Executive Summary

 

Parents of behavior disorder and violent children come to (Clinic) with similar stories.  Their children are hyperactive and have concentration problems, starting in infancy and grow only more challenging with each passing year.  In extreme cases, parents’ struggle with a child who hurts other kids, tortures animals, and shows extreme fascination with fire.  Scientific research identified neurotransmitters like serotonin that play an important role in determining behavior.  Drugs like Ritalin are effective 60 to 70% of the time but can cause undesirable side effects.  Many parents feel Ritalin only masks underlying biochemical problems but find few non-drug treatments available.

 

 (name of Client) is a researcher whose 30 years of investigations have led to a successful non-drug treatment for children with behavior disorders or violent behavior.  He established (Clinic) to unravel the role biochemistry plays in behavior and to treat individuals with biochemical imbalances.  (Clinic) conducts extensive biochemical analyses to identify imbalances in patients who seek treatment for behavior disorders, violent behavior, depression, and other mental health disorders.  Based on test results, (Clinic) prescribes individualized therapies consisting of vitamins, minerals, and amino acids that restore biochemical equilibrium and promote optimal health.

 

(Name of Client)’s research determined that there are two prominent biochemical profiles associated with violent behavior and developed screening methods to detect biochemical markers associated with violence.  (Clinic) proposes to conduct a community screening pilot study that will screen 100 children who are predisposed to violent behavior based on biochemical markers correlated with violence.  It will test a screening technique and non-drug treatment to correct biochemical imbalances associated with violent behavior.  (Clinic) will include treatment for 20% of the children who are most at risk for such behavior.  (Clinic) will also establish parameters for a future double blind, placebo controlled study.

 

We plan to begin testing boys this fall.  (Clinic) requires $48,800 to begin this groundbreaking project.  We respectfully ask xx Foundation to consider a $zz,zzz grant to test our screening technique and treatment approach for this at-risk group of children.  Results of this research will be written and published in a peer-reviewed journal; information that will provide up-to-date information to other researchers, doctors, and the public on biological factors contributing to violence and effective ways to identify and treat violence-prone youth.

 

 

Statement of Need

 

Recent scientific research shows imbalances in neurotransmitters can cause behavior disorders that may lead to violence.  In the past decade, several neurotransmitters have emerged as important regulators of aggressive behavior in animals including epinephrine, dopamine, acetylcholine, serotonin, and the amino acid GABA.  At Duke University, a study demonstrated by increasing serotonin in the brain hyperactive and impulsive behaviors could be reduced.[i]  Dr. Garza-Trevino conducted extensive analyses on neurotransmitters and psychiatric clinical research correlating different types of biological causes of aggression.  Summarizing his analysis, Garza-Trevino concluded that “Identification of biochemical markers can be used in predicting patients’ response to pharmacological interventions may be the next step in developing more rational treatment of violent patients.”[ii]

 

Conducting pioneering research is (Name of Client) who has identified specific biochemical markers in violence prone youth.  His research has found and identified the availability of amines, organic compounds needed to form neurotransmitters, are essential for proper production of serotonin and other important transmitters in the brain.  Amine production is directly influenced by amounts of vitamins, minerals, and nutrients available in the blood stream.  (Name of Client) also found deficiencies in essential vitamin and nutrients lead to low amine production that eventually effect availability of neurotransmitters.  Additionally, (Name of Client) was able to show how toxic build ups, such as lead or cadmium, contribute to violent behavior.  He defined two prominent biochemical profiles associated with violence.  Founding (Research Clinic) in 1983 and (Treatment Clinic) in 1989, (Clinic) is able to conduct intensive research and provide treatment to individuals with biochemical imbalances that cause mental health or behavior problems.  Since (Clinic) opened, more than 5,000 behavior-disordered and violence-prone children have come to (Clinic) for treatment with over a 90% treated successfully.

