- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00611052
Prevention of Adolescent Major Depression (CWSA-Fin)
April 19, 2016 updated by: Linnea Karlsson, Finnish Institute for Health and Welfare
"Adolescents Coping With Stress": Prevention of Adolescent Major Depression in School Health Care
The main purpose of this study is to assess the effect of a cognitive group intervention on prevention of major depression in 14-15-year-old adolescents.
Moreover, the effect on other selected mental health parameters are investigated.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
65
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Kuopio, Finland
- Kuopio University Hospital and Kuopio University
-
Turku, Finland
- Turku Primary Health care and Adolescent Psychiatric clinic
-
Vantaa, Finland
- Vantaa Primary Health Care
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 16 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- mild to moderate level depressive symptoms (RBDI self-report scale)
- adequate knowledge of the Finnish language
- informed consent from the adolescent (all) and his/her parent (under 15 years)
- healthy controls comprise subjects with no depressive symptoms
Exclusion Criteria:
- ongoing major depression, dysthymia or bipolar disorder
- ongoing other severe psychiatric illness precluding group participation
- mental retardation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 2
Treatment as usual
|
The usual treatment received by the adolescent with mild to moderate self-reported depressive symptoms in school health care.
|
|
Experimental: 1
Group cognitive intervention (the Adolescent Coping with Stress)
|
A group cognitive intervention, manualized and highly structured.
Includes 8 sessions (á 1.5 hours) and a booster session 6 months after termination of the actual intervention.
Groups leaders are specifically trained for this course.
|
|
Active Comparator: 3
Healthy controls, receive usual health education in school health care
|
usual health education given by the school nurses, targeted for healthy controls with no depressive symptoms according to the self-report scale
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Major depression (diagnostic interview) High level of depressive symptoms (self-report scale)
Time Frame: 3 months, 6 months, 12months, 24 months, 36 months
|
3 months, 6 months, 12months, 24 months, 36 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Suicidality (diagnostic interview, self-report scale)
Time Frame: 3 months, 6 months, 12 months, 24 months, 36 months
|
3 months, 6 months, 12 months, 24 months, 36 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Mauri J Marttunen, Professor, National Institute for Health nd Welfare, Dept of Mental Health and Substance Abuse Services
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2008
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
January 28, 2008
First Submitted That Met QC Criteria
February 7, 2008
First Posted (Estimate)
February 8, 2008
Study Record Updates
Last Update Posted (Estimate)
April 20, 2016
Last Update Submitted That Met QC Criteria
April 19, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KTL423-0
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.