Efficacity of Psychological Intervention on Reducing the Suicidal Ideations, Depression Level and Improving Reinsertion (MLADO)
Primary Purpose
Depressive Symptoms
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
weekly psychotherapeutic individual sessions
Usual care
Sponsored by
About this trial
This is an interventional prevention trial for Depressive Symptoms focused on measuring Depression, suicidal risk, self-harm behavior, young people
Eligibility Criteria
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).
Sites / Locations
- Bichat hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
intervention arm
usual care arm
Arm Description
follow weekly psychotherapeutic individual sessions following the IPT method during one year.
continue with the standard follow-up provided by the Mission Locale, including periodic meetings with a referee
Outcomes
Primary Outcome Measures
Depression level
Defined as the difference of ADRS clinician score (cf. Appendix 18.2.1) between inclusion and 6 month.
Secondary Outcome Measures
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
suicidal attempts and self-harm attempts
The number of suicidal attempts and self-harm attempts, at 6 and 12 months
drop out
The number of drop outs 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
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
working aIliance
The evolution on time of the working aIliance at 0, 3, 6, 9 and 12 months
Full Information
NCT ID
NCT03655730
First Posted
August 30, 2018
Last Updated
June 25, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT03655730
Brief Title
Efficacity of Psychological Intervention on Reducing the Suicidal Ideations, Depression Level and Improving Reinsertion
Acronym
MLADO
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
December 3, 2018 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
April 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Symptoms
Keywords
Depression, suicidal risk, self-harm behavior, young people
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigator
Allocation
Randomized
Enrollment
159 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intervention arm
Arm Type
Experimental
Arm Description
follow weekly psychotherapeutic individual sessions following the IPT method during one year.
Arm Title
usual care arm
Arm Type
Experimental
Arm Description
continue with the standard follow-up provided by the Mission Locale, including periodic meetings with a referee
Intervention Type
Other
Intervention Name(s)
weekly psychotherapeutic individual sessions
Intervention Description
weekly psychotherapeutic individual sessions following the IPT method during one year
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
the standard follow-up provided by the Mission Locale, including periodic meetings with a referee
Primary Outcome Measure Information:
Title
Depression level
Description
Defined as the difference of ADRS clinician score (cf. Appendix 18.2.1) between inclusion and 6 month.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
depression assessed at 0, 3, 9 and 12 months
Description
The ADRSc (clinician) questionnaire will be filled out by the assessor at 0, 3 and 9 and 12 months during follow-up visits
Time Frame
at 0, 3, 9 and 12 months
Title
suicidal attempts and self-harm attempts
Description
The number of suicidal attempts and self-harm attempts, at 6 and 12 months
Time Frame
at 6 and 12 months
Title
drop out
Description
The number of drop outs at baseline, 6 and 12 months
Time Frame
at baseline, 6 and 12 months
Title
time of the hopelessness
Description
The evolution on time of the hopelessness, assessed at 0, 3, 6, 9 and 12 months
Time Frame
t 0, 3, 6, 9 and 12 months
Title
global score on the GHQ28
Description
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
Time Frame
at 0, 3, 6, 9 and 12 months
Title
working aIliance
Description
The evolution on time of the working aIliance at 0, 3, 6, 9 and 12 months
Time Frame
at 0, 3, 6, 9 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoine Guedeney, PhD
Organizational Affiliation
APHP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bichat hospital
City
Paris
ZIP/Postal Code
75018
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Efficacity of Psychological Intervention on Reducing the Suicidal Ideations, Depression Level and Improving Reinsertion
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