A Qualitative Study Exploring the Acceptability of Taking Part in a Large Multicentre RCT of Medication for Anxiety in Autistic Adults (the STRATA Trial).
Alba X Realpe, Jade Eloise Norris, Ava Lorenc and 5 others
PMID 42494082WHAT IT FOUND
Autistic adults largely found a blinded medication trial for anxiety acceptable, with the main friction being not knowing whether they got the drug or a placebo.
This is about trial experience, not about whether sertraline works.
Key findings
01Most participants found the blinded randomised trial acceptable across all seven acceptability dimensions (feelings, effort, ethics, understanding, trade-offs, perceived benefit, confidence), with predominantly positive emotions and manageable practical demands.
02The main challenge was not knowing which treatment they had received: some found it frustrating or it clashed with a preference for control, but most accepted the rationale; two people who declined the trial cited the lack of control over allocation as a decisive barrier.
03Participants attributed their sense of benefit more to the structured, supportive trial process (regular contact with researchers, safety-check appointments, self-monitoring) than to the medication itself, regardless of whether they received sertraline or placebo.
STILL TO COME
How it was doneWhat they found
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What it does not show
The acceptability framework (TFA) was applied during analysis rather than shaping the study design, so some dimensions may have been explored less directly. Only two people who declined the trial were interviewed, and most decliners had not left contact details, so the views of non-participants are poorly represented. The sample was predominantly White (57 of 64), employed, and without intellectual disabilities, mirroring the broader overrepresentation of well-resourced groups in autism research. Interviews used different modalities (video, phone, email), which may have produced differences in how participants expressed themselves. Some exit interviews were conducted by researchers the participants already knew, which could have made them less likely to share negative feedback, though the authors note the 52-week rapport may have encouraged openness.
Declared interests
Funded by the UK National Institute for Health Research Health Technology Assessment programme (NIHR127337), the Australian NHMRC (GNT1171206), and the NIHR Bristol Biomedical Research Centre. The funders had no role in study design, data collection, analysis, interpretation, or writing. The authors declared no conflicts of interest.
The easy way to misread this
Do not read the positive acceptability findings as evidence that sertraline is effective for anxiety in autistic adults. This paper reports how participants experienced the trial process; it does not report whether the medication reduced anxiety. The 'perceived effectiveness' participants described was attributed by the authors to the supportive trial structure (regular contact, safety checks, self-monitoring) rather than to the drug itself, and the actual medication-experience findings are reported in a separate paper.