Protocol for a feasibility study and randomised pilot trial of the ICF Core Sets for Autism Strength and Needs Assessment in NHS diagnostic services

Introduction: There are approximately 700,000 Autistic people in the United Kingdom and Autism is increasingly being diagnosed in adulthood. Diagnosis on its own does not provide adequate information to plan post-diagnostic support for Autistic people and clinicians often plan support without the use of validated standardised tools which may exacerbate inequities in care. This study will evaluate a novel Strengths and Needs Assessment, based on the World Health Organisation’s International Classification of Functioning, Disability and Health Core Set for Autism, for use in adult diagnostic services immediately on receipt of an autism diagnosis. Methods and analysis: A two-arm, multi-site, randomised pilot trial design will be used to evaluate the ICF Core Sets for Autism Strengths and Needs Assessment in 3 diagnostic services in England. A total of 72 newly diagnosed Autistic adults will be recruited across the 3 sites over a 6-month period and randomised into an Intervention group (Strengths and Needs Assessment plus standard care) and a Treatment as Usual group (standard care only). Both groups will complete measures of mental health and Quality of Life at baseline and 3 months follow-up. Acceptability and feasibility will be measured for the Strengths and Needs assessment and for trial procedures using standardised measures, progression criteria and qualitative data from clinician focus groups and interviews with a subsample of Autistic participants. The study design and procedures are being co-produced with an Autistic advisor/PPI lead and with a steering group of Autistic adults. Ethics and dissemination: This study was reviewed by the East Midlands - Nottingham 2 Research Ethics Committee and was given Health Research Authority approval on 18th March 2025. The results will be disseminated via reports to the funder (NIHR), a peer-reviewed journal paper and academic conferences. We will email a summary report of findings to study participants and will invite participants to an information dissemination event at the end of the study. Links to reports and a lay summary will be provided on the research group’s website: https://sharl.sites.sheffield.ac.uk/home.