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Friday, April 8, 2011

Assessing the Efficacy and Safety of Psychotropic Drugs (Clinical Trials and their Importance)

Assessing the Efficacy and Safety of Psychotropic Drugs (Clinical Trials and their Importance) Prior to 1962, trials of new medications were largely based on a series of uncontrolled testimonials by clinicians associated with the studies. The change in the conduct of clinical trials arose largely in response to the public concern, and that of the medical profession, expressed as a result of the thalidomide disaster in which thousands of women in Europe produced offspring with serious limb deformations which occurred after taking the drug for the treatment of morning sickness during the first trimester of pregnancy. This tragedy resulted in the establishment of regulatory authorities in most European countries who established legal guidelines, mainly based on those of the Food and Drug Administration in the USA, which ensured that all new drugs would be subjected to adequate preclinical and clinical assessment before they could be marketed. This is not the place to describe in detail the pre-clinical and clinical studies which are now required by the Medicine Boards which were established by the European Commission to ensure that optimal standards are reached before any drug is made available for clinical use. However, the following summary will hopefully serve to illustrate the procedures involved in ensuring the efficacy and safety of drugs. Pre-clinical testing Drug discovery, almost without exception, is dependent on the pharmaceutical industry. This is understandable due to the enormous costs involved. Although there have been major developments in drug design (particularly with the application of combinatorial chemistry which enables the random synthesis of low molecular weight compounds by automated technology) that have helped to rationalize the methods used to identify novel compounds, the discovery of genuinely original drugs is still largely dependent on serendipity. Nowhere is this more apparent than in the area of psychopharmacology where, with few exceptions, the application of structure–activity relationships for the synthesis of new drugs has been disappointing. Thus it is still necessary for a lead compound to undergo extensive in vitro and in vivo testing to determine whether it will justify clinical development. Once it has been established that the compound is pharmacologically active at doses that do not cause major adverse side effects in rodents, and that it may offer benefits over the drugs that are already available, the compound is then submitted to extensive toxicological testing. This requires an assessment of the dose-related toxicity in at least two different species of mammal so that a risk–benefit assessment may be made regarding its suitability for further clinical development. In addition, information is obtained regarding the pharmacokinetic characteristics of the compound with regard to its bioavailability, metabolism, excretion and the occurrence of potentially toxic metabolites. Details of the manufacturing processes involved, together with details of the final dosage form which will be used in the initial clinical studies, must also be provided by the pharmaceutical company to the Medicines Board before the compound can undergo further testing. The processes involved in preclinical testing can take at least 5–7 years to complete in the case of a novel chemical entity but the period can be shorter if the compound is structurally related to a drug which is already in therapeutic use. One of the major problems facing the researcher who is attempting to discover novel drugs to treat psychiatric disorders lies in the difficulty of obtaining relevant animal models of the human disorder. It is self-evident that only man appears to suffer from any of the major psychiatric disorders, which therefore restricts the researcher to studying changes in behavioural parameters that show some similarity to those observed in the model following drug treatment (accurately predict its activity in the patient?), face validity (are the behavioural or physiological changes observed in the model similar to those seen in the patient?) and construct validity (are the causes of the changes observed in the model similar to those causing the disorder in man?). As the biological basis of all major psychiatric disorders, and most neurological disorders, is far from certain and the behavioural repertoire of most animals is quite different from that of humans, it is understandable why no animal model meets the optimum criterion. Despite these limitations it is still possible to obtain information by studying the effects of novel compounds on animals (usually rodents) that offer some predictive validity. The introduction of ‘‘knock-out’’ mice, or mice in which specific receptors, neurotransmitters or toxic proteins (such as the human beta-amyloid protein) are over-expressed (see p. 128), has helped in understanding the relationship between the changes in central neurotransmitter function and abnormalities in behaviour whichare amenable to drug treatment.

