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Trial registered on ANZCTR


Registration number
ACTRN12623000704695p
Ethics application status
Submitted, not yet approved
Date submitted
6/06/2023
Date registered
30/06/2023
Date last updated
30/06/2023
Date data sharing statement initially provided
30/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Parent Perceptions of a Communication Support for Autistic Children
Scientific title
Parent Perceptions of Augmented Input Using A Speech-Generating Device for Autistic Children
Secondary ID [1] 309784 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism
 330191 0
Condition category
Condition code
Mental Health 327068 327068 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study Overview

part 1 will involve semi-structured interviews with five sets of parents to map the families’ current communication landscape, including challenges and supports. This will help inform the development and content of augmented input support using an speech generating device (SGD). Part 2 will consist of a quantitative single case design, where parents will implement the augmented input support strategy using an SGD, after receiving coaching. Part 3 will involve further semi-structured interviews which will provide insight into the parents’ perceptions of augmented input using an SGD including acceptability, effectiveness, and experience of engagement/training.

The proposed intervention will take place over 24-26 weeks in participants' homes.

The lead researcher (a PhD student) proposes to visit with the family approximately three times for one hour each time prior to beginning the research, once to discuss the study, consent, and answer any questions, a second time and/or third time to undertake pre-study assessments and to continue to build a relationship. This is expected to take around 2 weeks.

The lead researcher will conduct one semi-structured interview about their family's communication landscape. This interview will last approximately an hour, as well as an opportunity for a follow-up interview if the participant would like to add any additional information after the initial interviews. This is expected to be around 1-2 weeks.

The lead researcher will then also train the parent to implement the communication support 2 times per week for 45 minutes to an hour each time, for a total of 24- 30 sessions (depending on how long the family is randomly allocated to the baseline phase) per family over 17-18 weeks.

Two extra weeks are set aside to allow for session reschedules or cancellations.

At the end of the intervention, the parent will take part in another part in a semi-structured interview about their perceptions of the support with the lead researcher. This will last approximately an hour, as well as an opportunity for a follow-up interview if the participant would like to add any additional information after the initial interviews. This is expected to be around 1-2 weeks.

All parts of the study will be completed within approximately 24-26 weeks. All parts of the study will be done face-to-face in the participants home.


Part 1: Semi-Structured Interviews that Focus on Mapping the Communication Landscape

Conversational style, semi-structured interview will be conducted with parents to determine parents’ views and perspectives on their child's communication abilities, barriers, and facilitators within the context of their daily routines in the home environment. Interviews wil be audio recorded.

The following areas will be covered in the interviews:
(a) How does their child currently communicate?
(b) How do they currently communicate with their child?
(c) What are some of the family’s strengths and what supports their communication?
(d) What are some of the most important communication-related challenges/barriers that parents and children experience?
(e) What are family and children's previous experiences of communication? How have these helped or hindered communication, what works or does not and why?

Part 2: Parent-Meditated Augmented Input Support Using an SGD

Materials and Settings

Materials that will be used in this study include the SGD and software/apps. This could be an iPad with an app such as Proloquo2Go. The SGD will display four communication icons per page. Three icons will consist of a photograph of an object that is typically used within the child’s preferred activity and a corresponding voice output with a written label. For example, a doll, a doll’s house, and a doll’s hairbrush. The fourth, distractor item, will consist of a neutral or less preferred item (e.g., sock, pen). Each child will have three preferred routines, with three separate pages on the SGD, with a total of 12 icons. Voice output will consist of a child voice that matches the participant’s gender. Participants’ preferred items for play activities will be the child’s own from the home. Training materials will include PowerPoint, a laptop to display PowerPoint and paper handouts. Recording equipment will be used to record sessions.

Parent training and all data collection (interviews and support) will take place in the participant's home or an agreed-upon location that is suitable for the child and comfortable for all participants, determined through a discussion with the parent.

Procedures
All baseline, augmented input coaching, augmented input implementation and follow-up sessions will be scheduled twice per week at times convenient for each family. If a session is missed due to sickness or other conflicts, all efforts will be made to reschedule this session within the next week.

Pre-assessment
Prior to the baseline, demographic information will be gathered. All participants will be assessed using the Vinelands Adaptive Behaviour Scale Third Edition (VABS-III; Sparrow et al., 2017). The VABS-III is a widely accepted, norm-referenced assessment tool used in the field of developmental disability research to assess a variety of adaptive skills ranging from communication to independent living (Sparrow et al., 2017). The VABS-III provides a comprehensive assessment of adaptive behaviour, covering the domains of daily living skills, communication, socialisation, motor skills and maladaptive behaviour. These domains combine to give the Adaptive Behaviour Composite, a measure of an individual’s general adaptive functioning.

