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Trial registered on ANZCTR


Registration number
ACTRN12620000164998
Ethics application status
Approved
Date submitted
22/11/2019
Date registered
17/02/2020
Date last updated
17/02/2020
Date data sharing statement initially provided
17/02/2020
Date results information initially provided
17/02/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Coaching Whilst Waiting: Feasibility of Occupational Performance Coaching and service navigation support to address child and family goals whilst waiting for autism assessment
Scientific title
Coaching Whilst Waiting: Feasibility of Occupational Performance Coaching and service navigation support to address child and family goals whilst waiting for autism assessment
Secondary ID [1] 299886 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
developmental delay 315305 0
autism spectrum disorder 315306 0
Condition category
Condition code
Mental Health 313607 313607 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A feasibility study will be conducted using recommended constructs and associated measures, and reported using CONSORT guidance. Participants will be randomised to one of three trial arms. One will include a coaching intervention that aims to address functional goals, Occupational Performance Coaching (OPC), delivered via four face to face sessions (Arm B), within four months of a child aged 1 to 7 years being referred to one of two Victorian services for an autism assessment. A second arm will provide coaching delivered over 4 sessions using video conference modalities (Arm C), and the third arm will be usual care (Arm A).

Occupational Performance Coaching (OPC) is an occupation-based intervention developed to address the functional support needs of children and families (Graham, 2009). It has been built upon several theoretical foundations including occupation-centred and family-centred practice, as well as ecological models of child health and well-being. The 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 then, through a series of interactive, semi-structured interview sessions, provides an opportunity for reflection, sharing of information, and the development of attainable actions for forthcoming review. Performance analysis, strategy generation and resource identification take place collaboratively, and actions are reviewed in subsequent sessions until goals are reached, or alternative strategies for goal attainment are identified. To date, this intervention has not been trialled specifically with families of children waiting for autism diagnostic assessment, nor have modes of treatment delivery been compared within the same study. This coaching will occur in the same way in both treatment arms, with only the mode of intervention as the point of difference. Families in the intervention arms (B and C) will receive coaching sessions between 2 and 6 weeks apart, for approximately 45 minutes each session. This will be in addition to usual care.

Arm C will rely on freely-available videoconference software such as Zoom(C) or Skype(C) to connect with participants at agreed times. Participants without current access to existing software will be supported by a member of the research team to safely download a preferred programme onto their chosen device, from a list of options made available to them, at no cost to either party. The research team and consenting participants will use existing access to computers and/or smartphones to undertake these sessions.

Preliminary efficacy measures, such as goal attainment across the three intervention arms, will be completed. Coaching will be delivered by a clinician researcher with over 15 years of early intervention expertise, who is trained in the application of OPC. Fidelity will be assessed for 30% of the intervention sessions, double coded by the clinician researcher and the author of OPC, via completion of a published OPC fidelity tool.
Intervention code [1] 316156 0
Treatment: Other
Comparator / control treatment
Usual care for children and families waiting for autism spectrum disorder assessment will form the comparison group. Usual care can consist of community services that the child is accessing, including but not limited to child-focused developmental therapies. Usual care also includes telephone access, 2 days per week, to a clinical coordinator that can provide service access support by way of service navigation recommendations.
Control group
Active

Outcomes
Primary outcome [1] 322057 0
A composite primary outcome of recommended feasibility options will be adopted. This will be based on Bowen et al's feasibility constructs, and include the following:
- Recruitment Rate
- Completion Rate (families involved in coaching arms). Complete participants will be those who participated in all four coaching sessions and completed 80% of outcome measures post intervention, if allocated to arms B and C.
- Acceptability via a specifically-designed quantitative and qualitative questionnaire, and two standardised measures; one which explores family-centredness of care received (The Measure of Processes of Care (King et al 1996)) and one which ascertains performance and satisfaction ratings around goal attainment (measured by Canadian Occupational Performance Measure (Law et al 1990)).
Timepoint [1] 322057 0
Recruitment rate - at closure of study's recruitment phase

All other measures: At the conclusion of the final participant's review session (T1): 4-6 months post baseline measure completion.
Secondary outcome [1] 377165 0
Parent-health related measures including:
- Parenting Stress Index (Abidin et al 2012)
Timepoint [1] 377165 0
Families in all study arms will attend a baseline (T0) and follow up session (T1); 60 minutes in duration each, approximately 4-6 months apart.
Secondary outcome [2] 380116 0
Child functioning measures - completed by primary caregiver as proxy:
- Vineland Adaptive Behaviour Scales (iii) - Caregiver completed form (Sparrow et al 2016)
- Social Responsiveness Scale (SRS) (Constantino et al 2012)
Timepoint [2] 380116 0
T1: 4 - 6 months post baseline measure completion
Secondary outcome [3] 380117 0
Number of services child and family are accessing for therapeutic support
Timepoint [3] 380117 0
T1: 4 - 6 months following baseline measure completion

