Abstract

BackgroundIn Australia, the average time between a first concern of autism spectrum disorder (ASD) and diagnosis is over 2 years. After referral for assessment, families often wait 6-12 months before their appointment. This can be a time of uncertainty and stress for families. For some families, other forms of assistance are not accessible and thus timely intervention opportunities are missed. There is little evidence about how to provide the best support for children or caregivers while on assessment waiting lists.ObjectiveThe aim of this study is to determine whether use of a coaching intervention called Occupational Performance Coaching (OPC) combined with service navigation support is feasible for families waiting for ASD assessment, as a crucial first step in planning a randomized controlled trial.MethodsA pilot and feasibility study will be conducted using recommended constructs and associated measures, which will be reported using CONSORT (Consolidated Standards or Reporting Trials) guidance. Participants will be child and caregiver dyads or triads, recruited within 4 months of their child (aged 1-7 years) being referred to one of two services for an ASD assessment in Victoria, Australia. A blinded randomization procedure will be used to allocate participants to one of three trial arms: (1) coaching and support intervention delivered face to face, (2) coaching and support intervention via videoconference, and (3) usual care. Descriptive statistics will be used to describe the sample characteristics of parents and children, inclusive of service access at baseline and follow up. Recruitment rates will be reported, and retention rates will be evaluated against a predicted rate of 70%-80% in each intervention arm. Goal attainment, using the Canadian Occupational Performance Measure, will indicate preliminary evidence for efficacy within the intervention arms, with an increase of 2 or more points on a 10-point performance and satisfaction scale considered clinically significant.ResultsThe study was approved by The Royal Children’s Hospital Research Ethics and Governance Department in September 2018. As of October 2020, 16 families have been recruited to the study. Data analysis is ongoing and results are expected to be published in 2021.ConclusionsStudy findings will support planning for a future randomized controlled trial to assess the efficacy of OPC and service navigation support for caregivers of children awaiting ASD assessment.Trial RegistrationAustralian New Zealand Clinical Trials Registry ACTRN12620000164998; www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378793&isReview=trueInternational Registered Report Identifier (IRRID)DERR1-10.2196/20011

Highlights

  • Background and objectives2a Scientific background and explanation of rationale for future definitive trial, and reasons for randomised pilot trial2b Specific objectives or research questions for pilot trialReported on page NoTitle and abstract page 1 Title and abstract page 1

  • 11a If done, who was blinded after assignment to interventions and how

  • 14a Dates defining the periods of recruitment and follow-up

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Summary

Introduction

Background and objectives2a Scientific background and explanation of rationale for future definitive trial, and reasons for randomised pilot trial2b Specific objectives or research questions for pilot trialReported on page NoTitle and abstract page 1 Title and abstract page 1. Checklist item Identification as a pilot or feasibility randomised trial in the title 1b Structured summary of pilot trial design, methods, results, and conclusions (for specific guidance see CONSORT abstract extension for pilot trials) 2a Scientific background and explanation of rationale for future definitive trial, and reasons for randomised pilot trial

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