STAR-CAT
Research type
Research Study
Full title
Clinical and cost-effectiveness of adapted online parent-led treatment compared to treatment as usual for autistic children with anxiety problems in clinical services: A randomised controlled trial.
IRAS ID
343622
Contact name
Cathy Creswell
Contact email
Sponsor organisation
University of Oxford, Research Governance, Ethics and Assurance'
Duration of Study in the UK
3 years, 8 months, 25 days
Research summary
Autistic children commonly experience anxiety problems, yet child and adolescent mental health services often struggle to provide timely evidenced-based care that meets the needs of families. There is good evidence for the clinical and cost-effectiveness of brief therapist-guided parent-led Cognitive Behaviour Therapy (CBT) for anxiety problems in non-autistic children. We have also shown that online delivery (using the OSI platform) substantially reduces therapist time without compromising child clinical outcomes. In a recent NIHR funded study we worked with children, parents and clinicians to co-adapt this treatment content to ensure it meets the needs of autistic children and their families. We now need to incorporate this content into the OSI platform and evaluate it within clinical services.
Our primary aim is to examine whether the new therapist supported online parent-led intervention (OSI-A) is non-inferior in reducing the impact of anxiety compared to treatment as usual (TAU) for anxiety problems among autistic children when delivered in clinical services.
We will recruit 650 children with an autism diagnosis or ‘likely autism’ and a primary anxiety problem. Participants will be randomised to Online Support and Intervention for child anxiety – adapted for autism (OSI-A) + therapist support or Treatment As Usual (TAU). The clinical effectiveness and cost effectiveness of both arms with be evaluated at 24- and 48-weeks post-randomisation.
An 8-month pilot phase will precede progression to the full trial recruitment. Progression will be according to criteria agreed with the funder; recruitment, attrition rate, and absence of serious adverse events
We will conduct qualitative interviews with a subgroup of parents (20-30), therapists(10-15), and up to 15 children to explore and to understand therapist and parents’ experiences of treating child anxiety in the context of autism. In addition, we will collect multimodal data from up to 50 children from the wider trial population using options to engage in the project using creative and visual methods
REC name
London - Central Research Ethics Committee
REC reference
24/LO/0875
Date of REC Opinion
8 Jan 2025
REC opinion
Further Information Favourable Opinion