 

Past studies conducted by (Clinic) demonstrate that slightly less than one fourth of every 100 males screened will have biochemistries associated with violent behavior.  Not all violence-prone individuals display biochemical markers; however, if markers are present, there is a high probability that violent behavior will occur.  To screen for biochemical imbalances, (Clinic) test urine and hair tissue samples.  Based on these test results, (Clinic) identifies individuals most prone to violent behavior, then conducts further tests on these individuals including a through physical examination, review of medical history, and further blood tests.  Individualized therapies are developed based on biochemical test results.  Therapies are designed to eliminate toxins or nutrient build-ups and replenish depleted nutrients.  Treatment consists of amino acids, minerals, vitamins, and other nutrients.  Each person’s therapy is individually formulated to help their body produce adequate supplies of important neurotransmitters.  (Clinic)’s approach relies on cooperative efforts of patients, biochemists, nutritionists, and medical doctors. 

 

(Clinic) proposes to conduct a pilot study to identify and treat violence-prone boys, ages six to 12 years old.  The study will screen a group of 100 high-risk youth for biochemistries associated with violence.  Twenty boys with extreme biochemical imbalances will be selected for further evaluation and treatment.  An independent psychologist will establish psychological and behavioral base lines for boys selected for treatment.  After psychological tests have been completed, (Clinic) will prescribe individualized biochemical nutrient therapy.  Boys will be re-evaluated after four to six months of such treatment to determine improvements in behavior and biochemistry.

 

The study will test (Clinic)’s ability to screen at-risk youth for violent tendencies and test effectiveness of biochemical treatment in reducing violent behavior.  In addition, groundwork will be laid to develop a double blind, placebo controlled study.  We respectfully request xx Foundation to consider funding $zz,000 to conduct this research.  Results will be made available to other researchers as well as to parents, educators, and social service agencies through publication in a peer-reviewed journal.  Integration of this information into medical literature is essential to inform professionals working with at-risk children on effective, low-cost screening and treatment methods. 

 

Project Description

 

(Clinic)’s primary goals are: 1) to test a biochemical screening method for identifying boys at-risk for violence, 2) to test a medical biochemical treatment for boys most at-risk for violent behavior, and 3) to develop parameters for a double blind, placebo controlled study.

 

(Clinic)’s primary objectives are: 1) to screen a random group of at-risk boys; 2) to treat boys with most extreme biochemistries associated with violence; 3) to evaluate results of screening and treatment; 4) to publish results in a peer-reviewed journal; and 5) to lay the ground work for a future double blind placebo controlled study.

 

As previously described, (Clinic) will screen 100 at-risk boys between the ages of six and 12 years old through analyses of urine and hair tissue samples, selecting approximately 20 boys for further testing and treatment.  A positive outcome of this study will lead to development of a double blind, and placebo controlled study.  To ensure subject’s rights, this study will be reviewed and monitored by (Clinic)’s Institutional Review Board (IRB).  IRB qualifies as a general assurance institutional review committee for protection of human subjects within the meaning of Code 45 of Federal Regulation CFR, Part 46.  (Clinic) will have a parental agreement form that parents or guardians sign in advance of testing and admittance into the research study.  Each child and guardian will have the right to discontinue treatment as a test subject for any reason, which will be documented.  Names and identities of all test subjects will be kept strictly confidential in all reports and final analyses.  Participants selected for further analysis and treatment will be responsible for payment of $460, since past experience has demonstrated that participant payment guarantees they take a personal interest in maintaining treatment compliance.  Without supplementation from grant contributions, this treatment would cost each family about $1,500. 

 

(Clinic) will employ the following methods to determine effectiveness of screening a random group of at-risk boys for violent behavior and treating most high-risk boys.  The general timeline is as follows:

 

Screening Phase                                       Duration 1 – 4  Months

 

·         Recruit violence-prone youth through three methods: 1) screen male patients who come to (Clinic); 2) advertise in local community; and 3) work with juvenile delinquency programs or other organizations working with troubled and violence-prone youth. 

