NCT03288649

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
129

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

August 23, 2024

Status Verified

August 1, 2024

Enrollment Period

4 years

First QC Date

September 13, 2017

Last Update Submit

August 22, 2024

Conditions

Outcome Measures

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

    2 years

Study Arms (3)

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)

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

adolescents with psychiatric disorders

You may qualify if:

  • 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:
  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHVictorDupouy

Argenteuil, 95100, France

Location

CHU Rouen

Rouen, 76000, France

Location

MeSH Terms

Conditions

Anorexia NervosaDepressionPhobia, School

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental DisordersBehavioral SymptomsBehaviorPhobic DisordersAnxiety Disorders

Study Officials

  • Anne Revah-Levy, MD PhD

    Paris diderot University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pr Anne Revah-Levy

Study Record Dates

First Submitted

September 13, 2017

First Posted

September 20, 2017

Study Start

January 1, 2016

Primary Completion

December 31, 2019

Study Completion

June 30, 2021

Last Updated

August 23, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations