**6. Alternative and complementary therapies: Helping families**

#### **6.1. Select credible treatment options**

ideally, intervening family members and children with autism are trained in familiar home environments where naturally reinforcing (caregiving) activities are more likely to occur. Al‐ so, children with autism are more likely to exhibit abnormal language in unfamiliar settings than at home [11]. For these reasons, it is important that AD children acquire communica‐ tion skills in naturalistic settings where they are most likely to encounter interactions and opportunities to utilize communication skills that are similar to the contexts of their daily

The use of the Internet has grown substantially over the last few years, with an estimated 260 million people now online in North America [24]. In addition, between 2000 and 2010 the proportion of Internet users who are black or Latino has nearly doubled, causing the In‐ ternet population to closely resemble the racial composition of the nation as a whole. Health information is one of the most important subjects researched online, and this is reflected in the autism community, where many families are heavily dependent upon Internet services for education, updates on autism treatment, and peer support via parent chat rooms [15].

However, despite the great interest in using the Internet as a resource for learning about au‐ tism, online parent training interventions are rare. Recently, considerable evidence has be‐ come available demonstrating that web-based feedback systems may increasingly provide feasible and cost-effective patient education [25] because they are available 24 hours a day and can be used repeatedly to enhance learning. Further, with wide-spread internet technol‐ ogy, it may now be possible to provide much needed training to families living remotely and to those representing previously underserved minorities. Clearly, there is an urgent need for clinicians and researchers who have manualized training interventions to adapt them for online use and systematically evaluate their effectiveness through clinical trials.

Until the 1980's, the diagnosis of autism was generally not well-known and most children diagnosed with autism were eventually institutionalized. Today, the majority of these chil‐ dren live with their families, who face enormous challenges in planning for and providing a lifetime of care. Families often experience significant financial burden [26], insecurity re‐ garding long-term family planning, and stress related to the child's social impairments and adverse behaviors that often interfere with family functioning [27, 28]. Because additional care giving has been shown to predict parental distress [29] and parents of children with au‐ tism may experience greater stress than parents of children with other disabilities, interven‐

Although caring for a child with ASD can adversely affect quality of life for both parents [35], most research related to parental stress has focused on mothers [36] who have reported

tions and techniques that can reduce stress are needed [30-34].

routines [11].

**4. Using new technologies to train families**

508 Recent Advances in Autism Spectrum Disorders - Volume I

**5. Managing family stress**

A report from the American Academy of Pediatrics' Council on Children with Disabilities states that treatment goals for children with autism are to: (a) maximize the child's ultimate functional independence and quality of life by minimizing the core features, (b) facilitate de‐ velopment and learning, (c) promote socialization, (d) reduce maladaptive behaviors, and (e) educate and support families [44]. While standard treatments meet these goals and thus, are generally accepted by the autism research community, the variety of novel approaches are less accepted due to their lack of empirical support. As a result, families, who often be‐ come desperate to identify a ready cure for the disorder, must be equipped with the knowl‐ edge to avoid scams by fully evaluating the potential of new therapeutic approaches.

While it is not possible to cover the multitude of novel and complementary treatments for autism, the author will provide a critical review of some of the most popular strat‐ egies, ferreting out those that are empirically validated from those that are unsubstantiat‐ ed. This section will include a discussion of findings from the author's previously published, randomized clinical trial that evaluated the effects of the popular Gluten-Free, Casein-Free diet on individuals with autism, and subsequently recommend directions for future research.

published in *The Journal of Autism and Developmental Disorders* (2006). The researchers evalu‐ ated the effects of the GFCF diet on: (a) autistic symptoms as measured by the Childhood Autism Rating Scale (CARS), Ecological Communication Orientation Scale (ECOS), and be‐ havioral frequencies of child social and language behaviors, and (b) urinary peptide levels of gluten and casein. After videotaping the participating 13 children, aged 2 to 16 years, dur‐ ing in-home play sessions for 15 minutes before the diet's introduction, at the end of the first 6-week period, and at the completion of the 12-week protocol, Elder [50] found that group analysis showed no significant differences in any of the outcomes measured or urinary pep‐ tide levels of gluten and casein. Even when they were told that the findings were insignifi‐ cant, parents of nine children kept the children on the diet, indicating that a strong "parent

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511

placebo effect" may exist and be responsible for perpetuating the diet's popularity.

and financial resources to continue the diet [7].

