Autism spectrum disorder (ASD) is a wide-ranging developmental disorder defined by atypical social communication and behaviors [1]. In Australia, ASD can affect between 1% and 4% of children [2], and is typically diagnosed by pediatricians, psychologists, or psychiatrists, with or without the support of allied health clinicians such as speech pathologists and occupational therapists [3].

Despite the high prevalence and increased community awareness of ASD, there remains a paucity of assessment services to meet demand across Australia, including in Victoria [4,5]. Such challenges and service inequities have a significant impact on the early pathway for children and families [6]. Although a prompt diagnosis is made for some children after seamless recognition and assessment by service providers, many families wait years between identification of learning, social communication, and behavior differences and diagnostic assessment [7]. It is common for families to be referred to multiple service providers before an understanding of service needs is obtained, or to wait extended periods on waiting lists for assessment before accessing vital therapy services [8].

Australia, similar to other parts of the world, currently faces the challenge of balancing the need for comprehensive assessment against high demands for diagnostic services [9,10]. Alongside establishment of the Australia-wide, age-limited Helping Children with ASD Package (FACSIA funding) in 2008 [11], demand for early diagnosis has increased and placed notable pressure on assessment services [12]. In Australia, this funding model was recently replaced with the individualized, client-controlled National Disability Insurance Scheme, which oversees both early intervention and disability support services in the country. In the context of this changed funding model, publicly funded ASD assessment services remain under-resourced and overburdened [13]. This is likely due to recommended comprehensive diagnostic practices, as well as an ongoing emphasis on diagnosis as the entry point for further service access in some of Australia’s disability and education systems [13,14]. Moreover, state-wide initiatives in Victoria have recently been funded to improve the identification of ASD risk in young children via early screening initiatives, but without a matched expansion of publicly funded diagnostic services [15]. This is likely to increase the existing burden on assessment services in the coming years, further extending wait times and service access delays for children and families. The issues surrounding timely service delivery are not limited to either ASD assessment or to Australian settings, but rather represent an international health service issue in pediatrics; thus, calls for action to address these delays are continuing [16,17].

For families of children with an identified risk of ASD, emerging concerns are exacerbated by limited service availability and a lack of clarity regarding suitable interventions and support [13,18]. Outside of research focusing on siblings of children with ASD, who are known to have an elevated risk for the disorder, there is little research to date that addresses how a child’s and family’s needs are met, or not met, at this crucial stage when concerns first arise [19]. Despite this limitation, there is a general consensus among clinicians and researchers about the importance of timely access to needs-based services that have the potential to improve a child’s long-term outcomes [20] and the outcomes for their family.

In particular, few studies have explored ways to support children and families while waiting for ASD assessment services [16]. Moreover, no study to date has provided a rigorous, methodological approach to reviewing what interventions, if any, best address caregiver-identified needs for their child and family at this stage.

Coaching interventions have been investigated for primary carers seeking support because their young child is experiencing developmental difficulties [21-23]. A recent systematic review highlighted their general acceptability, although only 5 randomized controlled trials (RCTs) have been reported [24]. Along with methodological flaws, the wide-ranging definitions for coaching and its subtypes were described. Coaching diversity and inconsistent outcome measurement were reported to have impeded efficacy conclusions. Occupation-orientated coaching, which has been delivered via face-to-face and videoconference modalities, is one coaching subtype [24,25] in which fidelity measures have been proposed and published as a way of addressing identified intervention inconsistencies [26,27].

Occupational Performance Coaching (OPC) is an occupation-informed intervention developed to address the functional support needs of children and families [23]. OPC is theoretically informed by occupation and family-centered practice, along with ecological models of child health and well-being. This approach involves supporting families to generate goals relating to themselves, their child’s functioning, or the functioning of their family as a whole. The therapist, through a series of interactive semistructured interview sessions, then provides opportunities for reflection, sharing of knowledge, and the development of attainable actions. Performance analysis, strategy generation, and resource identification take place collaboratively, and actions are reviewed in subsequent sessions until goals are reached. Effectiveness of this intervention holds promise and continues to be evaluated [28-30]. To date, OPC has been typically examined in face-to-face sessions around 60 minutes in length, with a range of dosages between 2 and 12 sessions [31]. However, OPC has not yet been tested specifically with families of children waiting for ASD assessment, nor have the modes of treatment delivery, including delivery via telehealth or videoconference modalities, been compared concurrently within the same study. These modalities require particular exploration given social distancing challenges brought about as a result of the COVID-19 pandemic.

