Research on a Children's Psychiatric Inpatient Service

Research on a Children's Psychiatric Inpatient Service MARK A. RIDDLE, M.D. Abstract. It is widely recognized that child psychiatry needs to expand its research enterprise. Psychiatric inpatient units that serve children and adolescents should serve important roles in clinical research in child psychiatry. This paper reviews the need for research on the nature and treatment of psychiatric disorders on children's psychiatric inpatient services and discusses the resources necessary for a productive inpatient research program. The intrinsic relationship between clinical care and clinical study is emphasized. J. Am . Acad. Child Adolesc. Psychiatry, 1989,28 , 1:42-46. Key Words: inpatient, research program, clinical care. The need for more research in the area of child mental health is now widely recognized (American Academy of Child Psychiatry, 1983; Wiener, 1988). One of the sites for child mental health research has been psychiatric inpatient units. With the exception of a few units designated for research (e.g., the unit at the Child Psychiatry Branch of the Intramural Program of the National Institute of Mental Health), this work has been carried out in units whose primary mission is to provide clinical service to children and adolescents with severe mental disorders. Performing research in a setting dedicated to clinical care presents special challenges and opportunities. The purpose of this paper is to examine the ingredients necessary for a successful research program in a clinical inpatient unit, the potential obstacles to a research effort, and the types of studies that are most likely to provide significant and clinically-useful knowledge. Much of the material for this paper comes from the author's experience in developing a clinical research program in a 15-bed children's psychiatric inpatient unit located in a major medical center hospital (see Woolston, 1989), (in this special section] for a description of this unit and from discussions with child psychiatrists who direct units in other medical centers. Many of the strategies outlined in this paper will be familiar to those working in inpatient units. Nevertheless, very little has been written about this topi c; a computerized literature search of the past five years failed to produce a single article devoted specifically to strategies for conducting research in clinical inpatient units for children.

proved clinical care and will make it easier for children to achieve their developmental potentials. Developing such a shared value is not necessarily easy. For example, given the minute-to-minute demands of clinical work with severely behaviorally disturbed children, supporting the research effort (e.g., filling out a clinical rating instrument or collecting a 24hour urine specimen) may be difficult if the clinical staff does not believe that children will ultimately benefit from the research. Another problem has to do with the focus of the work; much of the clinical care focuses on the individual child and family, while most research examines groups of children. The primary goal of a clinical service is to provide quality clinical care. The most valued outcome of clinical care is clinical improvement in the individual patient. The most valued outcome of research is increased knowledge. Unless the goal of the research efforts on a clinical service is to ultimately improve clinical care, these two valued outcomes can be incompatible. Failure to maintain clarity about the relative importance ofeach goal can lead to multiple obstacles to attaining either goal (Newton and Levinson, 1973; Reich and Weiss, 1975). When the goal of a particular research project is not related to improved clinical care, the research goal becomes secondary. Therefore, research studies lacking clinical relevance are rarely completed in clinical units. Much traditional research in child psychiatry has focussed on some aspect of a specific disorder, such as attention-deficit hyperactivity disorder (ADHD) or autism. Working in this "disorder specific" tradition, clinical researchers have generally wanted to study homogeneous groups of children. In addition to the disorder, this homogeneity has included developmentallevel, a specific symptom profile, socioeconomic status, or some combination of these or other variables. In contrast to this research wish for homogeneity, the clinical reality on most inpatient services is that the population is heterogeneous; although most clinical services have some exclusion criteria, children generally are admitted if their behavior is considered sufficiently disruptive in their family or community. Thus, children with mixed disorders and multiple diagnoses, and with diverse socioeconomic back grounds are admitted to inpatient services. If research on an inpatient setting is to be valued, it is important that the study ofthis heterogeneous group ofchildren be considered a worthwhile endeavor. The potential studies suggested below were selected because the research questions they address are well suited for heterogeneous populations. Clinical work in an inpatient unit requires the coordinated effort of multiple disciplines. Each discipline may also contribute uniquely and substantially to the research effort . A

The Ingredients

The Research Value The cornerstone of a successful research program is a shared value among the staff that new knowledge will lead to imAccepted September 13, 1988. From the Child Study Center, the Children's Clinical Research Center, and the Departments of Psychiatry and Pediatrics. Yale University School ofMedicine, New Haven. Connecticut. This work received generous support from the Leon Lo wenstein Foundat ion. Research Resources Grant RR·00125 from the National Institutes ofHealth, Clinical Research Center Grant MH-30929 from the National Institute of Mental Health. and Grant HD-03008 from the National Institute ofChild Health and Human Development. The author thanks Joseph L. Woolston. M .D., James F. Leckman , M.D ., John E. Schowalter, M.D. , and Donald J. Cohen, M.D. for their valuable comments and suggestions. The staffofthe Children's Psychiatric Inpatient Service, Yale-New Haven Medical Center provided many ofthe ideas for this paper. 0890-8567/89/280 1-0042$02.00/0© 1989 by the American Academy of Child and Adolescent Psychiatry. 42