A symbol comprehension test, implemented by the parent, will be used to gauge the child’s comprehension of the icons on the SGD, prior to the baseline phase. The researcher will explain to the parent that they are testing whether the child understands the icons or not. The parent will be coached to move through the pictures on the device in a randomly pre-determined order. The parent will say, “put your finger on [object]”, with the device open to the relevant page in front of the child. Parents will be instructed to provide praise regardless of the child’s response. A correct response will be defined as selecting the correct picture within 10s without selecting any other picture. If the child makes no response or selects a non-corresponding picture, this will be marked as incorrect. The researcher will change the screens on the device and direct the parent to the relevant phrases to read. A total of 12 pictures will be assessed.

Baseline Phase
A minimum of 3 baseline sessions will be completed for each dyad consisting of video-recorded 10-minute naturalistic play samples between the parent and child. Participants will be randomly allocated to baselines of 3, 4, 5 and 6 sessions, as a minimum of three baselines is required to establish a trend (Kennedy, 2005). If baseline is not stable after the assigned number of baseline sessions, additional sessions (as required) will be added until stability is achieved. The naturalistic play sample will entail a loosely arranged play activity using materials in the home (e.g., playing with a dollhouse or train set) based on the child’s individual preferences and routines as determined in Study 1. The parent will be presented with the SGD with the screen open to the page showing icons relevant to the child’s activity, and this will remain available throughout the session. The parent will be instructed to play with their child as they normally would. The researcher will not interact with the parent-child dyad and no coaching or feedback will be provided. Recording of the session will begin when the parent and child are settled into play.

Augmented Input Coaching.
This phase will consist of two sessions, whereby both parents or the nominated parent will be taught by the researcher strategies for using the SGD. Training will be aimed at teaching the parents to provide augmented input using the communication device during play activities. That is, the parent will be instructed to point to the symbols on the AAC system within 5s of proving spoken output. For example, “We are playing with the DOLLS” whilst touching the picture that represents the dolls. Training will comprise of two one-hour sessions and will include oral explanations, printed handouts, visual slides, video examples, role play, practice with the child, and discussions. The content covered will be an overview of what AAC is, why AAC benefits those with little or no spoken language, how to set up the device, what augmented input is and how to implement it. All training content is designed specifically for this study.

Augmented Input Implementation
This phase will involve a total of 14, 45-minute-long support sessions. In this phase, the parent will implement the augmented input on the AAC system. Prior to sessions commencing the researcher will check in with participants, to reflect on the last session and answer any questions (5-10 mins). Parents will be instructed to practice using the augmented input strategy, for 10 minutes. This will be video recorded for data collection and no feedback or coaching will be provided. After the video recording, the researcher will reflect with the participant on how the practice went, problem-solve any issues, practice with a new activity and provide feedback that is most beneficial to the parent (e.g., model if needed, verbal feedback). Additionally, the researcher will check in on what areas they would like to focus on until the next session (5-15 mins).

Follow-Up
Follow-up will be identical to the baseline phase and will commence one week after the final support session for each dyad and will consist of three sessions.

Post-assessment
The comprehension test will be repeated as outlined in the pre-assessment description.

Dependent Variables
Child and parent dependent variables are mostly the same: (1) speech-generating device use, (2) speech and speech approximation, (3) communicative gestures and, (4) total communication. The parent-dependent variables will also include (5) parent fidelity of implementation.


Parent Fidelity of Implementation
Fidelity of implementation is a measure of how well the parent adheres to the protocol for the correct implementation of the support. The researcher will develop a checklist to ensure consistency in implementation designed specifically for this study.

Data Collection
All sessions (baseline phase, augmented input coaching phase, augmented input implementation phase, follow-up phase) will be video recorded. For the preliminary assessments (i.e., VAB-III) scores will be calculated as outlined by the assessment manuals.


