Ethics and autism research
In a story from September 2008, Harold LD (an east coast Canadian blogger) calls attention to a large multi million dollar study, headed by Dr. Stanley Greenspan, professor of psychiatry at George Washington University. Greenspan, a long time researcher and expert on emotional and development disorders, will identify infants at risk for either autism spectrum disorder or attention deficit disorder, provide half of them with intensive behavioural intervention (IBI therapy — also sometimes referred to as ABA therapy) while the other half will have no therapy. All the children will be followed through to age 5.
Here’s the story From Harold LD’s blog: Autism Research Ethics – Is It Ethical to Deny ABA to Autistic Infants for Research Purposes?
It’s been proven that two things are beneficial for kids diagnosed with autism. The first thing is early intervention. Early identification that a child is “at risk” is a good indicator of a possible diagnosis. Many parents spend months and years, going from generalist to specialist, trying to find a diagnosis for their child. By the time some kids are diagnosed with autism, the window for effective early intervention may be closing. The second thing is IBI. Now, IBI is not without its critics — based on principles of behavioural therapy, it is incredibly expensive, highly focused on outcomes and rewarded reinforcement and frankly, it’s not a panacea for every kid diagnosed with some form of autism. However, there is clear evidence that this intensive therapy, when offered in various, individualized forms and delivery modes, can help many kids with autism to develop generalizable skills in areas of communication and socialization — two commonly affected areas in kids who are autistic.
The literature supports these two things as beneficial. Early intervention and at least a trial with IBI therapy is a good thing for most kids with autism, notwithstanding that if you have 20 kids with autism in a room, you’ll have 20 very different kids. But it’s pretty easy to say that, across the board, early intervention with effective therapy benefits these kids.
So, back to the question posed in the headline — is it ethical to deny some kids with autism or who are at risk of autism, access to IBI therapy? In medical trials, the principle of clinical equipoise is an important consideration. It is the ethical foundation of sound medical research projects that assign subjects to more than one arm. If it is evident that one arm or treatment is superior to another, the trial should not begin (if it hasn’t been started) or should not continue (if it is already underway). The notion of clinical equipoise implies real uncertainty over the relative benefits of one arm of treatment over another. A trial, designed to meet the criterion of clinical equipoise should, at it’s completion, be able to answer the question, “Which treatment is preferable?”. In this case, I would posit that we already know the answer to that question…
In this case, we know that early intervention is beneficial to kids at risk of autism or diagnosed with autism. (Note — the study notes that these kids are “at risk” of autism — not necessarily kids diagnosed with autism. So at risk kids in this group who are never diagnosed with autism will arguably benefit from close observation by simply being enrolled in the trial, through to age 5.)
However, it is foreseeable that a good number of these kids likely will be diagnosed with autism somewhere along the way and hopefully well before age 5 (it would make sense that they would be diagnosed early if they are being observed so closely). Should the children who go from being identified as at-risk to then being diagnosed with autism be removed from the trial in order to receive the clearly documented benefits of early intervention and treatment….?
Updates on this story to follow.
To read more about autism and IBI, here’s a good straightforward Q&A on autism and IBI therapy from the Sick Kids Hospital (Toronto, Canada) website.
To read more about clinical equipoise, here’s a short, clear article from the BMJ by Weijer, Shapiro and Glass: Clinical equipoise and not the uncertainty principle is the moral underpinning of the randomised controlled trial.
Research Ethics Blog 
HelloMy name is Harold L Doherty and I am the H L D mentioned in your comment. I may be misreading your article but you seem to be suggesting that early interventions other than ABA are effective evidence based intervention for autistic children and that ABA itself is not that critical.The ethical question I asked was inspired by an article in the journal of the Australian Medical Association “Children with autism deserve effective intervention” eMJA 2003; 178(9):424-425,Jennifer J Couper and Amanda J Sampson.These Australian Doctors reviewed the professional literature to that point, the studies documenting gains for autistic children resulting from ABA intervention. The two doctors are also parents of autistic children. They made the observation that:“A controlled trial of auditory integration (where the patient listens to music that has been computer modified to remove frequencies to which he or she is hypersensitive) showed no effect, yet it continues to be offered as a therapy.2 While ineffective therapies may be harmless, they waste parents’ money and the child’s valuable therapy time. Furthermore, the delay in implementing effective treatment may compromise the child’s outcome.”I have read the major, credible reviews of the professional literature including the American Academy of Pedatrics (2007), the NY State Department of Health revised (2005), the MADSEC (Maine) Autism Task Force Report revised (2000) and the Office of the US Surgeon General (1997). These credible reviews all document the numerous studies supporting the effectiveness of ABA as an effective, evidence based intervention for autistic children.The most effective time period for ABA intervention as alluded to in the Lovaas studies and in the Couper/Sampson article is the early years. To my knowledge the claim that early intervention is effective for assisting autistic children is based on early ABA intervention. Can you point to any reviews or studies that indicate that early intervention with OTHER interventions is effective?
Harold, Thanks for your comment. I’m happy to clarify what I was saying.I’m not claiming that there are any <>other<> proven effective first line therapies for early intervention with children with autism. However, I would want to emphasize two points. First, IBI therapy (or ABA therapy) is not effective for <>all<> children diagnosed with an autism spectrum disorder. It works very well for some kids and for others is ineffective or only marginally effective. Second, other adjunct therapies such as occupational therapy, physiotherapy, Floortime Therapy, speech therapy and different models of behavioural therapy can be helpful for some children with autism. The main point that I was driving at in this blog entry is that early intervention is key. We already know that observation alone, for children who are either at risk for or diagnosed with autism until age 5 (without any kind of therapy), is ineffective. Nancy