As part of the 2003 National Depression Screening Day (NDSD) on Oct. 9, the Children's Hospital Boston and Screening for Mental Health Inc. have collaborated on a campaign to raise awareness about the impact of parental depression on families.

The campaign--called "Can A Depressed Parent Be A Good Parent? You Bet!"--will feature brochures to be distributed at NDSD sites, including primary care sites.

Based on an intervention developed by William R. Beardslee, M.D., psychiatrist-in-chief at the Children's Hospital Boston, the campaign encourages depressed parents to talk with their children about their illness.  

Psychiatrists interested in hosting an NDSD event can contact Screening for Mental Health Inc. at (781)239-0071 or visit their Web site at <www.mentalhealthscreening.org>--TB

Articles

"Can a Depressed Parent be A Good Parent? You Bet!" This campaign, launched by the Children's Hospital in Boston and Screening for Mental Health, Inc. aims to raise awareness of parental depression and encourage parents to openly talk about their illness with their children.

Awareness Campaign for Parental Depression Launched

In the past decade, research from randomized clinical trials has produced strong and consistent evidence showing that cognitive-behavioral therapy (CBT) can play an important role in reducing social phobia, separation anxiety and generalized anxiety disorder (GAD) in children and adolescents (see Silverman and Berman [2001] for review).

This article presents the main therapeutic procedures and strategies used in CBT along three phases: education, application and relapse prevention. In practice, however, there is overlap among the procedures and strategies used across these different phases. 

Education. In the education phase, children first receive information that anxiety may manifest in three ways. One way involves "feelings in their bodies," such as heart beating fast, sweating or "butterflies in the stomach." Another manifestation involves certain behaviors, namely avoiding or staying away from situations or events that are anxiety-provoking. A third way involves thinking or what we "say to ourselves." In this phase, the therapist explains to the child that they will learn to recognize the specific reactions they get when they feel anxious, and they will learn to manage or reduce these reactions in therapy. 

The situations avoided and the anxious thoughts vary among patients with social phobia, separation anxiety and GAD. During the education phase, children learn to identify the situations and the nature of their thoughts. In social phobia, children generally avoid situations that involve social evaluation and/or performance in front of people. For example, children may fear giving an oral presentation in class, attending parties, or belonging to clubs or teams. The thoughts generally pertain to fears of social humiliation or embarrassment (e.g., "People will laugh at me"; "I will make a mistake and look stupid"). In separation anxiety disorder, children generally avoid situations in which parents or loved ones will be away from them or situations in which they need to be away from parents or loved ones. For example, children may avoid going to school, sleeping alone at night or being left alone with a baby-sitter. The thoughts generally pertain to fears of harm befalling either themselves or their parents/loved ones (e.g., "I might get kidnapped or killed and then I wouldn't be able to see my parents again"; "My parents may get into an accident and be killed, and I would never see them again"). In GAD, children engage in frequent, uncontrollable worry. The worry thoughts vary and may focus on everything and anything or specific areas, such as personal health, parents' health, their performance in school, world events or "little things" (e.g., "Maybe I said something that will be taken the wrong way"). Children with GAD also may show avoidant behaviors (e.g., not eating in restaurants due to a fear of getting sick, not attending school because there might be a terrorist attack). 

For children who experience bodily reactions when feeling anxious, the education phase might involve teaching relaxation strategies. This may be particularly helpful for children with GAD, for which physiological reactions are part of the diagnostic criteria. In this phase, primary emphasis is placed on informing children about the importance of "facing one's fears" rather than avoiding them. They are taught that by facing the fears, they have the opportunity to learn that the feared events are not bad after all. This, in turn, can help reduce their anxiety. The therapist explains to the child that exposures to anxiety-provoking situations/objects will be done in a gradual or graded fashion, not all at once, and children are reassured that they will not be asked to face their fear in a way they feel they cannot handle. 

Also during the education phase, the therapist tries to elicit as much information as possible about the avoided situations. For children with GAD, this may also involve eliciting the child's worries. This information will be included on the ladder or fear/anxiety hierarchy. The therapist explains that, as part of therapy, the child will be asked to complete each rung on the ladder or experience each exposure. 

Although parental involvement is not essential for positive treatment response, therapists may decide that parental involvement may be helpful in some cases. This may be particularly true for parents who seem to encourage avoidance behaviors or when working with young children. If parents are involved, they are taught behavioral strategies that are to be used to help increase child exposure and decrease child avoidance. One behavioral strategy taught is contingency management, which involves teaching parents basic concepts of positive reinforcement and the proper delivery of reinforcement. The importance of consistency and follow-through, as well as potential difficulties in effective follow-through, is explained. It also is important to differentiate among types of rewards (i.e., social, tangible, activity) and highlight the use of social and activity rewards in therapy. 

Since exposure or staying in a scary situation is difficult, children need to be taught skills they can use so they can face their fears. This involves teaching children cognitive or self-control strategies. Children should be taught to recognize when they are feeling scared and to recognize their scary thoughts or beliefs; to learn to think of other thoughts or beliefs when scary thoughts surface; and to praise themselves for successfully substituting better thoughts. 