**6.3. Other approaches**

In the second study by Hyman [51], children were given the GFCF diet and provided with food challenges; that is, snacks that contained gluten or casein, and which were disguised so that the participants could not identify if the snacks were GFCF. As in the other clinical tri‐ als, these investigators used a variety of well-established outcome measures but like Elder [50], found no significant differences or empirical support for the diet. Despite the insignifi‐ cant findings, the GFCF diet continues to be popular with parents, leading to the author's published recommendations about how to properly advise families regarding diet: first, pa‐ rents may use the GFCF diet as long as the child does not have a severely restricted food repertoire that could lead to a nutritional deficiency; and second, the family has the social

Similar to dietary interventions, nutritional supplements are frequently used by parents to to treat their child's symptoms although there is little sound empirical evidence to support their efficacy in autism. Vitamins C, D, and the B vitamins are generally known to improve immunity, brain function, and overall nervous system activity [52-55]. As a result, they are often included in special autism supplements, which are specifically blended to treat au‐ tism-related symptoms. Other supplements that are frequently used include probiotics and digestive enzymes, which may help treat gastrointestinal problems such as acid reflux and constipation, and melatonin, a natural sleep aid that may help reduce nighttime sleep dis‐ turbances [56]. Finally, Omega-3 fatty acids, which have been shown to enhance neurologi‐ cal health in the general population, are currently being evaluated in several clinical trials for the treatment of autism [57]. Despite the lack of empirical support for these supplements,

most are generally considered harmless if administered in age-appropriate doses.

Because of speculation that oxygen flow to the brain is reduced in children with autism, "hyperbaric treatments," in which individuals with autism are placed in a chamber and ex‐ posed to very high oxygen levels, have become popular. In 2009, the US ABC news network broadcast a story, "The Search for a Cure" describing preliminary results from a trial by Dr. Daniel A. Rossignol, himself a father of two children with autism. He and his colleagues evaluated hyperbaric treatment in 56 children with varying degrees of autism ranging in age from 2 to 7 years [58, 59]. Reports were positive, indicating that 30 percent of the children

#### **6.2. Dietary intervention and nutritional supplements in autism**

Increasingly, parents are using alternative treatments, such as dietary interventions or sup‐ plements, which they learn about from internet sites or anecdotal reports from other pa‐ rents. Perhaps the most well-known dietary intervention is the gluten-free casein-free (GFCF) diet that restricts consumption of wheat and dairy products, and which adherents claim can "cure" autism [45]. This diet is so popular that a person can simply type, "*GFCF"* and "*autism"* into Google's search engine, and hundreds of sites appear—from the "Gluten-Free Trading Co." to "GFCF Diet Success Stories" with endorsements such as the following: "Three weeks ago, I decided to give it [GFCF diet] a try. After three days without dairy, Wow! Suddenly we had an alert child! He was talking more, making sense of the world, and engaging with us! When I phased out wheat and gluten, he got even better. He is happier; his behavior is better; his muscle tone seems to be improving; his eye contact is great; he is speaking like a normal 4 year old!" [46] Although testimonies like these abound on the In‐ ternet, there is limited empirical data to support the claims, resulting in a lack of data that health care providers can use to effectively guide parents in making informed decisions.

This dietary intervention, which has clearly "raced ahead of science," poses health risks as well as financial and social drawbacks. While it is less costly than when it was originally in‐ troduced, the GFCF diet can still add financial strain to families and may even compromise nutritional health (e.g., insufficient calcium) in children with autism who already have re‐ stricted food repertoires. There are also social costs to the children, who cannot eat foods un‐ less they are prepared at home, ruling out the possibility of eating cake, for example, at a birthday party. Similarly, families experience a social cost because they have to prepare dual meals plans that often consist of time-consuming recipes. Thus, unless families have addi‐ tional financial or social assistance, the GFCF diet can represent a significant burden to a family already struggling with caring for a child with autism.

