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

Primary Purpose

Major Depressive Disorder

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Transcultural psychotherapy
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Major Depressive Disorder focused on measuring Transcultural psychotherapy, migrant, child, adolescent, Depressive Disorder, psychiatric care, mixed studies, bayesian design, qualitative study, Randomized Controlled Trial

Eligibility Criteria

6 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Service de Psychopathologie de l'enfant, de l'adolescent, CHU Avicenne
  • Service de médecine interne, unité de consultation transculturelle, CHRU Saint-André (CHU Bordeaux)
  • Service de psychiatrie de l'enfant et de l'adolescent, CHRU Gabriel Montpied
  • Maison de Solenn, Cochin Hospital
  • Secteur 75G23, Centre Médico-psychologique (CMP), GHU PARIS, Maison blanche
  • Centre Médico-psychologique, Service Universitaire de Psychiatrie de l'Enfant et de l'Adolescent, Hôpital La Grave, CHU Toulouse

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Transcultural psychotherapy

standard care

Arm Description

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.

usual care provided by the referent medical team

Outcomes

Primary Outcome Measures

Severity Score on the Improved Global Impression Scale (iCGI) to assess remission
.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. - Normal, not at all ill - Borderline mentally ill - Mildly ill - Moderately ill - Markedly ill - Severely ill - 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

Severity score on the iCGI
To compare the course of the severity of depression in each group over the first 34 weeks after inclusion
Score on the French version of the Children's Depression Rating Scale-Revised (CDRS-R)
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
Score on the French version of the State-Trait Anxiety Inventory for children (STAI-C)
To compare the course of the level of anxiety symptoms in each group over the first 34 weeks after inclusion
Score changes in Depression and anxiety Scores between Week 34 and week 52
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
analysis of the content of the clinical data collected during the visits
To describe the therapeutic processes that enabled the improvement of patients treated by transcultural psychotherapy
analysis of the content of the interview with the families and therapists at the end of the treatment
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

Full Information

First Posted
December 16, 2019
Last Updated
March 12, 2020
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
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1. Study Identification

Unique Protocol Identification Number
NCT04206969
Brief Title
Assessment of Transcultural Psychotherapy in Child Major Depressive Disorder
Acronym
EDPT-ADOS
Official Title
Assessment of Transcultural Psychotherapy to Treat Major Depressive Disorder in Children and Adolescents From Migrant Families: a Bayesian Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 2020 (Anticipated)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France

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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Transcultural psychotherapy, migrant, child, adolescent, Depressive Disorder, psychiatric care, mixed studies, bayesian design, qualitative study, Randomized Controlled Trial

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transcultural psychotherapy
Arm Type
Experimental
Arm Description
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.
Arm Title
standard care
Arm Type
No Intervention
Arm Description
usual care provided by the referent medical team
Intervention Type
Behavioral
Intervention Name(s)
Transcultural psychotherapy
Intervention Description
In addition to usual care, the participants receive transcultural psychotherapy
Primary Outcome Measure Information:
Title
Severity Score on the Improved Global Impression Scale (iCGI) to assess remission
Description
.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. - Normal, not at all ill - Borderline mentally ill - Mildly ill - Moderately ill - Markedly ill - Severely ill - 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).
Time Frame
at week 34 visit (v5)
Secondary Outcome Measure Information:
Title
Severity score on the iCGI
Description
To compare the course of the severity of depression in each group over the first 34 weeks after inclusion
Time Frame
at baseline and weeks 6, 13, 20, 27 and 34 and 52
Title
Score on the French version of the Children's Depression Rating Scale-Revised (CDRS-R)
Description
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
Time Frame
at baseline and weeks 6, 13, 20, 27 and 34 and 52
Title
Score on the French version of the State-Trait Anxiety Inventory for children (STAI-C)
Description
To compare the course of the level of anxiety symptoms in each group over the first 34 weeks after inclusion
Time Frame
at baseline and weeks 6, 13, 20, 27 and 34 and 52
Title
Score changes in Depression and anxiety Scores between Week 34 and week 52
Description
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
Time Frame
at 34 and 52 weeks
Title
analysis of the content of the clinical data collected during the visits
Description
To describe the therapeutic processes that enabled the improvement of patients treated by transcultural psychotherapy
Time Frame
between 34 and 44 weeks
Title
analysis of the content of the interview with the families and therapists at the end of the treatment
Description
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
Time Frame
between 34 and 44 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan LACHAL, PhD
Phone
00331 58 41 28 14
Email
jonathan.lachal@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Marie-Rose MORO, PhD
Phone
00331 58 41 28 01
Email
marie-rose.moro@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan LACHAL, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Psychopathologie de l'enfant, de l'adolescent, CHU Avicenne
City
Bobigny
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thierry Baubet, Pr
Email
thierry.baubet@aphp.fr
Facility Name
Service de médecine interne, unité de consultation transculturelle, CHRU Saint-André (CHU Bordeaux)
City
Bordeaux
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire Mestre, Dr
Email
claire.mestrelavaud@gmail.com
Facility Name
Service de psychiatrie de l'enfant et de l'adolescent, CHRU Gabriel Montpied
City
Clermont-Ferrand
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hélène Asensi, Dr
Email
helene.asensi@orange.fr
Facility Name
Maison de Solenn, Cochin Hospital
City
Paris
ZIP/Postal Code
75000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Lachal, PhD
Phone
00331 58 41 28 14
Email
jonathan.lachal@gmail.com
First Name & Middle Initial & Last Name & Degree
Marie-Rose MORO, PhD
Phone
00331 58 41 28 01
Email
marie-rose.moro@aphp.fr
Facility Name
Secteur 75G23, Centre Médico-psychologique (CMP), GHU PARIS, Maison blanche
City
Paris
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annie Msellati, Dr
Email
msellati@ghu-paris.fr
Facility Name
Centre Médico-psychologique, Service Universitaire de Psychiatrie de l'Enfant et de l'Adolescent, Hôpital La Grave, CHU Toulouse
City
Toulouse
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katia JOURNOT-REVERBEL, Dr
Email
journot.k@chu-toulouse.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Assessment of Transcultural Psychotherapy in Child Major Depressive Disorder

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