·         One hundred at-risk boys will be screened for biochemistries associated with violent behavior through analysis of urine and hair samples.  (Clinic) will look for important biochemical markers such as elevated kryptopyrroles.

·         An average of twenty-five at-risk boys will be screened each month with five boys selected for continued analysis and treatment.  Screening and recruitment will stop concomitantly with last of boys initiating treatment around four months.

 

Treatment Phase                                       Duration 1 – 4 Months

 

·         Boys identified with extreme aberrant biochemistries and who agree to further assessment will complete comprehensive psychological and behavioral evaluations conducted by an independent psychologist using tests such as Connor’s Scales, Behavior Evaluation Scales, and other standardized instruments.  Evaluations will include case histories taken from parents or guardians. 

·         Complete health histories and further biochemical tests will be conducted including in depth analyses of hair, urine, and blood samples.

·         Biochemical test results will be used to formulate individualized biochemical nutrient therapies to correct imbalances.  Therapies consist of specific combinations of vitamins, minerals, amino acids, or other nutrients that help rebalance each boy’s biochemistry.  Nutrients are compounded into capsules and taken daily. 

·         As an incentive to participate, patients selected for assessment and treatment will be provided with a one-year individualized supply of nutrient supplements.

 

Evaluation Phase                                       Duration 4 – 8 Months

 

·         Each boy will complete four to six months of treatment and then be re-evaluated by the same independent psychologist to determine if there are noticeable changes in his behavior. 

·         (Clinic) will re-test blood, urine, and hair samples to analyze if biochemical markers initially identified have returned to normal ranges. 

·         All findings will be analyzed, correlated, and evaluated with results written and submitted to a peer-reviewed journal.

 

 

Staff/Administration

 

(Name of Client) is the principal investigator.  (Clinic) staff include (Client information).  An independent psychologist will perform standardized before-and-after behavior testing.  Specialized laboratory sampling and chemical analyses will be performed by (Clinic) staff and outside laboratories.  Medical evaluation, diagnosis, treatment design, and aftercare will be responsibility of (Clinic).

 

(Name of Client), CEO and director of research at (Clinic), will conduct medical evaluations and health history for each boy through an interview with boys, parents, or guardians.  His time will not be compensated through this grant, but through payment by patients.  (Client Information) has a Ph.D. in chemical engineering with over 40 years of research experience.  He has dedicated the past 30 years to research on the correlations between biochemical imbalances and violent behavior.  His complete biography can be found in Appendix VII.

 

 

Evaluation

 

Evaluations will be made at six and 12 months.  The first evaluation will determine if our goal of screening 100 boys and selecting 20 for continued testing and treatment are being met as well as how the study is progressing.  Adjustments such as length of time each boy is on nutrient therapy, increased counseling, or education about nutrient therapy will be determined and implemented as required.

 

 

A final evaluation will be made at 12 months to summarize results of study and use of funds.  How well the study adhered to project timeline and explanation of alterations or adjustments made during study will be addressed.  A discussion of screening a large group of at-risk boys for violence and effectiveness nutrient treatment in alleviating or eliminating violent behavior will be made.  A summary of this report will be included in a final report to the foundation.

 

Parameters used to analyze data include the following components:

 

1)     Employment of standard variance analysis methods to evaluate results;

2)     Examination of incidences of biochemistries associated with violent behavior in total population screened;

3)     Estimate how frequent extreme violent behavior appears in at-risk populations participating in this study;

4)     Comparison of before and after behavior from psychological evaluations to determine if there was a reduction in violent behavior; and 

5)     Comparison of before and after biochemical tests to determine if identified biochemical imbalances were effectively returned to normal levels.  