Despite the continuing popularity of this diet, only five controlled studies have been pub‐ lished since 1999. Three of these studies—Knivsberg [47], Whiteley [48], and Johnson[49] were not double-blind. That is, parents not only knew when their children were receiving the GFCF diet but were also responsible for implementing it. Of these three single blind studies, Knivsberg [47] and Whiteley [48] reported positive findings but have been criticized for their reliance on reports from parents who were not blinded to the dietary intervention. However, it should be noted that Knivsberg [47] conducted a year-long study and some pro‐ ponents of the GFCF diet suggest that the short duration of other clinical trials may have been responsible for the insignificant findings.

The other two studies were double blind randomized control trials. In the first study, Elder [50] partnered with researchers and staff at the University of Florida's (UF) General Clinical Research Center [now part of UF's Clinical Translational Science Institute Research (CTSI)] to conduct the first double-blind placebo controlled clinical trial of the GFCF diet that was published in *The Journal of Autism and Developmental Disorders* (2006). The researchers evalu‐ ated the effects of the GFCF diet on: (a) autistic symptoms as measured by the Childhood Autism Rating Scale (CARS), Ecological Communication Orientation Scale (ECOS), and be‐ havioral frequencies of child social and language behaviors, and (b) urinary peptide levels of gluten and casein. After videotaping the participating 13 children, aged 2 to 16 years, dur‐ ing in-home play sessions for 15 minutes before the diet's introduction, at the end of the first 6-week period, and at the completion of the 12-week protocol, Elder [50] found that group analysis showed no significant differences in any of the outcomes measured or urinary pep‐ tide levels of gluten and casein. Even when they were told that the findings were insignifi‐ cant, parents of nine children kept the children on the diet, indicating that a strong "parent placebo effect" may exist and be responsible for perpetuating the diet's popularity.

In the second study by Hyman [51], children were given the GFCF diet and provided with food challenges; that is, snacks that contained gluten or casein, and which were disguised so that the participants could not identify if the snacks were GFCF. As in the other clinical tri‐ als, these investigators used a variety of well-established outcome measures but like Elder [50], found no significant differences or empirical support for the diet. Despite the insignifi‐ cant findings, the GFCF diet continues to be popular with parents, leading to the author's published recommendations about how to properly advise families regarding diet: first, pa‐ rents may use the GFCF diet as long as the child does not have a severely restricted food repertoire that could lead to a nutritional deficiency; and second, the family has the social and financial resources to continue the diet [7].

Similar to dietary interventions, nutritional supplements are frequently used by parents to to treat their child's symptoms although there is little sound empirical evidence to support their efficacy in autism. Vitamins C, D, and the B vitamins are generally known to improve immunity, brain function, and overall nervous system activity [52-55]. As a result, they are often included in special autism supplements, which are specifically blended to treat au‐ tism-related symptoms. Other supplements that are frequently used include probiotics and digestive enzymes, which may help treat gastrointestinal problems such as acid reflux and constipation, and melatonin, a natural sleep aid that may help reduce nighttime sleep dis‐ turbances [56]. Finally, Omega-3 fatty acids, which have been shown to enhance neurologi‐ cal health in the general population, are currently being evaluated in several clinical trials for the treatment of autism [57]. Despite the lack of empirical support for these supplements, most are generally considered harmless if administered in age-appropriate doses.

#### **6.3. Other approaches**

published, randomized clinical trial that evaluated the effects of the popular Gluten-Free, Casein-Free diet on individuals with autism, and subsequently recommend directions for

Increasingly, parents are using alternative treatments, such as dietary interventions or sup‐ plements, which they learn about from internet sites or anecdotal reports from other pa‐ rents. Perhaps the most well-known dietary intervention is the gluten-free casein-free (GFCF) diet that restricts consumption of wheat and dairy products, and which adherents claim can "cure" autism [45]. This diet is so popular that a person can simply type, "*GFCF"* and "*autism"* into Google's search engine, and hundreds of sites appear—from the "Gluten-Free Trading Co." to "GFCF Diet Success Stories" with endorsements such as the following: "Three weeks ago, I decided to give it [GFCF diet] a try. After three days without dairy, Wow! Suddenly we had an alert child! He was talking more, making sense of the world, and engaging with us! When I phased out wheat and gluten, he got even better. He is happier; his behavior is better; his muscle tone seems to be improving; his eye contact is great; he is speaking like a normal 4 year old!" [46] Although testimonies like these abound on the In‐ ternet, there is limited empirical data to support the claims, resulting in a lack of data that health care providers can use to effectively guide parents in making informed decisions.

