NCT04746027

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

February 4, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 9, 2021

Completed
Last Updated

February 9, 2021

Status Verified

January 1, 2020

Enrollment Period

9 months

First QC Date

February 4, 2021

Last Update Submit

February 8, 2021

Conditions

Keywords

psychologybiopsychologygenetics

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Mary's University

London, TW14SX, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

DNA samples extracted from saliva samples. These samples were collected via passive drool.

MeSH Terms

Conditions

Autistic DisorderAntisocial Personality Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersPersonality Disorders

Study Officials

  • Yiannis Mavrommatis, PhD

    St. Mary's University, Twickenham

    PRINCIPAL INVESTIGATOR
  • Kate Lawrence, PhD

    St Marys University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2021

First Posted

February 9, 2021

Study Start

July 1, 2017

Primary Completion

March 31, 2018

Study Completion

November 1, 2018

Last Updated

February 9, 2021

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Study Protocol Access

Locations