In teaching children self-control skills, the mnemonic STOP is often used: Scared, Thoughts, Other thoughts or 

 things I can do to handle my fear, and Praise myself for successful handling of my fear and exposure (e.g., "I'm really proud of myself"; "I am a brave boy/girl").

. In the application phase, children (and parents, if they are involved) practice the principles and procedures taught in the beginning sessions. This application occurs in the therapy session and out-of-session as homework assignments. The therapist's role is similar to a coach in terms of providing feedback, support and encouragement as the child engages in increasingly difficult anxiety-provoking exposure tasks. Children begin with the lowest (easiest) steps on the fear/anxiety hierarchy. The importance of staying with the feeling of fear/anxiety for as long as they can until the fear/anxiety is reduced is emphasized. At the same time, it should be emphasized that the exposure can be stopped if the feeling of fear/anxiety is more than the child feels willing or able to handle. However, if children are willing, they should stay in the situation almost until the exposure situation seems boring to ensure that the fear reaction will be successfully reduced on each step on the hierarchy. To help determine whether the fear has been reduced during the exposure, it is useful for children to rate their fear/anxiety on a rating scale or thermometer (i.e., 0 to 8 rating scale) before and throughout the exposure. The exposure can be terminated upon a successful reduction in the fear ratings (e.g., initial rating of 6 and a final rating of 1 or 2). 

If parents are involved, contingency management may be applied. The therapist helps the parent and child generate a contingency contract, which is a detailed written agreement about the specific exposure task that the child will try (e.g., what to do, when to do it, how long to do it), the specific reward the parent will provide for the child's successful attempt and/or completion of the task, and when the reward will be provided. 

Whether or not parents are involved in the treatment, it is important for children to apply the self-control strategies. In this way, children can ultimately be responsible for managing their own therapeutic change efforts. For example, if a child has a social phobia and the exposure involves going to parties, the child might practice STOP as follows: Yes, I feel Scared at the party; My Thoughts are that the other kids will think I am an idiot because I will say something stupid; Other thoughts or other things I can do include telling some of the new jokes I learned for kids' parties; and Praise myself because I should be really proud of myself for being brave and going to the party.

As much as possible, children with separation anxiety disorder and GAD should engage in in vivo exposures for those situations that commonly trouble them. For separation anxiety disorder cases, parents may be asked to leave the child alone or with a baby-sitter for increasingly longer time intervals. It also may involve the child staying at another child's house for increasingly longer time intervals. Using the previous example of the child with GAD who worried about getting sick from eating in restaurants, the exposure might involve having the child gradually visit and eat in restaurants. For the child who worried about terrorist attacks in school, the exposure might involve having the child gradually attend school. Emphasis in the sessions is on helping children to realize that their worst fears do not happen during the exposures. 

Although in vivo exposures are encouraged during the application phase, it may be difficult to devise an in vivo exposure for some patients with separation anxiety and GAD. In such cases, imaginal exposures can be used, where children imagine they are in a movie with anxiety-provoking scenes that involve a situation on their hierarchy. The details of the scene (e.g., clothes being worn, color of the room) should be elicited prior to having the exercise to help ensure a vivid image on the part of the child. The child should be asked to imagine the scene for as long as possible, but definitely until the anxiety decreases. 

The child can use STOP as needed to help decrease the anxiety response. For example, part of the T (anxious thoughts) for the child worried about eating in restaurants is that the bad thing may happen-children can get food poisoning in restaurants. In such instances, it helps to generate the O (other thoughts or other things to do) that the children can do to decrease the probability of this occurring (e.g., only eat in clean and established restaurants; if your food tastes funny, stop and ask someone else to try it for you). Also part of the O is to help children figure out that the probability of these things happening is considerably less than the probability of not happening. It also may be helpful to ask, "What if it did happen?"

. As the child meets with continued success, the therapist should begin discussing with the child issues relating to termination, including relapse prevention. Specifically, the importance of continued exposures is emphasized. However, children also should understand that like any accomplishment, if you don't use it, you lose it, and be warned of the possibility for slips. The analogy of a person on a diet who successfully loses 20 pounds but then eats a piece of cake at a party can be a helpful learning tool. Together, the child and the therapist should explore the different ways that the person could interpret their slip. This case is analyzed until it becomes evident that an adaptive interpretation is that the slip is a single event: "It does not mean that everything is blown or ruined. I need to pick myself back up and get back on the positive track I was on."

The treatment summarized in this article has empirical evidence for producing positive treatment response in children with social phobia, separation anxiety and generalized anxiety disorder. It would seem important, therefore, when working with children who present with these anxiety disorders to ensure that the main therapeutic procedures, particularly exposure exercises, are included in any treatment plan. The other strategies, such as the contingency contracting and self-control procedures, may be used to help facilitate the likelihood that children will engage in successful exposures (see Silverman and Kurtines [1996] for further details). 

Despite the evidence for the treatment, it is important that future research be conducted on examining the essential components of the exposure-based cognitive behavioral psychosocial interventions for use with anxiety disorders in children in terms of identifying and evaluating the main mediators of change. Also important is research on the moderators of changes in terms of identifying and evaluating for whom the treatment works. It also would be important that future research focus on comparing this treatment with other treatments, including other psychosocial interventions as well as psychopharmacological treatments. 

