Katherine A. Johnson, MS, BCBA, LBA, Catherine L. McHugh, MA, BCBA, LBA, and Thomas Zane, PhD, BCBA-D
Department of Applied Behavioral Science, University of Kansas
For many, finding an effective intervention for individuals with autism spectrum disorder (ASD), attention-deficit hyperactive disorder (ADHD), or other related disorders is no easy feat. Furthermore, the seemingly credible promises of overcoming the core symptoms of ASD, ADHD, and other related disorders are highly appealing. In fact, there are many treatment providers and marketers who would go so far as to claim that ASD and ADHD could be “a thing of the past.” This is what Dr. Robert Melillo, a licensed chiropractor and co-founder of Brain Balance, claims of the approximately $6,000 per-12-week program (Boulton, 2010; Lawrence, 2018).
What is the historical link between ASD and Brain Balance?
In addition to his background in chiropractics, Melillo claims that he possesses expertise in ASD, ADD/ADHD, obsessive-compulsive disorder (OCD), dyslexia, Tourette’s, bipolar disorder, other related disorders, neuroimmune disorders, and in diet and nutrition, according to his personal website (Melillo, 2020). Melillo touts the many “hats” of his career background as a clinician, university professor, brain researcher, best-selling author, radio and TV host, cutting-edge researcher, and creator of the Brain Balance Achievement Centers. According to Melillo, the common characteristics of ASD (e.g., motor and intellectual deficits as well as behavioral issues such as frequent, sometimes severe tantrums or other potentially dangerous behaviors) and other related disorders may be due to weak connections between the left- and right-hemispheres of the brain (Brain Balance Achievement Centers, 2021a; Leisman et al., 2010; Leisman et al., 2013; Melillo, 2009; Melillo, 2011). This theory of weak brain connections, first described in 1972 by Dr. Gerrald Leisman and later attributed by Melillo as the primary issue of ASD and other disorders is coined “functional disconnection syndrome” (Melillo, 2020). Additionally, Melillo goes as far as to say that functional disconnection syndrome has become one of the leading theories in the world related to ASD, ADHD, dyslexia, and more and is “leading the way toward understanding the underlying nature of these disorders and their causes.” According to Melilo, “functional disconnection syndrome” is a theory that attempts to explain the cause of a wide range of symptoms commonly observed in individuals with ASD, ADHD, and other related disorders (Leisman, 1972; Melillo & Leisman, 2009b; Melillo, 2020). However, it is important to note that it is not a medically recognized condition, and is not listed as a recognized disorder in the Diagnostic and Statistical Manual of Mental Disorders (5th ed.; DSM–5; American Psychiatric Association, 2013). Melillo and Leisman (2009b) claim that the cause of these core symptoms often found in ASD, ADHD, or other related disorders can primarily be attributed to weak brain hemisphere connections. Therefore, the most important treatment component touted by Leisman and Melillo involves achieving “temporal coherence,” or a state in which there is a balance of activity between the two hemispheres of the brain (Melillo & Leisman, 2009a). They claim that it is through these “brain exercises” that the brain’s connections can be renewed and strengthened such that the right- and left-hemispheres of the brain are better developed and integrated (Brain Balance Achievement Centers, 2021b; Leisman et al., 2010; Melillo & Leisman, 2009a; Melillo, 2009; Melillo, 2011).
In addition to weak brain connections as a causal factor in the core symptoms of ASD and other related disorders, Melillo and Leisman (2009a) also place a heavy emphasis on environmental factors such as the rise in environmental pollution and toxins, nutrition, as well as an increase in sedentary behaviors in early childhood such as watching television or playing video games (Melillo & Leisman, 2009a). They hypothesize that if they could develop a treatment package that includes exercises to improve motor and cognitive performance, nutritional guidance, and some behavioral modification, the main core symptoms of ASD, ADHD, and other related disorders would be greatly alleviated or cease altogether.
With this theory in mind, Melillo created the Brain Balance program with a three-pronged approach: academic tutoring, sensory-motor training, and nutritional guidance. The approaches appear to be fused together to comprise a treatment package that includes activities such as wearing specialized earphones or eyeglasses, computerized reading comprehension and math problems, sensory-motor training such as aerobic strengthening and conditioning on balance beams and exercise balls, and nutritional guidance plans (Brain Balance Achievement Centers, 2021a; Leisman et al. 2013).
Is there any research to support Brain Balance?
Despite its growing popularity, many of the treatment components used at Brain Balance lack empirical evidence, thus essentially meeting the definition of pseudoscientific or unproven fad treatments. These elements include:
- Sensory integration training – Sensory integration training has been found to lack empirical evidence of effectiveness and is considered a fad treatment (e.g., Smith et al., 2015).
