- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04746027
Empathy, Psychopathy and Autism: Behavioural Associations and the Role of an Oxytocin Receptor Polymorphism in a Non-clinical Adult Population
Empathy, Psychopathy and Autism: Behavioural Associations and the Role of an Oxytocin Receptor Polymorphism in a Non-clinical Population
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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London, United Kingdom, TW14SX
- St Mary's University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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31-item Questionnaire for Cognitive and Affective Empathy (QCAE)
Time Frame: 20 minutes
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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.
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20 minutes
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36-item 'Reading the Mind in the Eyes' behavioural task (RMET)
Time Frame: 20 minutes
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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.
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20 minutes
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26-item Levenson's Self-Report for Psychopathy (LSRP)
Time Frame: 20 minutes
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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.
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20 minutes
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50-item Autism Quotient (AQ)
Time Frame: 20 minutes
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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.
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20 minutes
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OXTR rs53576 genotype
Time Frame: 3 days
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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.
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3 days
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yiannis Mavrommatis, PhD, St. Mary's University, Twickenham
- Principal Investigator: Kate Lawrence, PhD, St Marys University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SMEC_2016-17_092
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Study Data/Documents
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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