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Cognitive Dysfunction and Psychological Well-being

This study is not yet open for participant recruitment.
Verified January 2013 by University Hospital of North Norway
Sponsor:
Collaborator:
University of Tromso
Information provided by (Responsible Party):
University Hospital of North Norway
ClinicalTrials.gov Identifier:
NCT01767207
First received: January 10, 2013
Last updated: January 14, 2013
Last verified: January 2013
History of Changes
  Purpose

Patients referred to pediatric rehabilitation services have often cognitive deficits/intellectual disabilities.

Neurocognitive assessment is, hence, important when designing treatment plans. Traditionally, assessments of cognitive function, language function and motor function etc. have been the main focus areas, while assessment and treatment for psychological disorders have been relatively more neglected. Accumulating evidence indicate that children with cognitive dysfunction have a significant higher risk of developing psychological disorders. Therefore assessment of such comorbid disorders should be offered. The main purpose of this pilot study is to systematically assess the prevalence and type of comorbid psychological disorders among children with cognitive dysfunction referred to a Norwegian outpatient pediatric rehabilitation clinic.


Condition Intervention
Psychological Disorders
Mental Disorders
 Other: screening for psychological disorders
Behavioral: screening for psychological disorders

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Cognitive Dysfunction and Psychological Well-being Among Children Refereed to Outpatient Pediatric Rehabilitation

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Aberrant Behavior Checklist

  • Current mental health status [ Time Frame: Within the first or second day the patient is undergoing an assessment at the hospital ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Social Responsiveness Scale


Estimated Enrollment: 100
Study Start Date: January 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
screening for psychological disorders
screening for psychological disorders
 Other: screening for psychological disorders
screening for psychological disorders
Behavioral: screening for psychological disorders
screening for psychological disorders
Other Name: screening for psychological disorders

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients referred to pediatric rehabilitation outpatient clinic

Criteria

Inclusion Criteria:

  1. Intelligence quotient (IQ) scaled scores between 35 and 85.
  2. Age from 6 years to 18 years
  3. Written informed consent to participate
  4. Fluent in Norwegian

  5. Normal or corrected to normal vision and hearing

    -

    Exclusion Criteria:

    -

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01767207

Contacts
Contact: Marianne Halvorsen, PhD +4798832102 marianne.halvorsen@unn.no

Locations
Norway
University Hospital of North Norway Enrolling by invitation
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

No publications provided

Responsible Party: University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT01767207     History of Changes
Other Study ID Numbers: 2012/1009 (Rek)
Study First Received: January 10, 2013
Last Updated: January 14, 2013
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Data Protection Authority
Norway: Directorate of Health

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Cognition Disorders
Schizophrenia and Disorders with Psychotic Features
Delirium, Dementia, Amnestic, Cognitive Disorders

ClinicalTrials.gov processed this record on June 17, 2013