Eligibility
Key inclusion criteria
Participants for this study are defined as a pair or group consisting of a young child, and one or two primary caregivers. The usual care and coaching interventions will be delivered to primary carers of children between 1 and 7 years of age referred to one of two centres in Melbourne with a query of autism spectrum disorder. Families may be recruited to the study within 4 months of receipt of their referral, and only following an independent clinical decision confirming service eligibility.
Minimum age
1 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Respondents whom are not currently the primary carer of the child referred to the assessment service
• Children with an existing diagnosis of autism spectrum disorder, or whom have been assessed for the disorder within the last 12 months.
• Primary carers who are accessing goal-directed coaching support services at the time of recruitment, and such services are sufficiently meeting their family goals and priorities
• Primary carers with known current mental health diagnoses currently under active treatment, supported by relevant health professional/s
• Primary carers of children with known developmental or medical diagnoses, whom have already accessed a multidisciplinary team (MDT) diagnostic assessment at a relevant paediatric health care service.

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)
Central randomisation by a computer programme, conducted offsite by an independent member of the research team.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation sequence conducted via a formula in a computer programme.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
The study is aiming to recruit 15 to 24 families to the study to allow for 5 to 8 participants randomised to each intervention arm. Based on clinical and research expertise across the team, this number was seen to be sufficient to inform process planning related to a future randomised control trial, and to satisfactorily meet the requirements for obtaining all research aims. With a sample size of 24, we will be able to predict a participation rate of 20% to within a 95% confidence interval of +/- 16%.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 15286 0
The Royal Childrens Hospital - Parkville
Recruitment hospital [2] 15287 0
Djerriwarrh Health Services - Melton Health - Melton West
Recruitment postcode(s) [1] 28596 0
3052 - Parkville
Recruitment postcode(s) [2] 28597 0
3337 - Melton West

Funding & Sponsors
Funding source category [1] 304343 0
University
Name [1] 304343 0
The University of Melbourne
Address [1] 304343 0
50 Flemington Rd
Parkville VIC 3052
Country [1] 304343 0
Australia
Primary sponsor type
Individual
Name
Ms Charmaine Bernie
Address
Department of Paediatrics
The University of Melbourne
50 Flemington Rd
Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 304594 0
None
Name [1] 304594 0
Address [1] 304594 0
Country [1] 304594 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304795 0
The Royal Children's Hospital Human Resource Ethics Committee
Ethics committee address [1] 304795 0
50 Flemington Rd
Parkville VIC 3052
Ethics committee country [1] 304795 0
Australia
Date submitted for ethics approval [1] 304795 0
28/06/2018
Approval date [1] 304795 0
01/10/2018
Ethics approval number [1] 304795 0
HREC 38154A

Summary
Brief summary
This study aims to investigate whether a short period of coaching sessions, delivered in person with a clinician or via videocall, helps families of young children who have recently become aware that there may be a risk of autism spectrum disorder. We hypothesise that families need support and guidance in this period, and that these needs are not currently being met by health or disability services. is the researchers' hope that findings from this study will help families in limbo, waiting for diagnostic assessments and unsure what to do or how to help their child in the meantime. This may assist to minimise wasteful waiting periods in a child's early years, when intervention can be of great benefit to children, families and communities.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98230 0
Ms Charmaine Bernie
Address 98230 0
Department of Paediatrics
The University of Melbourne
50 Flemington Rd
Parkville VIC 3058
Country 98230 0
Australia
Phone 98230 0
+61 3 9345 6487
Fax 98230 0
Email 98230 0
Charmaine.Bernie@rch.org.au
Contact person for public queries
Name 98231 0
Ms Charmaine Bernie
Address 98231 0
Department of Paediatrics
The University of Melbourne
50 Flemington Rd
Parkville VIC 3058
Country 98231 0
Australia
Phone 98231 0
+61 3 9345 6487
Fax 98231 0
Email 98231 0
Charmaine.Bernie@rch.org.au
Contact person for scientific queries
Name 98232 0
Ms Charmaine Bernie
Address 98232 0
Department of Paediatrics
The University of Melbourne
50 Flemington Rd
Parkville VIC 3058
Country 98232 0
Australia
Phone 98232 0
+61 3 9345 6487
Fax 98232 0
Email 98232 0
Charmaine.Bernie@rch.org.au

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 other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary