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CompletedNCT03288649EVAADOUpdated Aug 23, 2024

Qualitative Evaluation of Therapeutic Alliance in Adolescent Psychiatry

An observational study in Anorexia Nervosa, Depression and School Phobia, sponsored by Centre Hospitalier Victor Dupouy. Completed at 2 sites in France. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-08-23.

Sponsored by Centre Hospitalier Victor Dupouy · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
129
Ages
12 Years to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Anorexia Nervosa
  • Depression
  • School Phobia
03

Who can participate

Ages eligible
12 Years to 18 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

adolescents with psychiatric disorders

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

Exclusion Criteria:

  • acute symptoms and serious somatic and/or psychiatric co-morbidities
04

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
129 participants (actual)
Patient registry
No

Groups and cohorts

  • Anorexia nervosa

    adolescents with anorexia nervosa (N=20 ?), their parents (N=20), their physicians (N=20)

  • Anxiety based school refusal

    adolescents with anxiety based school refusal (N=20 ?), their parents (N=20), their physicians (N=20)

  • Depression

    adolescents with depression (N=20 ?), their parents (N=20), their physicians (N=20)

05

What researchers measure

Primary outcomes

  1. to describe the facilitators of therapeutic alliance within adolescent psychiatry using a qualitative approach

    qualitative methodology using verbal data analysis of semi-structured interviex

    Time frame: 2 years

06

Study locations

2 sites
  • CHVictorDupouy
    Argenteuil, 95100, France
  • CHU Rouen
    Rouen, 76000, France
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03288649
Lead sponsor
Centre Hospitalier Victor Dupouy
Responsible party
Anne Revah-Levy (Pr Anne Revah-Levy, Centre Hospitalier Victor Dupouy) — Principal investigator
First posted
Sep 20, 2017
Start date
Jan 1, 2016
Primary completion
Dec 31, 2019
Completion
Jun 30, 2021
Last update
Aug 23, 2024

Study contacts

Anne Revah-Levy, MD PhD
principal investigator · Paris diderot University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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