Clinical trial NCT04206969: Assessment of Transcultural Psychotherapy in Child Major Depressive Disorder
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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Transcultural psychotherapy
migrant
child
adolescent
Depressive Disorder
psychiatric care
mixed studies
bayesian design
qualitative study
Randomized Controlled Trial
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2019-12-20
Enrollment: 80
Sex: ALL
Minimum age (years): 6
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Severity Score on the Improved Global Impression Scale (iCGI) to assess remission
timeFrame: at week 34 visit (v5)
Secondary outcomes:
measure: Severity score on the iCGI
timeFrame: at baseline and weeks 6, 13, 20, 27 and 34 and 52
measure: Score on the French version of the Children's Depression Rating Scale-Revised (CDRS-R)
timeFrame: at baseline and weeks 6, 13, 20, 27 and 34 and 52
measure: Score on the French version of the State-Trait Anxiety Inventory for children (STAI-C)
timeFrame: at baseline and weeks 6, 13, 20, 27 and 34 and 52
measure: Score changes in Depression and anxiety Scores between Week 34 and week 52
timeFrame: at 34 and 52 weeks
measure: analysis of the content of the clinical data collected during the visits
timeFrame: between 34 and 44 weeks
measure: analysis of the content of the interview with the families and therapists at the end of the treatment
timeFrame: between 34 and 44 weeks
Other outcomes:
Locations:
city: Bobigny
country: France
facility: Service de Psychopathologie de l'enfant, de l'adolescent, CHU Avicenne
city: Clermont-Ferrand
country: France
facility: Service de psychiatrie de l'enfant et de l'adolescent, CHRU Gabriel Montpied
city: Paris
country: France
facility: Maison de Solenn, Cochin Hospital
city: Toulouse
country: France
facility: Centre Médico-psychologique, Service Universitaire de Psychiatrie de l'Enfant et de l'Adolescent, Hôpital La Grave, CHU Toulouse
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Jonathan LACHAL, PhD
role: PRINCIPAL_INVESTIGATOR
References: