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Trial registered on ANZCTR


Registration number
ACTRN12620000647932
Ethics application status
Approved
Date submitted
12/05/2020
Date registered
4/06/2020
Date last updated
4/06/2020
Date data sharing statement initially provided
4/06/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Training Inhibitory Control in Adolescents in Attention-Deficit/Hyperactivity Disorder
Scientific title
Training Inhibitory Control in Adolescents in Attention-Deficit/Hyperactivity Disorder: A randomised controlled trial of the Alfi Virtual Reality programme
Secondary ID [1] 300865 0
None
Universal Trial Number (UTN)
U1111-1250-4678
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Attention-Deficit/Hyperactivity Disorder 317243 0
Condition category
Condition code
Mental Health 315377 315377 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Alfi Virtual Reality programme (Alfi VR) is a novel, adaptive, game-based program designed to train inhibitory control in adolescents. Alfi VR is delivered using a HTC Vive headset and controllers, using immersive virtual reality technology. Participants complete 16 twice weekly training sessions over a period of 8 weeks. Training is delivered individually, face to face by trained research assistants. In the game participants are required to complete an Anticipated Response Task, set in a fantasy world where they must protect a magic crystal from dragons. Each training sessions last approximately 20 minutes. Participants must initiate a response and then either complete or inhibit the response based on visual cues. Training sessions are completed at the participants school, during class time. Compliance is defined as having completed 12 of the 16 allocated training sessions.
Intervention code [1] 317441 0
Treatment: Devices
Intervention code [2] 317651 0
Treatment: Other
Comparator / control treatment
This trial will use a treatment-as-usual control group. The treatment as usual is defined as participants attending their usual classes and programs within the school setting.
Control group
Active

Outcomes
Primary outcome [1] 323626 0
Response inhibition as measured by the Stop-signal reaction time from the Anticipated Response Task
Timepoint [1] 323626 0
Post-training assessment. This assessment will occur one week after the completion of the intervention; with the assessment to be scheduled no less than 3 days and no more than 10 days after the final training session.
Secondary outcome [1] 382422 0
Risk taking as measured by the Balloon Analogue Risk Task for Youth
Timepoint [1] 382422 0
Post-training assessment. This assessment will occur one week after the completion of the intervention; with the assessment to be scheduled no less than 3 days and no more than 10 days after the final training session.
Secondary outcome [2] 382423 0
Impulsivity as measured by the UPPS-P
Timepoint [2] 382423 0
Post-training assessment. This assessment will occur one week after the completion of the intervention; with the assessment to be scheduled no less than 3 days and no more than 10 days after the final training session.
Secondary outcome [3] 382424 0
Behavioural attention as measured by the SWAN
Timepoint [3] 382424 0
Post-training assessment. This assessment will occur one week after the completion of the intervention; with the assessment to be scheduled no less than 3 days and no more than 10 days after the final training session.
Secondary outcome [4] 382425 0
Executive function as measured by the BRIEF
Timepoint [4] 382425 0
Post-training assessment. This assessment will occur one week after the completion of the intervention; with the assessment to be scheduled no less than 3 days and no more than 10 days after the final training session.
Secondary outcome [5] 382426 0
Social functioning as measured by the Social Skills Questionnaire
Timepoint [5] 382426 0
Post-training assessment. This assessment will occur one week after the completion of the intervention; with the assessment to be scheduled no less than 3 days and no more than 10 days after the final training session.
Secondary outcome [6] 382427 0
Working memory as measured by the Digit Span
Timepoint [6] 382427 0
Post-training assessment. This assessment will occur one week after the completion of the intervention; with the assessment to be scheduled no less than 3 days and no more than 10 days after the final training session.
Secondary outcome [7] 383234 0
Emotion regulation as measured by the Perth Emotion Regulation Competency Inventory (PERCI)
Timepoint [7] 383234 0
Post-training assessment. This assessment will occur one week after the completion of the intervention; with the assessment to be scheduled no less than 3 days and no more than 10 days after the final training session.

Eligibility
Key inclusion criteria
Key inclusion criteria include;
- aged 13 years to 17 years 11 months
- has a diagnosis of ADHD, or an attention deficit (defined as a T-score above 60 on the Inattention, Hyperactive, DSM-Inattention or DSM-Hyperactive subscales of the Conners-3 Parent Rating Scale)
Minimum age
13 Years
Maximum age
17 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Key exclusion criteria include;
- History of epilepsy or seizures, loss of awareness, or other symptoms linked to an epileptic condition.
- Previous diagnosis of an intellectual or borderline delay, or who score an IQ <80 as measured by the KBIT-2.
- Previous brain injury or neurological disease.
- Sensory (e.g. colour blindness) or physical impairment that affects capacity to comprehend and follow study instruction.

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)
Group allocation will be completed by a research assistant from within the research group, who is not otherwise assigned to the trial and therefore is not involved in recruitment, screening, enrollment or assessment. Allocation sequences will be generated and concealed in sequential, opaque, sealed envelopes. The participant's study ID will be provided to the research assistant to be recorded on the envelope, prior to the envelope being provided to trial researchers responsible for enrollment and assessment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified, block randomisation using a computer program (R)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Possible mediating and predictive factors such as anxiety, emotional and behavioural problems, Autism features, family functioning and socioeconomic status will be assessed.

