Assessment of Transcultural Psychotherapy in Child Major Depressive Disorder (NCT04206969) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Assessment of Transcultural Psychotherapy in Child Major Depressive Disorder
France80 participantsStarted 2020-10-28
Plain-language 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.
Who can participate
Age range
6 Years – 20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Severity Score on the Improved Global Impression Scale (iCGI) to assess remission