Assessment of Transcultural Psychotherapy to Treat Major Depressive Disorder in Children and Adolescents From Migrant Families: a Bayesian Randomized Controlled Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Major Depressive Disorder
- Sponsor
- Assistance Publique - Hôpitaux de Paris
- Enrollment
- 80
- Locations
- 4
- Primary Endpoint
- Severity Score on the Improved Global Impression Scale (iCGI) to assess remission
- Status
- Active, Not Recruiting
- Last Updated
- last year
Overview
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.
Investigators
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:
- •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
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
Outcomes
Primary Outcomes
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 Outcomes
- Score on the French version of the State-Trait Anxiety Inventory for children (STAI-C)(at baseline and weeks 6, 13, 20, 27 and 34 and 52)
- analysis of the content of the clinical data collected during the visits(between 34 and 44 weeks)
- analysis of the content of the interview with the families and therapists at the end of the treatment(between 34 and 44 weeks)
- Severity score on the iCGI(at baseline and weeks 6, 13, 20, 27 and 34 and 52)
- Score changes in Depression and anxiety Scores between Week 34 and week 52(at 34 and 52 weeks)
- Score on the French version of the Children's Depression Rating Scale-Revised (CDRS-R)(at baseline and weeks 6, 13, 20, 27 and 34 and 52)