Thursday, April 7, 2011



Compulsory school attendance laws have been enacted in all states. The scope of those laws was narrowed in most states by the introduction of exemption clauses. These clauses excuse children considered unfi t or uneducable because of physical or mental handicaps from school attendance. Legal challenges by handicapped children for extension and protection of the right established under state law of equal access to educational opportunity ensued during the early 1970s. Those cases were followed by federal and state laws that mandate free appropriate public education to handicapped children and ensure their right to attend school regardless of the severity or type of their disability. Under IDEA and Section 504 of the Rehabilitation Act of 1973, a handicapped child must be educated in the least restrictive environment his or her needs allow. Children with serious, often chronic, health impairments who require special ducation and related services may receive instruction in hospitals or in the home. Schools use various approaches, including home visitations, school- to- home telephone communication, and interactive television to connect a homebound or hospitalized student with the classroom. Federal law recognizes that there are instances when, because of the nature or severity of a child’s handicap, the child must be educated in a setting other than the regular classroom. However, the least restrictive environment provisions prohibit placement of a child on homebound instruction or other exclusion from the regular educational environment solely because the child has disabilities. Homebound instruction may not be appropriate for the instructional needs of that child. There have been few studies of program and school attendance as a factor in the achievement of students with disabilities. There is some evidence that handicapped students attending regular schools are no more likely to be absent from school than nonhandicapped students (Sullivan & McDaniel, 1983). High rates of school attendance do not necessarily ensure high rates of program attendance or achievement. Sullivan and McDaniel (1983) concluded that children served in resource rooms may be receiving up to one- quarter less schooling time than is prescribed in their individualized education programs because of competing school activities and absences of either the resource room teacher or the student during a scheduled period. In various studies involving children with and without disabilities (Ivarie, Hogue, & Brulle, 1984; Rosenshine, 1979), investigators in the area of academic learning time as it relates to academic achievement have found a positive correlation between the learning of basic skills and the number of minutes students spend on academically relevant tasks. Researchers are continuing their study of increased active learning time as a powerful intervention technique for all students. Under the IDEA and Section 504, mandatory procedural safeguards exist that allow parents to challenge school disciplinary actions that would interrupt a handicapped child’s education. Expulsions, suspensions, and transfers to settings outside a regular classroom or school are considered placement changes because such measures remove students from their current school program or curtail attendance (Simon, 1984). A series of court decisions on this sensitive area have provided important guidelines for determining when and for what length of time handicapped students may be expelled or suspended under federal law (Reschly & Bersoff, 1999; Simon, 1984).


NEUROPHYSIOLOGICAL ABNORMALITIES The human nervous system consists of the brain, the spinal cord, and an intricate network of rve fi bers projecting from the brain and spinal cord. Structurally, the brain is differentiated into the two cerebral hemispheres, the brain stem, and the cerebellum. The brain, together with the spinal cord, traditionally has been conceptualized as the central nervous system (CNS). The entire network of nerve fi bers is then referred to as the peripheral nervous system (PNS). The brief discussion regarding normal neurological structure and function that follows is meant as an aid in the appreciation of neurophysiological disorders. The intent here is to offer an overview; for a more detailed account of the nervous system, the reader is referred to one of a number of neurophysiological texts (e.g., Bickerstaff, 1978; Lindsley & Holmes, 1984; Swaiman & Ashwal, 2006). Peripheral nerves are referred to by the direction the impulses fl ow and the site of their termination. Specifi cally, the direction of the impulses carried in relation to the CNS, the originating structure, or fi nal destination of the impulse, and the nature of the impulse itself, are used to classify peripheral nerves. For instance, the PNS contains sensory nerves that carry impulses