Silverman WK, Berman SL (2001), Psychosocial interventions for anxiety disorders in children: Status and future directions. In: Anxiety Disorders in Children and Adolescents: Research, Assessment and Intervention, Silverman WK, Treffers PDA, eds. Cambridge, U.K.: Cambridge University Press, pp313-334.
 

Silverman WK, Kurtines WM (1996), Anxiety and Phobic Disorders: A Pragmatic Approach. New York: Plenum Press.

Children can now play a more active role in the treatment of their disorders. Using skills and information taught throughout the three treatment phases of cognitive-behavioral therapy (education, application and prevention relapse), they can be taught to understand and address the very fears that cause their disability.

Using CBT in the Treatment of Social Phobia, Separation Anxiety and GAD

Next month in Miami, the American Academy of Child and Adolescent Psychiatry will hold its 50th anniversary meeting. In recognition of this event, the following is a brief history of the organization and of this subspecialty (Schowalter, 2000, 1994).

Most historians of child psychiatry date its beginning in this country to 1899, when Illinois established the nation's first juvenile court in Chicago. This occurrence set forth the following sequence of events. A group of influential, socially concerned women on the board of directors of Jane Addam's Hull House was shocked by juvenile delinquency. They wanted to understand its origin, prevention and treatment. These women were approximately 90 years ahead of the Centers for Disease Control and Prevention's decision to accept violence as a public health problem. In 1909, these foresighted women created the Juvenile Psychopathic Institute and hired a neurologist, William Healy, M.D., to be its first director. Although a neurologist interested in studying the delinquents' brain functioning and IQ, the perspective of the settlement house's board of directors made sure that attention also was paid to the delinquents' social factors, attitudes and motivations. To accomplish these broad evaluations and treatment strategies, Healy formed teams composed of a neuropsychiatrist, a psychologist and a social worker. This approach became the template used by most child guidance clinics for most of the 20th century. Child psychiatry's roots became implanted in the community, rather than in medical schools, and colleagues were more likely to be teachers, judges, social workers and social scientists, rather than physicians. 

Child guidance clinics blossomed in essentially all U.S. cities during the next two generations. The influence of European child psychoanalysts such as Hermine Hug-Hellmuth, Anna Freud and Melanie Klein became pervasive in this country. In the 1920s, Americans went abroad to study, and during the 1930s and 1940s, many psychoanalytically minded clinicians immigrated to the United States to escape religious persecution. Many, if not most, of these clinicians were women.

At the edges of the dominant psychodynamic and psychosocial viewpoints were organic psychiatry and behaviorism. Organic, or biologic, psychiatry was widely considered a failed pathway espoused by forgotten old men near retirement age. Behaviorism became popular in academic psychology, with John Watson and B.F. Skinner being articulate advocates. However, translations of strict academic behavioral paradigms to clinical use mainly failed. The majority of clinicians believed the behaviorists were so narrow and dogmatic that the "whole child" was lost. Anna Freud's 

, first published in German in 1936 and in English in 1946, and the first edition of 

 by Leo Kanner, M.D., in 1935 were very influential. Kanner took the name from the German term 

While it might seem curious, World War II helped child psychiatry in a number of ways. Because of the huge military draft, background histories were available for hundreds of thousands of late adolescents and young adults with varied backgrounds and socioeconomic levels--rich, poor, white, African-American, educated, uneducated, urbanite and farmer. By the end of the war, it was obvious that soldiers who had behavior problems as children were much more likely to be prematurely discharged, disciplined, wounded or killed. It was a statistic that could not be ignored. 

On July 3, 1946, President Harry Truman declared war on mental illness when he signed the National Mental Health Act. Three years later, the National Institute of Mental Health was born. Prevention was an important goal and the quality of mothering was considered key. Women's magazines cropped up like mushrooms. If mothers failed, professionals were needed to be available to intervene. A cadre of experts was building. Increasing numbers of trained psychiatrists spilled over into a greater number of child psychiatrists. At the same time, many pediatricians found that the new antibiotics made their specialty consist largely of well child care. Some found this boring. Federal training funding became available to convert pediatricians into pediatric psychiatrists.

The American Academy of Child Psychiatry was founded in 1953. It was preceded by two organizations interested in children's mental health. One such organization, the American Orthopsychiatric Association (AOA), was formed in 1924. It was multidisciplinary, and its main focus was prevention. Politically, members often leaned to the left and tended to view diagnoses as hurtful labels. In 1948, 54 child guidance clinics created an organization of clinics. The foci of this group, the American Association of Psychiatric Clinics for Children (AAPCC), were to develop standards for clinical care and for training. Before child psychiatry residencies, the gold standard credential for child psychiatry was an AAPCC certificate of training.

The movement toward subspecialization picked up speed in 1943 when the American Psychiatric Association converted its section on Mental Deficiency to the Section on Child Psychiatry. Six years later, the Section was elevated in status to the Standing Committee on Child Psychiatry. In 1947, the Group for the Advancement of Psychiatry appointed a Committee on Child Psychiatry. In 1951, the presidents of AAPCC and AOA--George Gardner, M.D., and James Cunningham, M.D.--called together 17 psychiatrists who worked with children to discuss the formation of a separate organization for child psychiatrists. The following year, 96 psychiatrists met in Atlantic City, N.J. They agreed to form the American Academy of Child Psychiatry (AACP) and have membership by invitation only. There were 107 charter members. Subsequent members were required to have three member sponsors and American Board of Psychiatry and Neurology (ABPN) certification. Members applying were also required to have made an "outstanding contribution to the field of child psychiatry," as reflected by unanimous approval by the AACP Council and a two-thirds majority of the members. (The requirements have changed; for more information, please visit <www.aacap.org/membership/joinaacap.htm>.)

