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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01767207
First Posted: January 14, 2013
Last Update Posted: July 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Tromso
Information provided by (Responsible Party):
University Hospital of North Norway
  Purpose

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.


Condition Intervention
Mental Disorders Other: mental disorders Behavioral: screening for mental disorders

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Mental Health and Cognitive Dysfunction: A Multicenter Study at Pediatric Rehabilitation Clinics in North Norway

Resource links provided by NLM:


Further study details as provided by University Hospital of North Norway:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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)


Other Outcome Measures:
  • Prevalence of maladaptive behavior [ Time Frame: Within the first or second day the patient is undergoing an assessment at the hospital ]
    Aberrant Behavior Checklist

  • 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

  • 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

  • Prevalence of social impairment [ Time Frame: Within the first or second day the patient is undergoing an assessment at the hospital ]
    Social Responsiveness Scale


Enrollment: 365
Actual Study Start Date: October 2012
Study Completion Date: June 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
screening for mental disorders
screening for mental disorders
Other: mental disorders
mental disorders
Behavioral: screening for mental disorders
screening for mental disorders

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients referred to pediatric rehabilitation outpatient clinic
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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01767207


Locations
Norway
Finnmarkssykehuset (The Finnmark Hospital Trust)
Hammerfest, Norway, 9600
University Hospital of North Norway
Tromsø, Norway, N-9019
Sponsors and Collaborators
University Hospital of North Norway
University of Tromso
Investigators
Principal Investigator: Marianne Halvorsen, PhD University Hospital of North Norway
  More Information

Responsible Party: University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT01767207     History of Changes
Other Study ID Numbers: 2012/1009 (Rek)
First Submitted: January 10, 2013
First Posted: January 14, 2013
Last Update Posted: July 14, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders


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