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shared research value may be most beneficial when issues arise regarding discipline-specific roles and rewards or the wish of a particular discipline to have sole responsibility for a research area. Although some interdisciplinary rivalry is inevitable, it can be minimized if there is a commonly held set of research goals and values among disciplines. Ideally, research questions will emerge from the ongoing clinical work. One example involved a series of referrals of children with ADHD who also had tic symptoms that were exacerbated by treatment with stimulant medications. Despite multidisciplinary clinical interventions, these children continued to exhibit symptoms of distractibility and hyperactivity that warranted a trial of medication. Because recent studies (Donnelly et al., 1986; Biederman and Wright, 1987) had shown that desipramine was effective in children with ADHD without tics, a trial of desipramine was initiated in this series of children with ADHD with tics (Riddle et al., 1988). In general, this new intervention was found to be safe and effective, and it is referred to by the staff of the unit as an example of how simple, straightforward research projects can directly benefit patients. Another study was designed in response to the need for a reliable and valid, yet inexpensive, method for screening children for possible speech, language, and/or hearing deficits. Many children referred for inpatient psychiatric treatment have multiple deficits, including communication problems. Establishing the optimal threshold for referral of such children for speech and language and audiology evaluation (which requires considerable time of a highly trained professional) is difficult. On the one hand, the threshold needs to be low enough so that children who have identifiable deficits are referred for extensive evaluation. On the other hand, the threshold needs to be high enough so that the number of children referred for comprehensive assessment who turn out not to have significant deficits remains relatively small. In response to this problem a simple screening procedure that can be administered by a staff nurse was developed and is administered to all children admitted to the unit. The ability of this screening procedure to accurately identify children for referral who are subsequently found to have significant deficits is being assessedin an ongoing research project.

Research Leadership A common strategy in inpatient services is to designate one individual as the leader or "coordinator" of research. To be effective, the research coordinator needs to occupy a significant position within the administrative hierarchy of the inpatient unit and to have strong ties to the research community within the division or department of child psychiatry. Structurally, there are several ways to accomplish these goals. Perhaps the most common is to have the director of the unit also serve as coordinator of research. The obvious advantage of this approach is that one individual can manage both the clinical and research efforts, minimizing the potential for conflict between the two. A disadvantage is that a Herculean effort is usually required to manage both the complicated clinical care and complex administrative issues involved in inpatient work with children and families, in addition to managing the administrative as well as scientific issues involved in coordinating research.

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An alternative approach is to distribute the leadership and responsibilities between two individuals, a director and an associate director. One can be primarily responsible for the clinical program and the other for the research program. To be successful, this structure requires that the director empower the research coordinator and provide the resources necessary to develop a research program. The director starts this process by demonstrating to the staff the importance that he/she places on the research effort. This may be accomplished by continually pointing out how the results of research studies have changed evaluation procedures or affected treatment decisions. The success or failure of both the clinical and research efforts on an inpatient unit is highly dependent on the active involvement of the nursing staff. Thus, it is critical to the research effort that the head nurse be actively involved in all research decisions that have an impact on the quality of clinical care and/or the roles and responsibilities of the nursing staff. Individual nurses may wish to provide leadership around the collection of clinical data for specific projects.

Research Resources Research requires resources. To test a hypothesis or answer a question it is necessary to develop a research plan, recruit subjects, collect data , assemble and analyze the data, and prepare manuscripts and presentations that describe the results. Perhaps the most difficult task in any research effort is assembling the resources necessary to carry out these tasks. Some resources for research on an inpatient setting may not require outside support . This is especiallytrue in the area of data collection. Much of the systematic data (e.g., psychoeducational testing, symptom ratings, diagnostic assessments) that are collected during a comprehensive inpatient evaluation of a child can be used for research purposes. For some studies, recruitment of subjects may not require additional effort since the research population and clinical populations overlap. Obviously, if information is being collected primarily for research purposes, informed consent must be obtained from the child's parent or guardian and assent to the procedure should be granted by the child. Some resources may be utilized that are available elsewhere in the institution with which the inpatient unit is affiliated (e.g., the division of child and adolescent psychiatry or department of psychiatry). Examples include office space and supplies for research personnel, consultation with experts in research design and statistical analysis, and access to computers. Investigators who are interested in using data generated in an inpatient unit are often willing to exchange these types of resources for access to the data. Other essential resources for research are not generally available in a clinical inpatient service. These includes salary support for: (1) the research coordinator's research time; (2) personnel to collect, manage, and analyze data; and (3) a secretary. Without such personnel very little substantive research can be accomplished. Traditionally, clinical services have been supported by revenues generated from billing patients for services rendered while research has been supported by grants from private and public sources. Another strategy for generating research resources would be to designate a certain percentage of revenues