In 1948, Frederick Allen, M.D., proposed that child psychiatry be recognized by the ABPN; however, nothing came of his proposal. Although some child psychiatrists favored an autonomous specialty, similar to pediatrics' break from internal medicine, this did not seem feasible. There was some debate as to whether the new specialty would be pediatric psychiatry or child psychiatry, but a vote by AAPCC clinic directors overwhelming favored a link to psychiatry rather than to pediatrics. 

In 1958, six child psychiatrists met with the ABPN's president and secretary to discuss the possible particulars for a new psychiatric discipline. There was agreement on a two-year child psychiatry residency, with the option to replace the third year of general psychiatry residency with the first year of child psychiatry training. The subspecialty was approved in February 1959. As a result, a six-person ABPN Committee on Certification in Child Psychiatry was formed. The American Board of Pediatrics (ABP), through the American Board of Medical Specialties, demanded that there always be an ABP non-voting observer on the committee to ensure that the ABPN treated child psychiatry right, and an ABP observer remains today. About 160 clinicians were grandfathered into the subspecialty. 

The first certifying exam was in the form of essay questions. The committee found them impossible to grade, so it announced there would be a follow-up oral examination. There are those today who are still hot with anger about first missing the cut to be grandfathered, then taking the essay exam, and then being forced to take a not previously announced oral exam. Nonetheless, in April 1960, 101 candidates passed the first child psychiatry boards. Also in 1960, the Accreditation Council for Graduate Medical Education's Residency Review Committee (RRC) in Psychiatry approved 11 child psychiatry residency programs. The stipulation that child psychiatry residencies must be linked to psychiatry residencies and that these must be linked to medical centers was an occurrence of extreme importance. It forced child psychiatry, sometimes kicking and screaming, from community child guidance centers to hospitals and medical schools. In my opinion, this saved child psychiatry from being marginalized. If it had not been pulled into medicine, it would have been replaced by a new iteration born in medicine.

During the 1960s, the AACP struggled with its identity. 

The Journal of the American Academy of Child Psychiatry

 was launched in 1962, granting the field its own publication. However, as more and more clinicians were trained and certified, they wanted to have an organization of their own. Regional organizations formed, and there was the beginning of a push for an open, not invitation-only, national association. The AACP, after much debate and a 176-11 vote, opened its organization in 1969 to include members on the basis of their practice and training in child psychiatry (Bemman, 1970). That year, its membership tripled from 218 to 688.

Although leadership of the American Psychiatric Association was ambivalent about this somewhat unexpected "child," in 1969, then Medical Director Walter Barton, M.D., offered rental space in the APA building, and eight file drawers of records were moved in. In 1973, Virginia Anthony was hired and she remains the academy's executive director. In 1983, the academy published 

Child Psychiatry: A Plan for the Coming Decades

. It was the summary of five years' work by 100 consultants to, and members of, six task forces. These were not only child psychiatrists, but also included nationally known general psychiatrists; pediatricians; deans; professors of epidemiology, nursing, psychology and law; leaders of the NIMH; and various child advocates. Recommendations were made for man power, clinical service delivery and training; the most important recommendation, however, was the challenge to develop research strategies that would allow data-based understanding and treatment of the mental illnesses of children. While child psychiatry had long gathered anecdotal data, particularly about social and psychodynamic influences, it was 10 years behind general psychiatry in biological and epidemiological research. Indeed, this document changed the field.

In the past 20 years, there has been a steady increase in residents who choose child psychiatry, and academy membership now numbers almost 7,000. In 1986, the academy voted to expand its name to the American Academy of Child and Adolescent Psychiatry and within a few years, this expansion was approved by the ABPN and the Psychiatry RRC.

Besides its journal, the AACAP has published books, both for professionals and the laity, approximately 50 policy statements and over 200 "Facts for Families." The latter are available to families and are printed in English, French, Spanish, German, Polish and Icelandic. The AACAP collaborates closely with the APA, the American Academy of Pediatrics and other organizations in regard to clinical, policy and research issues. During the past decade, the academy was awarded funding from both the NIMH and the National Institute on Drug Abuse to oversee five-year K-12 training grants for young investigators in child and adolescent psychiatry.

During the past 50 years, evolving interest in and understanding of developmental psychopathology have shown how intertwined developmental stages are for patients' diagnosis and treatment. In the decades to come, genetics, neuroimaging and other new techniques will not only affect our work with children, but also determine the type and number of professional organizations that will be needed to treat children and adolescents with mental illnesses.

AACP (1983), Child Psychiatry: A Plan for the Coming Decades. Washington, D.C.: American Academy of Child Psychiatry.
 

Bemman S (1970), Epilogue and a new beginning. J Am Acad Child Psychiatry 9(2):193-201.
 

Freud A (1946), The Ego and the Mechanisms of Defense. New York: International Universities Press Inc.
 

