Assessment of Transcultural Psychotherapy in Child Major Depressive Disorder

NCT04206969 | Active Not Recruiting

• 2 other identifiers: P1806012019-A01830-57
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 4

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.

Conditions

Major Depressive Disorder

Keywords

Transcultural psychotherapy; migrant; child; adolescent; Depressive Disorder; psychiatric care; mixed studies; bayesian design; qualitative study; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 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. 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).

  at week 34 visit (v5)

Secondary Outcomes (6)

• Severity score on the iCGI

  at baseline and weeks 6, 13, 20, 27 and 34 and 52

• 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

• 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

• Score changes in Depression and anxiety Scores between Week 34 and week 52

  at 34 and 52 weeks

• analysis of the content of the clinical data collected during the visits

  between 34 and 44 weeks

Study Arms (2)

Transcultural psychotherapy

EXPERIMENTAL

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

standard care

NO INTERVENTION

usual care provided by the referent medical team

Interventions

Transcultural psychotherapy BEHAVIORAL

In addition to usual care, the participants receive transcultural psychotherapy

Transcultural psychotherapy

Eligibility Criteria

• Age: 6 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (4)

Service de Psychopathologie de l'enfant, de l'adolescent, CHU Avicenne

Bobigny, France

Location

Service de psychiatrie de l'enfant et de l'adolescent, CHRU Gabriel Montpied

Clermont-Ferrand, France

Location

Maison de Solenn, Cochin Hospital

Paris, 75000, France

Location

Centre Médico-psychologique, Service Universitaire de Psychiatrie de l'Enfant et de l'Adolescent, Hôpital La Grave, CHU Toulouse

Toulouse, France

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depressive Disorder

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Study Officials

• Jonathan LACHAL, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2019
• First Posted: December 20, 2019
• Study Start: October 28, 2020
• Primary Completion: April 29, 2024
• Study Completion: May 1, 2025
• Last Updated: April 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)