- Specialized earphones – The use of specialized earphones to allegedly control for auditory input is reminiscent of auditory integration training, another treatment lacking scientific support (e.g., American Academy of Pediatrics, 2010; American Speech-Language-Hearing Association, 2004; Mudford & Cullen, 2005).
- Specialized eyeglasses – Specialized eyeglasses, suggestive of Irlen lenses, is another treatment for which there is no scientific evidence of effectiveness (e.g., Hyatt et al., 2009).
- Nutritional interventions – Several researchers (e.g., Williams & Foxx, 2016) have exposed the failure of nutritional interventions, such as the gluten- and casein-free diets, to show any significant improvement in symptoms.
Thus, there is nothing about the strategies and tactics of Brain Balance that have been supported by scientific research. We must conclude that Brain Balance lacks sufficient empirical evidence and should therefore be considered a pseudoscientific treatment.
Since the proponents of Brain Balance cannot rely on empirical scientific evidence to support the use of such a treatment, they instead evoke subjective, first-hand accounts and dozens of emotional caregiver testimonials containing miracle stories of lives changed for the better. Testimonials are considered nonevidence and provide little confidence of empirical proof (e.g., Mruzek, 2012).
In addition to Brain Balance employing the heavy appeal-to-emotions tactic through caregiver testimonials, there is an overall lack of high-quality research in support of Brain Balance as an effective treatment for individuals with ASD, ADHD, or other related disorders. Many of the studies that evaluate Brain Balance lack the necessary elements of research such as the demonstration of experimental control, reliability of measurement, replication by independent and third party researchers, measurable definition of behavior, experimental design, and control over threats to internal validity (Chambless & Hollon, 1998; Chorpita, 2003; Cooper et al., 2020; Cozby & Bates, 2019; Kazdin, 2011; Moran & Malott, 2004; Odom et al., 2010).
The most recent completed study found on the Brain Balance website examined the effects of the Brain Balance program on cognitive performance in children and adolescents with developmental and attentional issues (Jackson & Wild, 2021). The study consisted of three 1-hour sessions per week for a total of three months, or about 90 days, for the test group and for an average of 27 days for the control group. Pre- and post-tests were conducted for both groups to measure any changes in cognitive functioning. Results indicated participants in the test group demonstrated statistically significant gains on all cognitive tests compared to the control group who only demonstrated improvement on one cognitive test.
Despite these reported improvements in the test group, the findings of Jackson and Wild (2021) should be taken with caution for several reasons. Specifically, the study’s experimental design consists of several potential threats to internal validity, or the extent to which one can be confident that there is a cause-and-effect relationship between the treatment (i.e., Brain Balance) and the outcome measurements (i.e., participants’ performance on cognitive tests). Without a high degree of internal validity within a study, one cannot be sure if there is an actual causal link between the treatment variables and the outcome measures. For example, participants in the test group were exposed to Brain Balance services for about three times longer than those in the control group (about 90 days versus an average of 27 days, respectively). Because the test group had about three times the amount of exposure to the treatment variables than the control group, it is not surprising that there would be a higher degree of demonstrated improvement from the test group. Similar to what the author noted, these findings may provide potential indicators of which cognitive areas may improve with shorter versus longer duration of program participation (p. 37). Another limitation found in Jackson and Wild (2021) is that there were several different treatment components within the Brain Balance treatment package making it unclear which specific treatment variable(s) were responsible for any change in the participants’ outcome measures.
In addition to the methodological flaws found in Jackson and Wild (2021), the other previous studies evaluating Brain Balance and its treatment components (e.g., Jackson & Robertson, 2020; Leisman et al., 2010; Leisman et al., 2013; Teicher, 2019) should also be viewed with a skeptical eye. In fact, if we apply the National Autism Center’s Scientific Merit Rating Scale (SMRS), a means to objectively evaluate the quality and rigor of research studies on a 0-5 point scale (i.e., a score of 0-1 indicating insufficient scientific rigor, 2 indicating initial preliminary effects but more research needed, and 3-5 indicating sufficient research quality and rigor having been applied and that the outcomes are likely to be repeated) to the remaining Brain Balance studies, none of the studies would be scored above a 2, indicating a lack of quality empirical evidence (National Autism Center, 2015).
