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

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

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

Study Overview

• Status: Completed
• Conditions: Depressive Symptoms
• Intervention / Treatment: Other: weekly psychotherapeutic individual sessions; Other: Usual care

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.

• Study Type: Interventional
• Enrollment (Actual): 159
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75018
    • Bichat Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention arm; follow weekly psychotherapeutic individual sessions following the IPT method during one year.	Other: weekly psychotherapeutic individual sessions; weekly psychotherapeutic individual sessions following the IPT method during one year; Other: Usual care; the standard follow-up provided by the Mission Locale, including periodic meetings with a referee
Experimental: usual care arm; continue with the standard follow-up provided by the Mission Locale, including periodic meetings with a referee	Other: Usual care; the standard follow-up provided by the Mission Locale, including periodic meetings with a referee

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression level	Defined as the difference of ADRS clinician score (cf. Appendix 18.2.1) between inclusion and 6 month.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
depression assessed at 0, 3, 9 and 12 months	The ADRSc (clinician) questionnaire will be filled out by the assessor at 0, 3 and 9 and 12 months during follow-up visits	at 0, 3, 9 and 12 months
suicidal attempts and self-harm attempts	The number of suicidal attempts and self-harm attempts, at 6 and 12 months	at 6 and 12 months
drop out	The number of drop outs at baseline, 6 and 12 months	at baseline, 6 and 12 months
time of the hopelessness	The evolution on time of the hopelessness, assessed at 0, 3, 6, 9 and 12 months	t 0, 3, 6, 9 and 12 months
global score on the GHQ28	5. The evolution on time of the global score on the GHQ28 and on its 4 subscales (Somatization, Anxiety and Insomnia, Social dysfunction, Depressive mood), assessed at 0, 3, 6, 9 and 12 months	at 0, 3, 6, 9 and 12 months
working aIliance	The evolution on time of the working aIliance at 0, 3, 6, 9 and 12 months	at 0, 3, 6, 9 and 12 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Antoine Guedeney, PhD, APHP

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2018
• Primary Completion (Actual): March 31, 2021
• Study Completion (Actual): April 30, 2021

Study Registration Dates

• First Submitted: August 30, 2018
• First Submitted That Met QC Criteria: August 30, 2018
• First Posted (Actual): August 31, 2018

Study Record Updates

• Last Update Posted (Actual): June 28, 2021
• Last Update Submitted That Met QC Criteria: June 25, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Depression; young people; suicidal risk; self-harm behavior
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Depression; Suicidal Ideation; Psychotropic Drugs
• Other Study ID Numbers: K170104-J; 2018-A01255-50 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No