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for research. This is a standard practice of most successful businesses.Many manufacturers (e.g., pharmaceuticals, computers) depend on their research divisions (which are supported by revenues generated from the sale of products) for the development of more effective and efficient products. Perhaps research efforts designed to assess (and ultimately improve) the quality and efficacy of inpatient treatment programs would be best suited for funding from the revenues generated through patient billing. This strategy would be easiest to justify for research related to quality assurance, which is already considered a legitimate expense in modem hospitals. It may be difficult, however, to obtain necessary approval to allocate clinical revenues for the support of other research projects from state and federal regulatory bodies, who are especially concerned about cost containment. Professionalsinvolved in the delivery of inpatient treatment to children also may be reluctant to allocate precious financial resources for the purpose of research. Thus, it is important that research projects that can improve the understanding and treatment of children be given highest priority. Potential Projects The purpose of this section is to briefly describe a few examples of research projects that are especially well-suited for the clinical populations served on children's psychiatric inpatient services. These projects were selected because they are generally less affected by the constraints described above than are other potential projects. This is not meant to be a complete review of possible research projects. Instrument Development

One of the advantages of studying children in an inpatient setting is that they can be observed intensively and, if necessary, repeatedly for clinical assessment. This advantage also presents a challenge-how to capture the richness of the clinical information in a meaningful, valid, and reliable way. Many assessment instruments are available to child mental health researchers (Rapoport et al., 1985), but few of them have demonstrated validity and reliability in clinical inpatient settings. Thus, the development and application of rating instruments to this population of severely disturbed children presents a research challenge and opportunity. Development of methods for assessingthe risk factors that contribute to the decision to admit a child is of considerable clinical, social, and economic importance. Repeated assessment of behavioral symptoms in children is essential to research efforts designed to validate diagnoses and evaluate treatment outcome. A recent example of such an effort comes from a study (Kolko, 1988) that examined the psychometric properties, interrater reliability, and some aspects of validity of the Child Behavior Rating Form (CBRF) (Edelbrock, 1985), an instrument designed for staff ratings of individual behavioral and emotional symptoms exhibited by children residing in inpatient settings. The CBRF is modelled after the Child Behavior Checklist (CBCL) (Achenbach and Edelbrock, 1983), a widely studied and used parent-rated instrument for the assessment of symptoms in children. Another example of a rating instrument that deserves study is

the Brief Psychiatric Rating Scale for Children (BPRS-C) (Overall and Pfefferbaum, 1982). In addition to the need for the development of valid and reliable instruments for the daily assessment of symptom severity in children in inpatient settings, valid and reliable methods for establishing diagnoses are also needed. A seemingly natural study would be to compare DSM-III-R (American Psychiatric Association, 1987) diagnoses obtained by structured diagnostic interviews (e.g., DISC-R [Shaffer et al., 1987]) of the child and/or parent(s) with clinical assessment based on all the knowledge obtained regarding the child during the first few weeks of hospitalization. The ultimate goal of such studies would be to develop valid and reliable methods for establishing diagnoses so that valid comparisons of studies performed in different inpatient settings could be accomplished. Phenomenology ofMixed Disorders

Most systematic research in psychiatry focuses on pure, idealized cases. In contrast, inpatient units generally serve children with mixed or multiple disorders of behavior, mood, and cognition. Knowledgeregardingthe phenomenology, natural history, etiology,pathophysiology,and treatment of these mixed disorders is limited. In addition to phenomenologic studies, those described below could be applied to children with mixed disorders. Clinical Psychopharmacology

