Autism Spectrum DisorderDE-TSANCT06214013
Adaptation of Linehan's Biosocial Model to Emotional Dysregulation in Autism Spectrum Disorder
An observational study of Autism Spectrum Disorder, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autism Spectrum Disorder
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- 21 Feb 2023to 21 May 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult subjects (≥18 years old) Having been diagnosed with ASD without intellectual disability
Who may be able to join
- Adult subjects (≥18 years old)
- Having been diagnosed with ASD without intellectual disability
- Presenting severe ED with self-harming behaviors and/or suicidal behaviors
Who cannot join
- Subjects not meeting the study eligibility criteria
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Psychiatrie - CHU de Strasbourg - France
Strasbourg, 67091
About this study
Official title: 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.
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism Disorder
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
Adaptation of Linehan's biosocial model to emotional dysregulation in autism spectrum disorder
This study is based on a narrative literature review, and will propose an illustrative case conceptualization based on Linehan's biosocial model.
Measured: The bibliography research will cover the period from 2015 to 2021.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start21 Feb 2023
- Primary completion21 May 2023
- Study completion21 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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 only
- Time perspective
- Other
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06214013
- Sponsor's protocol ID
- 8726
- Acronym
- DE-TSA
- Status last verified
- Dec 2023
- First submitted
- 14 Dec 2023
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proposal for an Adaptation of Linehan's Biosocial Model to Emotional Dysregulation in Autism Spectrum Disorder: Narrative Review of the Literature and Clinical Case
- ClinicalTrials.gov ID
- NCT06214013
- Acronym / sponsor ID
- DE-TSA / 8726
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 21 Feb 2023 (actual)
- Primary completion
- 21 May 2023 (actual)
- Study completion
- 21 May 2023 (actual)
- First posted
- 19 Jan 2024 (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.
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 design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult subjects (≥18 years old) Having been diagnosed with ASD without intellectual disability
Key inclusion criteria (3 listed)
- Adult subjects (≥18 years old)
- Having been diagnosed with ASD without intellectual disability
- Presenting severe ED with self-harming behaviors and/or suicidal behaviors
Key exclusion criteria (1 listed)
- Subjects not meeting the study eligibility criteria
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
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.
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 13 Mar 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Autism Spectrum Disorder, run by University Hospital, Strasbourg, France 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 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 13 Mar 2024. 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?
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.). 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 13 Mar 2024.