Anxiety, emotional and behavioural problems and family functioning will be assessed at the baseline assessment and the post-training assessment using the Spence Children's Anxiety Scale, The Child Behaviour Checklist (Parent report) and the Family Assessment Device respectively.

Socio-economic status and Autism features will be measured during the screening and enrollment stage through use of a demographic questionnaire and the Social Responsiveness Scale 2nd Edition respectively.

Children will be screened using standardised measures of cognitive functioning (the Kaufman Brief Intelligence Test - 2nd Edition) and attention (the Conners-3 Parent Rating Scale) to confirm eligibility.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
A priori power analysis was conducted in G*Power V.3.1 to determine the necessary sample size required to detect significant changes in inhibitory control from pre-training (baseline) to post-training. A sample size of 98 was required for a Medium effect (f=0.25) and a power of 80%. The study will therefore aim to recruit 100 participants, with 50 per group assuming a 1:1 allocation ratio.

Latent Growth Curve Modelling will be used to compare primary and secondary outcomes from the post-training assessment across groups.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 30141 0
3800 - Monash University

Funding & Sponsors
Funding source category [1] 305318 0
Charities/Societies/Foundations
Name [1] 305318 0
5point Foundation
Address [1] 305318 0
PO Box 8096 Camberwell North, Victoria, 3124
Country [1] 305318 0
Australia
Primary sponsor type
Individual
Name
Kim Cornish
Address
Monash University
Wellington Road,
Clayton, VIC 3800
Country
Australia
Secondary sponsor category [1] 305988 0
None
Name [1] 305988 0
Address [1] 305988 0
Country [1] 305988 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305657 0
Monash University HREC
Ethics committee address [1] 305657 0
Monash University
Wellington Rd.
Clayton, VIC 3800
Ethics committee country [1] 305657 0
Australia
Date submitted for ethics approval [1] 305657 0
06/09/2019
Approval date [1] 305657 0
21/10/2019
Ethics approval number [1] 305657 0
21530
Ethics committee name [2] 305877 0
Department of Education and Training
Ethics committee address [2] 305877 0
Victorian Department of Education and Training
Level 3, 33 St Andrews Place, East Melbourne VIC 3002
Ethics committee country [2] 305877 0
Australia
Date submitted for ethics approval [2] 305877 0
16/01/2020
Approval date [2] 305877 0
10/03/2020
Ethics approval number [2] 305877 0
2020_004271

Summary
Brief summary
Children who are inattentive or impulsive often have difficulties in a range of areas including academically and socially. For many children with ADHD, these difficulties will continue on through adolescence and into adulthood, yet there are currently few tools available for those experiencing impulsivity and inattention. The Alfi VR program uses Virtual Reality (VR) to create a novel and engaging platform for teenagers to practice cognitive skills that are associated with impulsivity and inattention. The aim of the study is to determine whether VR cognitive training is associated with improvements in impulse control, and related domains such as attention, social skills and ADHD symptoms. It is hypothesised that adolescents who complete the Alfi VR program will show significant improvements in inhibitory control when compared to adolescents in the control group.
Trial website
https://www.monash.edu/turner-institute/research/alfi-vr-project
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101114 0
Dr Hannah Kirk
Address 101114 0
Monash University
Wellington Road
Clayton, VIC 3800
Country 101114 0
Australia
Phone 101114 0
+61 03 9905 0230
Fax 101114 0
Email 101114 0
hannah.kirk@monash.edu
Contact person for public queries
Name 101115 0
Dr Hannah Kirk
Address 101115 0
Monash University
Wellington Road
Clayton, VIC 3800
Country 101115 0
Australia
Phone 101115 0
+61 03 9905 3255
Fax 101115 0
Email 101115 0
alfivr@monash.edu
Contact person for scientific queries
Name 101116 0
Dr Hannah Kirk
Address 101116 0
Monash University
Wellington Road
Clayton, VIC 3800
Country 101116 0
Australia
Phone 101116 0
+61 03 9905 3255
Fax 101116 0
Email 101116 0
alfivr@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Relevant anonymised participant level data available on reasonable request to the researchers.
When will data be available (start and end dates)?
Data will be available following publication, with no determined end date
Available to whom?
Data will be made available on case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
Undetermined; to be assessed on a case-by-case basis at the discretion of the Primary Sponsor
How or where can data be obtained?
Access subject to approvals by Principal Investigators Dr Hannah Kirk and Professor Kim Cornish
hannah.kirk@monash.edu
kim.cornish@monash.edu
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 7793 0
Study protocol
Citation [1] 7793 0
Link [1] 7793 0
Email [1] 7793 0
Other [1] 7793 0
A study protocol is being submitted for publication. A link to access the protocol will be made available once published.
Attachment [1] 7793 0
Type [2] 7794 0
Informed consent form
Citation [2] 7794 0
Link [2] 7794 0
Email [2] 7794 0
Other [2] 7794 0
Type [3] 7797 0
Ethical approval
Citation [3] 7797 0
Link [3] 7797 0
Email [3] 7797 0
Other [3] 7797 0
Type [4] 8040 0
Ethical approval
Citation [4] 8040 0
Link [4] 8040 0
Email [4] 8040 0
Other [4] 8040 0
Summary results
No Results