Trial Review

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
ACTRN12620001245987
Ethics application status
Approved
Date submitted
9/09/2020
Date registered
20/11/2020
Date last updated
20/11/2020
Date data sharing statement initially provided
20/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Participation in a collaborative LEGO® robotics therapy for adolescents on the autism spectrum
Scientific title
What is the effect of LEGO® robotics therapy on the mental health and social skills of adolescents on the autism spectrum? A phase 1 trial
Secondary ID [1] 301852 0
CRF 20/13400858
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism spectrum disorders 318349 0
Condition category
Condition code
Mental Health 316356 316356 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
LEGO robotics therapy intervention will involve participants working in groups of three across eight one-hour sessions (once per week over eight weeks). The groups will work with a facilitator to build LEGO Robotics (Mindstorms EV3) set using LEGO therapy principles. Facilitators will be staff of Autism SA with extensive experience in working with young people with autism with professional training in special education or psychology. They will be formally trained in LEGO therapy principles. Using LEGO Mindstorms EV3 kits, participants will take turns to work in each of three distinct roles (one role per session). Using the LEGO instructions, the 'engineer' will describe the bricks needed to the 'supplier' who selects and supplies the pieces to the 'builder' who puts the pieces together. The group will work with a trained facilitator who will support communication, problem solving, negotiating, turn taking and cooperating. A session attendance checklist will be maintained.
Once participants have consented, allocation to intervention and wait-list group will be undertaken following discussion with school staff. This is to ensure that attending LEGO groups will not affect the participants' school lessons.
Intervention code [1] 318379 0
Behaviour
Comparator / control treatment
A wait-list control group will be used as the comparator. This group will receive intervention after the 8-week intervention period
Control group
Active

Outcomes
Primary outcome [1] 324843 0
Parent rated assessment of participant anxiety assessed using the Anxiety Scale for Children - Autism Spectrum Disorder (ASC-ASD) - parent
Timepoint [1] 324843 0
Pre intervention, Post 8-week waitlist (for waitlist group), Post 8-week intervention
Primary outcome [2] 324844 0
Parent, rated assessment of participant's social skills assessed using Social Skills Improvement System (SSIS) - SEL parent
Timepoint [2] 324844 0
Pre intervention, Post 8-week waitlist (for waitlist group), Post 8-week intervention
Primary outcome [3] 324845 0
Participant 's motivation and school engagement assessed by rating of Motivation and Engagement Scale - High School (MES-HS) by participants
Timepoint [3] 324845 0
Pre intervention, Post 8-week waitlist (for waitlist group), Post 8-week intervention
Secondary outcome [1] 385900 0
System Usability Scale Scale will assess utility and acceptance of LEGO Robotics by Parents, Teachers and Participants. This is a composite secondary outcome
Timepoint [1] 385900 0
Pre intervention, Post 8-week intervention
Secondary outcome [2] 385901 0
Online open-ended questions completed by participants to gather views and perceptions of LEGO Robotics therapy; it was designed specifically for this study.
Timepoint [2] 385901 0
Post 8-week intervention
Secondary outcome [3] 388049 0
semi-structured Interviews of parents; one-on-one, in-person or via telephone; Gathering views and perceptions on feasibility or usability of LEGO robotics therapy, etc.
Timepoint [3] 388049 0
Post 8 week intervention
Secondary outcome [4] 388050 0
Focus group with teachers; in-person; face-to-face, Gathering teachers' views on acceptability or efficacy of Lego robotics therapy, including running such program in schools,
Timepoint [4] 388050 0
post 8 week intervention
Secondary outcome [5] 388051 0
Focus group with intervention facilitators; in-person; Gathering views, perceptions and experiences of running of Lego robotics therapy including feasibility, efficacy,
Timepoint [5] 388051 0
post 8 week intervention
Secondary outcome [6] 389067 0
A Primary Outcome-Teacher rated assessment of participant anxiety assessed using the Anxiety Scale for Children - Autism Spectrum Disorder (ASC-ASD) - Teacher
Timepoint [6] 389067 0
Pre intervention, Post 8-week waitlist (for waitlist group), Post 8-week intervention
Secondary outcome [7] 389068 0
A Primary Outcome- Teacher rated assessment of participant's social skills assessed using Social Skills Improvement System (SSIS) - SEL Teacher
Timepoint [7] 389068 0
Pre intervention, Post 8-week waitlist (for waitlist group), Post 8-week intervention
Secondary outcome [8] 389069 0
A Primary Outcome- Student- Participant rated assessment of participant's social skills assessed using Social Skills Improvement System (SSIS) - SEL student
Timepoint [8] 389069 0
Pre intervention, Post 8-week waitlist (for waitlist group), Post 8-week intervention

