Integrating science and ethics in child and adolescent psychiatry research.

Research to elucidate the biological bases of psychopathology in children and adolescents is needed to understand pathogenesis and to develop effective and safe treatment and preventive interventions. Because of the effect of development, data collected in adults are not always applicable to youth, and direct participation of children in research is necessary. Many medications are currently used in the community to treat children and adolescents with neuropsychiatric disorders without adequate data about their safety and efficacy. Conducting research in children requires attention to specific ethical and regulatory factors. In deciding whether minors can participate in a study with potential direct benefit to the research subjects, the most important variable to consider is the balance between risks and potential benefit, in the context of the severity of the child's condition and the available alternatives. Research with no potential benefit to the participants is guided by the concepts of minimal risk (which may apply more to normal children) and minor increase over minimal risk (perhaps more relevant to children affected by psychopathology). Recently conducted studies relevant to this issue are reviewed. Of paramount importance is the ratio of risk/scientific value of the proposed experiment. In fact, no research is justifiable, no matter how low the risk may be, unless the potential yield of the study is important and may help advance our understanding of normal functioning and mental illness.

Outcomes of mental health care for children and adolescents: II. Literature review and application of a comprehensive model.

OBJECTIVE: Using a comprehensive model of outcomes, the authors review the scientific literature to determine the extent of knowledge concerning the outcomes of mental health care for children and adolescents. METHOD: Previous research is examined to determine the degree to which it addresses five salient outcome domains: symptoms/diagnoses, functioning, consumer perspectives, environments, and systems (the SFCES model). RESULTS: Despite numerous studies, only 38 met minimal scientific criteria. They generally fall into two categories, according either to their focus on the efficacy of treatment(s) for specific disorders or the effectiveness of a particular service or service system. Only two studies include outcome assessments across all five domains. CONCLUSIONS: As health care practices shift, improvements in mental health care will require credible evidence detailing the impact of clinical treatments and services on all salient outcome domains. Embedding efficacious treatments into effective service programs will likely improve care, but treatments will require modification to make them flexible, inclusive, and appropriate to multicultural populations. Furthermore, service delivery systems must be modified to meet the specific clinical needs of children with mental disorders and to embrace new efficacious treatments as they become available.

Treatment services for children with ADHD: a national perspective.

OBJECTIVE: To summarize knowledge on treatment services for children and adolescents with attention-deficit hyperactivity disorder (ADHD), trends in services from 1989 to 1996, types of services provided, service mix, and barriers to care. METHOD: A review of the literature and analyses from 2 national surveys of physician practices are presented. RESULTS: Major shifts have occurred in stimulant prescriptions since 1989, with prescriptions now comprising three fourths of all visits to physicians by children with ADHD. Between 1989 and 1996, related services, such as health counseling, for children with ADHD increased 10-fold, and diagnostic services increased 3-fold. Provision of psychotherapy, however, decreased from 40% of pediatric visits to only 25% in the same time frame. Follow-up care also decreased from more than 90% of visits to only 75%. Family practitioners were more likely than either pediatricians or psychiatrists to prescribe stimulants and less likely to use diagnostic services, provide mental health counseling, or recommend follow-up care. About 50% of children with identified ADHD seen in real-world practice settings receive care that corresponds to guidelines of the American Academy of Child and Adolescent Psychiatry. Physicians reported significant barriers to service provision for these children, including lack of pediatric specialists, insurance obstacles, and lengthy waiting lists. CONCLUSIONS: The trends in treatment services and physician variations in service delivery point to major gaps between the research base and clinical practice. Clinical variations may reflect training differences, unevenness in the availability of specialists and location of services, and changes in health care incentives.

Outcomes of mental health care for children and adolescents: I. A comprehensive conceptual model.

