Empathy, Psychopathy and Autism: Behavioural Associations and the Role of an Oxytocin Receptor Polymorphism in a Non-clinical Adult Population

February 8, 2021 updated by: St Mary's University College

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
126

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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • At least 18 years of age at time of participation
  • Proficient English reading comprehension

Exclusion Criteria:

  • Current or previous diagnosis of a psychopathy, autism or related conditions.
  • Not proficient in English reading comprehension

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
20 minutes
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.
20 minutes
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.
20 minutes
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.
20 minutes
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.
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
St Mary's University College

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yiannis Mavrommatis, PhD, St. Mary's University, Twickenham
  • Principal Investigator: Kate Lawrence, PhD, St Marys University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 4, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 9, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 9, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SMEC_2016-17_092

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Study Data/Documents

  1. Study Protocol

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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