NCT04692350

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 30, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 31, 2020

Completed
10 days until next milestone

Study Start

First participant enrolled

January 10, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

October 19, 2021

Status Verified

October 1, 2021

Enrollment Period

6 months

First QC Date

December 30, 2020

Last Update Submit

October 18, 2021

Conditions

Keywords

AdolescentsQuestionnaires

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 day

Secondary Outcomes (2)

  • Number of Inter-item correlational structure (ACP)

    1 day

  • links to psychopathology (especially Borderline personality)

    1 day

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
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).

You may qualify if:

  • The adolescent must be between 12 and 18 years old
  • The adolescent does not have to have any risky personality traits to participate in this study.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

Biospecimen

Retention: NONE RETAINED

NC

MeSH Terms

Conditions

Personality DisordersBorderline Personality Disorder

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Diane Purper-Ouakil, M.D., Ph. D.

    UH Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2020

First Posted

December 31, 2020

Study Start

January 10, 2021

Primary Completion

June 30, 2021

Study Completion

September 30, 2021

Last Updated

October 19, 2021

Record last verified: 2021-10

Locations