from the sense organs (eyes, ears, nose, etc.) to the CNS. By way of contrast, the motor nerves travel from the CNS to the periphery, exciting both skeletal (voluntary) and smooth (involuntary) muscle into movement. Included in PNS, the cranial nerves arise from or travel to the brain stem (connecting structure between spinal cord and cerebrum). Similarly, the spinal nerves travel to or from the spinal cord. The group of peripheral nerves that carry impulses to smooth muscle (causing involuntary movements of the intestines, heartbeat, constriction of the pupils, etc.) and those that incite the secretion of glands cause automatic changes in the body. These peripheral nerves are sometimes referred to collectively as the autonomic nervous system. Functionally, the fundamental building block of the nervous system is the neuronal circuit. The simplest neuronal circuit contains only two interconnected nerve cells, involving an input and an output cell (e.g., simple knee jerk refl ex). Local circuits exist at all levels of the nervous system and, in fact, such circuits in the spinal cord connect the cerebral cortex, brain stem, and cerebellum. These connections can function as modules in more complex circuits. Indeed, these integrated networks are capable of sustaining complex behavior (Gaddes, 1985; Kandel, Schwartz, & Jessell, 1991). As an example, sensory impulses traveling from the various sense organs to the brain are integrated, recorded, recognized, stored or remembered, as interpreted by the cerebral cortex. Moreover, skeletal movement may be affected by motor nerves traveling by way of the spinal cord. Generally, the entire system works to regulate and coordinate bodily responses to both internal and external changes in the environment (Taber, 1970). A malfunctioning neurological system results in an impaired capacity for responding adaptively to a changing environment. Neurophysiological abnormality may occur by means of many agents and during various stages of the life process; some stages offer more vulnerability than others. Antenatal agents (occurring before birth) described by Nelson (1969) include genetic factors, chromosomal aberrations, placental disease, maternal complications, number of previous pregnancies, age of both mother and father, intrauterine infection, toxic agents (including certain drugs and alcohol), and radiation. Various organ systems begin and end their prenatal development at different times, therefore their sensitivity to agents varies with maturity of the fetus. The most vulnerable period for the brain is from 15 to 25 days of gestation but, clearly, damage can occur at any time during the development of the nervous system (Hetherington & Parke, 1979). Perinatal (occurring just before or after birth) vulnerability to neurological insult is accentuated by premature birth. Inadequate oxygen during this stage, hemorrhage, trauma, and infection are the principal offenders (Nelson, 1969). Postnatal (occurring after birth) damage to the neurological system may include damage incurred after birth, during childhood, or throughout the various stages of adulthood. Infections, principally meningitis and encephalitis,injuries, and degenerative neurological disease have also been implicated (Nelson, 1969). Weller, Swash, McLellan, and Scholtz (1983) estimated that 40 percent of developmental malformations of the CNS arise from genetic abnormality. The most common genetic abnormality is Down’s syndrome. This disorder is associated with a group of chromosomal aberrations involving the 21st chromosome pair. In the great majority of cases, a failure to join occurs during the meiosis process, resulting in a trisomy (additional chromosome) of the 21st chromosome pair. Translocation and mosaician represent less frequently occurring aberrations of the 21st chromosome pair, also associated with Down’s syndrome (Kopp & Parmelee, 1979). The incidence of Down’s syndrome is between one and two per thousand live births for all races and ethnic groups (Gillberg, 1995; Norman, 1963). Although there is some variability in incidence, most researchers cite an increase in relation to maternal age (Benda, 1960; Lawrence, 1981; Weller et al., 1983). A gradual increase begins with maternal age of 35 and escalates drastically after 40. Metabolic or environmental factors in the mothers’ ovaries have been suggested as causes for the syndrome (Benda, 1960; Lawrence, 1981; Nelson, 1969; Norman, 1963; Weller, Swash, McLellan, & Scholtz, 1983). Structural inspection of the Down’s syndrome brain suggests impairment of both growth and differentiation (Benda, 1960). The brain is generally low in weight and the normal convolutional pattern of the brain is simplifi ed. The density of the nerve cells in the cerebral cortex is reduced (Weller et al., 1983). Rate of mental development is not only slower than