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Toward clinically relevant clinical trials

Arnold, L E; Hoagwood, K; Jensen, P S; Vitiello, B
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.
PMID: 9133765
ISSN: 0048-5764
CID: 169059

Developmental psychopathology and the notion of culture: Introduction to the special section on "The fusion of cultural horizons: Cultural influences on the assessment of psychopathology in children and adolescents"

Hoagwood, Kimberly; Jensen, Peter S
Introduces the special issue of Applied Developmental Science called "The Fusion of Cultural Horizons: Cultural Influences on the Assessment of Psychopathology in Children and Adolescents". It is noted that the essays in this special issue look for the common horizon that connects cultures; the essays recognize that each culture sets its own linguistical limits on experience; that rates of disorders based on diagnostic systems, when viewed through a cultural lens, automatically take into account that a diagnosis is an interpretation (and interpretations are meaning-based); and, finally, that language, as J. Habermas (1992) said, can close the distance between different cultures or it can perpetually restrict our vision. Conceptual and methodological problems related to the aligning of cultural psychology with the study of developmental psychopathology are discussed, as well as the implications of cultural variations for research on child psychopathology.
PSYCH:1999-00885-001
ISSN: 1532-480x
CID: 169224

Effectiveness of school-based mental health services for children: A 10-year research review

Hoagwood, Kimberly; Erwin, Holly D
Presents a literature review from 1985-1995 on school-based mental health services for children. Of the 5,046 references initially identified, 228 were program evaluations. Three inclusion criteria were applied to those studies: use of random assignment to the intervention; inclusion of a control group; and use of standardized outcome measures. Only 16 studies met these criteria. Three types of interventions were found to have empirical support for their effectiveness, although some of the evidence was mixed: cognitive-behavioral therapy, social skills training, and teacher consultation. The studies are discussed with reference to the sample, targeted problem, implementation, and types of outcomes assessed, using a comprehensive model of outcome domains, called the SFCES model. It is suggested that future studies of school-based mental health services should: (1) investigate the effectiveness of these interventions with a wider range of children's psychiatric disorders; (2) broaden the range of outcomes to include variables related to service placements and family perspectives; (3) examine the combined effectiveness of these empirically-validated interventions; and (4) evaluate the impact of these services when linked to home-based interventions.
PSYCH:1997-38863-005
ISSN: 1573-2843
CID: 169225

Ethical issues in research on child and adolescent mental disorders: Implications for a science of scientific ethics

Chapter by: Hoagwood, Kimberly; Jensen, Peter S; Leshner, Alan I
in: Innovative approaches for difficult-to-treat populations by Henggeler, Scott W; Santos, Alberto B [Eds]
Washington, DC, US: American Psychiatric Association; US, 1997
pp. -
ISBN: 0-88048-680-5
CID: 169288

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

Jensen, P S; Hoagwood, K; Petti, T
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.
PMID: 8755804
ISSN: 0890-8567
CID: 169060

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

Hoagwood, K; Jensen, P S; Petti, T; Burns, B J
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.
PMID: 8755803
ISSN: 0890-8567
CID: 169061

Ethical issues in mental health research with children and adolescents

Hoagwood, Kimberly; Jensen, Peter S.; Fisher, Celia B
Mahwah, N.J. : Lawrence Erlbaum Associates, 1996
Extent: xi, 313 p. ; 24 cm.
ISBN: 9780805819533
CID: 169179

Embedding prevention services within systems of care: Strengthening the nexus for children

Hoagwood, Kimberly; Koretz, Doreen
System-of-care models that offer a continuum of integrated mental health services for children are being widely implemented in local communities. Preventive services, arising from the theoretically grounded prevention sciences, are an important but neglected component of this model. Studies of the use of mental health services by children are reviewed, and an integrative model is proposed to incorporate prevention services as a component of the child mental health service system. Construction of the prevention sciences has followed a linear phase model that has advantages and disadvantages for bridging prevention sciences and services research. As prevention science progresses into broader field tests of its effectiveness, studies of child services can be informative, especially in advancing the applicability and dissemination of research findings. Future directions are outlined to strengthen the nexus between services research and prevention science, and to construct a new genre of prevention services research.
PSYCH:1996-06896-003
ISSN: 0962-1849
CID: 169226

Casebook on ethical issues in research with children and adolescents with mental disorders

Chapter by: Fisher, Celia B; Hoagwood, Kimberly; Jensen, Peter S
in: Ethical issues in mental health research with children and adolescents by Hoagwood, Kimberly; Jensen, Peter S; Fisher, Celia B [Eds]
Hillsdale, NJ, England: Lawrence Erlbaum Associates, Inc; England, 1996
pp. -
ISBN: 0-8058-1952-5
CID: 169289

Research ethics and human subjects protection in child mental health services research and community studies

Chapter by: Attkisson, C. Clifford; Rosenblatt, Abram; Hoagwood, Kimberly
in: Ethical issues in mental health research with children and adolescents by Hoagwood, Kimberly; Jensen, Peter S; Fisher, Celia B [Eds]
Hillsdale, NJ, England: Lawrence Erlbaum Associates, Inc; England, 1996
pp. -
ISBN: 0-8058-1952-5
CID: 169290