Efficacity of Psychological Intervention on Reducing the Suicidal Ideations, Depression Level and Improving Reinsertion
Condition: Depressive Symptoms
MeSH terms: Depression; Suicidal Ideation
Study type: Interventional

Summary: 
      Suicide is the third leading cause of death in adolescents and young adults in the United
      States and the second leading cause in European countries.

      Depressive disorders are consistently the most prevalent psychiatric disorder among
      adolescents who attempt suicide with a prevalence ranging from 49% to 64%. Depression in
      adolescent and young adults is a multifactorial phenomenon, as is the risk of suicidal
      attempt. To address such problems, effective and accessible treatment is needed, as
      recommended by the French Health Authority (HAS).

      Our primary objective is to demonstrate that a weekly psychotherapeutic intervention reduces
      the depression level.

      The primary assessment criterion is the variation of the clinician Adolescent Depression
      Rating Scale (ADRSc) from randomisation to month 6.

      The study also aims comparing in the 2 randomised groups

        -  ADRS depression global score (clinician and subject) at 0, 3, 9 and 12 months

        -  Number of suicidal attempts and self-harm attempts at 6 and 12 months

        -  Number of drop-out at 6 and 12 months

        -  Beck's Hopelessness Scale at 0, 3, 6, 9 and 12 months

        -  Global score on the GHQ-28 and scores on the 4 subscales (Somatization, Anxiety and
           Insomnia, Social dysfunction, Depressive mood) at 0, 3, 6, 9 and 12 months.

        -  Working AIliance Inventory (WAI) score at 0, 3, 6, 9 and 12 months
    

Detailed description: 
      Suicide is the third leading cause of death in adolescents and young adults in the United
      States and the second leading cause in European countries. In France, recent epidemiological
      data showed that the suicide rate in adolescents aged 15 to 19 is 4.1/100 000 inhabitants.
      Prevalence of suicidal ideations ranges from 15 to 25% in the general population and lifetime
      estimates of suicide attempts among adolescents range from 1.3 to 3.8% in males and from 1.5
      to 10.1% in females. Reducing suicide and suicide attempts is therefore a key public health
      target.

      Depressive disorders are consistently the most prevalent psychiatric disorder among
      adolescents who attempt suicide with a prevalence ranging from 49% to 64%. Depression in
      adolescent and young adults is a multifactorial phenomenon, as is the risk of suicidal
      attempt.

      Being in a situation of failure at school or not having a clear training or work project
      clearly increases the risk for depression. Some studies have targeted potential high school
      drop outs as a target for prevention of suicidality.

      To address such problems, effective and accessible treatment is needed, as recommended by the
      French Health Authority (HAS). However, only few studies assess, through a randomized
      protocol, efficacity and feasibility of psychotherapeutic treatment in psychiatry in general
      and particularly in this population, although individual psychotherapy is highly recommended
      in clinical practice for depressed adolescents and young adults.

      Our primary objective is to demonstrate that a weekly psychotherapeutic intervention reduces
      the depression level.

      The primary assessment criterion is the variation of the clinician Adolescent Depression
      Rating Scale (ADRSc) from randomisation to month 6.

      Others objectives are the following :

      To compare in the 2 randomised groups

        -  ADRS depression global score (clinician and subject) at 0, 3, 9 and 12 months

        -  Number of suicidal attempts and self-harm attempts at 6 and 12 months

        -  Number of drop-out at 6 and 12 months

        -  Beck's Hopelessness Scale at 0, 3, 6, 9 and 12 months

        -  Global score on the GHQ-28 and scores on the 4 subscales (Somatization, Anxiety and
           Insomnia, Social dysfunction, Depressive mood) at 0, 3, 6, 9 and 12 months.

        -  Working AIliance Inventory (WAI) score at 0, 3, 6, 9 and 12 months

      To describe, in the whole sample (randomised and not randomised),

      - the baseline level of abuse during childhood with the CTQ. The effectiveness of reinsertion
      activities (jobs, diploma, attendance to the Mission Locale) at 0, 3, 6, 9 and 12 months

      To evaluate the sensitivity to change of the French version of the ADRSc.

      330 subjects wil be included to have 132 randomized subjects into two arms: sustained
      psychotherapeutic intervention or usual care.
    

Intervention name(s): weekly psychotherapeutic individual sessions; Usual care
Intervention type(s): Other; Other
Intervention description(s): weekly psychotherapeutic individual sessions following the IPT method during one year; the standard follow-up provided by the Mission Locale, including periodic meetings with a referee
Intervention MeSH terms: Psychotropic Drugs
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study is a comparative, randomised controlled trial that aims at demonstrating the superiority of weekly psychotherapeutic intervention during one year in lowering depression symptoms compared to usual care.
The ratio between intervention and usual care arms will be 1:1.
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Depression; suicidal risk; self-harm behavior; young people