NCT02731053

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P25-P50 for phase_4 depression

Timeline
Completed

Started Mar 2016

Shorter than P25 for phase_4 depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

March 15, 2016

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 7, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

September 28, 2017

Status Verified

September 1, 2017

Enrollment Period

8 months

First QC Date

March 15, 2016

Last Update Submit

September 26, 2017

Conditions

Depression

Keywords

DepressionPreventionAdolescentsSchoolEffectiveness

Outcome Measures

Primary Outcomes (4)

  • Number of participants who develop a major depressive episode as measured using the SCID diagnostic interview (posttest, 6 month follow-up)

    6 months

  • Change in depressive symptoms as measured using continuous SCID scores (baseline, posttest, 6-month follow-up)

    6 months

  • Change in depressive symptoms as measured using the CES-D questionnaire (baseline, posttest, 6-month follow-up)

    6 months

  • Change in depressive symptoms as measured using the PHQ-9 questionnaire (baseline, posttest, 6-month follow-up)

    6 months

Secondary Outcomes (6)

  • 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)

    6 months

  • Change in anxiety symptoms as measured using the SCAS questionnaire (baseline, posttest, 6-month follow-up)

    6 months

  • Change in parent-child relationship as measured using a scale from the MASPAQ questionnaire (Leblanc, 1996) (baseline, posttest, 6-month follow-up)

    6 months

  • 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)

    6 months

  • Change in substance use as measured using a scale from the MASPAQ questionnaire (Leblanc, 1996) (baseline, posttest, 6-month follow-up)

    6 months

  • +1 more secondary outcomes

Study Arms (2)

Blues program

EXPERIMENTAL

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

Control

NO INTERVENTION

Participants will receive a brochure describing the nature, causes, and consequences of depression, as well as available prevention/treatment options

Interventions

Blues programBEHAVIORAL

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)

Blues program

Eligibility Criteria

Age14 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Elevated depressive symptoms (score of 20 or above on the Center for Epidemiological Studies - Depression screening questionnaire)

You may not qualify if:

  • Current major depression diagnosis
  • Current active suicidal behaviors
  • Being in a special school curriculum for academic or behavioral problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Université de Montréal

Montreal, Quebec, h3t 1j4, Canada

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Frederic N Briere, PhD

    Université de Montréal

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 15, 2016

First Posted

April 7, 2016

Study Start

March 1, 2016

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

September 28, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)