Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000614695
Ethics application status
Approved
Date submitted
25/05/2023
Date registered
5/06/2023
Date last updated
26/05/2024
Date data sharing statement initially provided
5/06/2023
Date results information initially provided
26/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Adapting an Autism Early Support Program for a Lower Income Family: A Case Study.
Scientific title
Adapting an Autism Support Program for a Lower Financially Resourced Family: A Case Study investigating parental perceptions and program acceptability.
Secondary ID [1] 309720 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism 330110 0
Condition category
Condition code
Mental Health 326996 326996 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The proposed case study will investigate both acceptability and parent perceptions of an adapted version of the Early Start Denver Model (ESDM) aimed at increasing accessibility and participation for lower income families. These adaptations have been developed to improve access and participation for lower income families, who access autism support programs at a reduced rate ((Nguyen et al., 2016; Pickard & Ingersoll, 2016) and face a higher number of barriers to such services when compared to higher income families (Wallace-Watkin et al., 2023). A key part of this adapted program is focused on parent choice. Parents will have the opportunity to build their own program of support based upon ESDM including selecting the topics they wish to gain education on. Topics offered will include education on autism, neurodiversity, and personalised ways to embed learning strategies into daily routines. Parents may choose the way in which the ESDM-based program will be delivered, either having the therapist work directly with their child, with the parent, and/or with the child’s teacher. Extended family members will be warmly invited to attend sessions at the parents’ request. Sessions will run for between 45 minutes to one hour either in person at the family home or at the Victoria University of Wellington Autism Clinic, or for parent/teacher coaching there will be the option to attend online via Zoom. Parents will select the location and method of delivery which best suits them and their family.
The support service will be provided by a community therapist - the lead researcher – who is a current PhD candidate with training (however is not certified) in the Early Start Denver Model (ESDM) approach, has worked with several families and/or their young autistic children over the past three years, and has over 10 years’ experience working with primary school aged autistic children in an educational setting. Additionally, the lead researcher has received training and education in neurodiversity affirming practices.
The ESDM-based support program will consist of six sessions each of direct therapy, parent coaching, and/or teacher coaching based upon the delivery method/s the parent has chosen. That is, parents may choose to receive up to six sessions of each delivery method (direct therapy, parent coaching, and/or teacher coaching) for a total number of 18 total sessions. It is anticipated these sessions will be delivered over six weeks, however an additional two weeks have been allocated at the end of the program to allow for catch-up sessions if cancellations have occurred. As aforementioned, the key adaptation to the program is an increase in parent choice, allowing for increased flexibility of the program. Additional ways this program has been adapted is to remove elements (i.e. child goals) which focus on neurotypical-based skills (e.g. making eye contact, specific approaches to play), offer opportunities to focus on child well-being and experience, increase the neurodiversity affirming content, removing technical language, removing costs by offering the program for free, and covering any potential travel costs.

Program adherence will be monitored through the use of session attendance checklists for each of the chosen delivery methods, as well as recording of reasons for cancellations/reschedules where the parent shares this information.

Nguyen, C. T., Krakowiak, P., Hansen, R., Hertz-Picciotto, I., & Angkustsiri, K. (2016). Sociodemographic disparities in intervention service utilization in families of children with autism spectrum disorder. Journal of Autism and Developmental Disorders, 46(12), 3729–3738. https://doi.org/10.1007/s10803-016-2913-3

Pickard, K.E., & Ingersoll, B.R. (2016). Quality versus quantity: The role of socioeconomic status on parent-reported service knowledge, service use, unmet service needs, and barriers to service use. Autism, 20(1), 106-115. https://doi.org/10.1177/1362361315569745