Kanner L (1935), Child Psychiatry. Springfield, Ill.: C. C. Thomas.
 

Schowalter JE (1994), The History of Child and Adolescent Psychiatry. In: Psychiatry, vol. 2, Michels R, Cooper A, Guze S et al., eds. Philadelphia: JB Lippincott, pp1-13.
 

Schowalter JE (2000), Child and Adolescent Psychiatry Comes of Age. In: American Psychiatry After World War II (1944-1994), Menninger R, Nemiah J, eds. Washington, D.C.: American Psychiatric Press, pp461-480.

The American Academy of Child & Adolescent Psychiatry will hold its 50th anniversary meeting in October, but the field can trace its U.S. origins to Chicago in 1899. Learn how the specialty has developed over the years in this historical essay.

A History of Child and Adolescent Psychiatry in the United States

A clinical trial of olanzapine (Zyprexa) to determine whether early intervention can delay or prevent onset of psychosis in prodromally symptomatic patients is underway (McGlashan et al., 2003). Prevention Through Risk Identification Management and Education (PRIME) is being conducted at four sites: Yale University; the University of North Carolina at Chapel Hill; the University of Toronto; and Foothills Hospital, Calgary, Alberta, Canada.

Although a prodromal phase of psychotic illness is usually recognized in retrospect after the first psychotic break, study investigators have employed new criteria to diagnose and treat prodromal patients. Sixty study subjects were identified through responders to advertisements about mental illness development or through referrals from practitioners and health services receiving study recruitment materials on early intervention.

The PRIME study is the first randomized, double-blind, placebo-controlled trial of an atypical antipsychotic in this newly defined clinical population. The study incorporates long-term phases with and without medication to ascertain rate of psychotic-onset conversion in this population, as well as the safety and efficacy of antipsychotic intervention at this stage of illness development.

"Whereas the idea is not new, several recent developments have made early intervention research feasible, ethical and compelling," observed lead investigator Thomas McGlashan, M.D., and colleagues (McGlashan et al., 2003).

There are indications that early antipsychotic treatment administered before (Falloon, 1992; McGorry et al., in press) or soon after psychotic onset (Lieberman and Fenton, 2000) can heighten treatment response and produce better long-term outcome. Although there have not been controlled trials, treatment in the prodromal phase has appeared to exert some preventive effect (McGorry et al., in press).

The development of atypical antipsychotics has also provided opportunity for safer early intervention, in the assessment of the investigators. Although acknowledging such side effects as weight gain and somnolence, McGlashan and colleagues consider the risks of acute adverse reaction to atypical antipsychotics in the prodromal phase to be lower than that with older agents. There remains, however, the particular hazard in attempting pre-emptive, preventive medication treatment in patients who may be incorrectly diagnosed as prodromal.

"While these risks accompany any treatment study of neuroleptics in schizophrenia," McGlashan and colleagues (2003) noted, "they are magnified in prodromal intervention because such samples may contain people who are false positive prodromals who are exposed to the risks, but not necessarily the benefits of diagnosis and antipsychotic treatment." 

An accurate method of identifying and rating symptoms of the prodromal syndrome was essential, then, for early intervention research to progress. The Scale of Prodromal Symptoms (SOPS) developed by McGlashan and colleagues (2001) provided a six-point scale and anchoring criteria for rating five attenuated positive symptoms, four disorganization symptoms and four general symptoms. The SOPS is distinguished from other scales of psychotic illness severity by having greater sensitivity for subpsychotic or attenuated symptoms.

The PRIME investigators embedded the SOPS rating scale into the diagnostic interview format of the Structured Interview for Prodromal Syndrome (SIPS) (Miller et al., 2002b). With this interview process, investigators could assess positive symptoms of the SOPS, employ the Global Assessment of Functioning (GAF) scale and obtain family history of mental illness. These assessments were then applied against the Criteria of Prodromal Syndromes (COPS) to classify patients into three high-risk prodromal subgroups having, respectively, genetic risk and deterioration state, attenuated positive symptom state, or brief intermittent psychotic state. These classifications have previously been reported predictive of psychosis onset within one year (Yung and McGorry, 1996).

To establish rate of psychosis development as well as treatment efficacy in this population, a final scale was developed to define onset of psychotic symptoms or "conversion" from the prodromal phase. The Presence of Psychosis Scale (POPS) marks onset by the presence of positive symptoms at the psychotic level of intensity and of sufficient frequency and duration (McGlashan et al., 2003).

The investigators have reported the SIPS to have high interrater reliability and predictive validity (Miller et al., 2002a; Miller et al., 2002b). Across study sites, patients meeting prodromal criteria experienced psychotic onset at a rate of between 36% and 54% within one year. Most patients converted within the first six months of baseline assessment. This indicated that the instruments and criteria were useful in identifying patients in the late prodromal phase of their illness: "The results support the validity of these criteria as defining prodromal states that mark high imminent risk for psychosis" (McGlashan et al., 2003).

During the study, following screening and baseline assessment, patients are randomized to double-blind, one-year tracks of olanzapine 5 mg/day to 15 mg/day or placebo. Psychosocial interventions are available, but vary in nature across study sites from a problem-solving training approach, to psychoeducation on symptoms and medications, to stress management.

