Prevention of Adolescent Major Depression (CWSA-Fin)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by National Institute for Health and Welfare, Finland.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Helsinki University
University of Eastern Finland
Kuopio University Hospital
City of Vantaa
City of Kuopio
City of Turku
Information provided by (Responsible Party):
Linnea Karlsson, National Institute for Health and Welfare, Finland
ClinicalTrials.gov Identifier:
NCT00611052
First received: January 28, 2008
Last updated: September 30, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention
Depressive Disorder
Behavioral: the Adolescent Coping with Stress
Behavioral: Treatment as usual
Other: usual health education

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: "Adolescents Coping With Stress": Prevention of Adolescent Major Depression in School Health Care

Resource links provided by NLM:


Further study details as provided by National Institute for Health and Welfare, Finland:

Primary Outcome Measures:
  • Major depression (diagnostic interview) High level of depressive symptoms (self-report scale) [ Time Frame: 3 months, 6 months, 12months, 24 months, 36 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Suicidality (diagnostic interview, self-report scale) [ Time Frame: 3 months, 6 months, 12 months, 24 months, 36 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1000
Study Start Date: March 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Group cognitive intervention (the Adolescent Coping with Stress)
Behavioral: 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: 2
Treatment as usual
Behavioral: Treatment as usual
The usual treatment received by the adolescent with mild to moderate self-reported depressive symptoms in school health care.
No Intervention: 3
Healthy controls, receive usual health education in school health care
Other: usual health education
usual health education given by the school nurses, targeted for healthy controls with no depressive symptoms according to the self-report scale

  Eligibility

Ages Eligible for Study:   14 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00611052

Locations
Finland
Kuopio University Hospital and Kuopio University
Kuopio, Finland
Turku Primary Health care and Adolescent Psychiatric clinic
Turku, Finland
Vantaa Primary Health Care
Vantaa, Finland
Sponsors and Collaborators
National Institute for Health and Welfare, Finland
Helsinki University
University of Eastern Finland
Kuopio University Hospital
City of Vantaa
City of Kuopio
City of Turku
Investigators
Study Director: Mauri J Marttunen, Professor National Institute for Health nd Welfare, Dept of Mental Health and Substance Abuse Services
  More Information

No publications provided

Responsible Party: Linnea Karlsson, senior researcher, National Institute for Health and Welfare, Finland
ClinicalTrials.gov Identifier: NCT00611052     History of Changes
Other Study ID Numbers: KTL423-0
Study First Received: January 28, 2008
Last Updated: September 30, 2011
Health Authority: Finland: Ethics Committee

Keywords provided by National Institute for Health and Welfare, Finland:
Depressive Disorder
Depressive Disorder, Major
Mental Health
Prevention

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on October 30, 2014