OBJECTIVE: Accountability for mental health care has become a standard of clinical practice. With the expansion of managed care as a corporate response to health reform, attention to outcomes will intensity. Assessment of clinical treatment has typically focused on symptom reduction at an individual level, whereas assessment of service effectiveness has more often targeted service-level change. METHOD: A dynamic and interactional model of outcomes is presented that broadens the range of intended consequences of care. The model comprises five domains: symptoms, functioning, consumer perspectives, environmental contexts, and systems. RESULTS: The model reflects the changeable interaction between children's evolving capacities and their primary environments (home, school, and community). CONCLUSIONS: As health care practices shift, attention to improved care is likely to depend increasingly on scientifically credible evidence of its impact. Greater integration between research and standard practice will be needed. Such a partnership can be strengthened by a more comprehensive view of the impact of care.

Psychoactive medication prescribing practices for U.S. children: gaps between research and clinical practice.

OBJECTIVE: To determine national pediatric prescribing practices for psychotropic agents and to examine these practices in view of the available evidence concerning their safety and efficacy in this age group. METHOD: Prescribing data from 2 national databases based on surveys of office-based medical practices were determined and reviewed vis-à-vis available safety and efficacy evidence. RESULTS: Data indicate that levels of psychotropic prescribing in children and adolescents are greatest for stimulants, resulting in nearly 2 million office visits and 6 million drug "mentions" in 1995. Selective serotonin reuptake inhibitors were the second most prescribed psychotropic agents, while anticonvulsant mood stabilizers (prescribed for a psychiatric reason), tricyclic antidepressants, central adrenergic agonists, antipsychotics, benzodiazepines, and lithium were also prescribed for a substantial number of office visits. Comparison of prescribing frequencies with available safety and efficacy data indicates significant gaps in knowledge for commonly used agents. CONCLUSIONS: Most psychotropic agents require further sustained study to ensure appropriate health care expenditures and vouchsafe children's safety. Recommendations for researchers, parents, federal agencies, and industry are offered as a means to accelerate the pace of research progress.

The Service Assessment for Children and Adolescents (SACA): adult and child reports.

OBJECTIVE: To describe differences in parent-child responses to the Service Assessment for Children and Adolescents (SACA). METHOD: Studies were done at UCLA and Washington University based on service-using and community subjects drawn from community households or public school student lists, respectively. Results are presented for 145 adult-youth pairs in which the youth was 11 or older. RESULTS: The SACA adult-youth correspondence for lifetime use of any services, inpatient services, outpatient services, and school services ranged from fair to excellent (kappa = 0.43-0.86, with most at 0.61 or greater). Similarly, the SACA showed a good to excellent correspondence for services that had been used in the preceding year (kappa = 0.45-0.77, with most greater than 0.50). The parent-youth correspondence for use of specific service settings in the above generic categories ranged from poor to excellent (kappa = 0.25-0.83, with half at 0.50 or greater). CONCLUSIONS: The SACA has better adult-youth correspondence than any service use questionnaire with published data, indicating that both adult and youth reports are not needed for all research on mental health services. This is especially encouraging news for researchers working with high-risk youth populations, in which a parent figure is often not available.

Introduction to the special section: efficacy and effectiveness in studies of child and adolescent psychotherapy.

This article introduces a special series on "transporting" studies of the efficacy of psychotherapy into studies of their effectiveness. Models of the relationship between efficacy and effectiveness are described. Traditional linear models of the phases of scientific expansion suggest that findings from efficacy studies can be transported into broader population samples only after a prescribed series of steps have been followed, with the ultimate goal of implementing treatments that have broad public health implications. An alternative 3-dimensional model is described. This new model posits as its organizing principle flexible movement between dimensions of efficacy and effectiveness across multiple axes.

Effectiveness, transportability, and dissemination of interventions: what matters when?

The authors identify and define key aspects of the progression from research on the efficacy of a new intervention to its dissemination. They highlight the role of transportability questions that arise in that progression and illustrate key conceptual and design features that differentiate efficacy, effectiveness, and dissemination research. An ongoing study of the transportability of multisystemic therapy is used to illustrate independent and interdependent aspects of effectiveness, transportability, and dissemination studies. Variables relevant to the progression from treatment efficacy to dissemination include features of the intervention itself as well as variables pertaining to the practitioner, client, model of service delivery, organization, and service system. The authors provide examples of how some of these variables are relevant to the transportability of different types of interventions. They also discuss sample research questions, study designs, and challenges to be anticipated in the arena of transportability research.

