Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000584134
Ethics application status
Approved
Date submitted
9/04/2019
Date registered
16/04/2019
Date last updated
15/11/2021
Date data sharing statement initially provided
16/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Use and Effectiveness of the Smiling Mind Smartphone Application on Wellbeing of Children and Adults with Autism Spectrum Disorder and Their Caregivers
Scientific title
Use and Effectiveness of the Smiling Mind Smartphone Application on Wellbeing of Children and Adults with Autism Spectrum Disorder and Their Caregivers
Secondary ID [1] 297900 0
None
Universal Trial Number (UTN)
U1111-1231-2343
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Wellbeing 312282 0
Anxiety 312283 0
Depression 312284 0
Stress 312285 0
Autism Spectrum Disorder 312374 0
Condition category
Condition code
Mental Health 310830 310830 0 0
Autistic spectrum disorders
Mental Health 310901 310901 0 0
Anxiety
Mental Health 310902 310902 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Once pre-intervention surveys have been completed, participants (include children (11-17) and adults (18+) with ASD, caregivers of children with ASD. Children are required to participate with a caregiver) will be randomly allocated to the waitlisted control or intervention groups using a computer generated randomization procedure (i.e. randomizer.org). Following group allocation, intervention participants will be emailed a prompt to download the Smiling Mind app. The download will activate the Smiling Mind app’s daily reminder and activity alarms. Intervention participants will then select mindfulness meditations provided by the Smiling Mind app, based on their age group. Each participant will be asked to spend 10mins (Children with caregivers) or 20mins (Adults with ASD, individual caregivers) each day for 5 days taking part in the meditation exercises. Intervention fidelity is measured through in app monitoring of meditations. Post intervention survey's are issued immediately post-intervention and 1 month post-intervention.

Once the intervention is completed a qualitative survey involving a subsample of participants (up to 30 participants required to achieve data saturation across all groups - including adults with ASD and caregivers, with their children if possible), who have consented to be interviewed. Participants will be contacted through their nominated email address for an interview, as provided through the survey. Participant interviews will be semi-structured. The focus will be on questions relating to the smartphone app and, in particular, whether participants found the mindfulness intervention beneficial and what aspects were beneficial. Interviews will be conducted via telephone or video conferencing software where required.
Intervention code [1] 314125 0
Treatment: Other
Comparator / control treatment
The control group will be required to spend between 10-20mins each day in quiet interaction with their smartphone for 5 days. Caregivers participating with children will spend 10mins in quiet interaction, together, using their smartphone. Adults with ASD and caregivers will also spend their daily allocated 10-20mins quietly interacting with their smartphone for 5 days.
Control group
Active

Outcomes
Primary outcome [1] 319671 0
Wellbeing (Composite)
World Health Organisation – Five Well Being Index (WHO5)
Total Depression Anxiety and Stress Scales – 21 item (DASS-21)
Mindful Attention Awareness Scale - MAAS
Timepoint [1] 319671 0
Immediately post-intervention
Primary outcome [2] 319672 0
Wellbeing (Composite)
World Health Organisation – Five Well Being Index (WHO5)
Total Depression Anxiety and Stress Scales – 21 item (DASS-21)
Mindful Attention Awareness Scale - (MAAS)
Timepoint [2] 319672 0
1-month post-intervention
Secondary outcome [1] 369115 0
Anxiety
Depression Anxiety and Stress Scales – 21 item (DASS-21)
Timepoint [1] 369115 0
Immediately post-intervention
Secondary outcome [2] 369116 0
Anxiety
Depression Anxiety and Stress Scales – 21 item (DASS-21)
Timepoint [2] 369116 0
1-month post-intervention
Secondary outcome [3] 369117 0
Depression
Depression Anxiety and Stress Scales – 21 item (DASS-21)
Timepoint [3] 369117 0
Immediately post-intervention
Secondary outcome [4] 369118 0
Depression
Depression Anxiety and Stress Scales – 21 item (DASS-21)
Timepoint [4] 369118 0
1-month post-intervention
Secondary outcome [5] 369119 0
Stress
Depression Anxiety and Stress Scales – 21 item (DASS-21)
Timepoint [5] 369119 0
Immediately post-intervention
Secondary outcome [6] 369120 0
Stress
Depression Anxiety and Stress Scales – 21 item (DASS-21)
Timepoint [6] 369120 0
1-month post-intervention
Secondary outcome [7] 369312 0
Qualitative - Self observed changes to thinking or behaviour
Semi-structure interviews
Timepoint [7] 369312 0
1-month post intervention

