Personality DisordersNCT04692350
French Adaptation of the AIDA (Assessment of Identity Development in Adolescence) and LoPF-Q (Levels of Personality Functioning Questionnaire) Scales.
An observational study of Personality Disorders and Borderline Personality Disorder, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The main objective of this study is to develop the French version of the two questionnaires AIDA and LoPF-Q. The secondary objective is to investigate the links between disrupted development of identity and adolescent psychopathology. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Personality Disorders, Borderline Personality Disorder
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jan 2021to 30 Sep 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
- No healthy volunteers
- Child, Adult
Study population: The population studied includes adolescents followed in psychiatry, whether they are hospitalized (UCAP or full hospitalization at MPEA Saint-Eloi in Montpellier) or followed on an outpatient basis (MPEAs Peyre Plantade and Saint-Eloi in Montpellier).
Who may be able to join
- The adolescent must be between 12 and 18 years old
- be able (see non-inclusion criteria below) and agree to complete the various evaluations proposed, and not present a psychotic episode at the time. time of the questionnaires.
- The adolescent does not have to have any risky personality traits to participate in this study.
Who cannot join
- insufficient levels of French and / or reading
- presence of an intellectual development disorder or a clinically proven current psychotic disorder,
- active or passive opposition of the patient and / or its legal representatives to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adaptation française Des échelles AIDA (Assessment of Identity Development in Adolescence) et LoPF-Q (Levels of Personnality Functioning Questionnaire), Designed to Assess Personality Development in Adolescence.
The main objective of this study is to develop the French version of the two questionnaires AIDA and LoPF-Q. The secondary objective is to investigate the links between disrupted development of identity and adolescent psychopathology.
To participate in the study, patients will have to complete online or paper versions of the questionnaires AIDA-LoPF and other assessments of personality and general psychopathology (BB5, SDQ). Parents will have to answer complete the parent version of the SDQ questionnaire. The BPFSC-11, which is a clinician-rated assessment, will be completed in a subgroup of patients, by the same healthcare professional, in order to assess the concurrent validity. The investigators will also add the clinical diagnoses according to ICD-10 found in the medical record.
Read the detailed description
A personality disorder is a lasting mode of behavior and lived experience that deviates significantly from what is expected in the culture of the individual is invasive and rigid, appears in early adolescence or adulthood, is stable over time and is a source of distress or impaired functioning.
Most of the tools for assessing high-risk personality disorders and traits have been developed in adults.Yet it is important to have effective tools to distinguish personality disorders from other mental disorders as early as possible. The identification of young people at high risk of personality disorders allows their rapid referral to appropriate psychotherapies.
The AIDA and LoPF-Q, screening questionnaires, were recently developed to include an assessment of personality functioning in the process of diagnosing emotional and behavioral disorders in adolescence. They have been tested in several countries such as Germany, USA, Mexico, Croatia… The results of the studies show that AIDA and LoPF questionnaires are reliable and valid instruments for assessing normal and disturbed identity in adolescents and distinguishes well between patients with psychiatric illnesses and healthy controls.
- Keywords
- Adolescents, Questionnaires
- Medical subject headings
- Personality Disorders, Borderline Personality Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
number of Iinternal consistency
Iinternal consistency (coefficient α) which is supposed to exceed 0.70 at the level of the scale and 0.60 at the level of the subscales.
Measured: 1 day
Secondary outcomes (2)
Number of Inter-item correlational structure (ACP)
Inter-item correlational structure (ACP)
Measured: 1 day
links to psychopathology (especially Borderline personality)
links to psychopathology (especially Borderline personality)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start10 Jan 2021
- Primary completion30 Jun 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Personality DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diane Purper-Ouakil, M.D., Ph. D., Principal investigator, UH Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04692350
- Sponsor's protocol ID
- RECHMPL20_0621
- Status last verified
- Oct 2021
- First submitted
- 30 Dec 2020
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation française Des échelles AIDA (Assessment of Identity Development in Adolescence) et LoPF-Q (Levels of Personnality Functioning Questionnaire), Designed to Assess Personality Development in Adolescence.
- ClinicalTrials.gov ID
- NCT04692350
- Acronym / sponsor ID
- RECHMPL20_0621
- Keywords
- Adolescents, Questionnaires
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 10 Jan 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 31 Dec 2020 (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.
The main objective of this study is to develop the French version of the two questionnaires AIDA and LoPF-Q. The secondary objective is to investigate the links between disrupted development of identity and adolescent psychopathology.
To participate in the study, patients will have to complete online or paper versions of the questionnaires AIDA-LoPF and other assessments of personality and general psychopathology (BB5, SDQ). Parents will have to answer complete the parent version of the SDQ questionnaire. The BPFSC-11, which is a clinician-rated assessment, will be completed in a subgroup of patients, by the same healthcare professional, in order to assess the concurrent validity. The investigators will also add the clinical diagnoses according to ICD-10 found in the medical record.
Detailed description
A personality disorder is a lasting mode of behavior and lived experience that deviates significantly from what is expected in the culture of the individual is invasive and rigid, appears in early adolescence or adulthood, is stable over time and is a source of distress or impaired functioning.
Most of the tools for assessing high-risk personality disorders and traits have been developed in adults.Yet it is important to have effective tools to distinguish personality disorders from other mental disorders as early as possible. The identification of young people at high risk of personality disorders allows their rapid referral to appropriate psychotherapies.
The AIDA and LoPF-Q, screening questionnaires, were recently developed to include an assessment of personality functioning in the process of diagnosing emotional and behavioral disorders in adolescence. They have been tested in several countries such as Germany, USA, Mexico, Croatia… The results of the studies show that AIDA and LoPF questionnaires are reliable and valid instruments for assessing normal and disturbed identity in adolescents and distinguishes well between patients with psychiatric illnesses and healthy controls.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The population studied includes adolescents followed in psychiatry, whether they are hospitalized (UCAP or full hospitalization at MPEA Saint-Eloi in Montpellier) or followed on an outpatient basis (MPEAs Peyre Plantade and Saint-Eloi in Montpellier).
Key inclusion criteria (3 listed)
- The adolescent must be between 12 and 18 years old
- be able (see non-inclusion criteria below) and agree to complete the various evaluations proposed, and not present a psychotic episode at the time. time of the questionnaires.
- The adolescent does not have to have any risky personality traits to participate in this study.
Key exclusion criteria (3 listed)
- insufficient levels of French and / or reading
- presence of an intellectual development disorder or a clinically proven current psychotic disorder,
- active or passive opposition of the patient and / or its legal representatives to participate in the study.
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
number of Iinternal consistency
Time frame: 1 day
Iinternal consistency (coefficient α) which is supposed to exceed 0.70 at the level of the scale and 0.60 at the level of the subscales.
2 secondary outcomes
Number of Inter-item correlational structure (ACP)
Time frame: 1 day
links to psychopathology (especially Borderline personality)
Time frame: 1 day
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 19 Oct 2021.
- Individual participant dataSharing planned: Undecided. NC
Related trials for Personality Disorders
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Ketamine Infusion for Symptomatic Improvement in Severe Borderline Personality Disorder
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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.
Diane Purper-Ouakil, M.D., Ph. D. principal investigator
UH Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Personality Disorders and Borderline Personality Disorder, run by University Hospital, Montpellier at 1 site 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 3 inclusion and 3 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 19 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
number of Iinternal consistency (time frame: 1 day). 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 19 Oct 2021.