- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06214013
Adaptation of Linehan's Biosocial Model to Emotional Dysregulation in Autism Spectrum Disorder (DE-TSA)
March 12, 2024 updated by: University Hospital, Strasbourg, France
Proposal for an Adaptation of Linehan's Biosocial Model to Emotional Dysregulation in Autism Spectrum Disorder: Narrative Review of the Literature and Clinical Case
Linehan's biosocial model conceptualizes the factors at play in the development of emotional dysregulation (ED), that is, difficulty regulating one's emotions, in borderline personality disorder (BPD).
The model explains ED as the result of the interaction between the person's biological emotional vulnerability and their exposure to early invalidating experiences from those around them.
Recently, ED has been shown to be prevalent in autism spectrum disorder (ASD).
The objective of the study is to propose an adaptation of Linehan's model to the specificities of ASD to conceptualize the factors contributing to ED in the context of this disorder.
To do this, the investigators will carry out a narrative literature review, as well as an illustrative case conceptualization based on the proposed model.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Strasbourg, France, 67091
- Service de Psychiatrie - CHU de Strasbourg - France
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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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Adult subjects (≥18 years old) Having been diagnosed with ASD without intellectual disability
Description
Inclusion Criteria:
- Adult subjects (≥18 years old)
- Having been diagnosed with ASD without intellectual disability
- Presenting severe ED with self-harming behaviors and/or suicidal behaviors
Exclusion Criteria:
- Subjects not meeting the study eligibility criteria
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adaptation of Linehan's biosocial model to emotional dysregulation in autism spectrum disorder
Time Frame: The bibliography research will cover the period from 2015 to 2021.
|
This study is based on a narrative literature review, and will propose an illustrative case conceptualization based on Linehan's biosocial model.
|
The bibliography research will cover the period from 2015 to 2021.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
February 21, 2023
Primary Completion (Actual)
May 21, 2023
Study Completion (Actual)
May 21, 2023
Study Registration Dates
First Submitted
December 14, 2023
First Submitted That Met QC Criteria
January 9, 2024
First Posted (Actual)
January 19, 2024
Study Record Updates
Last Update Posted (Actual)
March 13, 2024
Last Update Submitted That Met QC Criteria
March 12, 2024
Last Verified
December 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8726 (Other Grant/Funding Number: Mead Johnson Nutrition)
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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