Running head: ASD PROSPECTUS 1

The Dietary Causation of Autism Spectrum Disorder: A Prospectus

Dr. Shari Philpot M.D.

Northcentral University

Author Note

1570 Langdon Park Drive, Winder, Georgia

ASD PROSPECTUS 2

Abstract

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The Dietary Causation of Autism Spectrum Disorder: A Prospectus

The research question I selected for this assignment is are there dietary or environmental

inducers or Autism. My hypothesis is that Autistic- like behavior is strongly dependent on the

presence or absence of lactose, B vitamins, and sugar in the diet and can be induced and

aggravated by certain social environments. Since environmental and social factors are known

inducer of delayed or interrupted psychosocial development (especially in the areas of language,

attention, and memory), the assumption has been made that with these areas being variedly

affected in persons with ASD, there must be a link between them (Santrock, 2011). I have also

based this hypothesis on my experience in the mental health field with patients with Autism and

my personal experience with my son

.Keywords: Autism Spectrum Disorders, Dietary, Environment, Qualitative Methods,

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Introduction of Topic and Significance

According to CDC.gov, Autism Spectrum Disorder (ASD) is a developmental impairment

that often causes a significant amount of social, communication and behavioral issues (2014).

People with ASD may interact, learn, behave, and communicate different from others. The

impairment of one diagnosed with ASD can range from mild to severe. While some individuals

with ASD can use outpatient therapeutic interactions to cope with their symptoms, others may

require more individualized care plans. Autistic disorder, pervasive developmental disorder

(PDD-NOS), and Asperger Syndrome, have all been collectively placed under the ASD umbrella

(CDC, 2014).

Although each case of ASD can be unique in its presentation, individuals with ASD

usually show similar behavior patterns and symptoms (CDC, 2014). Some of the most pervasive

signs of and symptoms of ASD is an inability or avoidance of eye contact, an apparent

disconnection with the emotions one’s self and others, inability to pay attention to conversation

while showing increased objectivity to background noises, echolalia, repetitive behaviors or

speech patterns, and difficulty in socialization. Some individuals with ASD may even show

inappropriate reactions to tactile stimulation, sounds, tastes, and temperatures. Consequently,

many persons with ASD show a deterioration in cognitive, communicative, and social abilities

over time (CDC, 2014). Many of the symptoms that accompany ASD can present many

obstacles for practitioners and researchers alike (Medscape, 2014).

The signs and symptoms of ASD usually show an onset in early childhood (CDC, 2014).

However, it is not unheard of for symptoms to appear much later in life. Nevertheless, once the

symptoms have appeared they usually persist throughout the person’s life. Since there are

currently no serological tests for positive diagnosis of ASD, a diagnosis is usually made through

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behavior observation. Since there is currently no cure for ASD, early diagnosis and intervention

is the key to treatment (CDC, 2014).

While there is no one specific cause of ASD, there are some risk factors that have been

associated with the appearance of certain types or degrees of this disorder (Ross, 2011).

Research has proven that environmental, biologic and genetic factors may either independently

or conjointly play a role in the development of ASD (CDC, 2014). Although many genes are

under investigation for their role in ASD development, other genetically inherent conditions have

also been under scrutiny for their apparent connectivity and simultaneous appearance (Medscape,

2014).

In a study aimed at investigating comorbid factors and dysmorphic features of two male

siblings with autism, researchers highlighted several areas for genetic consideration of the

disorder and its highly variable displayed spectrum (Wentz, 2014). Both siblings were noted to

demonstrate severe learning disabilities, self-injurious behavior, tantrums, hyperactivity, and

neither exhibited any communicative language skills. In order to investigate these links, DNA

sequencing was performed on particular exons of the TWIST1 gene, the FGFR2 gene and the

FGFR3 gene from the siblings. In addition, the samples of DNA underwent microarray analysis.

Although the results of the chromosomal analysis were normal, the results of the microarray

analysis singled out an extra copy of a specific region on the X chromosome. More specifically,

the long arm of chromosome X, the chromosome band Xq13.1-q21.1 (Wentz, 2014).

