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Trial registered on ANZCTR

Registration number

ACTRN12619000705189p

Ethics application status

Submitted, not yet approved

Date submitted

2/05/2019

Date registered

10/05/2019

Date last updated

14/06/2019

Date data sharing statement initially provided

10/05/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Contributions of the Alexithymia Hypothesis to Emotion Recognition and the impact of a Novel Mimicry Task for Therapeutic Benefit

Scientific title

Contributions of the Alexithymia Hypothesis to Emotion Recognition in adults with and without Autism Spectrum Disorder and the impact of a Novel Mimicry Task for Therapeutic Benefit

Secondary ID [1]

none

Universal Trial Number (UTN)

U1111-1232-2299

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Autism Spectrum Disorders

Alexithymia

Facial Emotion Expression recognition

Condition category

Condition code

Mental Health

Autistic spectrum disorders

Mental Health

Studies of normal psychology, cognitive function and behaviour

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Firstly, participants will partake in a baseline assessment. This involves a task of facial emotion recognition ability using a computer. The emotion recognition baseline task will begin with a short description of seven listed emotions. The baseline assessment will be comprised of 21 trials. Each trial will begin with a neutral expression image from an emotional expression database displayed on the screen. After this image has been displayed for 3 seconds, it will quickly swap over to another image from the same model, except this image will be of an emotional expression (e.g., angry, sad). After 500ms, this image will then be replaced with the original neutral image. Seven buttons will then be displayed with labels for each of the emotions to choose. After pressing a button, the next trial will begin. This task is the same as the experimental exposure, however, the facial mimicry element has been removed.

Following the baseline task, participants will be immediately randomised to either a control or Instructed Facial Mimicry Exposure task and begin this task within approximately 1-3 minutes after the baseline assessment.

Instructed Facial Mimicry Exposure:
The aim of this task is to improve facial emotion recognition in people who have an Autism Spectrum Disorder (ASD), with high or low levels of Alexithymia, a personality trait. Prior research has found instructed facial mimicry to improve facial emotion recognition in people with high levels of Autism traits (Lewis & Dunn, 2017) however this has not been assessed in people with an ASD. Additionally, the Alexithymia hypothesis (Bird & Cook, 2013) suggests that emotion processing problems observed in ASD are instead due to Alexithymia which is prevalent in people with ASD, however, no studies have assessed if instructed facial mimicry improves emotion recognition in Alexithymia.

This task will be delivered in-person at the FedUni Clinic in Ballarat, Australia by the primary researcher Joshua Caine. Participants will take part in the task one participant at a time based on a mutually agreed upon time and date. Participants will only undergo this task once and it is expected to last roughly 30 minutes.

Participants will sit in front of a computer screen. On the screen, a brief description of the visual appearance of seven emotions and how to identify them will be displayed (Fear, surprise, sadness, happiness, anger, disgust, contempt). Following this, participants will be verbally advised by the experimenter, and also in on-screen text that a series of emotion recognition trials will begin shortly and that after each emotion is displayed, they should try their best to mimic (copy) the facial expression that they saw with their face. Once they have mimicked the expression, they should then use the seven labeled buttons on the right-hand side to choose which emotion was displayed. After selecting the answer using one of the seven buttons, a 5-point Likert scale on the computer screen will ask the participant “How well did you mimic the expression?” with responses ranging from 1 "not very well" to 5 "very well". This will repeat for each of the 56 trials. The trials will include various models of both male and female, depicting the 7 emotions.

Each trial will begin with a neutral expression image from an emotional expression database displayed on the screen. After this image has been displayed for 3 seconds, it will quickly swap over to another image from the same model, except this image will be of an emotional expression (e.g., angry, sad). After 500ms, this image will then be replaced with the original neutral image and the seven buttons with the seven emotion labels will appear on the right-hand side.

References:

Bird, G., & Cook, R. (2013). Mixed emotions: the contribution of alexithymia to the emotional symptoms of autism. Transl Psychiatry, 3, e285.

Lewis, M. B., & Dunn, E. (2017). Instructions to mimic improve facial emotion recognition in people with sub-clinical autism traits. The Quarterly Jn.of Experimental Psychology, 70(11), 2357-2370.

Intervention code [1]

Treatment: Other

Intervention code [2]

Behaviour

Comparator / control treatment

There will be two comparisons made.
The first is the comparison of the intervention exposure with a baseline emotion recognition task (i.e. before-after within-groups comparison against a baseline emotion recognition task). The intervention exposure and control tasks will occur directly after the baseline task (approximately 1-3 minutes).
The second is against a control group who will partake in a similar emotion recognition task that does not have the instructed to mimic element.

Baseline task:
All participants will first take part in a baseline task of facial emotion recognition ability using a computer. The emotion recognition baseline task will begin with a short description of seven listed emotions. The baseline assessment will be comprised of 21 trials. Each trial will begin with a neutral expression image from an emotional expression database displayed on the screen. After this image has been displayed for 3 seconds, it will quickly swap over to another image from the same model, except this image will be of an emotional expression (e.g., angry, sad). After 500ms, this image will then be replaced with the original neutral image. Seven buttons will then be displayed with labels for each of the emotions to choose. After pressing a button, the next trial will begin. This task is the same as the experimental exposure, however, the facial mimicry element has been removed.

