Condition category
Mental and Behavioural Disorders
Date applied
16/06/2012
Date assigned
30/07/2012
Last edited
30/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Autism-spectrum conditions are characterised by a number of deficits in social cognition. This includes a relative difficulty identifying emotional expression in others. Our pilot work has indicated that it is possible to modify how individuals perceive emotional expression, such that when viewing computer-generated ‘morph sequences’ running from one emotion to another, individuals see a change in the emotion somewhere in the middle. This balance point will be used to provide false feedback in the training phase, whereby participants will be trained to judge expressions previously judged as neutral as happy. In this way, sensitivity to a particular emotion can be increased. Pilot work in healthy volunteers shows that it is possible to sensitize(and desensitize) this population to individual emotions.
These early findings suggest that the emotion modification task could be beneficial for individuals with deficits in emotional processing. However, it remains unclear whether individuals with these deficits can engage with this type of task and show differences in processing after completing the task. We therefore propose to examine whether individuals with autism-spectrum conditions show similar changes in perception to individuals without an autism-related diagnosis.

Who can participate?
Participants will be 30 males and females aged 18 years or older with a diagnosis of an autism spectrum condition.

What does the study involve?
This is a computer-based intervention which presents faces on a neutral to happy morph sequence. Participants have to judge the emotion of the face presented. Feedback (informing participants whether they have made a correct or incorrect judgement) is used to train the participants after baseline measures of emotion perception have been taken. Participants will be randomly assigned to one of two groups: a treatment group, in which we attempt to change the perception of emotion, and a control group, in which feedback reflects their baseline performance (i.e. makes no attempt to change their perception of emotion).

What are the possible benefits and risks of participating?
A possible benefit would be an increased sensitivity to the perception of happy facial emotional expressions. There are no predicted risks of participating.

Where is the study run from?
The study is being run from The University of Bristol and the Bristol Autism Spectrum Service: Petherton Resource Centre (Bristol, UK).

When is the study starting and how long is it expected to run for?
June to September 2012

Who is funding the study?
University of Bristol (UK)

Who is the main contact?
Prof. Marcus Munafo
marcus.munafo@bristol.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Marcus Munafo

ORCID ID

http://orcid.org/0000-0002-4049-993X

Contact details

School of Experimental Psychology
University of Bristol
12a Priory Road
Bristol
BS8 1TU
United Kingdom
+44 (0)11 7954 6841
marcus.munafo@bristol.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

UoB1692

Study information

Scientific title

Modifying emotion perception in adults with autism spectrum conditions: a double-blind placebo-controlled study

Acronym

Study hypothesis

Autism-spectrum conditions are characterised by a number of deficits in social cognition. This includes a relative difficulty to identify emotional expression in others. Our pilot work has indicated that it is possible to modify how individuals perceive emotional expression, such that when viewing computer generated ‘morph sequences’ running from one emotion to another, individuals see a change in the emotion somewhere in the middle. This balance point will be used to provide false feedback in the training phase, whereby participants will be trained to judge expressions previously judged as neutral as happy. In this way, sensitivity to a particular emotion can be increased. Pilot work in healthy volunteers shows that it is possible to sensitize (and desensitize) this population to individual emotions.

These early findings suggest that the emotion modification task could be beneficial for individuals with deficits in emotional processing. However, it remains unclear whether individuals with these deficits can engage with this type of task and showdifferences in processing after completing the task. We therefore propose to examine whether individuals with autism-spectrum conditions show similar changes in perception to individuals without an autism-related diagnosis.

Ethics approval

National Research Ethics Service Committee South West - Frenchay, 8/05/2012, REC ref: 12/SW/0113

Study design

Double-blind placebo-controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Autism Spectrum Conditions

Intervention

Emotion recognition training versus control.

Participants will be randomly assigned to one of two groups
1. Treatment (in which we attempt to change the perception of emotion)
2. Control (in which feedback reflects their baseline performance – i.e. makes no attempt to change their perception of emotion)

This is a computer-based intervention which presents faces on a neutral to happy morph sequence. Participants have to judge the emotion of the face presented.

Feedback (informing participants whether they have made a correct or incorrect judgement) is used to train the participants after baseline measures of emotion perception have been taken.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Change in balance point on neutral to happy morph sequence

Secondary outcome measures

1. Reading the mind in the eyes test (Revised): Baron-Cohen, S., Wheelwright, S., Hill, J., Raste, Y., & Plumb, I. (2001). The " Reading the Mind in the Eyes" Test Revised Version: A Study with Normal Adults, and Adults with Asperger Syndrome or High-functioning Autism. Journal of Child Psychology and Psychiatry, 42(2), 241-251
2. Beck Depression Inventory ii (BDI-ii) score- Beck, A.T., Steer, R.A., & Brown, G.K. (1996), Manual for Beck Depression Inventory II (BDI-II). San Antonio, TX, Psychology Corporation.
3. Ritvo Autism Asperger Diagnostic Scale-Revised (RAADS-R). Ritvo et al. (2011). The Ritvo Autism Asperger Diagnostic Scale-Revised (RAADS-R): a scale to assist the diagnosis of Autism Spectrum Disorder in adults: an international validation study. Journal of Autism and Developmental Disorders, 41(8), 1076-1089.

Overall trial start date

18/06/2012

Overall trial end date

07/09/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Participants will be Service Users of the Bristol Autism Spectrum Service who have been diagnosed as having an Autism Spectrum Condition
2. Participants will be aged 18 years or over
3. Participants will have English as a first language or an equivalent level of fluency

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30 participants will be recruited (15 experimental, 15 control)

Participant exclusion criteria

1. Learning or intellectual disability
2. Severe enduring mental illness
3. History of severe head injury or trauma
4. Current use of antipsychotic medication
5. Uncorrected visual impairment
6. Participants deemed by the investigator or clinical team (Bristol Autism Spectrum Service) to be unable to complete the task
7. Participants deemed by the investigator or clinical team to be unable to give informed consent

Recruitment start date

18/06/2012

Recruitment end date

07/09/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

School of Experimental Psychology
Bristol
BS8 1TU
United Kingdom

Sponsor information

Organisation

University of Bristol (UK)

Sponsor details

Research Governance Officer
c/o Anna Brooke
Research and Enterprise Development
Senate House
Tyndall Avenue
Bristol
BS8 1TH
United Kingdom
+44 (0)11 7331 7709
anna.brooke@bristol.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

University of Bristol (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Data will be archived on the data.bris repository

Intention to publish date

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes