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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2015 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: July 6, 2015
Last verified: July 2015
  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
Psychological Disorders
Mental Disorders
Other: screening for psychological disorders
Behavioral: screening for psychological disorders

Study Type: Observational
Study Design: 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 ] [ 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: 320
Study Start Date: October 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: June 2016 (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

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

Ages Eligible for Study:   4 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. Age from 6 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
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, see Learn About Clinical Studies.

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

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

Locations
Norway
Finnmarkssykehuset (The Finnmark Hospital Trust) Recruiting
Hammerfest, Norway, 9600
Contact: Marianne Halvorsen, PhD    +4798832102    marianne.halvorsen@unn.no   
Principal Investigator: Marianne Halvorsen, PhD         
University Hospital of North Norway Recruiting
Tromsø, Norway, N-9019
Contact: Marianne Halvorsen, PhD    +4798832102    marianne.halvorsen@unn.no   
Principal Investigator: Marianne Halvorsen, PhD         
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: July 6, 2015
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Data Protection Authority
Norway: Directorate of Health

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

ClinicalTrials.gov processed this record on July 29, 2015