Wallace-Watkin, C., Sigafoos, J., Woods, L., & Waddington, H. (2023). Parent reported barriers and facilitators to support services for autistic children in Aotearoa New Zealand. Autism, Advanced online publication. https://doi.org/10.1177/13623613231168240
Intervention code [1] 326160 0
Treatment: Other
Intervention code [2] 326233 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 334880 0
Parent perceptions and experiences of the adapted support program explored through a semi structured interview, with questions designed specifically for this study.
Timepoint [1] 334880 0
Within two weeks of the conclusion of the program.
Primary outcome [2] 334881 0
Parent indication of the acceptability of the program measured using the Treatment Acceptability Rating Form - Revised (TARF-R).
Timepoint [2] 334881 0
Within two weeks prior to beginning the program, and repeated within two weeks of the program concluding.
Primary outcome [3] 334882 0
Parent perception of their and their child's experience attending each session and the fit of the program to their family measured using a check-in survey developed for this study, based on a survey used by Tupou et al. (2022).

Jessica Tupou, Chevelle Ataera & Hannah Waddington (2022) Exploring one Whanau Maori’s experience with an autism support program: a case study, Research and Practice in Intellectual and Developmental Disabilities, DOI: 10.1080/23297018.2022.2051197
Timepoint [3] 334882 0
The survey will be completed in week three and week six of the program.
Secondary outcome [1] 422321 0
Parent rating as to how helpful each of the adaptations strategies were using a Likert-type scale in a questionnaire designed for this study.
Timepoint [1] 422321 0
Within two weeks of the program concluding.
Secondary outcome [2] 422322 0
Rate of parent attendance will be measured through the use of a study-specific attendance/cancellation log tracking the number of sessions attended, cancelled, or rescheduled. This data will be recorded in a table, with a column for noting reasons for cancellations where these are provided.
Timepoint [2] 422322 0
This information will be recorded for each of the sessions.
Secondary outcome [3] 422510 0
Attendance by extended family members at sessions, along with a note as to the relationships of the family member to the parent participant, will be recorded in a study-specific checklist/table.
Timepoint [3] 422510 0
This information will be recorded for each of the sessions.

Eligibility
Key inclusion criteria
This study will include one parent/caregiver (herein collectively referred to as parent) of a child who is under the age of five who is, or is likely to be, autistic. The parent will also meet the following inclusion criteria: (1) lower income as defined as being eligible for or receiving an income-tested benefit or a community services card (A community services card (CSC) assists families with the costs of healthcare in New Zealand. This initiative is income-based and targets lower income New Zealand families/whanau), (2) speaks sufficient English to understand study requirements, written content, and to participate in one-on-one sessions, and (3) consents to being involved in the case study. The first eligible parent to make contact and provide informed consent will be included. Any of the child’s caregivers may participate, including parents of any gender, step parents, and extended whanau members. The family will be asked to elect one person to be the primary participant who will attend all sessions, fill in all surveys and take part in the semi-structured interview. Other parents/caregivers and/or extended whanau members may choose to participate in the program sessions and semi-structured interview if they wish.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. The participant is not a primary caregiver of an autistic child.

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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
This study will follow an intrinsic case study approach. Such an approach is suitable where the aim of the study is to gain an in-depth understanding of one specific case (Johnson & Christensen, 2020). This aligns with the aim of this study to understand the experiences of one family within an adapted autism support program. The adaptations which have been made to the ESDM-based program have been co-designed with five lower financially resourced parents of an autistic child who had previously received ESDM services. Additionally, feedback and suggestions were given by five community providers, including an autistic adult, who have worked with lower financially resourced family and whanau.
Qualitative data analysis
Interview data will be analysed using reflexive thematic analysis following the process outlined by Braun and Clarke (2019; 2022), including the following steps:
1. Familiarisation with data
2. Coding data
3. Generating initial themes
4. Developing and reviewing themes
5. Refining, defining, and naming themes
6. Summarisation – Write-up of results
Resulting themes will be shared with the participating parent to check for resonance and to invite feedback and comments.

