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Trial record 2 of 2 for:    LACHAL | paris, France

Assessment of Transcultural Psychotherapy in Child Major Depressive Disorder (EDPT-ADOS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04206969
Recruitment Status : Not yet recruiting
First Posted : December 20, 2019
Last Update Posted : December 20, 2019
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

The symptomatic and clinical expression of psychiatric disorders in children and adolescents is strongly influenced by the cultural setting they are growing up in. These cultural variations complicate psychiatric care, especially for migrant children, for whom appropriate care must be designed.

Transcultural psychotherapy is an original psychotherapeutic technique developed to meet these specific requirements in France and in different European and American countries. Its theoretical and methodological foundations rest on the works of George Devereux in ethnopsychiatry (1970). A psychotherapeutic technique intended for first-generation migrants was developed by Tobie Nathan and coll (1986). Marie-Rose Moro and colleagues (1990) have adapted this technique to second-generation migrants.

Indicated as a second-line treatment after the failure of standard management, this technique is fully formalized today. It comprises group consultations for the child and the family as a one-hour session each month, directed by a principal therapist, assisted by a group of co-therapists (of diverse cultural origins and occupations) and an interpreter in the family's mother tongue. The concept of culture is used to establish the therapeutic alliance, decode the symptoms, and propose treatment.

The children and adolescents receiving this treatment have varied psychopathological profiles, mostly involving depressive and/or anxiety disorders. Specifically, migrants' children are especially vulnerable to depression, their psychiatric care is generally longer and less effective than in the general population, and their rate of treatment failure higher.

Transcultural psychotherapy has demonstrated its value in these situations in numerous qualitative studies, but its efficacy has not yet been assessed by a method providing a high level of evidence, such as randomized controlled trials.


Condition or disease Intervention/treatment Phase
Major Depressive Disorder Behavioral: Transcultural psychotherapy Not Applicable

Detailed Description:
Mixed method study using a multicenter, Bayesian randomized clinical trial with blinded evaluation of the primary outcome. Two parallel groups of 40 children or adolescents from 6 to 20 years-old and their family will be included. In the experimental group, patients will attend six sessions of transcultural therapy in addition to usual care. The improved Clinical Global Impression scale scores at 6 months will be compared across groups. Qualitative analysis of families and therapists' interviews will allow to specify the therapeutic processes and acceptability of the therapy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Assessment of Transcultural Psychotherapy to Treat Major Depressive Disorder in Children and Adolescents From Migrant Families: a Bayesian Randomized Controlled Trial
Estimated Study Start Date : February 2020
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Transcultural psychotherapy
In addition to usual care, the participants in the treatment group receive transcultural psychotherapy in the inclusion centers, which consists of 5 sessions every 7 weeks (W6, W13, W20, W27, and W34). During all the research process, participants from both groups continue their usual care provided by the referent medical team outside the inclusion center.
Behavioral: Transcultural psychotherapy
In addition to usual care, the participants receive transcultural psychotherapy

No Intervention: standard care
usual care provided by the referent medical team



Primary Outcome Measures :
  1. Severity Score on the Improved Global Impression Scale (iCGI) to assess remission [ Time Frame: at week 34 visit (v5) ]

    .iCGI score is a scale ranging from 1 to 7, 1 being Normal, not at all ill, and 7 - Among the most extremely ill patients.

    1. - Normal, not at all ill
    2. - Borderline mentally ill
    3. - Mildly ill
    4. - Moderately ill
    5. - Markedly ill
    6. - Severely ill
    7. - Among the most extremely ill patients

    Remission is defined as a mean iCGI score over the 3 experts <4 at 28 weeks of treatment (W34).



Secondary Outcome Measures :
  1. Severity score on the iCGI [ Time Frame: at baseline and weeks 6, 13, 20, 27 and 34 and 52 ]
    To compare the course of the severity of depression in each group over the first 34 weeks after inclusion

  2. Score on the French version of the Children's Depression Rating Scale-Revised (CDRS-R) [ Time Frame: at baseline and weeks 6, 13, 20, 27 and 34 and 52 ]

    It's a 17-item scale with answers on 5 or 7-point Likert scale (total score ranges from 17 to 113). A score ≥ 40 is indicative of depression, whereas a score ≤28 is often used to define remission.

    To compare the course of the level of depressive symptoms in each group over the first 34 weeks after inclusion


  3. Score on the French version of the State-Trait Anxiety Inventory for children (STAI-C) [ Time Frame: at baseline and weeks 6, 13, 20, 27 and 34 and 52 ]
    To compare the course of the level of anxiety symptoms in each group over the first 34 weeks after inclusion

  4. Score changes in Depression and anxiety Scores between Week 34 and week 52 [ Time Frame: at 34 and 52 weeks ]
    To evaluate the persistence of the efficacy of transcultural psychiatry over time by describing the course of the severity of the depression and of the depressive and anxiety symptoms from 34 to 52 weeks after inclusion in the group of patients treated by transcultural psychotherapy during the first 34 weeks

  5. analysis of the content of the clinical data collected during the visits [ Time Frame: between 34 and 44 weeks ]
    To describe the therapeutic processes that enabled the improvement of patients treated by transcultural psychotherapy

