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Trial registered on ANZCTR


Registration number
ACTRN12622000206729
Ethics application status
Approved
Date submitted
17/12/2021
Date registered
7/02/2022
Date last updated
7/02/2022
Date data sharing statement initially provided
7/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A Social Robot for Anxious Children
Scientific title
Feasibility of a Social Robot for Anxious Children: A Randomised Controlled Trial
Secondary ID [1] 306077 0
None
Universal Trial Number (UTN)
U1111-1271-9638
Trial acronym
SORA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 324725 0
Condition category
Condition code
Mental Health 322175 322175 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This experimental program is an interactive technical adaptation of several core elements of Cognitive Behavioural Therapy, delivered via a social humanoid robot (NAO robot). The program delivers information about anxiety to increase knowledge (psychoeducation) and introduces different strategies for noticing and managing anxiety symptoms (emotion recognition and management). The program will be delivered in a single session of no longer than 60 minutes duration and will involve four different modules.
The first module of the program involves an introduction to anxiety, the second module discusses when anxiety can be helpful, the third module presents information regarding when anxiety is not helpful, and the fourth module teaches three simple strategies for managing anxiety symptoms. The program is based on a set session script which will have simplified branching options based on responses to questions and activities in the session.
Children will attend one face-to-face session with the robot at a Monash University facility during which the program is delivered, facilitated by a trained researcher. Children will be required to listen to the social robot and to respond to the robot by speaking or pressing buttons on different areas of the robot (e.g., feet, arms, head). After completion of the session, children and their parents/guardians will be asked a series of questions about their experience of the robot. Adherence to the robot program will be assessed via monitoring by the researcher for session engagement, and completion rates of the session and session activities.
Intervention code [1] 322479 0
Treatment: Devices
Intervention code [2] 322480 0
Behaviour
Comparator / control treatment
The active control program involves providing the same elements of Cognitive Behavioural Therapy, delivering information about anxiety to increase knowledge (psychoeducation) and strategies for noticing and managing anxiety symptoms (emotional recognition and management) as the intervention program, instead delivered online via written format. Children will be required to read the written information with access to an audio file, which should take no longer than 60 minutes to complete.
Adherence to the control program will be assessed via website analytics for monitoring engagement with the program.
Control group
Active

Outcomes
Primary outcome [1] 329943 0
The primary outcome is to determine if the social robot method is feasible to use with anxious children as an intervention modality. Feasibility of the social robot will be assessed as a composite of four metrics. The metrics will be as follows: 80% attendance to the robot sessions, 80% questionnaire completion rates, less than 10% of robot sessions on average that have been affected by technical difficulties that prevent completion of the session, and an average score of 5 or above on program evaluation from both parents/guardians and children assessed using an 11-point Likert scale.
Timepoint [1] 329943 0
At the end of the study.
Secondary outcome [1] 404361 0
Child anxiety symptoms will be assessed using the Spence Children’s Anxiety Scale Self Report total score.
Timepoint [1] 404361 0
Baseline, 2 weeks, and 4 weeks post intervention.
Secondary outcome [2] 404362 0
Child anxiety symptoms will be assessed using the Spence Children’s Anxiety Scale Parent Report total score.
Timepoint [2] 404362 0
Baseline, 2 weeks, and 4 weeks post intervention.
Secondary outcome [3] 404363 0
Life interference and impairment experienced resulting from anxiety symptoms will be assessed using the Child Anxiety Life Interference Scale Parent Version.
Timepoint [3] 404363 0
Baseline, 2 weeks, and 4 weeks post intervention.
Secondary outcome [4] 404364 0
Child sleep habits and difficulties with sleep will be assessed using the Children’s Sleep Habits Questionnaire.
Timepoint [4] 404364 0
Baseline, 2 weeks, and 4 weeks post intervention.
Secondary outcome [5] 404365 0
Child depression symptoms will be assessed using the Children’s Depression Inventory – Parent Report.
Timepoint [5] 404365 0
Baseline, 2 weeks, and 4 weeks post intervention.
Secondary outcome [6] 405594 0
Child executive functioning will be assessed using the Behaviour Rating Inventory of Executive Function.
Timepoint [6] 405594 0
Baseline, 2 weeks, and 4 weeks post intervention.
Secondary outcome [7] 405595 0
Feasibility of the social robot to deliver information to children about anxiety and strategies for managing anxiety symptoms will be assessed using qualitative data on levels of reported acceptability and feasibility from both parents/guardians and children collected during a brief interview after the session.
Timepoint [7] 405595 0
At the end of the study.