Patients are followed for an additional year after medication or placebo is discontinued. At the end of this second year, if they have not manifested psychosis, patients are triaged to appropriate non-study clinical oversight. If psychotic symptoms emerge in this period or earlier, patients are entered into a six-month rescue phase with open-label olanzapine 5 mg/day to 20 mg/day. A third one-year follow-along phase is open to completing patients and to those who have discontinued the study but wish to maintain contact. The open inclusion is intended to facilitate determining the rate of psychotic conversion among these patients with putative prodromal syndrome.

The study population is described in detail in a separate report (Miller et al., 2003). Each patient had some form of psychiatric contact prior to entering the study. Antidepressants were the most frequently prescribed psychiatric medication class, with approximately 40% of the patients reporting their use. All patients who had received antidepressant treatment had discontinued the medication prior to the study baseline evaluation due either to lack of effect or to becoming more symptomatic and/or functionally compromised while taking the medication.

The investigators noted, however, that the level of affective symptoms was not high at enrollment. They speculated that the antidepressant treatment could have served to screen out patients whose symptoms were prodrome of affective rather than psychotic illness. "It may be that we see prodromally symptomatic people for whom antidepressant treatment has not worked because the underlying pathophysiology is not affective in nature," they indicated. "Treatment with antidepressant, in a sense, triages patients with primary affective disorders to a different path" (Miller et al., 2003).

Most patients (93%) met criteria for the attenuated positive symptom prodromal state. Ten of these patients also met criteria for genetic risk and deterioration state, along with three others in this category. No patients were found with brief intermittent psychotic state. 

Although the severity of psychiatric symptoms generally did not exceed the level measured with SOPS, the GAF scores reflected substantial functional disability; with a 15-point loss of functional capacity in the year prior to contacting the study clinic. "This is a population that is clearly disabled despite a relative quiescence of symptomatic expression," the investigators observed (Miller et al., 2003).

This finding was consistent with Miller and colleagues' review of the literature, which indicated that prodrome symptoms ultimately emerge alongside functional decline (Davidson et al., 1999; Maurer and Hafner, 1995). "The prodromal phase appears to start with loss of complex instrumental capacities such as social and intellectual functioning," the investigators noted. "Symptom formation usually follows such developments, first with symptoms that are negative and/or affective, then with symptoms that are positive" (Miller et al., 2003).

The principal question posed in the PRIME study--whether early antipsychotic intervention can delay or prevent psychosis onset--will likely be broadened to consider whether such intervention improves level of functioning. These results probably comprising patients in late prodrome, given the high levels of functional disability, will also beg the question of whether, given sufficient diagnostic criteria, there would be additional benefit of intervening in early prodrome.

Davidson M, Reichenberg A, Rabinowitz J et al. (1999), Behavioral and intellectual markers for schizophrenia in apparently healthy male adolescents. Am J Psychiatry 156(9):1328-1335 [see comments].
 

Falloon IR (1992), Early intervention for first episodes of schizophrenia: a preliminary exploration. Psychiatry 55(1):4-15 [see comments].
 

Lieberman JA, Fenton WS (2000), Delayed detection of psychosis: causes, consequences, and effect on public health. Am J Psychiatry 157(11):1727-1730 [see comments].
 

Maurer K, Hafner H (1995), Methodological aspects of onset assessment in schizophrenia. Schizophr Res 15(3):265-276.
 

McGlashan TH, Miller TJ, Woods SW et al. (2001), A scale for the assessment of prodromal symptoms and states. In: Early Intervention in Psychotic Disorders, Miller TJ, Mednick S, McGlashan TH et al., eds. Boston: Kluwer Academic Publishing, pp135-150.
 

McGlashan TH, Zipursky RB, Perkins D et al. (2003), The PRIME North America randomized double-blind clinical trial of olanzapine versus placebo in patients at risk of being prodromally symptomatic for psychosis. I. Study rationale and design. Schizophr Res 61(1):7-18.
 

McGorry PD, Yung AR, Phillips LJ et al. (in press), Can first episode psychosis be delayed or prevented? A randomized controlled trial ofinterventions during the prepsychotic phase ofschizophrenia and related psychosis. Arch Gen Psychiatry. 
 

Miller TJ, McGlashan TH, Rosen ML et al. (2002a), Diagnosis and symptom assessment in theschizophrenia syndrome. 82B. Presented at the 155th Annual American Psychiatric Association Meeting. May 23; Philadelphia.
 

Miller TJ, McGlashan TH, Rosen JL et al. (2002b), Prospective diagnosis of the initial prodrome for schizophrenia based on the Structured Interview for Prodromal Syndromes: preliminary evidence of interrater reliability and predictive validity. Am J Psychiatry 159(5):863-865.
 

Miller TJ, Zipursky RB, Perkins D et al. (2003), The PRIME North America randomized double-blind clinical trial of olanzapine versus placebo in patients at risk of being prodromally symptomatic for psychosis. II. Baseline characteristics of the "prodromal" sample. Schizophr Res 61(1):19-30.
 

Yung AR, McGorry PD (1996), The initial prodrome in psychosis: descriptive and qualitative aspects. Aust N Z J Psychiatry 30(5):587-599.

