Major Depressive DisorderEDPT-ADOSNCT04206969
Assessment of Transcultural Psychotherapy in Child Major Depressive Disorder
A study testing Transcultural psychotherapy in people with Major Depressive Disorder, run by Assistance Publique - Hôpitaux de Paris at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 20 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Transcultural psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 4 sitesFrance
- Study dates
- 28 Oct 2020to May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 19Show fewer
- 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
Who cannot join
- 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.
Show all 17Show fewer
- 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)
- 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
Trial locations and contacts
4 sites in 1 country.
France4 sites
Service de Psychopathologie de l'enfant, de l'adolescent, CHU Avicenne
Bobigny
Service de psychiatrie de l'enfant et de l'adolescent, CHRU Gabriel Montpied
Clermont-Ferrand
Maison de Solenn, Cochin Hospital
Paris, 75000
Centre Médico-psychologique, Service Universitaire de Psychiatrie de l'Enfant et de l'Adolescent, Hôpital La Grave, CHU Toulouse
Toulouse
About this study
Official title: Assessment of Transcultural Psychotherapy to Treat Major Depressive Disorder in Children and Adolescents From Migrant Families: a Bayesian Randomized Controlled Trial
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.
Read more
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.
Read the 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.
- Conditions
- Major Depressive Disorder
- Being tested
- Transcultural psychotherapy
- Keywords
- Transcultural psychotherapy, migrant, child, adolescent, Depressive Disorder, psychiatric care, mixed studies, bayesian design, qualitative study, Randomized Controlled Trial
- Medical subject headings
- Depressive Disorder, Major, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcultural psychotherapyBehavioural
In addition to usual care, the participants receive transcultural psychotherapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Transcultural psychotherapy |
| standard care | No intervention | usual care provided by the referent medical team |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: at week 34 visit (v5)
Secondary outcomes (6)
Severity score on the iCGI
To compare the course of the severity of depression in each group over the first 34 weeks after inclusion
Measured: 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)
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
Measured: 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)
To compare the course of the level of anxiety symptoms in each group over the first 34 weeks after inclusion
Measured: 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
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
Measured: at 34 and 52 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
Measured: between 34 and 44 weeks
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
Measured: between 34 and 44 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2019
- Study start28 Oct 2020
- Primary completion29 Apr 2024
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan LACHAL, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04206969
- Sponsor's protocol ID
- P180601
- Other IDs
- 2019-A01830-57
- Acronym
- EDPT-ADOS
- Status last verified
- Mar 2025
- First submitted
- 16 Dec 2019
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Transcultural Psychotherapy to Treat Major Depressive Disorder in Children and Adolescents From Migrant Families: a Bayesian Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04206969
- Acronym / sponsor ID
- EDPT-ADOS / P180601
- Conditions
- Major Depressive Disorder
- Keywords
- Transcultural psychotherapy, migrant, child, adolescent, Depressive Disorder, psychiatric care, mixed studies, bayesian design
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 28 Oct 2020 (actual)
- Primary completion
- 29 Apr 2024 (actual)
- Study completion
- May 2025 (estimated)
- First posted
- 20 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcultural psychotherapy | Experimental | Behavioral: Transcultural psychotherapyIn 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. |
| standard care | No intervention | –usual care provided by the referent medical team |
Who may qualify
- Ages
- 6 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (19 listed)
- 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:
Key exclusion criteria (17 listed)
- 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)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcultural psychotherapyIn addition to usual care, the participants receive transcultural psychotherapy | Behavioural | Transcultural psychotherapy |
Primary outcome
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).
6 secondary outcomes
Severity score on the iCGI
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: at 34 and 52 weeks
analysis of the content of the clinical data collected during the visits
Time frame: between 34 and 44 weeks
analysis of the content of the interview with the families and therapists at the end of the treatment
Time frame: between 34 and 44 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan LACHAL, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcultural psychotherapy in people with Major Depressive Disorder, run by Assistance Publique - Hôpitaux de Paris at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity Score on the Improved Global Impression Scale (iCGI) to assess remission (time frame: at week 34 visit (v5)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.