Anorexia NervosaEVAADONCT03288649
Qualitative Evaluation of Therapeutic Alliance in Adolescent Psychiatry
An observational study of Anorexia Nervosa and Depression, run by Centre Hospitalier Victor Dupouy at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Anorexia Nervosa, Depression, School Phobia
- How many people
- 129 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Jan 2016to 30 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- Child, Adult
Study population: adolescents with psychiatric disorders
Who may be able to join
- 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
Who cannot join
- acute symptoms and serious somatic and/or psychiatric co-morbidities
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: 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.
- Conditions
- Anorexia Nervosa, Depression, School Phobia
- Medical subject headings
- Anorexia Nervosa, Depression, Phobia, School
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
to describe the facilitators of therapeutic alliance within adolescent psychiatry using a qualitative approach
qualitative methodology using verbal data analysis of semi-structured interviex
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2017
- Study start1 Jan 2016
- Primary completion31 Dec 2019
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Victor Dupouy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Revah-Levy, Centre Hospitalier Victor Dupouy
- Investigators
- Anne Revah-Levy, MD PhD, Principal investigator, Paris diderot University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03288649
- Sponsor's protocol ID
- 20140600001072
- Acronym
- EVAADO
- Status last verified
- Aug 2024
- First submitted
- 13 Sep 2017
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qualitative Evaluation of Therapeutic Alliance in Adolescent Psychiatry: Crossing Perspectives of Adolescents, Parents and Physicians
- ClinicalTrials.gov ID
- NCT03288649
- Acronym / sponsor ID
- EVAADO / 20140600001072
- Conditions
- Anorexia Nervosa, Depression, School Phobia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Centre Hospitalier Victor DupouyUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 20 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- adolescents with psychiatric disorders
Key inclusion criteria (5 listed)
- 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:
- 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
Key exclusion criteria (1 listed)
- acute symptoms and serious somatic and/or psychiatric co-morbidities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Revah-Levy, MD PhD principal investigator
Paris diderot University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anorexia Nervosa and Depression, run by Centre Hospitalier Victor Dupouy at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to describe the facilitators of therapeutic alliance within adolescent psychiatry using a qualitative approach (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.