Evidence-based practice in child and adolescent mental health services.

The authors review the status, strength, and quality of evidence-based practice in child and adolescent mental health services. The definitional criteria that have been applied to the evidence base differ considerably across treatments, and these definitions circumscribe the range, depth, and extensionality of the evidence. The authors describe major dimensions that differentiate evidence-based practices for children from those for adults and summarize the status of the scientific literature on a range of service practices. The readiness of the child and adolescent evidence base for large-scale dissemination should be viewed with healthy skepticism until studies of the fit between empirically based treatments and the context of service delivery have been undertaken. Acceleration of the pace at which evidence-based practices can be more readily disseminated will require new models of development of clinical services that consider the practice setting in which the service is ultimately to be delivered.

Reliability of the services assessment for children and adolescents.

OBJECTIVE: This study examined the test-retest reliability of a new instrument, the Services Assessment for Children and Adolescents (SACA), for children's use of mental health services. METHODS: A cross-sectional survey was undertaken at two sites. The St. Louis site used a volunteer sample recruited from mental health clinics and local schools. The Ventura County, California, site used a double-blind, community-based sample seeded with cases of service-using children. Participating families completed the SACA and were retested within four to 14 days. The reliability of service use items was calculated with use of the kappa statistic. RESULTS: The SACA- Parent Version had excellent test-retest reliability for both lifetime service use and previous 12-month use. The SACA also had good to excellent reliability when administered to children aged 11 and older for lifetime and 12-month use. Reliability figures for children aged nine and ten years were considerably lower for lifetime and 12-month use. The younger children's responses suggested that they were confused about some questions. CONCLUSIONS: This study demonstrates that parents and older children can reliably report use of mental health services by using the SACA. The SACA can be used to collect currently unavailable information about use of mental health services.

Medication management of stimulants in pediatric practice settings: a national perspective.

Using a nationally representative sample of office-based physicians, the management practices of pediatricians, psychiatrists, and family practice physicians were investigated. The major aims were to determine (1) what types of services these physicians were providing to children who received stimulants, (2) what factors predicted receipt of stimulants, and (3) whether these practices were concordant or discordant with professional consensus on diagnosis and treatment of attention-deficit hyperactivity disorders (ADHD). Prescribing and management practice data from the 1995 National Ambulatory Medical Care Survey (NAMCS) were analyzed for children ages 0 to 17 years who were seen for psychiatric problems and received stimulant medication. Results indicated that 2 million visits by children were made in 1995 to psychiatrists, pediatricians, or family practitioners in which psychotropic medications were prescribed. In pediatric visits where stimulant medication was prescribed, mental health counseling was provided 47.3% of the time and psychotherapy 21.6%. Follow-up arrangements were made in 79.1% of the visits. Psychiatrists were significantly more likely to provide psychotherapy and to specify follow-up visits than were pediatricians, but less likely to provide other health counseling. Controlling for demographic and physician effects, the factors with the most significant effect on the probability of receiving stimulants were geographic region (living in the South), race (being white), receiving mental health counseling, not receiving psychotherapy, and having health insurance. Less than 50% of pediatric visits for psychiatric reasons involving stimulant medications included any form of psychosocial intervention. In 21% of these visits, no recommendations were made for follow-up care. These practices diverge from National Institutes of Health (NIH) consensus panel recommendations and association-issued practice parameters.

School-based mental health services: a research review.

This paper provides a synthetic review of research on school-based mental health services. Schools play an increasingly important role in providing mental health services to children, yet most school-based programs being provided have no evidence to support their impact. A computerized search of references published between 1985 and 1999 was used to identify studies of school-based mental health services for children. Study inclusion was determined by (i) use of randomized, quasi-experimental, or multiple baseline research design; (ii) inclusion of a control group; (iii) use of standardized outcome measures; and (iv) baseline and postintervention outcome assessment. The application of these criteria yielded a final sample of 47 studies on which this review is based. Results suggest that there are a strong group of school-based mental health programs that have evidence of impact across a range of emotional and behavioral problems. However, there were no programs that specifically targeted particular clinical syndromes. Important features of the implementation process that increase the probability of service sustainability and maintenance were identified. These include (i) consistent program implementation; (ii) inclusion of parents, teachers, or peers; (iii) use of multiple modalities; (iv) integration of program content into general classroom curriculum; and (v) developmentally appropriate program components. Implications of these findings and directions for future research are discussed.

