Efficacity of a Sustained Weekly Psychological Intervention for Adolescents and Young Adults Attending to Local Missions for Reinsertion, on Reducing the Suicidal Ideations, Depression Level and Improving Reinsertion Compared to Usual Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 159
- 试验地点
- 1
- 主要终点
- Depression level
研究概览
简要总结
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
详细描述
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.
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, Investigator)
入排标准
- 年龄范围
- 16 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be followed in one of the five participating centres of Mission Locale in Paris,
- •Be between 16 (inclusive) and 25 (inclusive) years old at the date of inclusion,
- •Agrees to participate in the research and, in the case of a minor, the legal representant agrees with the subject's participation in research.
- •Have a Social Security number
- •Be fluent in French
- •With signed informed consent
排除标准
- •Be already followed in a mental health/addiction service, attending to a private or public psychiatric service, or abusing drugs.
- •Randomisation criteria :
- •Included subjects will be randomised if at least one of the following conditions is met: baseline ADRSc score greater or equal than 8 or abuse and/or deprivation according to the Childhood Trauma Questionnaire (CTQ, short version):
- •score greater or equal than 11 relative to physical abuse
- •score greater or equal than 16 relative to emotional abuse
- •score greater or equal than 14 relative to physical deprivation
- •score greater or equal than 11 relative to sexual abuse).
研究组 & 干预措施
intervention arm
follow weekly psychotherapeutic individual sessions following the IPT method during one year.
干预措施: weekly psychotherapeutic individual sessions (Other)
intervention arm
follow weekly psychotherapeutic individual sessions following the IPT method during one year.
干预措施: Usual care (Other)
usual care arm
continue with the standard follow-up provided by the Mission Locale, including periodic meetings with a referee
干预措施: Usual care (Other)
结局指标
主要结局
Depression level
时间窗: 6 months
Defined as the difference of ADRS clinician score (cf. Appendix 18.2.1) between inclusion and 6 month.
次要结局
- drop out(at baseline, 6 and 12 months)
- time of the hopelessness(t 0, 3, 6, 9 and 12 months)
- global score on the GHQ28(at 0, 3, 6, 9 and 12 months)
- depression assessed at 0, 3, 9 and 12 months(at 0, 3, 9 and 12 months)
- suicidal attempts and self-harm attempts(at 6 and 12 months)
- working aIliance(at 0, 3, 6, 9 and 12 months)