Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12616001291471
Ethics application status
Approved
Date submitted
5/09/2016
Date registered
14/09/2016
Date last updated
4/03/2020
Date data sharing statement initially provided
1/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Computer Games and Online mentoring: Can it help adults on the autism spectrum to improve emotion recognition skills?
Scientific title
Evaluation of a Computer-based Emotion Recognition Intervention among Individuals on the Autism Spectrum
Secondary ID [1] 289895 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorders 299856 0
Emotion recognition skills 299857 0
Condition category
Condition code
Mental Health 299762 299762 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: Computer game and online mentoring
Description of intervention:
1. Computer game: The study will evaluate an existing computer game called Mindreading, previously developed and evaluated by the University of Cambridge. The game contains three main sections, the emotions library (access to various video and audio clips of different emotions), learning centre (contains a variety of lessons and quizzes) and game zones (five different themed emotion recognition games).

2. Online mentoring: The online mentoring program, Mindchip focuses on equipping adults on the autism spectrum with tools to observe/recognise emotions as well as to explore potential strategies to cope with certain social situations. Participants will meet with a mentor (a therapist) via teleconferencing.

Materials: (1) Computer for teleconferencing (3) Emotion recognition Computer Game, 'Mindreading'

Procedures: Participants will receive a copy the Mindreading computer game (DVD format). They will be asked to play the computer game for at least 1 hour per week. In addition to the computer game, participants allocated to this group will receive the Mindchip online mentoring program. They will meet with a mentor/therapist via teleconferencing once a week over 10 weeks (one hour per week).

Who will deliver the intervention: Postgraduate students with a background in research and occupational therapy.

Mode of delivery: Online/home based intervention

Duration and intensity of intervention: All participants will receive approximately 10x 1 hour online mentoring sessions, once per week for ten weeks. Participants will be requested to dedicate approximately 1 hour per week playing the Mindreading computer game

Location: The intervention will mainly be held online.

Adherence: Prior to the trial, the researcher will provide the participants with information on the intervention. Participants will be encouraged to discuss the study with someone whom they are comfortable with. During the first meeting, the researchers will provide further explanations on what the study involves (with visual instructions, if necessary). These explanations can include demonstrations of the equipment which will be used in the study.
Intervention code [1] 295572 0
Treatment: Other
Intervention code [2] 295886 0
Treatment: Devices
Comparator / control treatment
Brief name: Computer Game without online mentoring
Goal: To measure the impact of online mentoring in improving emotion recognition skills
Materials and Procedure: Participants in the active control group will receive a copy of the Mindreading computer game. They will be advised to play the computer game for at least one hour per week over 10 weeks.
Control group
Active

Outcomes
Primary outcome [1] 299237 0
ET behaviour when viewing emotion stimuli - The remote eye tracker will be used to record eye tracking movements to the eyes, nose, mouth or other areas when viewing the Cambridge Mindreading Face-Voice Battery (CAM) and Movie for the Assessment of Social Cognition (MASC).
Timepoint [1] 299237 0
Two weeks before intervention, immediately after intervention and 12-weeks follow-up
Primary outcome [2] 299238 0
Emotion recognition behaviour when viewing emotion stimuli- Emotion recognition accuracy and response time will be measured using the Cambridge Mindreading Face-Voice Battery (CAM) and Movie for the Assessment of Social Cognition (MASC). This is a composite primary outcome to measure emotion recognition behaviour outcomes in a context that is similar to the intervention and whether the skills translate to a context with social interactions within a natural environment.
Timepoint [2] 299238 0
Two weeks before intervention, immediately after intervention and 12-weeks follow-up
Secondary outcome [1] 326599 0
Engagement during the intervention measured by drop-out rates
Timepoint [1] 326599 0
During intervention and immediately after intervention
Secondary outcome [2] 326600 0
Self-efficacy in emotion recognition. To assess self-efficacy, the Emotion Recognition Self-Efficacy Questionnaire was designed for this study. This includes questions on the participants level of confidence in emotion recognition outcomes.
Timepoint [2] 326600 0
Two weeks before intervention, immediately after intervention and 12-weeks follow-up
Secondary outcome [3] 327146 0
Quantified EEG (alpha, theta, beta) when viewing emotion stimuli adapted from the Cambridge Mindreading Face-Voice Battery (CAM)
Timepoint [3] 327146 0
Two weeks before intervention, immediately after intervention and 12-weeks follow-up
Secondary outcome [4] 327688 0
Participants' perception on the game and the online mentoring program- This will be assessed using a questionnaire designed for this study to obtain qualitative feedback of the game and the online mentoring program
Timepoint [4] 327688 0
During intervention and immediately after intervention
Secondary outcome [5] 327689 0
Screening outcomes- Participants will be undergo screening assessments [Weschler Abbreviated Scale of Intelligence II (WASI-II) and Test of Everyday Attention (TEA)] to screen for intelligence and attention performance,
Timepoint [5] 327689 0
Pre-intervention (two weeks before the intervention)

Eligibility
Key inclusion criteria
Participants will consist of adults with a formal diagnosis of high functioning autism, Asperger syndrome or Pervasive Developmental Disorder Otherwise Not Specified under the Diagnostic Statistical Manual of Mental Disorders IV.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if:
1. They are on a new medication regime for less than three months
2. Have a history of severe brain injury
3. Acute mental health illness

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The allocation will involve a third party (e.g. a researcher who is not involved in data collection) who holds the allocation schedule and will generate the group allocation. This researcher will be contacted to determine the allocation of the participant. This allocation is only be known to the researchers but will be concealed from the participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Each participant will be assigned with a number. An online number randomiser (e.g. https://www.randomizer.org/) will be used to determine the group allocation for each participant.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
We will be recruiting approximately 30 adults on the autism spectrum for a pilot randomised controlled trial. Participants will be randomly allocated to two groups, and matched based on age, gender, handedness and intelligence quotient (IQ) scores. This will be a pilot randomised control trial, evaluating the feasibility, acceptability and preliminary efficacy of the online mentoring and/or computer program.

Statistical analysis will be conducted to compare the performance between both groups. A Kolmogorov-Smirnov test will be firstly used to determine the distribution of the data. Following to this, univariate analyses using a Mann-Whitney U test or an independent t-test will be used to determine association between the behavioural outcomes (intelligence, attention, autism symptomology and theory of mind) impacting on emotion recognition tasks. Multivariate analyses will then be conducted using modelling to account for the repeated measures contributed by each participant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2018
Actual
25/06/2018
Date of last participant enrolment
Anticipated
30/06/2019
Actual
8/03/2019
Date of last data collection
Anticipated
31/12/2019
Actual
1/07/2019
Sample size
Target
30
Accrual to date
Final
25
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 294270 0
Other
Name [1] 294270 0
Cooperative Research Centre for Living with Autism (Autism CRC)
Country [1] 294270 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Sonya Girdler
Address
School of Occupational Therapy and Social Work,
Curtin University,
Kent St, Bentley WA 6102
Country
Australia
Secondary sponsor category [1] 293105 0
Individual
Name [1] 293105 0
Associate Professor Tele Tan
Address [1] 293105 0
School of Mechanical Engineering,
Curtin University,
Kent St, Bentley WA 6102
Country [1] 293105 0
Australia
Other collaborator category [1] 279181 0
Individual
Name [1] 279181 0
Prof Murray Mayberry
Address [1] 279181 0
School of Psychology,
The University of Western Australia (M304),
35 Stirling Highway
CRAWLEY WA 6009
Australia
Country [1] 279181 0
Australia
Other collaborator category [2] 279205 0
Individual
Name [2] 279205 0
Professor Sven Bolte
Address [2] 279205 0
CAP; Karolinska Institutet/KIND; Gavlegatan 22B, plan 8, 113 30 STOCKHOLM , Sweden
Country [2] 279205 0
Sweden
Other collaborator category [3] 279206 0
Individual
Name [3] 279206 0
Professor Ottmar Lipp
Address [3] 279206 0
School of Psychology and Speech Pathology,
Curtin University,
Kent St, Bentley WA 6102
Country [3] 279206 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295698 0
Curtin University Human Research Ethics Committe
Ethics committee address [1] 295698 0
Ethics committee country [1] 295698 0
Australia
Date submitted for ethics approval [1] 295698 0
18/02/2016
Approval date [1] 295698 0
10/03/2016
Ethics approval number [1] 295698 0
HR38/2016

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

Contacts
Principal investigator
Name 68138 0
A/Prof Sonya Girdler
Address 68138 0
School of Occupational Therapy and Social Work,
Curtin University,
Kent Street, Bentley, Perth, Western Australia 6102
Country 68138 0
Australia
Phone 68138 0
+61892663630
Fax 68138 0
Email 68138 0
[email protected]
Contact person for public queries
Name 68139 0
Sonya Girdler
Address 68139 0
School of Occupational Therapy and Social Work,
Curtin University,
Kent Street, Bentley, Perth, Western Australia 6102
Country 68139 0
Australia
Phone 68139 0
+61892663630
Fax 68139 0
Email 68139 0
[email protected]
Contact person for scientific queries
Name 68140 0
Sonya Girdler
Address 68140 0
School of Occupational Therapy and Social Work,
Curtin University,
Kent Street, Bentley, Perth, Western Australia 6102
Country 68140 0
Australia
Phone 68140 0
+61892663630
Fax 68140 0
Email 68140 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
At present, release of individual participant data has not been approved by ethics.


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.