- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07407764
Representations of the Body's Interior in Adolescence (RICA)
Exploratory Study of the Representations of the Inside of the Body of Adolescents With and Without Borderline Personality Disorder, Assessed Through a Drawing of the Inside of the Body, Interviews and Questionnaires.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The aim of this exploratory study is to describe the representations of the inside of the body of adolescents with borderline personality disorder, and adolescent without borderline personality disorder.
During an interview with a psychomotor specialist, participants will undergo tests, questionnaires and Internal body drawing test
Study Type
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Non-clinical cohort :
- Adolescents aged 15 to 19
- High school students (seconde to terminale)
- Having signed a consent form to participate in the research, as well as their legal representative
- Affiliated to a social security regime
Clinical cohort :
- Adolescents aged 15 to 19
- With a high school level (3rd year completed, transition to second year pronounced), whether enrolled or not.
- Having signed a consent form to participate in the research and their legal representative.
- Currently under psychiatric or pediatric care for psychiatric reasons.
- Diagnosed or suspected of having a borderline personality disorder,
- Affiliated to a social security regime
Exclusion Criteria:
Non-clinical cohort
- Serious somatic pathology under treatment (e.g. cancer; recent or planned operations...)
- Recognized sensory or neurological disability.
- Known, diagnosed psychiatric pathologies (TCA, schizophrenia, etc.).
- Refusal to participate by adolescent or parental guardians.
Clinical cohort :
- Serious somatic pathology under treatment (e.g. cancer, recent or planned operations, etc.)
- Recognized sensory or neurological disability.
- Refusal to participate by adolescent or parental guardians.
- Psychomotor assessment or follow-up by the researcher.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Clinical cohort
Adolescents with borderline personality disorder
|
Use of various validated and non-validated tools to identify certain common characteristics, as well as more specific weaknesses, in the representations of the inside of the body of adolescents with no pathology, and adolescents with borderline personality disorder.
|
|
Other: Non-clinical cohort
Adolescent without borderline personality disorder
|
Use of various validated and non-validated tools to identify certain common characteristics, as well as more specific weaknesses, in the representations of the inside of the body of adolescents with no pathology, and adolescents with borderline personality disorder.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Type of organs represented
Time Frame: From enrollment to 2 months after enrollment
|
Type of organs represented on drawing of body' s interior
|
From enrollment to 2 months after enrollment
|
|
Type of systems represented
Time Frame: From enrollment to 2 months after enrollment
|
Type of systems represented on drawing of body' s interior
|
From enrollment to 2 months after enrollment
|
|
Number of organs represented
Time Frame: From enrollment to 2 months after enrollment
|
Completeness of drawing of the inside of the body
|
From enrollment to 2 months after enrollment
|
|
Number of systems represented
Time Frame: From enrollment to 2 months after enrollment
|
Completeness of drawing of the inside of the body + captions
|
From enrollment to 2 months after enrollment
|
|
Level of drawing elaboration
Time Frame: From enrollment to 2 months after enrollment
|
Qualitative analyse of the drawing evaluated (complete and functional systems) - Minimum value: 0 (no elaboration / very simple drawing, incomplete or non-functional systems) Maximum value: 3 (high elaboration / detailed drawing with complete and functional systems) Interpretation: higher scores indicate a better outcome (higher level of drawing elaboration).
|
From enrollment to 2 months after enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Symbolic elements added to drawing
Time Frame: From enrollment to 2 months after enrollment
|
Describe "non-anatomical" themes added to the drawing
|
From enrollment to 2 months after enrollment
|
|
Type of anatomical errors in the drawing
Time Frame: From enrollment to 2 months after enrollment
|
Describe anatomical errors in the drawing
|
From enrollment to 2 months after enrollment
|
|
Scores obtained from questionnaires: Multidimensional Assessment of Interoceptive Awareness):Interoceptive awareness,
Time Frame: From enrollment to 2 months after enrollment
|
Demonstrate alterations in various dimensions in borderline adolescents
|
From enrollment to 2 months after enrollment
|
|
Scores obtained from questionnaires: Postural Awareness Scale_Proprioceptive awareness,
Time Frame: From enrollment to 2 months after enrollment
|
Demonstrate alterations in various dimensions in borderline adolescents
|
From enrollment to 2 months after enrollment
|
|
Scores obtained from questionnaires: Toronto Alexithymia Scale-20)_Emotional awareness (degree of alexithymia)
Time Frame: From enrollment to 2 months after enrollment
|
Demonstrate alterations in various dimensions in borderline adolescents
|
From enrollment to 2 months after enrollment
|
|
Scores obtained from questionnaires: Body Image Questionnaire_Body satisfaction
Time Frame: From enrollment to 2 months after enrollment
|
Demonstrate alterations in various dimensions in borderline adolescents
|
From enrollment to 2 months after enrollment
|
|
Frequency of responses to questions about drawing the inside of the body
Time Frame: From enrollment to 2 months after enrollment
|
Gather participants' opinions on the proposed inner-body drawing test
|
From enrollment to 2 months after enrollment
|
|
Type of symbolic representations emerging through the interview
Time Frame: From enrollment to 2 months after enrollment
|
Evaluate symbolic representations of the body through language.
|
From enrollment to 2 months after enrollment
|
|
Frequency of responses to additional questions about the body's interior
Time Frame: From enrollment to 2 months after enrollment
|
Evaluate participants' level of preoccupation with and experience of the inner body.
|
From enrollment to 2 months after enrollment
|
|
Questionnaire scores by age
Time Frame: From enrollment to 2 months after enrollment
|
To explore differences attributable to the developmental aspect of representations of the body's interior: 30 control high school students (RICA)/200 young adult students and adult students over 25 (results obtained in a preliminary study).
|
From enrollment to 2 months after enrollment
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Personality Disorders
- Borderline Personality Disorder
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Interviews as Topic
- Surveys and Questionnaires
Other Study ID Numbers
- RICA
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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