There is a paucity of well-designed, double-blind, placebocontrolled trials of CNS-active medications in children and adolescents (Campbell and Spencer, 1988). Many of the controlled studies that have been published have been performed in outpatient settings. Thus, child psychiatrists working in inpatient services, where perhaps 50% or more of children receive psychoactive medications, are often required to make clinical decisions despite inadequate scientific information. One might suspect that such a situation would provide fertile ground for the development of clinical psychopharmacology studies. Unfortunately, although the need clearly exists, economic considerations make it difficult to carry out such studies. Generally, third party payers are reluctant to subsidize the treatment of children who are participating in research protocols that involve the administration of placebo medication. Although it may be entirely reasonable (from a scientific and clinical perspective) to administer a placebo during one phase of a trial of a medication whose indications and side effect profile have not been sufficiently established in the pediatric population , it is not an easy task to convince third party payers of the wisdom of such an approach. Inpatient units do, however, provide an ideal setting for other types of pharmacological studies. These include crossover comparisons of two active medications (e.g., methylphenidate vs. desipramine in children with ADHD), placebocontrolled single case studies (Guyatt et al., 1986), and small open-label trials of novel treatment approaches. The clinical trial of desipramine in children with ADHD and tics (described above) is an example of such a study. Another example involves the use of fluoxetine (a new antidepressant medication that does not have cardiac side effects in adults) in the

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treatment of depressed children or adolescents who have intolerable cardiac side effects or an inadequate treatment response on traditional antidepressant medications.

staying on the CRC, this approach has obvious economic advantages. Treatment Efficacy

Neurochemical Studies

Inpatient units are well suited for certain types of neurochemical studies in children and adolescents. The best examples are studies that require a single venipuncture for blood sampling or repeated collection of 24-hour urine specimens in the same subject. Since children admitted to a hospital generally have blood drawn for clinical purposes during the first few days of hospitalization, it is relatively easy to obtain a few additional milliliters of blood for research purposes (provided that informed consent has been obtained from the child's parent or guardian and assent is obtained from the child). An excellent example of this strategy is the series of studies by Rogeness et al. (1988) that involved a single plasma sample that was assayed for dopamine-B-hydroxylase in hospitalized boys with conduct and other disorders. This protocol also included the collection ofthree consecutive 24-hour urine specimens, a procedure that is relatively easy to do in an inpatient setting where patients are available on consecutive days and where nursing staff is available to supervise the collection of the urine specimens. This strategy could also be applied to the study of state regulation and adaptation following admission to the unit. More technically complicated neurochemical studies require additional research resources. For example, a common strategy in neurochemical research is to administer a single dose of a medication with a known and specific mechanism of action. Behavioral and neurochemical measures are collected at multiple time points during several hours before and after the administration of the medication (Young et al., 1987). The goal of this "pharmacological challenge" strategy is to obtain information about the pathophysiology of a particular neuropsychiatric disorder and to delineate relationships between behavioral and specific neurochemical responses. Numerous resources must be dedicated to such a research protocol and include a medically equipped hospital room , a nurse trained in the performance of such studies, and a metabolic kitchen capable of preparing special diets. The resources necessary to support this type of intensive metabolic research are available, for example, at selected medical centers through federally-funded clinical research centers (CRCs). These CRCs have hospital beds and support staff dedicated to clinical research. Some CRCs are designed and staffed for clinical research with school-age children and adolescents. These sites include Baylor University, Columbia University, Cornell University, Harvard University (The Children's Hospital), Johns Hopkins University, University of California (Los Angeles), University of California (San Francisco), University of Cincinnati, University of Colorado, University of Minnesota, Un iversity of Pennsylvania, University of Pittsburgh, Washington University (St. Louis), and Yale University (U.S. Department of Health and Human Services, 1986). At these medical centers, children who are participating in intensive metabolic research studies can be transferred briefly from the clinical unit to the research unit. Because the child's family or third-party payer are not charged while the child is

There is increasing pressure from third-party payers and public sources to decrease the amount of time required to treat hospitalized patients. Two payers in this journal (Harper, 1989; Nurcombe, 1989) propose methods for making inpatient treatment of children more effective and specific. If proposals such as these are implemented in inpatient services, research aimed at assessing the ability of these procedures to reduce length of stay and to effect lasting therapeutic change deserves support. Such research will require considerable resources, which might be generated from an allocation of clinical revenues, as suggested above. Outcome and Prediction ofOutcome Studies