Eligibility
Key inclusion criteria
Aged between 13- 16 years, eligible to recieved services from Autism SA, enrolled in a participating school
Minimum age
13 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Do not provide assent or do not received written informed consent from parent / guardian

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Intervention group gets Lego Robotics therapy for 8 weeks; Waitlist group doesn't receive anything during this period. The wait-list group receives intervention after the Intervention group has received LEGO Therapy. Outcome measures completed twice by pre/post by Intervention group; Outcome measures completed thrice by waitlist group.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
27/11/2020
Actual
Date of last participant enrolment
Anticipated
27/08/2021
Actual
Date of last data collection
Anticipated
20/12/2021
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 306276 0
Charities/Societies/Foundations
Name [1] 306276 0
Channel 7 Children’s Research Foundation of South Australia
Country [1] 306276 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Sturt Rd, Bedford Park
South Australia 5042
Country
Australia
Secondary sponsor category [1] 306767 0
None
Name [1] 306767 0
Address [1] 306767 0
Country [1] 306767 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306487 0
Flinders University Social and Behavioural Research Ethics Committee
Ethics committee address [1] 306487 0
Sturt Rd, Bedford Park
South Australia 5042
Ethics committee country [1] 306487 0
Australia
Date submitted for ethics approval [1] 306487 0
Approval date [1] 306487 0
23/12/2019
Ethics approval number [1] 306487 0

Summary
Brief summary
LEGO® therapy is a proven intervention that uses a child’s natural interest to motivate learning and to collaboratively build a LEGO® set with others through the social division of labour.. It has been found to be effective in increasing social skills and reducing maladaptive behaviours in younger children with autism spectrum disorder (ASD), however, there is limited information about the effectiveness of LEGO® therapy for children over the age of 13 years. LEGO® robotics therapy – which uses the principles of LEGO® therapy applied to LEGO® robotics – may be an age-appropriate intervention to reduce anxiety
and increase social skills in adolescents with ASD. The primary aim of this Phase 1 clinical trial is to investigate whether LEGO® robotics therapy can reduce anxiety and increase social skills and school engagement in adolescents aged 13-16 years with ASD. The
second aim is to measure the engagement, utility, and acceptance of LEGO® robotics with this cohort, while the third aim is to formally gather the views and perceptions of the intervention from all stakeholders (adolescents with ASD, parents, teachers, and LEGO® therapist/facilitators). The fourth and final aim is to develop a training manual for school staff and parents to support adolescents with ASD. The manual would support the reach, generalisation and longevity of the LEGO® robotics therapy program across educational, clinical, home and community settings. The findings of this study will inform the development of a larger randomised controlled trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104050 0
A/Prof Parimala Raghavendra
Address 104050 0
Flinders University, Collège of Nursing & Health Sciences, Sturt Rd, Bedford Park
South Australia 5042
Country 104050 0
Australia
Phone 104050 0
+61 8 82013426
Fax 104050 0
Email 104050 0
[email protected]
Contact person for public queries
Name 104051 0
A/Prof Parimala Raghavendra
Address 104051 0
Flinders University, Collège of Nursing & Health Sciences, Sturt Rd, Bedford Park
South Australia 5042
Country 104051 0
Australia
Phone 104051 0
+61 8 82013426
Fax 104051 0
Email 104051 0
[email protected]
Contact person for scientific queries
Name 104052 0
A/Prof Parimala Raghavendra
Address 104052 0
Flinders University, Collège of Nursing & Health Sciences, Sturt Rd, Bedford Park
South Australia 5042
Country 104052 0
Australia
Phone 104052 0
+61 8 82013426
Fax 104052 0
Email 104052 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9096Informed consent form    380248-(Uploaded-09-09-2020-11-37-06)-Study-related document.docx



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.