 

 

Budget

 

Patient

Project

Total

Patient Screening                             

($100/patient, 100 patients)           

0

$ 10,000

$ 10,000

Patient Evaluation/Treatment Design

($860/patient, 20 patients)

$  9,200

$   8,000

$ 17,200

Behavior Testing                  

($100/test, 2 tests, 20 patients)

0

$   4,000

$   4,000

Follow Up Evaluation                      

($390/patient, 20 patients)

0

$   7,800

$  7,800

Supplements                         

($600/year/patient, 20 patients)

0

$ 12,000

$ 12,000

Management                         

(10% of Principle Investigator)

0         

$   7,000

$   7,000

Total:

$  9,200

$ 48,800

$ 58,000

Amount requested:                

$ 32,800

 

 

 

Organizational History

 

When (name of Client) began his inquiries into biological components of violence, most research in mental health and criminology was not very promising.  As a volunteer at Stateville Penetiary in Illinois, he observed many criminals sought treatment at very early ages yet still ended up in jail.  (name of Client) was convinced biology played a role in manifestation of violence and began searching for a correlation between biochemistry and behavior. 

 

He made significant progress in mapping biochemical markers associated with violence through collaboration with Dr. Carl Pfeiffer of Princeton, New Jersey.  Pfeiffer conducted over 30 years of research on biochemical imbalances in schizophrenia and developed biochemical treatments for them.  His methods proved very helpful to (Name of Client) in testing and classifying similar biochemical imbalances in persons prone to violence.  (Name of Client) conducted preliminary tests, including evaluations of 700 criminals or ex-convicts.  Over 95 percent of the time, (name of Client) accurately identified individuals prone to violent behavior from blind samples of hair sent to him for testing. 

 

(Name of Client) established (Research Clinic) in 1983 to conduct in-depth research on biochemical factors of violent behavior.  The first definitive results came through a sibling study that tested 24 pairs of brothers living together in the same households.  Each pair consisted of one brother who had a violent history and the other with excellent behavior.  Results showed two distinct biochemical trace-metal patterns in violent boys that were not present in their non-violent brothers.  Results were replicated in three separate blind, controlled studies.  Further research correlated violent behavior with trace-metal imbalances seldom found in persons with non-violent behavior.  A type A biochemical pattern involves elevated serum copper, depressed plasma zinc, elevated copper/sodium ratio in hair, elevated blood lead, and abnormal blood histamine.  Patrick Sherrill, convicted in the Oklahoma Post Office slayings, tested with a strong type A biochemistry.  A type B biochemical pattern involves elevated blood histamine, elevated urine kryptopyrroles, low blood spermine, low plasma zinc, depressed copper/sodium ratio in hair and elevated lead in blood and hair.  Henry Lee Lucas, convicted serial killer, and Charles Manson tested as extreme type B biochemical patterns.

 

In 1989, (Treatment Clinic) was established to provide effective treatment alternatives for families struggling with a behavior disordered or violent child.  Over 5,000 behavior-disordered children and adults have been treated at (clinic) with a 90% treatment success rate.

 

Conclusion

 

Violence in America cripples communities, families, and schools.  (Clinic) has researched and developed effective methods to identify and treat many forms of violent behavior.  Applications of this research and treatment are significant and hold promise for an effective, low-cost tool to identify violence prone individuals and treat them before they act on their violent impulses.

 

The ability to identify and treat violent behavior are concerns our funding research indicate are consistent with your interests.  Without funding, (Clinic) can not commit professional time and resources required to conduct this important study nor make results available to experts and professionals working with troubled youth in juvenile detention facilities or doctors’ offices.  With xx Foundation’s support, we can conduct this study and establish important groundwork for a future double blind, placebo controlled study.  I am grateful for your serious consideration of funding this project.

 

 



[i] Ritalin: How Does it Work?  Dateline: 1/19/99 and Genetic of Childhood Disorders: XXIII. ADHD, part 7: The Serotonin System

 

[ii] Enrique S. Garza-Trevino, MD,  Neurobiological Factors in Aggressive Behavior,  July 1994, Hospital and Community Psychiatry, Vol. 45, No. 7, p. 690-699.