The afore mentioned results, combined with the lack of apparent mutations detected in

the sequenced exons, led to the conclusion that this copied region of the X chromosome may be a

etiological factor in Autism Spectrum Disorder (Wentz, 2014). Cross comparison of this case

with previously tested patients showed similar results and also reiterated the need for further

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investigation into the predisposing properties of these three genes along with the consequence of

sagittal craniosynostosis (Wentz, 2014). While the results of this research did little more than

lead to more questions about the etiology of ASD, the results did show a congruency with the

statistic put forth by the CDC that children with ASD are higher risk of themselves developing

this disorder (CDC, 2014).

It is also important to consider the nature of the symptoms of ASD are such that they can

mimic those of other cognitive and motor dysfunctions (Ross, 2011). For this reason, the issue

of considering alternative and dual diagnoses if of great concern to researchers, medical, and

psychological care professionals. Autism Spectrum Disorder also tends to occur in a comorbid

fashion. That is, it is more likely to occur and be diagnosed in individuals with one or more

other conditions (Ross, 2011). The acquisition of certain chromosomal abnormalities such as

fragile X syndrome or tuberous sclerosis, affords a greater risk (CDC, 2014).

While the jury is still out on the causation mechanism behind Autism, there is a continued

need for efforts to trace and observe its etiology, development, and manifestation. ASD’s are

nondiscriminatory; it occurs in all ethnicities, races, and socioeconomic groups (CDC, 2014).

According to the Centers for Disease Control, males are five times as likely to portray Autistic-

like behavior, and therefore are diagnosed more often than their female counterparts. In recent

years, the numbers of cases of ASD in United States has dramatically risen. It is now estimated

that 1 in every 68 children are identified as having some type of ASD (CDC, 2014).

Research Question(s)

The research question this research is aimed at answering is whether or not dairy food

products and Vitamin B12 are dietary inducers of Autism Spectrum Disorders. It is my

hypothesis that Autistic- like behavior is strongly dependent on the presence or absence of

ASD PROSPECTUS 7

lactose, B vitamins, and sugar in the diet. If there is a conclusive diagnosis of ASD, behaviors

and the intensity of the behaviors can be induced, magnified, and aggravated by certain social

conditions and environments. In congruence with this, it is also possible that environmental and

social factors themselves could induce a delay or interruption in psychosocial development

(especially in the areas of language, attention, and memory) that may imitate the symptoms of

ASD. Since the assumption has been made that since the areas affected in persons with ASD are

variedly, there is a strong need to define a possible link or association between them (Santrock,

2011).

To answer this question, 20 participants between the ages of 2 and 35 with ASD will be

allocated. They will be separated into four categories, two of which will serve as control groups.

These groups will be separated as follows: (1) ASD with B vitamin supplementation, (2) ASD

without B vitamin supplementation, (3) ASD without dairy in their diet, and finally (4) ASD with

dairy in their diet. In this study, behavior is the dependent variable. This study will attempt to

change the dependent variable (behavior) by manipulating the dietary intake of milk-based foods

or by supplemental intake in the participants diet (the independent variable).

Research Design

The research design for this study takes into consideration the ethical aspects of working

with subjects with an ASD diagnosis, while also aiming for a realistic observation of their

behaviors. In lieu of a true experimental design, a between-subject, quasi-design has been opted

for. The rationale for using a quasi-experimental design is to find a causal relationship between

outcome variables and to account for the complexity of the display of symptoms of ASD.

Participants will be selected from several mental healthcare providers in the state of

Georgia. These participants will be divided into five groups. For the purpose of the study, we

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will randomly select participants from a pool of subjects with similar behavioral manifestation of

ASD. For the parameters of this research, socioeconomic status, gender, race, an educational

level will not be taken into consideration. Further funding opportunities may provide a more in

depth look at gender differences in the future research.