Eligibility
Key inclusion criteria
• Children with ASD from 11 to 17yrs of age (to participate with caregivers)
• Adults (aged 18+) with ASD (to participate either by themselves or with a caregiver)
• Caregivers (informal primary care provider to child or adult with ASD such as parents or grandparents) to participate either by themselves or with their ASD child who must be a minimum of 11yrs old (minimum age for survey validity)
Minimum age
11 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children: Unable to understand and follow verbal commands (as determined/assessed by parent/caregiver)
Adults with ASD: Not fluent in written and spoken English, no smartphone availability
Caregivers: Not fluent in written and spoken English, no smartphone availability

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)
Central randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Minimisation of placebo effects from group or therapist interaction through using Smartphone for application of intervention
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Using power analysis the number of eligible participants will include caregivers of individuals with ASD and individuals with ASD (target sample size = ~52, Power = .8, alpha = .05, large effect size d = .8).

With participant consent, app usage data sourced from Smiling Mind will be used to assess treatment fidelity. This will include information relating to mindfulness meditations. Survey data will be analysed in R or SPSS software. Analyses will be performed on an intention-to treat basis with differences examined between intervention and control groups of participants using Reliable Change Indices (RCI). The comparison immediately post-intervention (i.e. 5 week survey) will be considered the primary outcome. Participant interviews will be semi-structured. The focus will be on questions relating to the smartphone app and, in particular, whether participants found the mindfulness intervention beneficial and what aspects were beneficial (See Appendix D for examples). Interviews will be conducted via telephone or video conferencing software where required.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2019
Actual
20/05/2019
Date of last participant enrolment
Anticipated
9/12/2019
Actual
20/04/2020
Date of last data collection
Anticipated
17/02/2020
Actual
25/04/2020
Sample size
Target
100
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,VIC

Funding & Sponsors
Funding source category [1] 302419 0
University
Name [1] 302419 0
The University of Adelaide
Country [1] 302419 0
Australia
Primary sponsor type
University
Name
School of Psychology, Faculty of Health and Medical Sciences, The University of Adelaide
Address
The University of Adelaide, North Tce,
Adelaide, South Australia
5005 Australia
Country
Australia
Secondary sponsor category [1] 302368 0
None
Name [1] 302368 0
Address [1] 302368 0
Country [1] 302368 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303088 0
The University of Adelaide Human Research Ethics Committe
Ethics committee address [1] 303088 0
Ethics committee country [1] 303088 0
Australia
Date submitted for ethics approval [1] 303088 0
22/01/2019
Approval date [1] 303088 0
05/03/2019
Ethics approval number [1] 303088 0
H-2019-036

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

Contacts
Principal investigator
Name 92430 0
Dr Diana Dorstyn
Address 92430 0
Level 5, Hughes building
North Terrace campus
The University of Adelaide
SA 5005 Australia
Country 92430 0
Australia
Phone 92430 0
+61 088313 0649
Fax 92430 0
Email 92430 0
[email protected]
Contact person for public queries
Name 92431 0
Matthew Hartley
Address 92431 0
Level 2, Hughes building
North Terrace campus
The University of Adelaide
SA 5005 Australia
Country 92431 0
Australia
Phone 92431 0
+61 08 8313 3978
Fax 92431 0
Email 92431 0
[email protected]
Contact person for scientific queries
Name 92432 0
Matthew Hartley
Address 92432 0
Level 2, Hughes building
North Terrace campus
The University of Adelaide
SA 5005 Australia
Country 92432 0
Australia
Phone 92432 0
+61 088313 3978
Fax 92432 0
Email 92432 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
As per ethics approval, only group, rather than individual data will be considered in any analyses and subsequent publication.


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
SourceTitleYear of PublicationDOI
EmbaseChallenges encountered with a mindfulness app: Lessons learnt from a pilot randomized trial involving caregivers and individuals with autism.2022https://dx.doi.org/10.1016/j.rasd.2022.101991
N.B. These documents automatically identified may not have been verified by the study sponsor.