Quantitative data analysis
To assess the acceptability of the program, results from the TARF-R will be analysed. Social acceptability will be indicated by a total acceptability score above the midpoint (60 or higher). Both the results of the check-in questionnaire and the ratings of adaptations will be presented in table format. Attendance will be reported descriptively, with the number of sessions which were rescheduled stated, the number of individuals attending each session recorded (i.e. both parents, number of extended whanau members) and the overall percentage of sessions attended calculated. The length of time to complete the program will also be reported.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/06/2023
Actual
11/07/2023
Date of last participant enrolment
Anticipated
Actual
11/07/2023
Date of last data collection
Anticipated
Actual
1/09/2023
Sample size
Target
1
Accrual to date
Final
1
Recruitment outside Australia
Country [1] 25556 0
New Zealand
State/province [1] 25556 0
Wellington

Funding & Sponsors
Funding source category [1] 313913 0
University
Name [1] 313913 0
Victoria University of Wellington
Country [1] 313913 0
New Zealand
Primary sponsor type
University
Name
Victoria University of Wellington
Address
Victoria University of Wellington
PO BOx 600
Kelburn
Wellington
6012
Country
New Zealand
Secondary sponsor category [1] 315795 0
None
Name [1] 315795 0
None
Address [1] 315795 0
None
Country [1] 315795 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313059 0
Northern B Health and Disability Ethics Comittee
Ethics committee address [1] 313059 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 313059 0
New Zealand
Date submitted for ethics approval [1] 313059 0
24/03/2023
Approval date [1] 313059 0
19/05/2023
Ethics approval number [1] 313059 0
2023 EXP 15593

Summary
Brief summary
Despite there being several promising evidence-based early support services designed for young autistic children and their families, access to these services does not currently appear to be equitable. A family’s available economic resources appear to impact upon support service access and/or participation. One way in which greater equitability could be obtained is through adapting a support service to a specific population. Forming such adaptations through community-research partnerships ensure approaches are relevant to the targeted population. Minimal research has been conducted which has utilised a research-community partnership to adapt an early autism support service to the needs of lower income families.
The aim of this study is to evaluate parent/caregiver perceptions of the acceptability and impact of an adapted support program based upon the Early Start Denver Model (ESDM), when delivered to one lower income parent of an autistic child. The study aims to answer the following three questions:
The following questions pertain to one lower income parent with an autistic child:
1. How does the parent describe their experience of receiving an adapted ESDM-based program?
2. Does the parent find an adapted ESDM-based program acceptable?
3. How helpful does the parent find the adaptations to the ESDM-based program?
We hypothesise that: (1) the parent will generally have a positive perception of the adapted program; (2) individualised adaptations to the ESDM program will be acceptable to the parent involved; and (3) the adaptations will generally be rated as helpful or very helpful in increasing access to and/or participation in the ESDM program.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126850 0
Mrs Carla Wallace-Watkin
Address 126850 0
C/O Victoria University of Wellington
15C Waiteata Road
Kelburn
Wellington
6012
Country 126850 0
New Zealand
Phone 126850 0
+64212437664
Fax 126850 0
Email 126850 0
carla.wallacewatkin@vuw.ac.nz
Contact person for public queries
Name 126851 0
Mrs Carla Wallace-Watkin
Address 126851 0
C/O Victoria University of Wellington
15C Waiteata Road
Kelburn
Wellington
6012
Country 126851 0
New Zealand
Phone 126851 0
+64212437664
Fax 126851 0
Email 126851 0
carla.wallacewatkin@vuw.ac.nz
Contact person for scientific queries
Name 126852 0
Mrs Carla Wallace-Watkin
Address 126852 0
C/O Victoria University of Wellington
15C Waiteata Road
Kelburn
Wellington
6012
Country 126852 0
New Zealand
Phone 126852 0
+64212437664
Fax 126852 0
Email 126852 0
carla.wallacewatkin@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
For ethical reasons, individual participants' data will be kept confidential to the research team.


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.