This dietary intervention, which has clearly "raced ahead of science," poses health risks as well as financial and social drawbacks. While it is less costly than when it was originally in‐ troduced, the GFCF diet can still add financial strain to families and may even compromise nutritional health (e.g., insufficient calcium) in children with autism who already have re‐ stricted food repertoires. There are also social costs to the children, who cannot eat foods un‐ less they are prepared at home, ruling out the possibility of eating cake, for example, at a birthday party. Similarly, families experience a social cost because they have to prepare dual meals plans that often consist of time-consuming recipes. Thus, unless families have addi‐ tional financial or social assistance, the GFCF diet can represent a significant burden to a

Despite the continuing popularity of this diet, only five controlled studies have been pub‐ lished since 1999. Three of these studies—Knivsberg [47], Whiteley [48], and Johnson[49] were not double-blind. That is, parents not only knew when their children were receiving the GFCF diet but were also responsible for implementing it. Of these three single blind studies, Knivsberg [47] and Whiteley [48] reported positive findings but have been criticized for their reliance on reports from parents who were not blinded to the dietary intervention. However, it should be noted that Knivsberg [47] conducted a year-long study and some pro‐ ponents of the GFCF diet suggest that the short duration of other clinical trials may have

The other two studies were double blind randomized control trials. In the first study, Elder [50] partnered with researchers and staff at the University of Florida's (UF) General Clinical Research Center [now part of UF's Clinical Translational Science Institute Research (CTSI)] to conduct the first double-blind placebo controlled clinical trial of the GFCF diet that was

**6.2. Dietary intervention and nutritional supplements in autism**

family already struggling with caring for a child with autism.

been responsible for the insignificant findings.

future research.

510 Recent Advances in Autism Spectrum Disorders - Volume I

Because of speculation that oxygen flow to the brain is reduced in children with autism, "hyperbaric treatments," in which individuals with autism are placed in a chamber and ex‐ posed to very high oxygen levels, have become popular. In 2009, the US ABC news network broadcast a story, "The Search for a Cure" describing preliminary results from a trial by Dr. Daniel A. Rossignol, himself a father of two children with autism. He and his colleagues evaluated hyperbaric treatment in 56 children with varying degrees of autism ranging in age from 2 to 7 years [58, 59]. Reports were positive, indicating that 30 percent of the children who received the treatment had greatly increased functioning, while only 8 percent in the control group did. In response to this study, Paul Ott, a M.D., autism expert, and author of *Autism's False Prophets* commented on the questionable efficacy of the treatment and empha‐ size its potential to financially drain families [60]. For example, a one-hour treatment can cost \$100 to \$900, and generally at least 40 are recommended. Despite his warning, however, the ABC report concluded on an approving note by stating, "While its positive effects re‐ main unclear, hyperbaric chamber therapy does not present the dangers that other therapies do," thus encouraging parents to consider using an unproven and expensive treatment.

In addition to the special education and pharmacological interventions that may be necessa‐ ry, traditional treatment approaches include providing a child with speech, behavioral, oc‐ cupational, and physical therapy as indicated in some cases. Although public schools in the United States are required by law to provide such services, the frequency, type, and quality of these services vary considerably. Consequently, parents need to actively participate in meetings where Individualized Educational Plans (IEP), or the equivalent, are developed to specifically address a child's behavioral or learning needs. Furthermore, parents should maintain close contact with educational personnel to help evaluate their children's progress

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If the future direction includes medications, parents must carefully analyze the costs and benefits by questioning their health care provider regarding possible improvements and side effects. Although medications do not cure autism, sometimes they can alleviate behav‐ ioral symptoms that distress the child and interfere with therapeutic efforts such as inten‐ sive education and socialization [66-68]. These behavioral symptoms include hyperactivity, self-injury, aggression, compulsions (repetitive behaviors), mood lability, anxiety, and sleep

