Efficacity of Psychological Intervention on Reducing the Suicidal Ideations, Depression Level and Improving Reinsertion — MLADO  

Depressive Symptoms Clinical Trial

Official title: 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

Status Completed

Clinical Trial 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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Depression
• Depressive Symptoms
• Suicidal Ideation

• NCT number: NCT03655730
• Study type: Interventional
• Source: Assistance Publique - Hôpitaux de Paris
• Status: Completed
• Phase: N/A
• Start date: December 3, 2018
• Completion date: April 30, 2021