  6. analysis of the content of the interview with the families and therapists at the end of the treatment [ Time Frame: between 34 and 44 weeks ]
    For this secondary objective concerning the group of patients treated by transcultural psychotherapy, a qualitative design will be used to explore the perceived efficacity and acceptability of the therapy. Investigators will organize two semi-structured interviews after the fifth therapy session. These semi-structured interviews will be conducted by a psychologist trained in transcultural care. One interview will concern the family and will explore, with the help of an interpreter speaking the native language of the family, the acceptability of the care as well as success factors identified by the family. The other interview will concern the therapists and will explore the success factors identified by the professionals. The interviews guides have been constructed by specialists of transcultural care in childhood and adolescence To describe the perceived efficacy and acceptability of the transcultural psychotherapy for the patient and the family



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Ages Eligible for Study:   6 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be a child aged or an adolescent aged 6-20 years-old (this may be a declaratory age at the time of the consultation or based on a document for a residence request if no other identity documents are available)
  • Be a first or second-generation migrant (born abroad or born from at least one parent who is born abroad)
  • Have a psychological and/or psychiatric follow-up by a first-line care
  • Have been referred for transcultural psychotherapy by their first line care to treat depression resistant to standard management.
  • Present a depression according to the clinician who proposes the transcultural treatment (first line therapist), based on usual as well as cultural symptoms criteria of the below list:

    • Sadness
    • Diminish interest or pleasure in most of the usual activities
    • Insomnia or hypersomnia
    • Psychomotor agitation
    • Asthenia, loss of energy
    • Feeling of worthlessness or excessive guilt
    • Recurrent throughs of death
    • School problems (school failure, drop in grades, aggressivity with adult, school refusal…)
    • Mutism, and selective mutism
    • Runaways
    • Aggressivity
    • Impulsivity
    • Violence and delinquency
    • Conflicts with parents and adults from the community
    • Exclusion from family
    • Somatic pains
    • Massive separation anxiety
    • Regressive symptoms - loosing of an already acquired function such as speech, walk, stay alone for a sufficient time in relation to age, manage stress or anxiety for reasonable situations…
    • Denial of medical care for a chronic disease with no evident reasons
    • Cultural designation such as possessed by a spirit, being a child witch, or other cultural designations
    • State of trance The list is not exhaustive, and some other symptoms may be accepted if the first line clinician as well as the referent agree. The patients will be well characterized after inclusion.
  • Present a score >= 4 on the iCGI - Severity at inclusion.
  • Present transcultural issues confirmed by the referent (usual procedure of indirect pre-selection based on the presentation of the situation by referring physician)
  • Have an informed consent signed by both parents/ one parent / tutor / adult patient (cf. 14.1 paragraph)

Exclusion Criteria:

  • Patient or family has previously had transcultural psychotherapy
  • Patient presents an acute psychiatric disorder which hinders the realization of the transcultural therapy - for example, excited delirium with great psychic disorganization, or high suicidal risk patients. These situations will be excluded during the screening time based on the first line therapist evaluation
  • Patient presents an acute somatic disease which may hinder the well organization of the therapy
  • Patient addressed for a legal expertise
  • Child's/Adolescent's refusal
  • Pregnant or breastfeeding (for women for young women of childbearing age)
  • Participation in another interventional study
  • Patient under guardianship or curatorship

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04206969


Contacts
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Contact: Jonathan LACHAL, PhD 00331 58 41 28 14 jonathan.lachal@gmail.com
Contact: Marie-Rose MORO, PhD 00331 58 41 28 01 marie-rose.moro@aphp.fr

Locations
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France
Service de Psychopathologie de l'enfant, de l'adolescent, CHU Avicenne
Bobigny, France
Contact: Thierry Baubet, Pr       thierry.baubet@aphp.fr   
Service de médecine interne, unité de consultation transculturelle, CHRU Saint-André (CHU Bordeaux)
Bordeaux, France
Contact: Claire Mestre, Dr       claire.mestrelavaud@gmail.com   
Service de psychiatrie de l'enfant et de l'adolescent, CHRU Gabriel Montpied
Clermont-Ferrand, France
Contact: Hélène Asensi, Dr       helene.asensi@orange.fr   
Maison de Solenn, Cochin Hospital
Paris, France, 75000
Contact: Jonathan Lachal, PhD    00331 58 41 28 14    jonathan.lachal@gmail.com   
Contact: Marie-Rose MORO, PhD    00331 58 41 28 01    marie-rose.moro@aphp.fr   
Secteur 75G23, Centre Médico-psychologique (CMP), GHU PARIS, Maison blanche
Paris, France
Contact: Annie Msellati, Dr       msellati@ghu-paris.fr   
Centre Médico-psychologique, Service Universitaire de Psychiatrie de l'Enfant et de l'Adolescent, Hôpital La Grave, CHU Toulouse
Toulouse, France
Contact: Katia JOURNOT-REVERBEL, Dr       journot.k@chu-toulouse.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
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Principal Investigator: Jonathan LACHAL, PhD Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04206969    
Other Study ID Numbers: P180601
2019-A01830-57 ( Other Identifier: ID-RCB (ANSM) )
First Posted: December 20, 2019    Key Record Dates
Last Update Posted: December 20, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Transcultural psychotherapy
migrant
child
adolescent
Depressive Disorder
psychiatric care
mixed studies
bayesian design
qualitative study
Randomized Controlled Trial
Additional relevant MeSH terms:
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Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms