Effectiveness Trial of the French Blues Indicated Depression Prevention Program (French Blues)
Primary Purpose
Depression
Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Blues program
Sponsored by
About this trial
This is an interventional prevention trial for Depression focused on measuring Depression, Prevention, Adolescents, School, Effectiveness
Eligibility Criteria
Inclusion Criteria:
- Elevated depressive symptoms (score of 20 or above on the Center for Epidemiological Studies - Depression screening questionnaire)
Exclusion Criteria:
- Current major depression diagnosis
- Current active suicidal behaviors
- Being in a special school curriculum for academic or behavioral problems
Sites / Locations
- Université de Montréal
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Blues program
Control
Arm Description
Participants will attend 6 weekly 1-hour sessions of group cognitive-behavioral therapy administered by school staff, and will do home practice between sessions and after the program individually using a web site (called the Blues App)
Participants will receive a brochure describing the nature, causes, and consequences of depression, as well as available prevention/treatment options
Outcomes
Primary Outcome Measures
Number of participants who develop a major depressive episode as measured using the SCID diagnostic interview (posttest, 6 month follow-up)
Change in depressive symptoms as measured using continuous SCID scores (baseline, posttest, 6-month follow-up)
Change in depressive symptoms as measured using the CES-D questionnaire (baseline, posttest, 6-month follow-up)
Change in depressive symptoms as measured using the PHQ-9 questionnaire (baseline, posttest, 6-month follow-up)
Secondary Outcome Measures
Change in social adjustment as measured using "Évaluation sociale de Soi chez les jeunes adultes" questionnaire (Michaud et al., 2006) (baseline, posttest, 6-month follow-up)
Change in anxiety symptoms as measured using the SCAS questionnaire (baseline, posttest, 6-month follow-up)
Change in parent-child relationship as measured using a scale from the MASPAQ questionnaire (Leblanc, 1996) (baseline, posttest, 6-month follow-up)
Change in affective school engagement as measured using a subscale of the school engagement questionnaire (Archambault et al., 2009) (baseline, posttest, 6-month follow-up)
Change in substance use as measured using a scale from the MASPAQ questionnaire (Leblanc, 1996) (baseline, posttest, 6-month follow-up)
Change in delinquent behaviors as measured using a scale from the MASPAQ questionnaire (Leblanc, 1996) (baseline, posttest, 6-month follow-up)
Full Information
NCT ID
NCT02731053
First Posted
March 15, 2016
Last Updated
September 26, 2017
Sponsor
Université de Montréal
1. Study Identification
Unique Protocol Identification Number
NCT02731053
Brief Title
Effectiveness Trial of the French Blues Indicated Depression Prevention Program
Acronym
French Blues
Official Title
Pilot Effectiveness Trial of the French Blues Indicated Depression Prevention Program
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Montréal
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this pilot study is to test the effectiveness of French adaptation of the Blues program, a school-based indicated depression prevention intervention. The program will be delivered by the endogenous psycho-social staff of 3 Montreal secondary schools to adolescents with sub-clinical depressive symptoms and compared to a no-intervention (Informational Brochure only) control condition, designed to represent the "usual intervention" in these schools.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, Prevention, Adolescents, School, Effectiveness
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Blues program
Arm Type
Experimental
Arm Description
Participants will attend 6 weekly 1-hour sessions of group cognitive-behavioral therapy administered by school staff, and will do home practice between sessions and after the program individually using a web site (called the Blues App)
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants will receive a brochure describing the nature, causes, and consequences of depression, as well as available prevention/treatment options
Intervention Type
Behavioral
Intervention Name(s)
Blues program
Intervention Description
Participants will attend 6 weekly 1-hour sessions of group cognitive-behavioral therapy administered by school staff, and will do home practice between sessions and after the program individually using a web site (called the Blues App)
Primary Outcome Measure Information:
Title
Number of participants who develop a major depressive episode as measured using the SCID diagnostic interview (posttest, 6 month follow-up)
Time Frame
6 months
Title
Change in depressive symptoms as measured using continuous SCID scores (baseline, posttest, 6-month follow-up)
Time Frame
6 months
Title
Change in depressive symptoms as measured using the CES-D questionnaire (baseline, posttest, 6-month follow-up)
Time Frame
6 months
Title
Change in depressive symptoms as measured using the PHQ-9 questionnaire (baseline, posttest, 6-month follow-up)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in social adjustment as measured using "Évaluation sociale de Soi chez les jeunes adultes" questionnaire (Michaud et al., 2006) (baseline, posttest, 6-month follow-up)
Time Frame
6 months
Title
Change in anxiety symptoms as measured using the SCAS questionnaire (baseline, posttest, 6-month follow-up)
Time Frame
6 months
Title
Change in parent-child relationship as measured using a scale from the MASPAQ questionnaire (Leblanc, 1996) (baseline, posttest, 6-month follow-up)
Time Frame
6 months
Title
Change in affective school engagement as measured using a subscale of the school engagement questionnaire (Archambault et al., 2009) (baseline, posttest, 6-month follow-up)
Time Frame
6 months
Title
Change in substance use as measured using a scale from the MASPAQ questionnaire (Leblanc, 1996) (baseline, posttest, 6-month follow-up)
Time Frame
6 months
Title
Change in delinquent behaviors as measured using a scale from the MASPAQ questionnaire (Leblanc, 1996) (baseline, posttest, 6-month follow-up)
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Elevated depressive symptoms (score of 20 or above on the Center for Epidemiological Studies - Depression screening questionnaire)
Exclusion Criteria:
Current major depression diagnosis
Current active suicidal behaviors
Being in a special school curriculum for academic or behavioral problems
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederic N Briere, PhD
Organizational Affiliation
Université de Montréal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Université de Montréal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
h3t 1j4
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
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Effectiveness Trial of the French Blues Indicated Depression Prevention Program
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