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Trial record 61 of 1549 for:    child psychiatry

Quality of Life and Mental Health in Children and Adolescents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00159601
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : April 4, 2017
Sponsor:
Collaborators:
Norwegian Council for Mental Health
SINTEF Health Research
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Tracking Information
First Submitted Date September 9, 2005
First Posted Date September 12, 2005
Last Update Posted Date April 4, 2017
Actual Study Start Date June 2003
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00159601 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Quality of Life and Mental Health in Children and Adolescents
Official Title Quality of Life and Mental Health in Children and Adolescents in a Child and Adolescent Psychiatric Outpatient Clinic and in the Normal Population
Brief Summary The purpose of this study is to investigate different aspects of Quality of Life and mental health in patients under treatment in a child and adolescent psychiatric outpatient clinic and in the normal population.
Detailed Description

Measuring and monitoring Quality of Life in children and youths continues to increase in importance to both researchers and decision makers. Only a limited number of well validated instruments that measure Quality of Life in children exists, and in Norway only few has been translated into Norwegian. Up to date there are no studies investigating the quality of Life in Norwegian child and adolescent psychiatric patients in a longitudinal perspective, compared to the normal population.

Two generic Quality of Life instruments (KINDL, Bullinger & Ravens-Sieberer 2000 and the ILC, Matejatt & Remschmidt 1998) are introduced in Norway by this study in addition to the use of other well established measures like the "Child behaviour Check List" (Achenbach et al. 2001), etc.

Comparisons: 400 patients and their parents in a child psychiatric outpatient clinic 2000 pupils from the normal population in the middle of Norway Repeated measures after 6 months in both groups. In addition a follow up study for the clinical group 3 years after referral started in june 2006.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All patients 8-10 years of age consecutively referred to the child psychiatric outpatient clinic in the period from 1th of June 2003 until 31th of December 2005, having a minimum of two direct contacts with the clinical staff. Follow up study finished in 2008.
Condition
  • Psychiatric Diagnosis
  • Mental Disorders
Intervention Not Provided
Study Groups/Cohorts
  • outpatients in Child and Adolescent Mental Health Service
  • youth from general population
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 3, 2009)
2342
Original Enrollment
 (submitted: September 9, 2005)
2400
Actual Study Completion Date December 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • All children 9-16 years of age, attending the 4th, 6th, 8th or 10th grades at public or private schools with at least 50 pupils, in the period from the 1st of September 2004 until 15th of July 2005 in the county of Sør-Trøndelag. Subjects and parents have to give their informed consent.
  • All patients 8-10 years of age consecutively referred to to the child psychiatric outpatient clinic in the period from the 1st of June 2003 until 31st of December 2005, having a minimum of two direct contacts with the clinical staff. Patients and parents have to give their informed consent.
  • Follow up: Three years after the patients met at the outpatient clinic for the first time.

Exclusion Criteria:

  • Pupils lacking sufficient competence in the Norwegian language, due to foreign background or having a mental developmental level of more than two grades under the respective grade.
  • Patients with psychosis or serious mental retardation.
Sex/Gender
Sexes Eligible for Study: All
Ages 8 Years to 16 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Norway
Removed Location Countries  
 
Administrative Information
NCT Number NCT00159601
Other Study ID Numbers NTNU-47019800
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Norwegian University of Science and Technology
Study Sponsor Norwegian University of Science and Technology
Collaborators
  • Norwegian Council for Mental Health
  • SINTEF Health Research
Investigators
Principal Investigator: Thomas Jozefiak, M.D. NTNU Norwegian University of Science and Technology
PRS Account Norwegian University of Science and Technology
Verification Date March 2017