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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04746027
Other study ID # SMEC_2016-17_092
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2017
Est. completion date November 1, 2018

Study information

Verified date January 2020
Source St Mary's University College
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. Participants will also be genotyped for OXTR rs53576 to assess whether this mutation associates with any of the behavioural traits investigated.


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.


Recruitment information / eligibility

Status Completed
Enrollment 126
Est. completion date November 1, 2018
Est. primary completion date March 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Locations

Country Name City State
United Kingdom St Mary's University London

Sponsors (1)

Lead Sponsor Collaborator
St Mary's University College

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 20 minutes
Primary 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. 20 minutes
Primary 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. 20 minutes
Primary 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. 20 minutes
Primary 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. 3 days
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