In novel clinical trial applications, the importance of initial feasibility testing and reporting has been reiterated in recent years [32,33]. Therefore, the aim of this study is to assess whether a small number of coaching sessions is feasible for families and has potential to address family needs while waiting for ASD assessment. The intervention’s acceptability, practicality, expandability, and demand, as well as the types of needs in the local context that require interventions [34] will be examined. Such explorations are essential to inform a future randomized clinical trial protocol, with risk of bias minimization and appropriate methodological rigor.

The specific aims of this study are: (1) to assess the feasibility, including constructs of acceptability, practicality, and preliminary efficacy, of an RCT study design exploring goal-directed support for families of children waiting for ASD assessment; and (2) inform protocol planning for a future RCT to assess efficacy of short-phase coaching and family support via face-to-face and videoconference modalities.

It is envisaged that the combined results from this feasibility study and a future RCT will inform service planning as well as service standards to address the needs of families with a child waiting for ASD assessment. The findings may also support new methods to eradicate wasteful waiting periods and prevent clinical practices that hinder access to needs-based interventions.

The trial has concluded recruiting families of children referred for an ASD assessment throughout 2019. It remains under ethical approval and will continue throughout 2020. As of October 2020, 16 families have been recruited to the study.

Results will be reported according to CONSORT guidance [56] following the conclusion of this study. Feasibility findings as described above will be reported as primary outcomes. Preliminary efficacy findings will be reported as primary and secondary outcomes, as described in Tables 1 and 2.

To our knowledge, this is the first study measuring the feasibility of OPC via two different parallel modalities for families awaiting ASD assessment. Given the lag time between identification of concerns and assessment that many families experience, identification of an intervention that addresses primary family concerns in this interim period is warranted

Uncertainty exists in relation to optimal feasibility study methodology when testing new interventions or existing treatments for alternative populations. In recent years, efforts have been made to make recommendations regarding pilot and feasibility studies; however, there remains no consistent approach as to how such studies should be conducted and measured [34,54]. As such, we have incorporated a diverse range of feasibility constructs and outcomes to ensure comprehensive evaluation that can inform future trial planning.

Additional strengths of this study include broad participant inclusion, consideration of alternative modes of service delivery in comparison with usual care, and incorporation of fidelity measures. Exclusion criteria have been kept to a minimum to allow the research team to have a broad sense of the nature of families who are interested in, and able to complete, the intervention. In particular, the availability of an interpreter service is aimed at encouraging participation of families for whom English is their second language. Moreover, the study will measure the feasibility of two different modes of service delivery in comparison with usual care, and explore the tolerance of randomization to these study arms. Finally, the fidelity of the intervention will be measured using a published tool as described previously [37].

In spite of these strengths, there are several limitations to consider during interpretation of the feasibility results. In line with suggested general pilot and feasibility methodologies, the sample size will be smaller than that used in full-scale clinical trials or efficacy studies. Preliminary efficacy findings will only be used as an aid to plan for a future RCT. Nevertheless, the planned sample size is consistent with similar studies that have focused on coaching, telehealth, or videoconference interventions [25,52], and is appropriate to address the research aims.

Although a broad participant recruitment strategy has been formulated, occurring across two sites, data collection and face-to-face coaching sessions will be carried out at only one site (RCH). This may prove to be a limitation in either recruitment or retention. Additionally, given that these sites offer publicly funded services, the participant sample has the potential to be biased, likely excluding families for whom a prompt, private service for assessment was accessible. Such predictions are in line with previous research in publicly funded developmental assessment services in Australia [57], in which the researchers found that families accessing such services were more likely to have a lower sociodemographic status or have English as a second language when compared to the general population. Given our plan to include families who may require interpreting services, translation and tool validation–related issues will mean that the secondary feasibility measures will need to be interpreted with caution. A future RCT will likely require coaching to be delivered at multiple sites to maximize the recruitment and generalizability of results.

Finally, all families who are participating in the study, regardless of study arm allocation, will continue to receive usual care. This is likely to be highly variable given that service access depends on family resources, geographical location, and other factors not yet known to the research team. Usual care will be described and considered in relation to relevant findings.

This study is the first step toward addressing an evidence gap by exploring potential interventions that can support families when on an ASD assessment waiting list. Findings of this study could inform the best care for families and children on waiting lists for other presentations, catering to an ongoing issue in health systems internationally.