Can olanzapine (Zyprexa) delay or even prevent psychosis in patients with prodromal symptoms of schizophrenia? A new study being conducted in four research centers in North America is attempting to answer that question. Prevention Through Risk Identification Management and Education (PRIME) uses several new scales developed specifically for this study to identify and rate symptoms of prodromal symptoms to assist in early intervention research.

Antipsychotic Tested in 'Prodromal Syndrome'

The right of consent, which gives individuals the power to keep personal health information private, has always been recognized under state law and has always been strongly upheld by state and federal courts. When President Bush made the Health Insurance Portability and Accountability Act (HIPAA) the law of the land in April 2001, the Privacy Rule gave every American the federal right to consent to the release of their medical records.

Originally, the HIPAA Privacy Rule did in fact protect every citizen's right to medical privacy, and Bush was lauded as the Privacy President. But behind the scenes, powerful corporate interests worked to turn it into its polar opposite, a "disclosure rule." The Bush Administration opened the door so that the hospital and insurance industries could amend the privacy regulations. Distracted by war, we missed completely the elimination of our precious constitutional right to privacy, the right to be let alone, as the so-called Privacy Rule went into effect.

A massive campaign of disinformation has led the media and public to blind acceptance of the Administration's claims that HIPAA will increase medical privacy protections. In actuality, the amendments to the HIPAA Privacy Rule surgically excised every citizen's right of consent to release their medical records and replaced it with a new doctrine of federal "regulatory permission" (67 Fed. Reg. 53,182, Aug. 14, 2002). This new right of access given to over 600,000 "covered entities" and their innumerable "business associates" allows them to access every American's cradle-to-grave medical records without consent, without notice and without recourse. It is unlikely that any identifiable health information, past or future, will be immune from use and disclosure under this new standard. This technical exception, embedded deep in the several-inch-thick Rule, created a loophole the size of Texas that insurers, employers, banks, state and federal agencies, and all their "business associates" can drive through with truckloads full of medical records. (Final modifications to the Privacy Rule, in the Aug. 14, 2002, 

 and the Complete Privacy Rule Text, as modified Oct. 10, 2002, are available at <www.hhs.gov/ocr/hipaa/finalreg.html>.)

The loss of meaningful consent for patients will have far-reaching consequences for medical care in the United States. These consequences have yet to be understood by most physicians, not to mention the public, the media or arguably even the promulgators of this impending disaster. Even if treatment is paid for out-of-pocket or an individual never has another contact with the health care system, their personal health information may now be accessed. The amendments to the HIPAA Privacy Rule grant breathtakingly broad and unprecedented powers to both private corporations and government entities to collect and amass the individual medical data of every person in the United States. Never in history has such a crucial right been eliminated for every member of the population.

The loss of consent will insidiously yet radically alter the physician-patient relationship and destroy the trust that patients must feel to share sensitive and painful medical and mental health information with all health care professionals.

Will there be a physician or patient or consumer-led uprising? Not necessarily. But there will inevitably be a profound shift in patient behavior. People refuse treatment when they believe their diagnosis or prescription records will be seen by employers, insurers and bankers and used to discriminate against them. When patients realize neither they nor their doctors have the right to stop the flow of sensitive medical information out of doctors' offices and other treatment sites, they will fight back. Patients will begin to avoid or leave doctors and hospitals that use their medical records without permission. They will avoid treatment for as long as possible, they will omit sensitive information, or they will provide false information to try and protect themselves.

The elimination of the right of consent will provide fertile ground for a black market in private medical treatment for those who can afford it. The only other guarantee of medical privacy will be to get treatment under an alias. If the doctrine of federal "regulatory permission" is not reversed through litigation or legislation by the U.S. Congress, the currently existing stronger protections for medical records in the states will likely be eliminated in order to bring state laws into conformity with HIPAA. Powerful industries that profit from access to identifiable medical information will introduce legislation in every state to eliminate consent and conform with the limitless disclosures allowed under HIPAA. This has already happened in Texas and Oregon.

Understandably, physicians and patients have been focusing almost exclusively on the hassles and bureaucratic forms required to comply with HIPAA. But the loss of the right of consent in the new Privacy Rule imposes several subtle and several more obvious problems and potential conflicts on every part of the system. While the federal Privacy Rule requires "covered entities" to fully inform patients of their rights under state and common law, this is just not being done. The privacy notices being given to patients across the nation are not only defective, misleading and inadequate, but illegal.

Federal regulations provide the floor for patient privacy, not the ceiling. The Rule still requires providers to give patients notice about how to utilize the greater medical privacy protections contained in state laws. It further specifies that health care professionals should continue to use and follow the longstanding professional codes of ethics for their field or specialty and should develop privacy policies and notices in accordance with these traditional ethical principles. Yet HIPAA legal experts have simply not advised providers of the full extent of their legal and ethical obligations under the Privacy Rule.

Privacy notices typically imply that patients have lost the right of consent, in flagrant violation of the core ethical principle of every medical and health profession. What does your privacy notice say? Does it cite the American Psychiatric Association and American Medical Association (AMA) Codes of Medical Ethics on the right of consent? Most privacy notices do state that patients have the right to request a consent process; but under the federal Privacy Rule, providers have no obligation to provide one. Although privacy notices are required to inform patients that more stringent state laws and medical ethics governing the right of consent actually prevail over the federal Privacy Rule, I have yet to find a single privacy notice that does that.

