Trial Review

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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] 298043 0
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 312515 0
Alexithymia 312516 0
Facial Emotion Expression recognition 312517 0
Condition category
Condition code
Mental Health 311056 311056 0 0
Autistic spectrum disorders
Mental Health 311057 311057 0 0
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] 314275 0
Treatment: Other
Intervention code [2] 314276 0
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] 319924 0
Percent change in the number of emotional facial expressions correctly labeled in the exposure task compared to the baseline task.
Timepoint [1] 319924 0
Directly after the baseline assessment task.
Directly after the exposure 'Instructed mimicry' task and control task.
Primary outcome [2] 319925 0
Percent change in the number of emotional facial expressions correctly labeled in the exposure task compared to the control task.
Timepoint [2] 319925 0
Directly after the baseline assessment.
Directly after the exposure 'Instructed mimicry' task and control task.
Secondary outcome [1] 369888 0
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] 369888 0
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
64
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,SA,VIC

Funding & Sponsors
Funding source category [1] 302572 0
University
Name [1] 302572 0
Federation University Australia
Country [1] 302572 0
Australia
Primary sponsor type
University
Name
Federation University Australia
Address
University Dr, Mount Helen VIC 3350
Country
Australia
Secondary sponsor category [1] 302570 0
None
Name [1] 302570 0
Address [1] 302570 0
Country [1] 302570 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 303215 0
Federation University Australia Human Research Ethics Committee (HREC)
Ethics committee address [1] 303215 0
Ethics committee country [1] 303215 0
Australia
Date submitted for ethics approval [1] 303215 0
18/04/2019
Approval date [1] 303215 0
21/05/2019
Ethics approval number [1] 303215 0
A19-036

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92878 0
Prof Britt klein
Address 92878 0
Federation University Australia
University Dr, Mount Helen VIC 3350
Country 92878 0
Australia
Phone 92878 0
+61 (03) 53276717
Fax 92878 0
Email 92878 0
[email protected]
Contact person for public queries
Name 92879 0
Joshua Caine
Address 92879 0
Federation University Australia
University Dr, Mount Helen VIC 3350
Country 92879 0
Australia
Phone 92879 0
+61 411849054
Fax 92879 0
Email 92879 0
[email protected]
Contact person for scientific queries
Name 92880 0
Joshua Caine
Address 92880 0
Federation University Australia
University Dr, Mount Helen VIC 3350
Country 92880 0
Australia
Phone 92880 0
+61 411849054
Fax 92880 0
Email 92880 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.