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Effectiveness Trial of the French Blues Indicated Depression Prevention Program (French Blues)

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ClinicalTrials.gov Identifier: NCT02731053
Recruitment Status : Completed
First Posted : April 7, 2016
Last Update Posted : September 28, 2017
Sponsor:
Information provided by (Responsible Party):
Frédéric N. Brière, PhD, Université de Montréal

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.

Condition or disease Intervention/treatment Phase
Depression Behavioral: Blues program Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Pilot Effectiveness Trial of the French Blues Indicated Depression Prevention Program
Study Start Date : March 2016
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Blues program
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)
Behavioral: Blues program
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)

No Intervention: Control
Participants will receive a brochure describing the nature, causes, and consequences of depression, as well as available prevention/treatment options



Primary Outcome Measures :
  1. 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 ]
  2. Change in depressive symptoms as measured using continuous SCID scores (baseline, posttest, 6-month follow-up) [ Time Frame: 6 months ]
  3. Change in depressive symptoms as measured using the CES-D questionnaire (baseline, posttest, 6-month follow-up) [ Time Frame: 6 months ]
  4. Change in depressive symptoms as measured using the PHQ-9 questionnaire (baseline, posttest, 6-month follow-up) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. 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 ]
  2. Change in anxiety symptoms as measured using the SCAS questionnaire (baseline, posttest, 6-month follow-up) [ Time Frame: 6 months ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]


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Ages Eligible for Study:   14 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02731053


Locations
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Canada, Quebec
Université de Montréal
Montréal, Quebec, Canada, h3t 1j4
Sponsors and Collaborators
Université de Montréal
Investigators
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Principal Investigator: Frederic N Briere, PhD Université de Montréal

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Responsible Party: Frédéric N. Brière, PhD, Principal Investigator, Université de Montréal
ClinicalTrials.gov Identifier: NCT02731053     History of Changes
Other Study ID Numbers: FRQSC2016-NP-191870
First Posted: April 7, 2016    Key Record Dates
Last Update Posted: September 28, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Frédéric N. Brière, PhD, Université de Montréal:
Depression
Prevention
Adolescents
School
Effectiveness

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