Reporting Adverse Events in Autism Intervention Research

An adverse event is an unfavorable outcome that occurs either during or after the intervention is provided (for example, a child who participates in the intervention has a health issue that develops during the intervention). An adverse effect is an adverse event that is directly caused by the intervention (for example, a child has severe anxiety that is a result of participating in the intervention). Little is known about adverse events that might occur in autism early intervention research. However, this issue is important because understanding potential adverse events could help researchers, practitioners, and policy-makers accurately communicate the potential benefits as well potential negative consequences that could occur when autistic children participate in early intervention. 

We looked through the 150 research reports that were collected as part of the main study, and coded these for adverse events, adverse effects, and reasons that participants withdrew from the interventions. The frequencies and percentages of each were calculated to determine how often these are reported within early intervention studies.

Only about 7% of reports mentioned adverse events or effects during or after the intervention. Of the reports that mentioned whether or not an adverse event occured,  about one-third indicated that an adverse event or effect occurred. In addition, 36% of the studies reported reasons that participants withdrew from the intervention, and about one-third of these studies described reasons that we coded as an adverse event or effect (even though the researchers didn’t describe them this way). Given these results, we believe that although adverse events and effects are rarely reported and probably affect only a small minority of participants, they are probably somewhat common in autism early intervention research at the study level. That is, at least a few participants in about a third of intervention studies will experience an adverse event or effect.

A systematic way of monitoring and reporting adverse events is important for researchers to understand the prevalence and types of adverse events that are possible for different types of early intervention. When we know more about adverse events, policy makers and parents who need to make decisions about enrolling their children in early intervention will be able to weigh potential benefits of early interventions with potential negative outcomes.