Very little is known about the response to treatment and long-term social and emotional adaptation of children who receive inpatient psychiatric treatment. A recent review (Blotcky et al., 1984) indicates that good prognosis is positively correlated with adequate intelligence, nonpsychotic and nonorganic diagnoses, absence of antisocial features and bizarre symptoms, healthy family functioning , adequate length of stay, and involvement in aftercare. However, the authors recommended caution in the interpretation of these conclusions because of the complex methodological issues involved in outcome research. Perhaps of most concern is the lack of information regarding the relationship between length of stay and outcome-information that may be vital if children's psychiatric inpatient services can expect to be supported at a level necessary to provide the highest quality of care. Conclusion Clinical inpatient services can provide a unique setting for studying children and adolescents with severe neuropsychiatric and psychosocial impairments. Research leadership, values, and resources are the minimal requirements for a successful research program. Certain studies appear to be well suited for the inpatient setting. The ultimate goal of research is to improve the clinical assessment and care of the children and families served by inpatient units. References Achenbach , T. M. & Edelbrock , C. S. (1983) , Manual for the Child Behavior Checklist and Revised Child Beha vior Profile. Burlington, VT: Thomas M. Achenbach. American Academy of Child Psychiatry (1983), Child Psychiatry: A Plan for the Coming Decades. Washington, DC, American Academy of Child Psychiatry . American Psychiatric Association (1987) , Diagnostic and Stat istical Manual ofM ental Disorders, Third Edition , Revised. Washington, DC, American Psychiatric Association. Biederman, J. & Wright , V. (1987) , Desipramine in the treatm ent of children and adolescents with attention deficit disorder. Presented at the New Research Poster Section , 34t h Annual Meeting of the American Academy of Child and Adolescent Psychiatry, Washington , DC. Blotcky, M. J., Dimperio, T. L. & Gossett , J. T. (1984) , Follow-up of children treated in psychiatric hospitals. Am. J. Psychiatry, 141:1499-1507.

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Campbell, M. & Spencer, M. K. (1988), Psychopharmacology in child and adolescent psychiatry. J. Am. Acad. Child Adolesc. Psychiatry, 27:269-279. Donn elly, M.,. Zametkin, A. J., Rapoport, J. L. et al. (1986), Treatment of childhood hyperactivity with desipramine. Clin. Pharmacal. Ther., 39:72-8 I. Edelbrock, C. S. (1985), Child behavior rating form. Psychopharm. Bull., 21:835-837. Guyatt, G., Sackett, D., Taylor, D. W., Chong, J., Roberts, R. & Pugsley, S. (1986), Determining optimal therapy-randomized trials in individual patients. N. Eng/. J. Med., 314:889-892. Harper, G. (1989), Focal inpatient treatment planning . J. Am. Acad. Child Adolesc. Psychiatry 28:31-37. Kolko, D. J. (\988), Daily ratings on a child psychiatric unit. J. Am. Acad. Child Adolesc. Psychiatry, 27: 126-132. Newton, P. M. & Levinson, D. J. (1973), The work group within the organization. Psychiatry, 36:115-142 . Nurcombe, B. (1989), Goal-directed treatment plann ing and the principles of brief hospitalization . J. Am. Acad. Child Adolesc. Psychiatry, 28:00-00. Overall, J. E. & PfetTerbaum, B. (1982), The brief psychiatric rating scale for children. Psychopharm . Bull., 18:10-16. Rapoport, J., Connors, C. K. & Reatig, N. (guest editors) (\985), Rating scales and assessment instruments for use in pediatric psychopharmacology research. Psychopharm. Bull., 21:713-1125. Reich, L. H. & Weiss, B. L. (1975), The clinical research ward as a

therapeutic community: Incompatibilities. Am. J. Psychiatry, 132:48-5 I. Riddle, M. A., Hardin, M. T., Cho, S. c.. Woolston, J. L. & Leckman, J. F. (1988), Desipramine treatment of boys with attention-deficit hyperactivity disorder and tics. J. Am . Acad. Child Adolesc. Psychiatry,27:811-814. Rogeness, G. A., Maas, J. W., Javors, M. A., Macedo, C. A., Harris, W. R. & Hoppe, S. K. (1988), Diagnoses, catecholamine metabolism, and plasma dopamine-B-hydroxylase. J. Am. Acad. Child Adolesc. Psychiatry, 27:121-125. Shaffer, D., Schwab-Stone, M., Fisher, P., Davies, M. & Cohen, P. (1987), A modified version ofthe Diagnostic Interview Schedule for Children (Disc 2). Presented at the New Research Poster Section, 34th Annual Meeting of the American Academy of Child & Adolescent Psychiatry. U.S. Department of Health and Human Services (1986), General Clinical Research Centers, A Research Resources Directory, Sixth R evised Edition. Wiener, J. M. (\988), The future of child and adolescent psychiatry. J. Am. Acad. Child Adolesc. Psychiatry, 27:8-10. Woolston, J. L. (1989), Transactional risk model for short and intermediate term psychiatric inpatient treatment of children. J. Am. Acad. Child Adolesc. Psychiatry, 28:38-41. Young, G. J., Leven, L. I. & Cohen, D. J. (1987), Clinical neurochemical strategies in child psychiatry. In: Psychiatry, Volume 2, ed. R. Michaels & J. O. Cavenar, Chapter 12.