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

Mental Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01767207
• Other study ID #: 2012/1009 (Rek)
• Status: Completed
• Phase: N/A
• First received: January 10, 2013
• Last updated: July 11, 2017
• Start date: October 2012
• Est. completion date: June 2016

Study information

• Verified date: July 2017
• Source: University Hospital of North Norway
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 365
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 18 Years

Eligibility

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:

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders

Intervention

Other:
• mental disorders
mental disorders

Behavioral:
• screening for mental disorders
screening for mental disorders

Locations

Country	Name	City	State
Norway	Finnmarkssykehuset (The Finnmark Hospital Trust)	Hammerfest
Norway	University Hospital of North Norway	Tromsø

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital of North Norway	University of Tromso

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Prevalence of maladaptive behavior	Aberrant Behavior Checklist	Within the first or second day the patient is undergoing an assessment at the hospital
Other	Current mental health status	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
Other	General functioning of children	Children's Global Assessment	Within the first or second day the patient is undergoing an assessment at the hospital
Other	Prevalence of social impairment	Social Responsiveness Scale	Within the first or second day the patient is undergoing an assessment at the hospital
Primary	Prevalence of mental disorders	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	Prevalence of mental disorders	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