Mental Health and Cognitive Dysfunction: A Multicenter Study at Pediatric Rehabilitation Clinics in North Norway

NCT ID: NCT01767207

Last Updated: 2017-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

365 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2016-06-30

Brief Summary

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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

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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.

Conditions

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Mental Disorders

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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screening for mental disorders

screening for mental disorders

mental disorders

Intervention Type OTHER

mental disorders

screening for mental disorders

Intervention Type BEHAVIORAL

screening for mental disorders

Interventions

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mental disorders

mental disorders

Intervention Type OTHER

screening for mental disorders

screening for mental disorders

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

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Exclusion Criteria

\-
Minimum Eligible Age

4 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Tromso

OTHER

Sponsor Role collaborator

University Hospital of North Norway

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marianne Halvorsen, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of North Norway

Locations

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Finnmarkssykehuset (The Finnmark Hospital Trust)

Hammerfest, , Norway

Site Status

University Hospital of North Norway

Tromsø, , Norway

Site Status

Countries

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Norway

Other Identifiers

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2012/1009 (Rek)

Identifier Type: -

Identifier Source: org_study_id

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