Quality of Life and Mental Health in Children and Adolescents - Full Text View

Sponsors and Collaborators:	Norwegian University of Science and Technology Norwegian National Council of Mental Health SINTEF Health Research
Information provided by:	Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:	NCT00159601

Purpose

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.

Condition	Intervention	Phase
Psychiatric Diagnosis Mental Disorders	Behavioral: General child psychiatric interventions	Phase II Phase III

MedlinePlus related topics: Child Mental Health Mental Health

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective
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

Further study details as provided by Norwegian University of Science and Technology:

Estimated Enrollment:	2400
Study Start Date:	June 2003
Estimated Study Completion Date:	December 2009
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Usual daily child psychiatric treatment

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.

Eligibility

Ages Eligible for Study:	8 Years to 16 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Study Population

All patients 8-10 years of age consecutively referred to to the childpsychiatric 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.

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00159601

Contacts

Contact: Thomas Jozefiak, M.D.

+47 73 59 01 56

thomas.jozefiak@ntnu.no

Locations

Norway
NTNU Norwegian University of Science and Technology	Recruiting
Trondheim, Norway, NO-7489
Contact: Thomas Jozefiak, M.D. +4773590156 thomas.jozefiak@ntnu.no
Contact: BO LARSSON, Prof +4773551500 bo.larsson@ntnu.no
Principal Investigator: Thomas Jozefiak, M.D.

Sponsors and Collaborators

Norwegian University of Science and Technology

Norwegian National Council of Mental Health

SINTEF Health Research

Investigators

Principal Investigator:

Thomas Jozefiak, M.D.

NTNU Norwegian University of Science and Technology

More Information

Responsible Party:	Norwegian University of Science and Technology ( MD Thomas Jozefiak )
Study ID Numbers:	NTNU-47019800, RHP-2004/2/0319
Study First Received:	September 9, 2005
Last Updated:	January 23, 2008
ClinicalTrials.gov Identifier:	NCT00159601
Health Authority:	Norway: Norwegian Social Science Data Services

Keywords provided by Norwegian University of Science and Technology:

Quality of Life
Mental health
Children

Adolescents
Childpsychiatry
Normal population

Study placed in the following topic categories:

Mental Disorders
Quality of Life

ClinicalTrials.gov processed this record on January 14, 2009