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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03288649
Other study ID # 20140600001072
Secondary ID
Status Recruiting
Phase N/A
First received September 13, 2017
Last updated September 19, 2017
Start date January 1, 2016
Est. completion date June 30, 2018

Study information

Verified date September 2017
Source Centre Hospitalier Victor Dupouy
Contact Jordan Sibeoni, MD
Phone +33 134232598
Email jordan.sibeoni@ch-argenteuil.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Context: Psychiatric disorders (anorexia nervosa, depression, anxiety based school refusal) are a major public health concern in adolescence. Their treatment is a challenge for the families, the health care system and society. The treatment is complex and non-standardized. In clinical practice, the relational dimension between the stakeholders is recognized by all. Nevertheless no study has ever crossed their perspectives about therapeutic alliance in adolescent psychiatry.

Objective: to explore, within a qualitative approach, how a therapeutic alliance is established in three different clinical situations according to the adolescents, their parents and their physicians by crossing their perspectives.

Methods: This is a national (France) multi-center qualitative study based on 180 semi-structured interviews. Participants (purposively selected until data saturation) came from three different sub-samples: (i) adolescents with anorexia nervosa (N =20) plus their parents (N=20) and their physicians (N=20), (ii) adolescents with depressions (N=20) plus their parents (N=20) and their physicians (N=20), and (iii) adolescents with anxiety-based school refusal (N=20) plus their parents (N=20) and their physicians (N=20). Data are collected through open ended semi structured interviews and independently analyzed with NVivo V.11 software by three researchers according to the principles of Interpretative Phenomenological Analysis.


Recruitment information / eligibility

Status Recruiting
Enrollment 180
Est. completion date June 30, 2018
Est. primary completion date December 31, 2017
Accepts healthy volunteers
Gender All
Age group 12 Years to 18 Years
Eligibility Inclusion Criteria:

- adolescents, boys and girls, aged 12 to 18 years, speaking fluent French, with (i) anorexia nervosa according to DSM 5 criteria (ii) depressive disorders (dysthymia, depressive episode) according to DSM 5 criteria (iii) anxiety-based school refusal according to four criteria:

1. refusal to attend school (to operationalize this first criterion, adolescents were included if they had not attended school at all for at least one month before starting treatment); (2) presence of a DSM-5 anxiety disorder (except obsessive-compulsive or post-traumatic stress disorders) with emotional upset at the prospect of attending school; (3) absence of a DSM-5 conduct disorder; and (4) parental knowledge of the adolescent's whereabouts during the period of non-attendance.

that led to treatment that had begun at least six months earlier and clinically determined to be well enough to participate in a research interview.

- receiving treatment for at least 6 months

- one parent at least agrees to participate

Exclusion Criteria:

- acute symptoms and serious somatic and/or psychiatric co-morbidities

Study Design


Locations

Country Name City State
France CHVictorDupouy Argenteuil
France CHU Rouen Rouen

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Victor Dupouy

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary to describe the facilitators of therapeutic alliance within adolescent psychiatry using a qualitative approach qualitative methodology using verbal data analysis of semi-structured interviex 2 years
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