In addition to medication, parents may consider using a behavioral intervention, which re‐ searchers have refined over time and developed into a highly successful treatment ap‐ proach. In particular, two comprehensive behavioral early interventions—Lovaas' Model based on Applied Behavior Analysis (ABA) and the Early Start Denver Model—have been shown to be helpful in improving symptoms related to autism [70, 71]. Mounting evidence also supports the use of other commonly used therapies such as Floortime, Pivotal Response Therapy and Verbal Behavior Therapy [72-74]. For up-to-date information regarding behav‐ ioral interventions, visit the website for Autism Speaks, an internationally recognized organ‐ ization within the autism community, at http://www.autismspeaks.org/what-autism/ treatment. By visiting this site, parents will learn about the many valid treatments available that are safe, effective, and capable of producing a better quality of life for children with au‐

**8. Relationship of family training intervention research to NIH's priorities and NIMH's sponsored work-group recommendations**

Finding ways to improve quality of life for ADS children and their families is one of the top priorities of NIH and congressionally mandated research as noted in the Combating Autism Act of 2006 [75, 76]. A report from a NIMH-supported work group of well-known autism authorities addresses what has traditionally been problematic in the field of autism [77]; namely, that fragmented and isolated individual study approaches have not been effective in systematically advancing the most effective behavioral interventions [78]. In response, Smith et al. proposed a developmental process for designing and conducting studies on psy‐ chosocial interventions in autism, which provides a way to systematically validate and dis‐ seminate interventions; the process includes the following steps: (a) conduct initial efficacy

and determine the future direction of treatment.

disturbances [69].

tism and their families.

Although hyperbaric treatments are one of the latest alternative therapies to become popu‐ lar in the autism community, parents have long used other unsubstantiated, pharmaceutical approaches. For example, antibiotics have often been prescribed for children with autism who have frequent respiratory or gastrointestinal infections; similarly, antifungal agents, such as nystatin and fluconazole, have been prescribed for children who suffer from an overgrowth of gastrointestinal yeast (e.g. Candida) [61]. In both situations, the medications are prescribed due to the erroneous belief that an infection or "imbalance" is the root cause of the disorder. Other speculative treatments include the intravenous administration of se‐ cretin, a gastrointestinal hormone, and immunoglobulin-G, an immune system antibody, which are popular because of a few, uncontrolled studies that demonstrated improvement [62]. Despite their questionable efficacy—several gold standard clinical trials have invalidat‐ ed the use of secretin—alternative treatments are high in demand, generating countless arti‐ cles on the Internet, and sparking heated discussion on autism message boards [63]. This prevailing popularity, which shows no sign of slowing in the future, is a testament to the struggle many parents experience in caring for a child with autism.

Another popular, yet more controversial treatment is chelation therapy, which removes mercury—an alleged contributor to autism—from the body. When using this therapy, pa‐ rents typically have a medical doctor treat their child for lead poisoning or they may also buy unregulated chelation agents from Internet sites. Unlike hyperbaric treatment and other interventions that are intended to complement evidence-based treatments, advocates of che‐ lation therapy espouse it as a cure. Yet, to date, there is no proven link between mercury exposure and autism [64]. Joecker, a researcher from the Mayo Clinic warns that not only is chelation therapy's efficacy unproven, but also that it can be associated with serious side ef‐ fects, including potentially deadly liver and kidney damage and as a result should be assid‐ uously avoided [65].

#### **7. Interventions with empirical validation**

After the preceding discussion of popular yet largely unproven interventions, the author would be remiss not to provide at least a brief overview of interventions that are empirically sound. Because autism presentations can vary greatly among individuals, each intervention should be customized to meet the needs of the individual child, and be accompanied with the early speech/language and occupational therapy that are typically indicated.