Part 3: Parents’ Experiences and Perceptions of the Augmented Input Support

Semi-structured interviews will be conducted with parent participants, following the same procedures outlined in Part 1, however, in this study the questions will focus on parents' experiences of parent coaching and augmented input support. The following topics will be covered:

a) What are parents' views/perceptions of the coaching/training? (What was helpful or challenging? How might coaching be improved?)
b) What are parents' views/perceptions of the use of augmented input using an SGD (What did they find helpful and/or challenging? How acceptable was it? Why did they think it was acceptable or not? How effective was it from their view? Why did they think it was effective or not? What needs to change and why?
Intervention code [1] 326216 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 334920 0
Parents’ perspectives on their child's communication abilities determined from semi-structured interviews
Timepoint [1] 334920 0
Part 1: semi-structured interviews conducted in the first week of participation.
Primary outcome [2] 335141 0
Parent and child communication assessed through review of video footage of parents and children using coding designed for the purpose of this study.
Timepoint [2] 335141 0
Part 2: Week prior to starting intervention (pre-assessment), Baseline (week 0), every week during the 14-week intervention period, 1-week post-intervention completion (follow-up).
Primary outcome [3] 335142 0
Parent perceptions and experiences of an augmented input support.
Timepoint [3] 335142 0
Part 3: semi-structured interviews conducted in the final week of participation, following completion of part 2 (follow-up).
Secondary outcome [1] 423250 0
Comprehension of SGD icons, a test that will be implemented by the parents and coached through by the lead researcher designed for the purpose of this study.
Timepoint [1] 423250 0
The week prior to starting intervention (pre-assessment), and the week following post-intervention completion (follow-up) (post-assessment).

Eligibility
Key inclusion criteria
To be eligible to participate in the study, children must:
a) Have a confirmed clinical diagnosis of autism or showing signs of autism on a gold standard screening tool (e.g., The Social Attention and Communication Surveillance Tool)
b) Have less than 10 intelligible spoken words.
c) Be aged 2 - 12 years at the start of the study.
d) Not regularly using a speech-generating device (SGD) in their home environment.
e) Have sufficient motor skills to operate an SGD, as determined by parent report, and
f) Have no hearing and visual impairments that could potentially interfere with the use of an SGD.
Parents must:
a) Be able to understand and consent to the research and to describe their perspective in English.
b) Be willing to participate in approximately 2-3 hours of interviews and in-home support sessions and commit to the research project for up to 6 months.
c) Not concurrently receive any SGD supports.
Minimum age
0 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Educational / counselling / training
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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/07/2023
Actual
Date of last participant enrolment
Anticipated
31/07/2023
Actual
Date of last data collection
Anticipated
29/03/2024
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 25581 0
New Zealand
State/province [1] 25581 0
Wellington

Funding & Sponsors
Funding source category [1] 313968 0
University
Name [1] 313968 0
Victoria University of Wellington
Country [1] 313968 0
New Zealand
Primary sponsor type
University
Name
Victoria University of Wellington
Address
Victoria University of Wellington
PO Box 600
Kelburn,
6140 Wellington
Country
New Zealand
Secondary sponsor category [1] 315919 0
None
Name [1] 315919 0
none
Address [1] 315919 0
none
Country [1] 315919 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 313103 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 313103 0
Ethics committee country [1] 313103 0
New Zealand
Date submitted for ethics approval [1] 313103 0
21/06/2023
Approval date [1] 313103 0
Ethics approval number [1] 313103 0

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

Contacts
Principal investigator
Name 127018 0
Ms Siobhan Gardiner
Address 127018 0
Victoria University of Wellington
School of Education
Block C
15 Waiteata Road,
Kelburn,
Wellington, 6012, New Zealand
Country 127018 0
New Zealand
Phone 127018 0
+64 4 463 9500
Fax 127018 0
Email 127018 0
siobhan.gardiner@vuw.ac.nz
Contact person for public queries
Name 127019 0
Siobhan Gardiner
Address 127019 0
Victoria University of Wellington
School of Education
Block C
15 Waiteata Road,
Kelburn,
Wellington, 6012, New Zealand
Country 127019 0
New Zealand
Phone 127019 0
+64 4 463 9500
Fax 127019 0
Email 127019 0
siobhan.gardiner@vuw.ac.nz
Contact person for scientific queries
Name 127020 0
Siobhan Gardiner
Address 127020 0
Victoria University of Wellington
School of Education
Block C
15 Waiteata Road,
Kelburn,
Wellington, 6012, New Zealand
Country 127020 0
New Zealand
Phone 127020 0
+64 4 463 9500
Fax 127020 0
Email 127020 0
siobhan.gardiner@vuw.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This study is a small study consisting of a maximum of 5 families


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.