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临床试验/NCT02731053
NCT02731053已完成4 期

Pilot Effectiveness Trial of the French Blues Indicated Depression Prevention Program

Université de Montréal2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2016年3月最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
72
试验地点
2
主要终点
Change in depressive symptoms as measured using continuous SCID scores (baseline, posttest, 6-month follow-up)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
14 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

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)

干预措施: Blues program (Behavioral)

Control

No Intervention

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

结局指标

主要结局

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

时间窗: 6 months

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

时间窗: 6 months

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

时间窗: 6 months

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

时间窗: 6 months

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Frédéric N. Brière, PhD

Principal Investigator

Université de Montréal

研究点 (2)

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