normal but also deteriorates progressively with age in Down’s syndrome (Cornwell & Birch, 1969; Dicks- Mireaux, 1972; Gillberg, 1995). Many explanations, including neurophysiologic changes, have been offered as explanation for this progressive deterioration. Weller et al. (1983) noted that the microscopic study of brain tissue of Down’s syndrome victims during autopsy reveals patterns of neurofi brillary tangles, senile plaques, and granulovacular degeneration such as are found in Alzheimer’s disease (deteriorative disease of the elderly involving degeneration of the smaller blood vessels of the brain). Kopp and Parmelee (1979) suggest that the severe limitations in higher level integrative abilities evident in Down’s syndrome may cause defi cits in information processing (e.g., use of language) that could have progressive detrimental effects on the child’s intellectual development over time. The child’s capacity for responding adaptively to changing stimulus conditions, a necessity for proper intellectual development, may be impaired directly by the nature of the syndrome. However, the nature of the environment in which these children fi nd themselves, whether it is enriched or impoverished, also can affect development. In contrast to Down’s syndrome, which is genetically related, spina bifi da seems to be more infl uenced by environmental factors. Although genetic factors are suggested by the higher incidence in infants born to parents with a family history of such lesions, it seems that racial, geographical, and even seasonal factors also may be implicated (Kopp & Parmelee, 1979; Weller et al., 1983). Clearly, the interaction of genetic and environmental factors has recently been given prominence. Genetic predisposition combined with certain environmental factors may be the causal condition for spina bifi da occurrence (Carter, 1974). Spina bifi da represents a malformation of the nervous system that appears to be more localized and variable in effect than that of Down’s syndrome. This defect occurs as a result of faulty prenatal development, in which the lower end of embryotic CNS fails to close. The contents of the spinal column (nerve fi bers, meninges, and fl uid) may protrude from the lower back in a sac (meningomyelocele). Individual defects vary depending on the extent of damage to the nerve fi bers and the existence of other associated conditions (Kleinberg, 1982). The spinal cord is frequently abnormal above and below the level of the spina bifi da (Weller et al., 1983). Hydrocephalus, abnormal accumulation of cerebral spinal fl uid, frequently is associated with spina bifi da. Untreated hydrocephalus creates severe enlargement of the head, increased pressure, and subsequent damage to the brain (Kleinberg, 1982). Intellectual levels of victims with spina bifi da are variable, ranging from an IQ of 137 to severe subnormality (Gillberg, 1995; Hunt, 1981). More specifi cally, Spain (1974) associates mental retardation with protrusion of a portion of the brain (cranial meningocele and cephalocele), whereas infants with other forms are considered to have potentially normal intellect. Many individuals with spina bifi da are incontinent of urine and feces, and have weakness of their legs with sensory loss below the level of the lesion (Kleinberg, 1982). Owing to the presence of the typical locomotor problems in spina bifi da, it is unclear whether some defi cits are due to neurological impairment or environmental infl uence. Spain’s (1974) longitudinal spina bifi da studies have revealed signifi cant defi cits in spatial and manipulative development. The fact that the disorder limits the individual’s experience may, in fact, cause or infl uence the specifi c defi - cits in spatial and manipulative development. Among the educational problems noted are diffi culties with arithmetic and perseveration in language, as well as emotionality and poor motivation (Kopp & Parmelee, 1979). Primary disorders of the CNS, like Down’s syndrome and spina bifi da, represent a relatively small proportion of the neurological problems in infants (Horwitz, 1973). More frequently, the genetic programs for potentially normal neurological development are subverted by adverse prenatal or birthing conditions such as lack of oxygen (hypoxia). Cerebral hemorrhage often occurs during prolonged hypoxia. The accumulation of stagnate blood that follows circulatory collapse may cause bleeding and ultimate damage to brain tissue (Weller et al., 1983). Premature infants are especially vulnerable to hypoxia. Since the respiratory system is notfully perfected until the last four to six weeks of gestation, these infants are often born without an optimally functioning respiratory system. Postmortem studies on premature children show that the bleeding usually occurs within one of the cavities of the brain or the space below the