Each of these groups will receive a different treatment. Group 1 will receive the USDA

recommended amounts of dairy products in their diets. In Group 2 all food products with

notable amounts of dairy contained in them will be removed from their diets completely. Group

3 would be given a Cobalamin (B 12 vitamin) supplement. Group 4 would abstain from any

food items with subsequent amounts of this vitamin and no supplement will be given. The final

group of participants will serve as the control group. The results would be compared to

investigate the effects of the variable on participant behavior, social skills, and communicative

abilities. Meta-analysis may be needed to further investigate similar results from other published

experiments.

Similar to the within-subject design, a baseline behavior summary will be established for

all participants. The expected amount of observation time will not exceed thirty days.

Questionnaires will be given to caretakers and or parents to compare with the observed baseline

behavior. (See sample questions attached.) This thirty days will function as the placebo period.

The testing phase of this research will occur over ninety days. The total expected time of this

experiment is 120 days.

In a quasi-experimental study, it can be increasingly important to collect multiple forms

of data (Rosenthal, 1991). This is usually a combination of quantitative and qualitative data. In

this research I would need to collect empirical data on dosage of Vitamin B 12, as well as the

intake of dairy as it increases or decreases. Collecting data on specific dosage amounts confirms

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the fidelity of the research. A qualitative description of the behavioral changes observed would

provide a clear interpretation of the treatment outcomes and the conditions set forth by this study

(Heppner, 1999). Graphical analysis of behavior would be compiled, DNA microarray

assessments of participants would be compared, and pre and post dietary logs would be

evaluated. Questionnaires regarding lactose intake and vitamin supplementation would be

included in both the pretesting observation stage, the active experiment, and during the post

testing phase.

Finally, having both empirical data and descriptive information in the results would also

prove to be helpful in the replication of the research in future studies. Since a definite causal

relationship cannot be inferred by quasi-experimental quantitative data independently, it is

important to also include the qualitative aspect of the findings (Cook, 1979). This will include

surveys and questionnaire responses, observed behaviors, and communication assessment or

social skills test scores.

Ethical Adherence and Participant Protective Measures

The APA describes nine ethical concerns that should govern research: Collaborative

Science, Conflicts of Interest and Commitments, Data Acquisition, Management, Sharing and

Ownership, Human Research Protections, Lab Animal Welfare, Mentoring, Peer Review,

Publications Practices and Responsible Authorship, and Research Misconduct (APA, 2010).

These areas encompass many of the situations that may induce physical or psychological harm to

participants. Adherence to the guidelines set forth by the APA, allows the principles of

Beneficence and Non maleficence, Fidelity and Responsibility, Integrity, Justice, and Respect for

People's Rights and Dignity, to be encompassed in the work we display. Collectively, these sets

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of principles denote the psychologist’s position, whether in research or in practice, as an

advocate and insurant of social justice (APA, 2010).

According to the National Center for Technology Innovation, there are three areas in

which ethical concerns are presented in quasi-experimental projects: (1) recruitment of

participants, (2) data collection, and (3) data analysis (National Center for Technology

Innovation, 2014). Before embarking on the actual study, the pool of participants must be

identified for efficacy. Whatever treatment or condition the researcher is investigating must hold

potential benefits to the intended population (National Center for Technology Innovation, 2014).

Participants must be informed of possible side effects impending the study. In certain instances,

researchers may be unable to obtain informed consent from the participants. Depending on the

functioning capabilities of these participants, this will be a concern (Rosenthal, 1991). Thus, for

the protection of the participants, it will be necessary to obtain consent from a parent, guardian,

or caretaker.

According to an article published by the Autism Self Advocacy Network, while research

in the area of autism is abundant, little attention has been paid to the ethical issues posed by new

findings in autism research or to the ways this research is often put into action (ASAN Website,

2011). Therefore, an internal ethics board will be constructed to ensure that proper procedures

are put in place and implemented to protect the privacy and rights of participants and their

families. The intensifying complexity of ethical issues has prompted the growth and promotion

of ethical committees (Jonsen, 2002).