Effective treatment for mental disorders in children and adolescents.

As pressure increases for the demonstration of effective treatment for children with mental disorders, it is essential that the field has an understanding of the evidence base. To address this aim, the authors searched the published literature for effective interventions for children and adolescents and organized this review as follows: (1) prevention; (2) traditional forms of treatment, namely outpatient therapy, partial hospitalization, inpatient treatment, and psychopharmacology; (3) intensive comprehensive community-based interventions including case management, home-based treatment, therapeutic foster care, and therapeutic group homes; (4) crisis and support services; and (5) treatment for two prevalent disorders, major depressive disorder and attention-deficit hyperactivity disorder. Strong evidence was found for the treatment of attention-deficit hyperactivity disorder, depression, anxiety, and disruptive behavior disorders. Guidance from the field relevant to moving the evidence-based interventions into real-world clinical practice and further strengthening the research base will also need to address change in policy and clinical training.

Poststructuralist historicism and the psychological construction of anxiety disorders.

When applied to the construction of anxiety disorders, theories of poststructuralist historicism emphasize acts of interpretation that constitute and construct the disorders and problematize the processes by which meaning is constructed. An examination of the historical formulations of anxiety disorders, and in particular, agoraphobia, provides the opportunity for reanalyzing traditional approaches to the classifications of disorders. Psychological issues of paradox, attachment, and personal identity, which are crucial to current conceptualizations of agoraphobia, are acutely problematized within a poststructuralist historicist hermeneutic. A rethinking of disorder construction from within this hermeneutic suggests replacing individualistic conceptualizations of personal identity with a broader view that recognizes and celebrates multiplicity and that displays formulations of the self in a contextualized and historicized status, thus enabling a fuller engagement with the social world.

The book of names: DSM-IV in context.

The authors review the constraints of current mental disorder classification systems that rely upon descriptive symptom-based approaches, and weigh the benefits and hazards of these classification and diagnostic strategies. By focusing principally on superficial descriptions of symptoms, current systems fail to address the complex nature of persons' transactions within and adaptations to difficult environments. While attempting to be atheoretical, current systems exclude types of information that may elucidate individuals' functioning across various contexts, often because it is difficult to obtain such data reliably. With current approaches, misdiagnosis is likely, particularly when diagnostic criteria are applied to persons in nonclinical settings. Alternative approaches that take fuller advantage of clinicians' expertise and other forms of clinical data are reviewed, and recommendations are made for the next generation of classification systems. Application of evolutionary theory to psychiatry and psychology, as well as development of a theory and nosology of context in terms of persons' adaptations, are needed to expand our knowledge of normal and abnormal human development and psychopathology.

Toward clinically relevant clinical trials.

This article grapples with two closely related tensions threatening the credibility and relevance of clinical trials to clinicians as well as patients and their families: (1) the tension between clinical flexibility and scientific standardization of protocol and (2) the tension between the need to ensure scientific integrity through a standard, pre-specified protocol and the need to increase compliance by involving patients and their families in goal setting and treatment planning. We propose four partial solutions: (1) relaxed exclusion criteria to maximize generalizability, using only those exclusion criteria essential to the treatment; (2) extensive use of clinical algorithms to incorporate clinical flexibility in a standardized way; (3) active involvement of therapists in decision-making, including cross-site clinical decision panels; and (4) active involvement of families through a goal-setting and treatment-planning session as the first step of treatment. Although we focus on clinical trials with children and adolescents, the principles and ideas may also apply to clinical trials with patients of any age. This article summarizes and elaborates on presentations made by three of the authors at workshops on psychiatric clinical trials in children and adolescents at the May 1996 New Clinical Drug Evaluation Unit (NCDEU) meeting. The focus was on enhancing the clinical relevance of clinical trials-making the results useful and credible to practitioners and patients and their families.