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

July 11, 2017 updated by: University Hospital of 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

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.

Study Type

Observational

Enrollment (Actual)

365

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Hammerfest, Norway, 9600
        • Finnmarkssykehuset (The Finnmark Hospital Trust)
      • Tromsø, Norway, N-9019
        • University Hospital of North Norway

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients referred to pediatric rehabilitation outpatient clinic

Description

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:

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Marianne Halvorsen, PhD, University Hospital of North Norway

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2012

Primary Completion (ACTUAL)

June 1, 2016

Study Completion (ACTUAL)

June 1, 2016

Study Registration Dates

First Submitted

January 10, 2013

First Submitted That Met QC Criteria

January 10, 2013

First Posted (ESTIMATE)

January 14, 2013

Study Record Updates

Last Update Posted (ACTUAL)

July 14, 2017

Last Update Submitted That Met QC Criteria

July 11, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 2012/1009 (Rek)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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