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Completed

NCT Number: NCT02731053

Effectiveness Trial of the French Blues Indicated Depression Prevention Program

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

14 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Université de Montréal

Montreal, Quebec, h3t 1j4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blues program

Behavioral

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Université de Montréal

Other

Registry information

Official study title

Pilot Effectiveness Trial of the French Blues Indicated Depression Prevention Program

Acronym: French Blues

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 7, 2016
Registry last updated
Sep 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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