Directly after this task (1-3 minutes), participants will be randomized to either the experimental exposure or the control task. The control task is the same as the baseline task, however, participants will be instructed to pay particular attention to the entire face prior to selecting which emotion they think they saw. This is to try and match for attention levels with the experimental exposure.

Control group

Active

Outcomes

Primary outcome [1]

Percent change in the number of emotional facial expressions correctly labeled in the exposure task compared to the baseline task.

Timepoint [1]

Directly after the baseline assessment task.
Directly after the exposure 'Instructed mimicry' task and control task.

Primary outcome [2]

Percent change in the number of emotional facial expressions correctly labeled in the exposure task compared to the control task.

Timepoint [2]

Directly after the baseline assessment.
Directly after the exposure 'Instructed mimicry' task and control task.

Secondary outcome [1]

Enjoyment of the exposure "mimicry" task as measured by a self-developed questionnaire about satisfaction and enjoyment of the task which was developed for this study.

Timepoint [1]

Roughly 10 minutes post completion of the exposure task.

Eligibility

Key inclusion criteria

Participants must be adults (18 years or older).

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Participants must not have any indication of mental illness or distress other than an Autism Spectrum Disorder (ASD) or high levels of Alexithymia. Participants with an ASD must not have Intelectual disability (ID).

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Allocation is not concealed

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Permuted block randomisation with stratification across age and gender.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Other

Other design features

Participants will be assigned to either the Autism group or control group based on if they have an Autism Spectrum Disorder Diagnosis. Additionally, participants from each of these groups will be randomly assigned to either an exposure mimicry task or a matched control task.

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

The number of participants was determined using power analyses based on the effect sizes of two previous studies measuring similar constructs and similar tasks (Cook et al., 2013; Lewis & Dunn, 2017). To achieve a medium to large effect (e.g. Gpower f2 test = 0.27) with a significance of 5% (p = .05) and power of 80%, 58 participants will be required, with an additional 6 participants to account for an expected attrition rate of 10% which equates to 64 participants.

Primary data analyses will be done using Statistical Package for Social Sciences (SPSS, Version 25). The study design is a mixed-factor 2x2x2 within-between design and therefore, the most appropriate test of difference is going to be a mixed factorial ANOVA, This ANOVA will assess the accuracy of facial emotional expression labeling of participants across groups (Autism group vs. Non-Autism group) and between baseline to experimental tasks. It will also compare across the two experimental conditions, being participants assigned to the control task versus participants who are assigned to the exposure 'mimicry' task. In total, this equates to two groups (Autism vs No-Autism) with participants randomly exposed to control vs mimic exposure task across two time points (baseline score versus exposure or control task score),

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

29/07/2019

Actual

Date of last participant enrolment

Anticipated

3/04/2020

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,SA,VIC

Funding & Sponsors

Funding source category [1]

University

Name [1]

Federation University Australia

Address [1]

University Dr, Mount Helen VIC 3350

Country [1]

Australia

Primary sponsor type

University

Name

Federation University Australia

Address

University Dr, Mount Helen VIC 3350

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Federation University Australia Human Research Ethics Committee (HREC)

Ethics committee address [1]

University Dr, Mount Helen VIC 3350

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

18/04/2019

Approval date [1]

21/05/2019

Ethics approval number [1]

A19-036

Summary

Brief summary

This project will aim to determine the effectiveness of an instructed facial mimicry to improve facial emotion recognition in Autism Spectrum Disorders (ASD’s) and in Alexithymia, a personality trait. Participants will be asked to copy, or mimic facial expressions presented on a computer and the number of correctly identified facial expressions will be compared to when the expressions are not copied or mimicked. We hypothesize that when participants mimic the facial expressions, the number of correctly identified expressions will increase.

Trial website

Trial related presentations / publications

Public notes

This trial accepts participants both with and without an Autism Spectrum Disorder.

Contacts

Principal investigator

Name

Prof Britt klein

Address

Federation University Australia
University Dr, Mount Helen VIC 3350

Country

Australia

Phone

+61 (03) 53276717

Fax

[email protected]

Contact person for public queries

Name

Mr Joshua Caine

Address

Federation University Australia
University Dr, Mount Helen VIC 3350

Country

Australia

Phone

+61 411849054

Fax

[email protected]

Contact person for scientific queries

Name

Mr Joshua Caine

Address

Federation University Australia
University Dr, Mount Helen VIC 3350

Country

Australia

Phone

+61 411849054

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Data may be shared between trusted colleuges but for ethical reasons, will not be made available to the public.

What supporting documents are/will be available?

Current supporting documents:

Updated to:

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
23735	Study protocol	Caine JA, Klein B, Edwards SL Emotion Recognition in adults with ASD and Alexithymia: the impact of a Novel Mimicry Task for Therapeutic Benefit Study Protocol JMIR Research Protocols. 24/02/2021:24543 (forthcoming/in press)	https://preprints.jmir.org/preprint/24543/accepted
23736	Ethical approval			[email protected]	Please contact [email protected] a... [More Details]	377455-(Uploaded-17-05-2021-13-18-39)-Study-related document.docx

Results publications and other study-related documents

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Documents added automatically

No additional documents have been identified.

Trial Review

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