NCT01767207

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
365

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2012

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 14, 2013

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

July 14, 2017

Status Verified

July 1, 2017

Enrollment Period

3.7 years

First QC Date

January 10, 2013

Last Update Submit

July 11, 2017

Conditions

Mental Disorders

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Prevalence of mental disorders

    within 6 months after the initial assessment

Other Outcomes (4)

  • Prevalence of maladaptive behavior

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

  • Current mental health status

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

  • General functioning of children

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

  • +1 more other outcomes

Study Arms (1)

screening for mental disorders

screening for mental disorders

Other: mental disordersBehavioral: screening for mental disorders

Interventions

mental disordersOTHER

mental disorders

screening for mental disorders
screening for mental disordersBEHAVIORAL

screening for mental disorders

screening for mental disorders

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients referred to pediatric rehabilitation outpatient clinic

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Finnmarkssykehuset (The Finnmark Hospital Trust)

Hammerfest, 9600, Norway

Location

University Hospital of North Norway

Tromsø, N-9019, Norway

Location

MeSH Terms

Conditions

Mental Disorders

Interventions

Patient Health QuestionnaireMass Screening

Intervention Hierarchy (Ancestors)

Surveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesPsychological TestsBehavioral Disciplines and ActivitiesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthDiagnostic Techniques and ProceduresDiagnosisHealth SurveysDiagnostic ServicesPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPublic Health Practice

Study Officials

  • Marianne Halvorsen, PhD

    University Hospital of North Norway

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2013

First Posted

January 14, 2013

Study Start

October 1, 2012

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

July 14, 2017

Record last verified: 2017-07

Locations

NO(2)