Ignite Creation Date:
2024-05-06 @ 2:05 PM
Last Modification Date:
2024-10-26 @ 1:24 PM
Study NCT ID:
NCT04206969
Status:
UNKNOWN
Last Update Posted:
2020-03-16
First Post:
2019-12-16
Brief Title:
Assessment of Transcultural Psychotherapy in Child Major Depressive Disorder
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Assessment of Transcultural Psychotherapy to Treat Major Depressive Disorder in Children and Adolescents From Migrant Families a Bayesian Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2019-12
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EDPT-ADOS
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 familys 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 andor 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
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 familys 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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2019-A01830-57 | OTHER | ID-RCB ANSM | None |