: 1. 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.
2. 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).
3. Investigate user satisfaction with the health service, i.e., the Pediatric

Rehabilitation Services.

Eligibility criteria: Inclusion Criteria:

1. Age from 4 years to 18 years
2. Written informed consent to participate
3. Fluent in Norwegian
4. Normal or corrected to normal vision and hearing

   -

   Exclusion Criteria:

   -

Primary outcomes:
measure: Prevalence of mental disorders
timeFrame: Within the first or second day the patient is undergoing an assessment at the hospital
Secondary outcomes:
measure: Prevalence of mental disorders
timeFrame: within 6 months after the initial assessment
Other outcomes:
measure: Prevalence of maladaptive behavior
timeFrame: Within the first or second day the patient is undergoing an assessment at the hospital
measure: Current mental health status
timeFrame: Within the first or second day the patient is undergoing an assessment at the hospital
measure: General functioning of children
timeFrame: Within the first or second day the patient is undergoing an assessment at the hospital
measure: Prevalence of social impairment
timeFrame: Within the first or second day the patient is undergoing an assessment at the hospital
Locations:
city: Hammerfest
country: Norway
facility: Finnmarkssykehuset (The Finnmark Hospital Trust)
city: Tromsø
country: Norway
facility: University Hospital of North Norway
Study officials:
affiliation: University Hospital of North Norway
name: Marianne Halvorsen, PhD
role: PRINCIPAL_INVESTIGATOR
References: