EmpathyNCT04746027
Empathy, Psychopathy and Autism: Behavioural Associations and the Role of an Oxytocin Receptor Polymorphism in a Non-clinical Adult Population
An observational study of Empathy and Autism, run by St Mary's University College at 1 site in United Kingdom.
Trial summary
This is an investigation into the associations between psychopathic traits, autistic traits and empathy (cognitive and affective) in the general population as measured using three self report questionnaires and one behavioural task. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Empathy, Autism, Psychopathy
- How many people
- 126 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2017to 1 Nov 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population is intended to be representative of the general population. Participants must be over 18 years of age, proficient in English comprehension and no current or previous diagnosis of psychopathy, autism or related conditions. Recruitment will not be excluded based on on ethnicity, nationality, sex, gender, religion, sexual orientation or any other characteristic. For the analysis of the behavioural traits investigated, 128 participants (58 male, 70 female) between the ages of 19 and 68 years (median age = 26) were included in the final analysis. For the genetic aspect of the study, 96 participants (40 male, 56 female) between the ages of 19 and 68 years (median age = 26) were included in the final analysis.
Who may be able to join
- At least 18 years of age at time of participation
- Proficient English reading comprehension
Who cannot join
- Current or previous diagnosis of a psychopathy, autism or related conditions.
- Not proficient in English reading comprehension
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Empathy, Psychopathy and Autism: Behavioural Associations and the Role of an Oxytocin Receptor Polymorphism in a Non-clinical Population
This is an investigation into the associations between psychopathic traits, autistic traits and empathy (cognitive and affective) in the general population as measured using three self report questionnaires and one behavioural task. Participants will also be genotyped for OXTR rs53576 to assess whether this mutation associates with any of the behavioural traits investigated.
Read the detailed description
In clinical populations with psychopathy or autism, associations with different forms of empathy have been found. An increase in autistic traits has been found to be associated with a decrease in cognitive empathy traits but no difference in affective empathy traits, while an increase in psychopathic traits has been found to be associated with a decrease in both cognitive and affective empathy traits. The current investigation is to establish whether this previously observed relationship between cognitive empathy, affective empathy, psychopathic traits and autistic traits found in clinical populations is also found in a non-clinical population. This will be assessed by three self report questionnaires and one behavioural task (as described in 'Outcome Measures'). This investigation will also assess the potential link between of all of the traits measured and a specific SNP on the Oxytocin Receptor Gene (OXTR rs53576) to establish whether this mutation is associated with any of these behaviours.
- Conditions
- Empathy, Autism, Psychopathy
- Keywords
- psychology, biopsychology, genetics
- Medical subject headings
- Autistic Disorder, Antisocial Personality Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
31-item Questionnaire for Cognitive and Affective Empathy (QCAE)
Self-reported empathy levels. 19 items assessing cognitive empathy, 12 items assessing affective empathy. All items are rated on a Likert scale of agreement from 1 (strongly disagree) to 4 (strongly agree) with 4 items being reverse scored prior to analysis.
Measured: 20 minutes
36-item 'Reading the Mind in the Eyes' behavioural task (RMET)
A behavioural task to assess a sub-scale of cognitive empathy, emotion recognition. RMET establishes an individual's ability to recognise the emotional state of strangers in photographs with only their eyes as visual cues, with each item consisting of a photograph of a stranger expressing a specific emotional state. Each item is scored as 1 for correct and 0 for incorrect, with a higher total score indicating a greater ability at recognising the emotional state of others.
Measured: 20 minutes
26-item Levenson's Self-Report for Psychopathy (LSRP)
A self reporting questionnaire assessing psychopathic traits without the requirement fo a clinical assessment. 16 items assess primary psychopathy and 10 items assess secondary psychopathy. All items are rated on a Likert scale of agreement of 1 (strongly agree) to 4 (strongly disagree) with 7 items having their score reversed prior to analysis.
Measured: 20 minutes
50-item Autism Quotient (AQ)
A self reporting questionnaire to assess autistic traits. The scale consists of 50 items, with 10 items fort each of the 5 subscales; social skill, attention switching, attention to detail, communication and imagination. Items are rated on a Likert scale of agreement from 0 (strongly or slightly disagree) to 1 (strongly or slightly agree), with 50% of the items being reversed prior to analysis.
Measured: 20 minutes
OXTR rs53576 genotype
Saliva is collected from participants via passive drool, and stabiliser provided by the DNA extraction kit manufacturer is added (SalivaGene Collection Module II; Stratec Molecular GmbH). An extraction protocol provided by the kit manufacturer is followed to extract DNA from each saliva sample (PSP® SalivaGene 17 DNA Kit 1011, Stratec Molecular GmbH). Genotyping was carried out using a StepOnePlus thermocycler (Applied Biosystems) with a predesigned TaqMan® SNP genotyping assay for rs53576 with code C__3290335_10. Each DNA sample was run in duplicate and the PCR procedure was performed following manufacturer guidelines. Results will be flagged as either AA, AG or GG genotype.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start1 Jul 2017
- Primary completion31 Mar 2018
- Study completion1 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmpathyStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- St Mary's University College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yiannis Mavrommatis, PhD, Principal investigator, St. Mary's University, TwickenhamKate Lawrence, PhD, Principal investigator, St Marys University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04746027
- Sponsor's protocol ID
- SMEC_2016-17_092
- Status last verified
- Jan 2020
- First submitted
- 4 Feb 2021
- Last updated
- 9 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empathy, Psychopathy and Autism: Behavioural Associations and the Role of an Oxytocin Receptor Polymorphism in a Non-clinical Population
- ClinicalTrials.gov ID
- NCT04746027
- Acronym / sponsor ID
- SMEC_2016-17_092
- Conditions
- Empathy, Autism, Psychopathy
- Keywords
- psychology, biopsychology, genetics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- St Mary's University CollegeUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 9 Feb 2021 (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.
This is an investigation into the associations between psychopathic traits, autistic traits and empathy (cognitive and affective) in the general population as measured using three self report questionnaires and one behavioural task. Participants will also be genotyped for OXTR rs53576 to assess whether this mutation associates with any of the behavioural traits investigated.
Detailed description
In clinical populations with psychopathy or autism, associations with different forms of empathy have been found. An increase in autistic traits has been found to be associated with a decrease in cognitive empathy traits but no difference in affective empathy traits, while an increase in psychopathic traits has been found to be associated with a decrease in both cognitive and affective empathy traits. The current investigation is to establish whether this previously observed relationship between cognitive empathy, affective empathy, psychopathic traits and autistic traits found in clinical populations is also found in a non-clinical population. This will be assessed by three self report questionnaires and one behavioural task (as described in 'Outcome Measures'). This investigation will also assess the potential link between of all of the traits measured and a specific SNP on the Oxytocin Receptor Gene (OXTR rs53576) to establish whether this mutation is associated with any of these behaviours.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is intended to be representative of the general population. Participants must be over 18 years of age, proficient in English comprehension and no current or previous diagnosis of psychopathy, autism or related conditions. Recruitment will not be excluded based on on ethnicity, nationality, sex, gender, religion, sexual orientation or any other characteristic. For the analysis of the behavioural traits investigated, 128 participants (58 male, 70 female) between the ages of 19 and 68 years (median age = 26) were included in the final analysis. For the genetic aspect of the study, 96 participants (40 male, 56 female) between the ages of 19 and 68 years (median age = 26) were included in the final analysis.
Key inclusion criteria (2 listed)
- At least 18 years of age at time of participation
- Proficient English reading comprehension
Key exclusion criteria (2 listed)
- Current or previous diagnosis of a psychopathy, autism or related conditions.
- Not proficient in English reading comprehension
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
31-item Questionnaire for Cognitive and Affective Empathy (QCAE)
Time frame: 20 minutes
Self-reported empathy levels. 19 items assessing cognitive empathy, 12 items assessing affective empathy. All items are rated on a Likert scale of agreement from 1 (strongly disagree) to 4 (strongly agree) with 4 items being reverse scored prior to analysis.
36-item 'Reading the Mind in the Eyes' behavioural task (RMET)
Time frame: 20 minutes
A behavioural task to assess a sub-scale of cognitive empathy, emotion recognition. RMET establishes an individual's ability to recognise the emotional state of strangers in photographs with only their eyes as visual cues, with each item consisting of a photograph of a stranger expressing a specific emotional state. Each item is scored as 1 for correct and 0 for incorrect, with a higher total score indicating a greater ability at recognising the emotional state of others.
26-item Levenson's Self-Report for Psychopathy (LSRP)
Time frame: 20 minutes
A self reporting questionnaire assessing psychopathic traits without the requirement fo a clinical assessment. 16 items assess primary psychopathy and 10 items assess secondary psychopathy. All items are rated on a Likert scale of agreement of 1 (strongly agree) to 4 (strongly disagree) with 7 items having their score reversed prior to analysis.
50-item Autism Quotient (AQ)
Time frame: 20 minutes
A self reporting questionnaire to assess autistic traits. The scale consists of 50 items, with 10 items fort each of the 5 subscales; social skill, attention switching, attention to detail, communication and imagination. Items are rated on a Likert scale of agreement from 0 (strongly or slightly disagree) to 1 (strongly or slightly agree), with 50% of the items being reversed prior to analysis.
OXTR rs53576 genotype
Time frame: 3 days
Saliva is collected from participants via passive drool, and stabiliser provided by the DNA extraction kit manufacturer is added (SalivaGene Collection Module II; Stratec Molecular GmbH). An extraction protocol provided by the kit manufacturer is followed to extract DNA from each saliva sample (PSP® SalivaGene 17 DNA Kit 1011, Stratec Molecular GmbH). Genotyping was carried out using a StepOnePlus thermocycler (Applied Biosystems) with a predesigned TaqMan® SNP genotyping assay for rs53576 with code C__3290335_10. Each DNA sample was run in duplicate and the PCR procedure was performed following manufacturer guidelines. Results will be flagged as either AA, AG or GG genotype.
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 9 Feb 2021.
- Individual participant dataSharing planned: No
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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.
Yiannis Mavrommatis, PhD principal investigator
St. Mary's University, Twickenham
Kate Lawrence, PhD principal investigator
St Marys University
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 Empathy and Autism, run by St Mary's University College at 1 site in United Kingdom.
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 2 inclusion and 2 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 9 Feb 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 United Kingdom. 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?
31-item Questionnaire for Cognitive and Affective Empathy (QCAE) (time frame: 20 minutes). The study lists 5 primary outcomes in all. 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 9 Feb 2021.