As a matter of record, defective privacy notices are part of the basis for a lawsuit filed against the U.S. Department Health and Human Services (HHS) on April 10, 2003, in federal district court in Philadelphia. The lawsuit was filed on behalf of the American Psychoanalytic Association and 15 other health and advocacy organizations and individuals. Its main purpose is to overturn the amendments to HIPAA and restore the right of consent (see 

Citizens for Health et al. v Tommy G. Thompson, Secretary, US Dept of HHS

, CA No. 03-2267 [E.D. Pa.]). The lawsuit cites three typical "privacy notices" from national corporations that did not advise patients of the existence of more stringent state and common laws governing medical privacy, did not advise patients about ethics governing medical privacy, and also failed to inform them about how to exercise their rights under state laws. For example, a privacy notice that states "stricter state laws may provide greater protections for people with HIV or AIDS" is totally inadequate. Surely HHS did not intend for each citizen to be forced to become an expert on the medical privacy statutes in their state.

Many hospitals and academic institutions view the right of consent as inefficient, or as a barrier or impediment to treatment or research, rather than viewing the body of laws and ethical principles as necessary and important conditions of effective treatment. But psychiatrists know from direct experience just how far many parents and patients will go to protect their children or their jobs, and to hide or omit information to keep others from knowing intimate personal or family secrets. Our patients will not share any sensitive information at all if they believe it can be accessed by anyone other than the person who is treating them.

The U.S. Supreme Court recognized that effective psychotherapy cannot exist without the guarantee of absolute privacy. In 

 (No. 95-266 [1996]), the justices rejected any balancing test to weigh the needs of private individuals or entities against the right of patients to have privacy. The court noted that it was in the best interests of the nation to have effective psychotherapy available for citizens, so they affirmed the absolute right to privacy of the communications between patient and psychotherapist by recognizing a federal therapist-patient privilege.

Advocacy for patients and protection of patient privacy are core ethical principles for physicians and most health professionals. Therein lies the moral and ethical guidance our nation needs. Section III in the Preamble of the AMA Principles of Medical Ethics (2001) affirms the physician's role as an advocate for patients, stating, "A physician shall respect the law and also recognize a responsibility to seek changes in those requirements which are contrary to the best interests of the patient." Section IV in the Preamble states, "A physician shall respect the rights of patients, colleagues, and other health professionals, and shall safeguard patient confidences and privacy within the constraints of the law." Both principles are incorporated into the Principles of Medical Ethics of the APA.

Here are some tangible steps you can take to safeguard patient privacy, advocate for the best interests of patients and inform the public:

Ask groups and individuals to support the federal lawsuit to restore the right to consent.

 Contributions can be made to help pay the costs of litigating the lawsuit. Tax-deductible checks can be sent directly to the Appeal for Privacy Foundation, P.O. Box 248, Austin, TX 78767.

 If they do not tell patients the steps they can take to protect their medical records under state laws and medical ethics, they are illegal. Ask your HIPAA expert to prepare privacy notices that follow the law.

Keep abreast of national efforts to protect medical privacy.

 See <www.medicalprivacycoalition.org> and <www.patientprivacy.info> for more information about medical privacy.

Encourage your congressional delegation to co-sponsor or draft other legislation to fix the serious privacy defects in HIPAA.

 Restoring the right to consent is the centerpiece of the bipartisan Stop Taking Our Health Privacy Act, STOHP (HR 1709). Co-sponsors Reps. Edward J. Markey (D-Mass.) and Dana Rohrbacher (R-Calif.) stated:

The purpose of this Act is to restore patient privacy protections essential for the delivery of high-quality health care that were undermined when the medical privacy rule was modified in August 2002. STOHP will restore the core medical privacy protections of the December 2000 medical privacy rule by:

A) Reinstating the patient consent requirement for treatment, payment and health care operations.

B) Returning to the 2000 definition of and thus ensuring that activities typically considered 'marketing,' such as drug companies paying pharmacies to send product recommendations to patients, fall under the rule's privacy protections governing marketing activities.

C) Eliminating the broad 'public health' loophole created by the August 2002 rule.

No single approach to medical privacy can preserve such an important individual right. When the privacy rights of individuals are pitted against corporations and governmental agencies that want unfettered access to the most valuable personal information that exists, eternal vigilance is the only effective response.

 American Medical Association (2001), Principles of Medical Ethics, Preamble, Section 3. Available at: 

www.ama-assn.org/ama/pub/category/4256.html

 Citizens for Health et al. v Tommy G. Thompson, Secretary, US Dept of HHS, CA No. 03-2267 (E.D. Pa.).

Initially, it seemed that the privacy rule for HIPAA would protect patients' privacy, but in reality it has opened the door for insurance companies and hospitals to view private health care information. How can physicians and patients protect their privacy from further erosion?

Psychiatric Times Vol 20 No 9

Awareness Campaign for Parental Depression Launched

Using CBT in the Treatment of Social Phobia, Separation Anxiety and GAD

A History of Child and Adolescent Psychiatry in the United States

Antipsychotic Tested in 'Prodromal Syndrome'

Guest Editorial: The Loss of the Right of Consent