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Prevention of Adolescent Major Depression (CWSA-Fin)

Primary Purpose

Depressive Disorder

Status

Terminated

Phase

Not Applicable

Locations

Finland

Study Type

Interventional

Intervention

the Adolescent Coping with Stress

Treatment as usual

usual health education

About this trial

This is an interventional prevention trial for Depressive Disorder focused on measuring Depressive Disorder, Depressive Disorder, Major, Mental Health, Prevention

Eligibility Criteria

14 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Kuopio University Hospital and Kuopio University
Turku Primary Health care and Adolescent Psychiatric clinic
Vantaa Primary Health Care

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Group cognitive intervention (the Adolescent Coping with Stress)

Treatment as usual

Healthy controls, receive usual health education in school health care

Outcomes

Primary Outcome Measures

Major depression (diagnostic interview) High level of depressive symptoms (self-report scale)

Secondary Outcome Measures

Suicidality (diagnostic interview, self-report scale)

Full Information

NCT ID

NCT00611052

First Posted

January 28, 2008

Last Updated

April 19, 2016

Sponsor

Finnish Institute for Health and Welfare

Collaborators

University of Helsinki, University of Eastern Finland, Kuopio University Hospital, City of Vantaa, City of Kuopio, City of Turku

1. Study Identification

Unique Protocol Identification Number

NCT00611052

Brief Title

Prevention of Adolescent Major Depression

Acronym

CWSA-Fin

Official Title

"Adolescents Coping With Stress": Prevention of Adolescent Major Depression in School Health Care

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Terminated

Why Stopped

Unsuccessful recruitment, failed training of the group leaders leading into lack of study groups

Study Start Date

March 2008 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Finnish Institute for Health and Welfare

Collaborators

University of Helsinki, University of Eastern Finland, Kuopio University Hospital, City of Vantaa, City of Kuopio, City of Turku

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depressive Disorder

Keywords

Depressive Disorder, Depressive Disorder, Major, Mental Health, Prevention

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Non-Randomized

Enrollment

65 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Group cognitive intervention (the Adolescent Coping with Stress)

Arm Title

Arm Type

Active Comparator

Arm Description

Treatment as usual

Arm Title

Arm Type

Active Comparator

Arm Description

Healthy controls, receive usual health education in school health care

Intervention Type

Behavioral

Intervention Name(s)

the Adolescent Coping with Stress

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Treatment as usual

Intervention Description

The usual treatment received by the adolescent with mild to moderate self-reported depressive symptoms in school health care.

Intervention Type

Other

Intervention Name(s)

usual health education

Intervention Description

usual health education given by the school nurses, targeted for healthy controls with no depressive symptoms according to the self-report scale

Primary Outcome Measure Information:

Title

Major depression (diagnostic interview) High level of depressive symptoms (self-report scale)

Time Frame

3 months, 6 months, 12months, 24 months, 36 months

Secondary Outcome Measure Information:

Title

Suicidality (diagnostic interview, self-report scale)

Time Frame

3 months, 6 months, 12 months, 24 months, 36 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mauri J Marttunen, Professor

Organizational Affiliation

National Institute for Health nd Welfare, Dept of Mental Health and Substance Abuse Services

Official's Role

Study Director

Facility Information:

Facility Name

Kuopio University Hospital and Kuopio University

City

Kuopio

Country

Finland

Facility Name

Turku Primary Health care and Adolescent Psychiatric clinic

City

Turku

Country

Finland

Facility Name

Vantaa Primary Health Care

City

Vantaa

Country

Finland

12. IPD Sharing Statement

Learn more about this trial

Prevention of Adolescent Major Depression

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