Psychiatric DiagnosisNCT00159601
Quality of Life and Mental Health in Children and Adolescents
An observational study of Psychiatric Diagnosis and Mental Disorders, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Psychiatric Diagnosis, Mental Disorders
- How many people
- 2,342 participants
- Where
- 1 siteNorway
- Study dates
- Jun 2003to Dec 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 16 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Norway1 site
NTNU Norwegian University of Science and Technology
Trondheim, NO-7489
About this study
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
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.
Read the 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.
- Conditions
- Psychiatric Diagnosis, Mental Disorders
- Keywords
- Quality of Life, Mental health, Children, Adolescents, Normal population
- Medical subject headings
- Mental Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| outpatients in Child and Adolescent Mental Health Service | Not described | |
| youth from general population | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJun 2003
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Psychiatric DiagnosisStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2,342 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Council for Mental Health, SINTEF Health Research
- Responsible party
- Sponsor
- Investigators
- Thomas Jozefiak, M.D., Principal investigator, NTNU Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00159601
- Sponsor's protocol ID
- NTNU-47019800
- Status last verified
- Mar 2017
- First submitted
- 9 Sep 2005
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jozefiak T, Sonnichsen Kayed N. Self- and proxy reports of quality of life among adolescents living in residential youth care compared to adolescents in the general population and mental health services. Health Qual Life Outcomes. 2015 Jul 22;13:104. doi: 10.1186/s12955-015-0280-y.
PubMed 26197764Jozefiak T, Larsson B, Wichstrom L, Wallander J, Mattejat F. Quality of Life as reported by children and parents: a comparison between students and child psychiatric outpatients. Health Qual Life Outcomes. 2010 Nov 22;8:136. doi: 10.1186/1477-7525-8-136.
PubMed 21092189
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00159601
- Acronym / sponsor ID
- NTNU-47019800
- Conditions
- Psychiatric Diagnosis, Mental Disorders
- Keywords
- Quality of Life, Mental health, Children, Adolescents, Normal population
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,342 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Norwegian Council for Mental Health, SINTEF Health Research
- Study start
- Jun 2003 (actual)
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| outpatients in Child and Adolescent Mental Health Service | – | – |
| youth from general population | – | – |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
- Results publication: PubMed 26197764Jozefiak T, Sonnichsen Kayed N. Self- and proxy reports of quality of life among adolescents living in residential youth care compared to adolescents in the general population and mental health services. Health Qual Life Outcomes. 2015 Jul 22;13:104. doi: 10.1186/s12955-015-0280-y.
- Results publication: PubMed 21092189Jozefiak T, Larsson B, Wichstrom L, Wallander J, Mattejat F. Quality of Life as reported by children and parents: a comparison between students and child psychiatric outpatients. Health Qual Life Outcomes. 2010 Nov 22;8:136. doi: 10.1186/1477-7525-8-136.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Jozefiak, M.D. principal investigator
NTNU Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychiatric Diagnosis and Mental Disorders, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00159601, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2017; AzTrials last refreshed its copy on 8 Nov 2026.