arachnoid membrane that contains cerebrospinal fl uid (subarachnoid space [Horwitz, 1973]). Later complications of such subarachnoid hemorrhage involve epilepsy, dementia, and hydrocephalus (Weller et al., 1983). Full- term infants are more likely to suffer from hemorrhage in the mid- brain stem (pons) and the posterior portion of the cerebral cortex (hippocampus). Cause for these differences are not, as yet, fully understood. The location and size of brain lesions at or soon after birth are the primary determinants of the extent of nervous system impairment. The results may range from a gross alteration of brain organization to more minimal effects such as motor overactivity, shortened attention span, or slight muscle impairment (Pincus & Tucker, 1974; Teberg et al., 1982). Large injuries in infants tend to produce more widespread defi cits in intellectual abilities than similar injuries in adults. Dulling of many areas of intellectual functioning, as opposed to having an effect in specifi c functioning (e.g., language development, visual- spatial relationship comprehension), is also a hallmark effect of the diffuse damage that follows hypoxia (Rapin, 1982). Neurological defi ciencies from early injury are diffi cult to predict. The nervous system of the newborn infant is extremely immature, functioning largely at brain stem and spinal cord level. The neurologic refl exes such as Moro, grasping, and stepping represent primitive neuronal function that is largely uninhibited by higher cerebral control. Changes in these refl exes are usually not helpful in localizing the lesion, and may occur with either cortical or subcortical dysfunction (Horwitz, 1973). Damage to the cerebral cortex, for instance, may not be evident until the age when behavior dependent on the damaged part makes its developmental appearance. Thus, pathology of fi ne motor coordination, speech, and cognition is unlikely to be diagnosed in infancy (Rapin, 1982). However, changes in refl exes and disorganized activity of the subcortical structures expressed as a movement disorder or spasticity continue to be used as indicators of neurological damage. In Teberg et al.’s study of low birth weight infants (1982), spastic quadriplegia did, in fact, emerge as the indicative diagnosis of neurological handicap. Churchill, Masland, Naylor, and Ashworth (1974) support this fi nding. Turkewitz (1974) contended that the standard methods used for the early identifi cation of neurologic handicaps are insensitive to many forms of neurological involvement. Infants who have had diffi culties shortly before or during the birth process frequently appear to recover in a few days. However, abnormalities in motor, language, and intellectual functioning become apparent later in infancy and childhood. Studies using indicators of higher levels of neurological organization (e.g., left / right preference) are being investigated in an effort to identify infants who have experienced neurological damage that is normally not expressed until later in life. However, normative patterns of left / right preference for infants must be established fi rst, before atypical patterns can be interpreted. The possibilities for neurophysiological dysfunction are limitless; the pathologies presented should not be considered as inclusive by any means. However, it is hoped that an appreciation of the complexity of cerebral neural structure and the corresponding intricacies of impairment resulting from neurophysiological dysfunction will encourage the reader to treat each impaired patient as a unique individual, for heterogeneity of outcome is common (Gaddes, 1985; Goldstein & Reynolds, 1999; Kopp & Parmelee, 1979).


ABAB DESIGN The ABAB design is one of the oldest and most widely used single- case designs developed in behavioral psychology. It was initially used in laboratory studies with animals (Sidman, 1960); however, as the applied behavior analysis movement got under way (Baer, Wolf, & Risley, 1968), it became a prototype for applied behavioral investigations conducted in the natural environment. Although the number of single- case designs has increased markedly since the early days of applied behavior analysis (e.g., Kazdin, 1980; Kratochwill, 1978), the ABAB design still occupies a prominent place in applied behavioral research. Moreover, because of the high degree of experimental control that it provides, it has been widely used with individuals manifesting various types of handicaps (Bergan, 1977). For example, the ABAB design has been particularly useful in studying environmental variables affecting language acquisition in retarded children (Bergan, 1977). The ABAB design is intended to reveal a functional relationship between an experimental treatment and a behavior targeted for change. For example, it might be used to establish a functional relationship between the use