Medical ethics committee are responsible for being familiar with the methodology of

bioethics and are available to counsel regarding areas of concern (Jonsen, 2002). Since my

primary focus as a physician is the incorporation of and medical etiology of ASD disorders, this

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research would be addressed from a biopsychological standpoint. With this in mind, it will be

increasingly important not only to adhere to the APA standards for practices in research, but also

to the AMA’s recommendations for ethical praxis.

As an antecedent of collaboration, a plan will be compiled which includes goals and

direction of the research, a detailed list of the responsibilities of all contributors, credit and

ownership details, and the medium of publication (APA, 2013). This is to avoid any issues that

may arise during the course of this study and ensure this research’s optimal success. All research

will be conducted in responsible manner, giving credit where it is due, and assuming ownership

of any resulting errors or misconduct involving any aspect of the research. This also applies to

publishing the findings of research in reputable sources (APA, 2013).

Funding

There may be several public agencies that would benefit from this research. The Centers

for Disease Control, WHO, the APA, and the AMA would be the most obvious choices for

possible funding opportunities for a research initiative like this. Some private associations,

agencies, and lobbyists may also show interest. In addition to these venues, state health and

mental health collaborators may have grants available to study these factors and their association

to ASD.

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References

Feldman, R. (2014) Development across the life span (7th Edition) Pearson Education

Limited: United Kingdom.

Autistic Self Advocacy Network Website. (2011). Ethical, legal and social implications of

Autism research. [Data File]. Retrieved from http://autisticadvocacy.org/2011/09/ethical-

legal-and-social- implications-of-autism-research/.

Jonsen, A. (2002). Clinical ethics. (5th ed) New York, NY: McGraw-Hill Publishing Company.

Gordis, L. (2009). Epidemiology. (4th ed) Philadelphia, PA: Saunders Elsevier Publishing

Company.

Oklahoma State Website. (1997). Sampling. [Data File]. Retrieved from

http://www.okstate.edu/ag/agedcm4h/academic/aged5980a/5980/newpage15.htm.

Shamoo, A.E., Resnik, B.R. (2009). Responsible conduct of research. (2nd ed) New York, NY:

Oxford University Press.

American Psychological Association. (2013). Responsible Conduct of Research. Retrieved from

http://www.apa.org.proxy1.ncu.edu/research/responsible/index.aspx.

Ross, M. (2011). Histology: A text and atlas. (6th Ed) Baltimore, MD: Lippincott Williams &

Wilkins.

Medscape Website. (2014). Genetics of autism spectrum disorders. [Data File]. Retrieved from

http://emedicine.medscape.com/article/2024885-overview#aw2aab6b3.

The National Commission for the Protection of Human Subjects of Biomedical and

Behavioral Research. (1979). The Belmont Report. Washington, DC: Department of

Health and Human Services. Retrieved from

http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html.

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Centers for Disease Control. (2013, November 21). ADHD. Retrieved from CDC:

http://www.cdc.gov/ncbddd/adhd/research.html#social.

Shuttleworth, M. (2009). Within subject design. [Data File]. Retrieved from

https://explorable.com/within-subject-design.

Santrock, J. W. (2011). A topical approach to lifespan development (6th ed)

McGraw-Hill Higher Education: Boston, MA.

Education Portal Website. (2014). Between-subject designs: Definitions and examples. [Data

File]. Retrieved from http://education-portal.com/academy/lesson/between-subjects-

designs-definition-examples.html#lesson.

Cook, T. D., Campbell, D. T. (1979). Quasi-experimentation: Design and analysis issues for field

settings. Boston, MA: Houghton Mifflin Company.

May, D., Luth, M., Schwoerer, C. (2014). The influence of business ethics education on moral

efficacy, moral meaningfulness, and moral courage: A quasi-experimental study. Journal

of Business Ethics, 124(1), 67-80. doi: 10.1007/s10551-013-1860-6.

National Center for Technology Innovation Website. (2014). Quasi-experimental study. [Data

File]. Retrieved from http://www.nationaltechcenter.org/index.php/products/at-research-

matters/quasi-experimental-study/.

