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Completed

NCT Number: NCT01767207

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

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Key information

Conditions

Mental Disorders

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Finnmarkssykehuset (The Finnmark Hospital Trust), Hammerfest, Norway

Loading trial locations.

About this study

  • 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.

  • 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).

  • Investigate user satisfaction with the health service, i.e., the Pediatric

Rehabilitation Services.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age from 4 years to 18 years
  • Written informed consent to participate
  • Fluent in Norwegian
  • Normal or corrected to normal vision and hearing

-

Exclusion criteria

-

Treatment and study plan

mental disorders

Other

mental disorders

screening for mental disorders

Behavioral

screening for mental disorders

Primary outcomes

  1. 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 outcomes

  1. 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 outcomes

  1. Prevalence of maladaptive behavior

    Time frame: Within the first or second day the patient is undergoing an assessment at the hospital

    Aberrant Behavior Checklist

  2. 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

  3. 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

  4. Prevalence of social impairment

    Time frame: Within the first or second day the patient is undergoing an assessment at the hospital

    Social Responsiveness Scale

Sponsors and collaborators

Lead sponsor

University Hospital of North Norway

Other

Collaborators

  • University of Tromso

Registry information

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jan 14, 2013
Registry last updated
Jul 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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