of the plural form of a noun and a treatment such as praise following the occurrence of a plural noun. The demonstration of a functional relationship between praise and plural nouns would require an association between the frequency of plural- noun production and the occurrence of verbal praise. Given that a functional relationship were established, verbal praise could be assumed to function as a positive reinforcer increasing the probability of occurrence of plural nouns by the subject or subjects participating in the experiment. The ABAB technique has often been referred to as a single- case design (e.g., Kratochwill, 1978). However, it may be applied with more than one subject. Thus, the term single case is a bit misleading. Glass, Wilson, and Gottman (1975) among others called attention to the fact that the ABAB design is a time- series design in that it refl ects an effort to determine changes in behavior occurring across a series of points in time. Recognition of the ABAB design as a time- series design opened the way for linking the design to the statistical procedures associated with time- series analysis (see, for example, Glass, Wilson, & Gottmann, 1975). Application of time- series analysis procedures affords a statistical test for hypotheses that may be investigated with the ABAB design. However, despite this advantage, time- series techniques have not been widely used in applied investigations involving the ABAB design. There are a variety of reasons for this. Among them is the fact that the graphing techniques suggested by behavioral psychologists (e.g., Parsonson & Baer, 1978) as an alternative to statistical analysis are easier to implement and to interpret than time- series statistics. Nonetheless, time- series procedures constitute a potentially powerful tool for applied behavioral research and their use can be expected to increase in the future. As the letters in its name suggest, the ABAB design includes four phases. The initial A phase is a baseline period that records behavior across a series of points in time in the absence of intervention. The length of the baseline period varies depending on the variability of the behavior being recorded. If the behavior is highly variable, a longer baseline is required than if the behavior is highly stable. More data are required to get a sense of the fl uctuations that may be expected without intervention for a highly variable behavior than for a highly stable behavior. The second phase, denoted by the letter B, is a treatment phase. During this phase the treatment is introduced. The treatment may be implemented in accordance with a variety of different schedules. For example, treatment may be implemented with every occurrence of the target behavior. For instance, praise might be given following every occurrence of a plural noun. On the other hand, treatment might be implemented in accordance with one of the many available partial reinforcement schedules. Thus, praise might be given after every third occurrence of a plural noun. The third phase, also denoted by the letter A, constitutes a return to baseline. The return to baseline may be brought about by various means. One is to withdraw the treatment. For instance, praise might not be given following plural- noun utterances during the return- to- baseline phase. Another procedure is to introduce another treatment intended to bring the target behavior back to baseline level. For example, reinforcement of a behavior that is incompatible with the target behavior may be introduced during the return- to- baseline phase. The fi nal phase in the ABAB design, denoted by the second occurrence of the letter B, is a second implementation of the treatment. The second implementation is intended to demonstrate treatment control over the target behavior by minimizing the possibility that environmental infl uences occurring coincidentally with the treatment could be responsible for the observed behavior change. The major advantage of the ABAB design lies in the fact that it minimizes the likelihood of coincidental environmen-tal infl uences on the target behavior. There are two potential disadvantages to the approach (Kazdin, 1973). One is that some behaviors are not easily reversed. For example, a skill that has been well- learned may not be easy to unlearn. The second disadvantage is that there are cases in which it may not be practical to carry out a return- to- baseline even if it is possible to do so. For instance, a teacher may not want to return a child’s performance of an academic skill to baseline even for a short period of time. Despite these shortcomings, the ABAB design has been shown to be useful in establishing a functional relationship between a treatment and behavior in countless applications. It is truly a mainstay in applied behavioral research and will continue to be used widely.


