Implementation of the QuinteT Recruitment Intervention to facilitate recruitment in a placebo-controlled complex trial with autistic adults

AbstractBackground: People with neurodevelopmental conditions such as autism are frequently excluded from clinical trials, either explicitly or via lack of trials or inaccessible recruitment. The QuinteT Recruitment Intervention (QRI) developed methods to understand and maximise participant recruitment and retention in trials. The QRI was applied for the first time to a placebo-controlled trial for a co-occurring mental health condition in autistic adults. Objectives: To investigate recruitment enablers and barriers, as well as strategies to address these in a large medication trial involving autistic adults through application of the QRI. Methods: We employed mixed methods to investigate recruitment processes. Data collection included screening logs, 16 staff interviews, and 233 audio recordings of consultations between trial researchers and autistic adults about trial participation. Triangulation of quantitative and qualitative data provided a comprehensive understanding of recruitment barriers and facilitators. Results: The trial successfully recruited 318 autistic adults, 104% of the required sample of 306, demonstrating the feasibility of conducting large-scale RCTs with autistic adults. Closely involving the autistic community in the design and delivery of the trial was a crucial enabler. Other key enablers included tailored communication to autistic people’s needs and offering remote follow-up, further improving accessibility. Barriers such as low initial response rates were addressed through direct outreach, facilitating self-referrals, and partnerships with autism interest groups.Discussion: Our findings offer guidance to other researchers in designing and conducting trials involving people with neurodevelopmental conditions. Our experience underscores the importance of close collaboration between clinicians, researchers, and the autistic community in conducting relevant, well-designed trials, aligning with participatory research principles. Pre-conceived ideas about resistance to trial procedures in this group (e.g., treatment allocation blinding, randomisation, etc.) should be challenged.