In addition to the special education and pharmacological interventions that may be necessa‐ ry, traditional treatment approaches include providing a child with speech, behavioral, oc‐ cupational, and physical therapy as indicated in some cases. Although public schools in the United States are required by law to provide such services, the frequency, type, and quality of these services vary considerably. Consequently, parents need to actively participate in meetings where Individualized Educational Plans (IEP), or the equivalent, are developed to specifically address a child's behavioral or learning needs. Furthermore, parents should maintain close contact with educational personnel to help evaluate their children's progress and determine the future direction of treatment.

who received the treatment had greatly increased functioning, while only 8 percent in the control group did. In response to this study, Paul Ott, a M.D., autism expert, and author of *Autism's False Prophets* commented on the questionable efficacy of the treatment and empha‐ size its potential to financially drain families [60]. For example, a one-hour treatment can cost \$100 to \$900, and generally at least 40 are recommended. Despite his warning, however, the ABC report concluded on an approving note by stating, "While its positive effects re‐ main unclear, hyperbaric chamber therapy does not present the dangers that other therapies do," thus encouraging parents to consider using an unproven and expensive treatment.

512 Recent Advances in Autism Spectrum Disorders - Volume I

Although hyperbaric treatments are one of the latest alternative therapies to become popu‐ lar in the autism community, parents have long used other unsubstantiated, pharmaceutical approaches. For example, antibiotics have often been prescribed for children with autism who have frequent respiratory or gastrointestinal infections; similarly, antifungal agents, such as nystatin and fluconazole, have been prescribed for children who suffer from an overgrowth of gastrointestinal yeast (e.g. Candida) [61]. In both situations, the medications are prescribed due to the erroneous belief that an infection or "imbalance" is the root cause of the disorder. Other speculative treatments include the intravenous administration of se‐ cretin, a gastrointestinal hormone, and immunoglobulin-G, an immune system antibody, which are popular because of a few, uncontrolled studies that demonstrated improvement [62]. Despite their questionable efficacy—several gold standard clinical trials have invalidat‐ ed the use of secretin—alternative treatments are high in demand, generating countless arti‐ cles on the Internet, and sparking heated discussion on autism message boards [63]. This prevailing popularity, which shows no sign of slowing in the future, is a testament to the

Another popular, yet more controversial treatment is chelation therapy, which removes mercury—an alleged contributor to autism—from the body. When using this therapy, pa‐ rents typically have a medical doctor treat their child for lead poisoning or they may also buy unregulated chelation agents from Internet sites. Unlike hyperbaric treatment and other interventions that are intended to complement evidence-based treatments, advocates of che‐ lation therapy espouse it as a cure. Yet, to date, there is no proven link between mercury exposure and autism [64]. Joecker, a researcher from the Mayo Clinic warns that not only is chelation therapy's efficacy unproven, but also that it can be associated with serious side ef‐ fects, including potentially deadly liver and kidney damage and as a result should be assid‐

After the preceding discussion of popular yet largely unproven interventions, the author would be remiss not to provide at least a brief overview of interventions that are empirically sound. Because autism presentations can vary greatly among individuals, each intervention should be customized to meet the needs of the individual child, and be accompanied with

the early speech/language and occupational therapy that are typically indicated.

struggle many parents experience in caring for a child with autism.

**7. Interventions with empirical validation**

uously avoided [65].

If the future direction includes medications, parents must carefully analyze the costs and benefits by questioning their health care provider regarding possible improvements and side effects. Although medications do not cure autism, sometimes they can alleviate behav‐ ioral symptoms that distress the child and interfere with therapeutic efforts such as inten‐ sive education and socialization [66-68]. These behavioral symptoms include hyperactivity, self-injury, aggression, compulsions (repetitive behaviors), mood lability, anxiety, and sleep disturbances [69].

In addition to medication, parents may consider using a behavioral intervention, which re‐ searchers have refined over time and developed into a highly successful treatment ap‐ proach. In particular, two comprehensive behavioral early interventions—Lovaas' Model based on Applied Behavior Analysis (ABA) and the Early Start Denver Model—have been shown to be helpful in improving symptoms related to autism [70, 71]. Mounting evidence also supports the use of other commonly used therapies such as Floortime, Pivotal Response Therapy and Verbal Behavior Therapy [72-74]. For up-to-date information regarding behav‐ ioral interventions, visit the website for Autism Speaks, an internationally recognized organ‐ ization within the autism community, at http://www.autismspeaks.org/what-autism/ treatment. By visiting this site, parents will learn about the many valid treatments available that are safe, effective, and capable of producing a better quality of life for children with au‐ tism and their families.