SUPPORT AREAS AND ACTIVITIES OF AAMR Human Development Activities • Providing physical development opportunities that include eye- hand coordination, fi ne motor skills, and gross motor activities • Providing cognitive development opportunities such as using words and images to represent the world and reasoning logically about concrete events • Providing social and emotional developmental activities to foster trust, autonomy, and initiative Teaching and Education Activities • Interacting with trainers and teachers and fellow trainees and students • Participating in making decisions on training and educational activities • Learning and using problem- solving strategies • Using technology for learning • Learning and using functional academics (reading signs, counting change, etc.) • Learning and using self- determination skills Home Living Activities • Using the restroom or toilet • Laundering and taking care of clothes • Preparing and eating food • Housekeeping and cleaning • Dressing • Bathing and taking care of personal hygiene and grooming needs • Operating home appliances and technology • Participating in leisure activities within the home Community Living Activities • Using transportation • Participating in recreation and leisure activities • Going to visit friends and family • Shopping and purchasing goods • Interacting with community members • Using public buildings and settings Employment Activities • Learning and using specifi c job skills • Interacting with coworkers • Interacting with supervisors • Completing work- related tasks with speed and quality • Changing job assignments • Accessing and obtaining crisis intervention and assistance Health and Safety Activities • Accessing and obtaining therapy services • Taking medication • Avoiding health and safety hazards • Communicating with health care providers • Accessing emergency services • Maintaining a nutritious diet • Maintaining physical health • Maintaining mental health and emotional well- being Behavioral Activities • Learning specifi c skills or behaviors • Learning and making appropriate decisions • Accessing and obtaining mental health treatments • Accessing and obtaining substance abuse treatments • Incorporating personal preferences into daily activities • Maintaining socially appropriate behavior in public • Controlling anger and aggression Social Activities • Socializing within the family • Participating in recreation and leisure activities • Making appropriate sexual decisions • Socializing outside the family • Making and keeping friends • Communicating with others about personal needs • Engaging in loving and intimate relationships • Offering assistance and assisting others Protection and Advocacy Activities • Advocating for self and others • Managing money and personal finances • Protecting self from exploitation • Exercising legal rights and responsibilities • Belonging to and participating in self- advocacy or support organizations • Obtaining legal services • Using banks and cashing checks


AAMR CLASSIFICATION SYSTEMS Founded in 1876, the American Association on Mental Retardation (AAMR) is the world’s oldest and largest interdisciplinary organization of professionals concerned about Mental Retardation. With headquarters in Washington, DC, the AAMR has a constituency of more than 50,000 people and an active core membership in the United States and in 55 other countries. The mission of the AAMR is to promote progressive policies, sound research, effective practices, and universal rights for people with intellectual disabilities. The AAMR has led the fi eld of developmental disabilities by officially defining the condition known as Mental Retardation. A diagnostic and classifi cation system remains important in today’s society because it is used to determine who can access publicly funded services and supports. The AAMR has updated the defi nition of Mental Retardation 10 times since 1908. Changes in the defi nition have occurred when there is new information, or there are changes in clinical practice or breakthroughs in scientifi c research. The 10th edition of Mental Retardation: Definition, Classification, and Systems of Supports (AAMR, 2002) contains a comprehensive update to the landmark 1992 system and provides important new information, tools, and strategiesfor the fi eld and for anyone concerned about people with mental retardation. The 10th edition discusses the 2002 AAMR defi nition and classifi cation system in great detail. It presents the latest thinking about Mental Retardation and includes important tools and strategies to determine if an individual has Mental Retardation along with detailed information about developing a personal plan of individualized supports. It is available from the AAMR through their web site at http: // / bookstore / or by calling 301- 604- 1340. The overall AAMR defi nition of Mental Retardation is that it is a disability characterized by signifi cant limitations both in intellectual functioning and in adaptive behavior as expressed in conceptual, social, and practical adaptive skills. This disability originates before the age of 18. The AAMR considers fi ve assumptions that are essential to the application of this definition: 1. Limitations in present functioning must be considered within the context of community environments typical of the individual’s age peers and culture. 2. Valid assessment considers cultural and linguistic diversity as well as differences in communication, sensory, motor, and behavioral factors. 3. Within an individual, limitations often coexist with strengths. 4. An important purpose of describing limitations is to develop a profi le of needed supports. 