In addition to the lack of high-quality research demonstrating the effectiveness of Brain Balance, there are a number of potential ethical issues surrounding conflicts of interest and the Brain Balance program. The presence of conflicts of interest in research may increase the likelihood for ethical issues such as the increased risk of bias and poor judgement on the part of the researcher. An increased risk of bias may skew or influence the results of a research study and may result in poor judgement or misconduct (e.g., falsification of data). For instance, a number of the studies evaluating Brain Balance were conducted by individuals who potentially have a vested interest (i.e., monetary gains) in the success of the program . For example, Leisman, a researcher involved in many of the Brain Balance studies, is a chiropractor who was subjected to a three-year ban from federal research grants in the 1990s due to misrepresenting his credentials to the Office of Research Integrity (Lawrence, 2018). Additionally, Melillo was involved as an experimenter and researcher in several of the provided studies on Brain Balance, often alongside Leisman (e.g., Leisman et al., 2010, Melillo & Leisman, 2009a, Melillo & Leisman, 2009b). The presence of conflicts of interests, especially when those individuals are involved in providing services for those in vulnerable populations such as those with ASD or other related disorders, is a significant red flag and should be considered when judging the quality of their findings and claims.
Given these points, the materials that have been published on the efficacy of Brain Balance show that most involve testimonials, self-reports, and only a few, low-quality research studies. All of these elements of “proof” that Brain Balance is effective are weak in terms of empirical evidence and should be considered with caution.
Future Research
The review of the conceptual foundation of Brain Balance, a critique of the multiple components of its treatment, and a review of the empirical research assessing the impact of this procedure, results in a conclusion that it has no justification for its use. The conceptualization is weak and far-fetched. Testimonials should be read with great caution and do not substitute for empirical studies, and the empirical work done shows no causal relationship between the use of Brain Balance and any significant improvement of any condition. Thus, the suggestion is that future research should not be conducted. It is unlikely that future studies would show any positive impact on any dependent measure attributable to Brain Balance. According to Bloomberg Businessweek (Lawrence, 2018), Melillo is quoted on his lackadaisical approach to science, “Just because something’s not proven, doesn’t mean it doesn’t work…that’s the thing about research” (para. 23). Clearly, Melillo does not consider Brain Balance’s lack of empirical evidence to be an issue. ASAT’s position is that scientific evidence is absolutely essential when making decisions about treatment selection and implementation and that no provider should ever get a pass on having to objectively demonstrate that their treatments actually work. It is vital that evidence is valid and reliable when deciding to spend time and resources on treatment.
Position statements by professional organizations
Several professional organizations have made public declarations in regard to Brain Balance specifically or to the specific treatment components used by Brain Balance and state that Brain Balance lacks sufficient empirical evidence on its effectiveness. Specifically, the Wisconsin Department of Health Services Autism and Other Developmental Disabilities Treatment Intervention Advisory Committee (2015) has twice concluded that Brain Balance lacks empirical support to be considered a proven and effective treatment on the basis of a) other authoritative bodies (e.g., National Autism Center) not recognizing Brain Balance as having enough evidence, b) a lack of at least one high quality study that demonstrates experimental control and favorable outcomes of Brain Balance’s treatment package, and c) the studies were conducted by the creator/provider of the treatment (p. 5).
Furthermore, the National Standards Report (2015) put out by the National Autism Center identifies some components of Brain Balance’s main treatment package (e.g., sensory integration, gluten- and casein-free diets) as “unestablished treatments” meaning there is little to no evidence in the scientific literature to draw any firm conclusions on its treatment effectiveness (p. 73).
What is the bottom line?
At this time, there is not enough high-quality research that demonstrates experimental control and favorable outcomes for the Brain Balance program. In addition to the lack of high-quality evidence, the high cost and extensive time requirements that could be spent on evidence-based treatments poses the potential for harm to families in desperate search of effective treatment and supports.
Furthermore, there are several well-established evidence-based treatments for these populations including behavioral interventions (e.g., Charlop-Christy, 2008; Gerhardt & Crimmins, 2013; Leaf & McEachin, 1999; Lovaas, 2002; Luiselli & Cameron, 1998; Luiselli, 2014; Matson, 2009; Maurice et al., 1996; Maurice et al., 2001; National Standards Project, 2015; Neef et al., 2005; Thompson & Odom, 2011) and some pharmacological interventions (e.g., Weyandt et al., 2014).
In summary, practitioners and families searching for evidence-based interventions for individuals with ASD, ADHD, or other related disorders should avoid interventions like Brain Balance that lack empirical evidence and should utilize interventions with an established evidence base.
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Citation for this article:
Johnson, K. A., McHugh, C. L., & Zane, T. (2021). Brain Balance: Is there science behind that?Science in Autism Treatment, 18(8).
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