Qualitative Evaluation of Therapeutic Alliance in Adolescent Psychiatry (EVAADO)

September 19, 2017 updated by: Anne Revah-Levy, Centre Hospitalier Victor Dupouy

Qualitative Evaluation of Therapeutic Alliance in Adolescent Psychiatry: Crossing Perspectives of Adolescents, Parents and Physicians

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

adolescents with psychiatric disorders

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
to describe the facilitators of therapeutic alliance within adolescent psychiatry using a qualitative approach
Time Frame: 2 years
qualitative methodology using verbal data analysis of semi-structured interviex
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Victor Dupouy

Investigators

  • Principal Investigator: Anne Revah-Levy, MD PhD, Paris Diderot University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Anticipated)

December 31, 2017

Study Completion (Anticipated)

June 30, 2018

Study Registration Dates

First Submitted

September 13, 2017

First Submitted That Met QC Criteria

September 19, 2017

First Posted (Actual)

September 20, 2017

Study Record Updates

Last Update Posted (Actual)

September 20, 2017

Last Update Submitted That Met QC Criteria

September 19, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20140600001072

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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