5. With appropriate personalized supports over a sustained period, the life functioning of the person with Mental Retardation generally will improve (AAMR, 2002). A complete and accurate understanding of Mental Retardation involves realizing that Mental Retardation refers to a particular state of functioning that begins in childhood, has many dimensions, and is affected positively by individualized supports. As a model of functioning, it includes the contexts and environment within which the person functions and interacts and requires a multidimensional and ecological approach that refl ects the interaction of the individual with the environment and the outcomes of that interaction with regards to independence, relationships, societal contributions, participation in school and community, and personal well- being. Adaptive behavior is the collection of conceptual, social, and practical skills that people have learned so they can function in their everyday lives. Signifi cant limitations in adaptive behavior impact a person’s daily life and affect the ability to respond to a particular situation or to the environment. Limitations in adaptive behavior can be determined by using standardized tests that are normed on the general population, including people with disabilities and people without disabilities. On these standardized measures, sigfor the fi eld and for anyone concerned about people with mental retardation. The 10th edition discusses the 2002 AAMR defi nition and classifi cation system in great detail. It presents the latest thinking about Mental Retardation and includes important tools and strategies to determine if an individual has Mental Retardation along with detailed information about developing a personal plan of individualized supports. It is available from the AAMR through their web site at http: // / bookstore / or by calling 301- 604- 1340. 2 standard deviations below the mean of either (1) one of the following three types of adaptive behavior: conceptual, social, or practical, or (2) an overall score on a standardized measure of conceptual, social, and practical skills (AAMR, 2002). Table 1 includes some specifi c examples of adaptive behavior skills. The concept of supports originated about 15 years ago with the AAMR, and it has revolutionized the way habilitation and education services are provided to persons with Mental Retardation. Rather than mold individuals into preexisting diagnostic categories and force them into existing models of service, the supports approach evaluates the specific needs of the individual and then suggests strategies, services, and supports that will optimize individual functioning. The supports approach also recognizes that individual needs and circumstances will change over time. Supports were an innovative aspect of the 1992 AAMR manual, and they remain critical in the 2002 system. In 2002, they have been dramatically expanded and improved to reflect significant progress over the last decade. Supports are defi ned as the resources and individual strategies necessary to promote the development, education, interests, and personal well- being of a person with Mental Retardation. Supports can be provided by a parent, friend, teacher, psychologist, and doctor or by any appropriate person or agency. Providing individualized supports can improve personal functioning, promote self- determination and societal inclusion, and improve personal well- being ofa person with Mental Retardation. Focusing on supports as the way to improve education, employment, recreation, and living environments is an important part of personcentered approaches to providing supports to people with Mental Retardation. The AAMR recommends that an individual’s need for supports be analyzed in at least nine key areas: human development, teaching and education, home living, community living, employment, health and safety, behavioral, social, and protection and advocacy.


AMERICAN ASSOCIATION ON MENTAL RETARDATION The AAMR promotes progressive policies, sound research, effective practices, and universal human rights for people with intellectual and developmental disabilities. It has been a major force in recent years in shaping current beliefs about all aspects of Mental Retardation. In terms of AAMR’s principles, it has adopted a 13- point set of principles to accomplish the mission: • Achieving full societal inclusion and participation of people with intellectual and developmental disabilities • Advocating for equality, individual dignity, and other human rights • Expanding opportunities for choice and selfdetermination • Infl uencing positive attitudes and public awareness by recognizing the contributions of people with intellectual disabilities • Promoting genuine accommodations to expand participation in all aspects of life • Aiding families and other caregivers to provide support in the community • Increasing access to quality health, education, vocational, and other human services and supports • Advancing basic and applied research to prevent or minimize the effects of intellectual disability and to enhance the quality of life • Cultivating and providing leadership in the field • Seeking a diversity of disciplines, cultures, and perspectives in our work • Enhancing skills, knowledge, rewards, and conditions of people working in the fi eld • Encouraging promising students to pursue careers in the fi eld of disabilities • Establishing partnerships and strategic alliances with organizations that share our values and goals The AAMR’s goals specify how the general policy directions of the organization’s mission will be carried out by (1) building association capacity, (2) building capacity to serve professionals who work with individuals with intellectual and developmental disabilities, and (3) building societal capacity. The AAMR can be reached online at http: // . It has an excellent web site for professionals, families, and individuals with Mental Retardation that promotes conferences, publications, policies, and other helpful sources of information. Contact information for the AAMR is as follows: American Association on Mental Retardation 444 North Capitol Street Washington, DC 20001- 1512 Phone: 202- 387- 1968 Fax: 202- 387- 2193 Web site: http: //