Eligibility
Key inclusion criteria
Participants may participate in the study if they: (a) are between the ages of 8 to 11 years and 11 months at the time of enrolment into the study (i.e., signing the consent form); (b) score within the “elevated” or above range of the Spence Children’s Anxiety Scale (total T-score > 60); and (c) have a legally acceptable representative (i.e., parent or guardian) capable of understanding the informed consent document and providing consent on their behalf.
Minimum age
8 Years
Maximum age
11 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded from the pilot study if they: (a) have visual, hearing, or physical impairments that would prevent them from understanding the assessment requirements or engaging in the digital intervention; (b) are not English speaking; (c) have diagnosed or borderline intellectual delay, or who have an IQ < 70; and (d) children with comorbid diagnoses that, in the opinion of a research team member, may confound study data/assessments, i.e., oppositional defiant disorder, conduct disorder or severe mental health conditions (e.g., severe selective mutism) by impacting on their ability to participate in the session with the content and/or robot in a safe way. No further exclusion criteria will be applied.

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 not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation (ratio 1:1, with blocks of 4) will be used to maintain balance between intervention arms. Computer-generated random numbers will be used to allocate participants. The randomisation will not be stratified.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Demographics and feasibility data will be assessed using descriptive statistics. A General Linear Model (GLM) with repeated measures with an intention-to-treat approach will be used to assess treatment differences both between-groups (2: robot, online) and within-groups (3: baseline, week 2 and week 4). Statistical significance will be set at the alpha level of 0.05. Qualitative analysis will be conducted using thematic content analysis.

As a feasibility study, the sample size is estimated based on the observed effect sizes of group differences on the Spence Children’s Anxiety Scale, the expected primary outcome of a future clinical trial, and the extent to which this outcome indicates an effect size > 0 will be calculated.
We estimate the power for this study assuming the effect size for a full trial would be moderate to large (d = 0.6-0.8). Assuming alpha = 0.05 and 1-beta = 0.8, the required sample size to detect the assumed effect size would be n = 26 (effect size d = 0.8) or 45 (effect size d = 0.6) per group based on the following parameters:
- t-test; means: difference between two independent means (two groups)
- Tails: two-tailed
- Number of groups: 2
Assuming a sample size of n = 33 per group (n = 66 in total; for a large effect size) or n = 57 per group (n = 114 in total; for a moderate effect size) will allow for 80% attendance to the robot sessions and/or 80% completion rates of the follow-up questionnaires.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2022
Actual
Date of last participant enrolment
Anticipated
30/09/2022
Actual
Date of last data collection
Anticipated
14/11/2022
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 310411 0
University
Name [1] 310411 0
Monash University
Country [1] 310411 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Monash University, Wellington Rd, Clayton VIC 3800
Country
Australia
Secondary sponsor category [1] 311567 0
None
Name [1] 311567 0
Address [1] 311567 0
Country [1] 311567 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310059 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 310059 0
Ethics committee country [1] 310059 0
Australia
Date submitted for ethics approval [1] 310059 0
03/08/2021
Approval date [1] 310059 0
21/10/2021
Ethics approval number [1] 310059 0
29370

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

Contacts
Principal investigator
Name 116346 0
Dr Nicole Robinson
Address 116346 0
Monash University, Wellington Rd, Clayton VIC 3800
Country 116346 0
Australia
Phone 116346 0
+61 3 9905 5481
Fax 116346 0
Email 116346 0
Nicole.robinson@monash.edu
Contact person for public queries
Name 116347 0
Sally Richmond
Address 116347 0
Monash University, Wellington Rd, Clayton VIC 3800
Country 116347 0
Australia
Phone 116347 0
+61 3 9905 3028
Fax 116347 0
Email 116347 0
Sally.richmond@monash.edu
Contact person for scientific queries
Name 116348 0
Nicole Robinson
Address 116348 0
Monash University, Wellington Rd, Clayton VIC 3800
Country 116348 0
Australia
Phone 116348 0
+61 3 9905 5481
Fax 116348 0
Email 116348 0
Nicole.robinson@monash.edu

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


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.