Heppner, P. P., Kivlighan, D. M., Wampold, B. E. (1999). Research design in counseling (2nd

ed.) New York, NY: Brooks/Cole.

Rosenthal, R., Rosnow, R. L. (1991). Essentials of behavioral research: Methods and data

analysis. (2nd ed.) New York, NY: McGraw-Hill, Inc.

The University of California Davis Website. (2014). Experiment types. [Data File]. Retrieved

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from

http://psychology.ucdavis.edu/faculty_sites/sommerb/sommerdemo/experiment/types.htm

Research Methods Knowledge Base Website. (2006). Factorial design. [Data File]. Retrieved

from http://www.socialresearchmethods.net/kb/expfact.php.

Gustafsson, M., Borglin, G. (2013). Can a theory-based educational intervention change nurses'

knowledge and attitudes concerning cancer pain management? A quasi-experimental

design. Bmc Health Services Research, 13. Retrieved from

http://eds.b.ebscohost.com.proxy1.ncu.edu/eds/pdfviewer/pdfviewer?sid=1911c466-

b059-4aca-96ae-a57b4c1397b9%40sessionmgr112&vid=2&hid=117.

CDC Website. (2014). Autism Spectrum Disorder. [Data File]. Retrieved from

http://www.cdc.gov/ncbddd/autism/facts.html.

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Sample Questionnaire

The ASD Assessment Scale/ Screening Questionnaire

This is an experimental screening tool that requires a traditionally

established ASD diagnosis.

------------------------------------------------------------------------------

NAME OF SUBJECT DATE

Non-Resolved Mild Moderate Severe

SOCIAL INTERACTION DIFFICULTIES (with same age peer)

1. Poor eye contact, or staring from unusual angle

2. Ignores when called, pervasive ignoring, not turning head to voice

3. Excessive fear of noises (vacuum cleaner); covers ears frequently

4. In his/her own world (aloof)

5. Lack of curiosity about the environment

6. Facial expressions don't fit situations

7. Inappropriate crying or laughing

8. Temper tantrums, overreacting when not getting his/her way

9. Ignores pain (bumps head accidentally without reacting)

10. Doesn't like to be touched or held (body, head)

11. Hates crowds, difficulties in restaurants and supermarkets

12. Inappropriately anxious, scared

13. Inappropriate emotional response (not reaching to be picked up)

14. Abnormal joy expression when seeing parents

15. Lack of ability to imitate

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SPEECH AND LANGUAGE DELAY

1. Loss of acquired speech

2. Produces unusual noises or infantile squeals

3. Voice louder than required

4. Frequent gibberish or jargon

5. Difficulty understanding basic things ("just can't get it")

6. Pulls parents around when wants something

7. Difficulty expressing needs or desires, using gestures

8. No spontaneous initiation of speech and communication

9. Repeats heard words, parts of words or TV commercials

10. Repetitive language (same word or phrase over and over)

11. Can't sustain conversation

12. Monotonous speech, wrong pausing

13. Speaks the same to kids, adults, objects (can't differentiate)

14. Uses language inappropriately (wrong words or phrases)

ABNORMAL SYMBOLIC OR IMAGINARY PLAY

1. Hand or finer flapping; self-stimulation

2. Head banging

3. Self-mutilation, inflicting pain or injury

4. Toe walking, clumsy body posture

5. Arranging toys in rows

6. Smelling, banging, licking or other inappropriate use of toys

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7. Interest in toy parts, such as car wheels

8. Obsessed with objects or topics (trains, weather, numbers, dates)

9. Spinning objects, self, or fascination with spinning objects

10. Restricted interest, (watching the same video over and over)

11. Difficulty stopping repetitive "boring" activity or conversation

12. Attachment to unusual objects, (sticks, stones, strings, or hair)

13. Stubborn about rituals and routines; resists to change

14. Restricted taste by consistency, shape or form (refuses solids)

15. Savant ability, restricted skill superior to age group (reads early,

memorizes books)

BEHAVIORAL DIFFICULTIES

LEVEL OF DYSFUNCTIONTOTAL SCORE __________________

Administrative Notes:

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