Adverse event reporting in intervention research for young autistic children.
Kristen Bottema-Beutel, Shannon Crowley, Micheal Sandbank and 1 others
PMID 33076682WHAT IT FOUND
Most autism intervention studies for young children do not monitor or report harms.
Only 11 of 150 reports mentioned adverse events, and just 4 noted actual harm. Withdrawal reasons often revealed distress or family crises, while negative outcomes were rarely labelled as adverse effects.
Key findings
01Only 11 of 150 reports included text about adverse events, and of those, only four reported that an adverse event or effect had occurred.
02Among 87 randomized controlled trials, 11 negative and significant effect sizes were found indicating regression, yet none of the study authors discussed these as potential adverse effects.
03Reasons for withdrawal frequently included children's distress or dislike of the intervention (seven studies) and family crises (six studies), but no studies described systematic procedures for determining these reasons.
STILL TO COME
How it was doneWhat they foundWhat it means for SLPs
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What it does not show
The review was restricted to group-design research, so it does not capture adverse events in single-case or behavioral studies. The analysis relied on what was reported in published papers, meaning actual adverse events may have occurred but were never documented. The authors note that adverse events are likely under-reported, so the true prevalence of harm is unknown.
Declared interests
One author is the parent of an autistic son and was involved in conceptualizing the study, interpreting findings, and editing the manuscript.
The easy way to misread this
Do not interpret the low number of reported adverse events as evidence that these interventions are safe. The study found that only 7% of reports even mentioned adverse events, and none used systematic monitoring, meaning harms are likely widespread but invisible in the literature.