Janet L. Brody

Ethnic Matching and Treatment Outcome With Hispanic and Anglo Substance-Abusing Adolescents in Family Therapy

This study examined treatment outcomes of 86 highly acculturated Hispanic and Anglo substance-abusing adolescents in functional family therapy, testing the hypothesis that ethnic matching of therapist and client is related to better treatment outcomes for clients. Adolescents reported on their substance use pre- and posttreatment on a timeline follow-back interview. Ethnically matched Hispanic adolescents demonstrated greater decreases in their substance use compared with Hispanic adolescents with Anglo therapists. Ethnic match status was not related to treatment outcome for Anglo clients. Thus, the matching hypothesis was supported for Hispanic clients only. The results underscore the importance of greater ethnic diversity among therapists and better cultural competency training for Anglo therapists. More research is needed on individual differences in the effects of ethnic matching.

Voluntary Assent in Biomedical Research With Adolescents: A Comparison of Parent and Adolescent Views

An informed consent and voluntary assent in biomedical research with adolescents is contingent on a variety of factors, including adolescent and parent perceptions of research risk, benefit, and decision-making autonomy. Thirty-seven adolescents with asthma and their parents evaluated a high or low aversion form of a pediatric asthma research vignette and provided an enrollment decision; their perceptions of family influence over the participation decision; and evaluations of risk, aversion, benefit, and burden of study procedures. Adolescents and their parents agreed on research participation decisions 74% of the time, yet both claimed ultimate responsibility for the participation decision. Both rated most study procedures as significantly more aversive than risky. Parents were more likely to rate aspects of the hypothetical study as beneficial and to provide higher risk ratings for procedures. Disagreements concerning research participation decisions and decision-making autonomy have implications for the exercise of voluntary assent in biomedical research.

Ethical issues in research on the treatment of adolescent substance abuse disorders

Treatment research on adolescent substance use disorders raises a number of important ethical and legal concerns which have not been widely acknowledged. This paper explores these concerns as they relate to fundamental ethical principles in the conduct of human research. The issues discussed include tensions between conflicting regulations governing informed consent for research and treatment of adolescents, the capacity of adolescents to give informed consent, potentially coercive elements related to research on substance use treatment, problems associated with confidentiality and release of information, research vulnerability associated with substance use, and ethical implications of distinctions between effectiveness and efficacy research. Suggestions for ways investigators may address these concerns are provided.

Ethnic Background, Therapeutic Alliance, and Treatment Retention in Functional Family Therapy With Adolescents Who Abuse Substances

In this study, the authors examined the role of balance between adolescent-therapist and parent-therapist alliances in the retention of functional family therapy clients. Therapeutic alliances of mothers, fathers, and adolescents were assessed from videotapes of the 1st treatment session for 43 Hispanic and 43 Anglo families. Hispanic families who dropped out before completing the requisite number of sessions were found to have greater imbalance in alliance (parent-adolescent) than those who did complete therapy. However, this finding was not replicated with Anglo families. Results are interpreted in terms of previous research on family-level balanced alliance effects.

Family and Physician Influence on Asthma Research Participation Decisions for Adolescents: The Effects of Adolescent Gender and Research Risk

OBJECTIVE. There is considerable ethical and legal ambiguity surrounding the role of adolescents in the decision-making process for research participation. Depending on the nature of the study and the regulations involved, adolescents may have independent responsibility for providing informed consent, they may be asked to provide their assent, or they may be completely excluded from the decision-making process. This study examined parent and adolescent perceptions of decision-making authority and sources of influence on adolescent research participation decisions, and examined whether perceptions of influence differed based on adolescent gender and level of research risk. STUDY DESIGN: Adolescents (n = 36) with asthma and their parents reviewed 9 pediatric research protocols, decided whether they would choose to participate, rated the extent they would be responsible for the actual decision, and indicated the ability of family and physician to influence their decisions. Multivariate analyses of variance were used to evaluate differences in perceptions of decision-making authority and sources of influence on the decisions. RESULTS: Adolescents were less willing to cede decision making authority to parents than parents anticipated. Parents and adolescents acknowledged a greater openness to influence from physicians than from family for above minimal risk studies. Parents were more willing to consider opinions from male adolescents. CONCLUSIONS: Adolescents desire responsibility for research participation decisions, though parents may not share these views. Physicians’ views on research participation are important to families, especially for above minimal risk studies. Parents may grant more decision-making autonomy to adolescent males than to females. Researchers, physicians, and institutions play a key role in facilitating the ethical enrollment of adolescents into biomedical research. Educational, policy, and oversight processes that support both adolescent autonomy and parental responsibility for research participation decision-making in biomedical research are discussed.

Influences upon willingness to participate in schizophrenia research: An analysis of narrative data from 63 people with schizophrenia

Schizophrenia affects more than 1% of the worlds population, causing great personal suffering and socioeconomic burden. These costs associated with schizophrenia necessitate inquiry into the causes and treatment of the illness but generate ethical challenges related to the specific nature and deficits of the illness itself. In this article, we present a systematic analysis of narrative data from 63 people living with the illness of schizophrenia collected through semistructured interviews about their attitudes, beliefs, and experiences related to psychiatric research. In the comments of these individuals, half of whom had had prior personal experience in research protocols, we identified factors influencing openness toward research involvement as well as deterrents that appear to lessen interest in participation. Clear response pattern differences emerged between those with prior research experience and those without such experience. In the discussion, we explore these key findings and outline the implications for safeguards in mental illness research.

Teaching medical students to discern ethical problems in human clinical research studies.

Purpose Investigators and institutional review boards are entrusted with ensuring the conduct of ethically sound human studies. Assessing ethical aspects of research protocols is a key skill in fulfilling this duty, yet no empirically validated method exists for preparing professionals to attain this skill. Method The authors performed a randomized controlled educational intervention, comparing a criteria-based learning method, a clinical-research- and experience-based learning method, and a control group. All 300 medical students enrolled at the University of New Mexico School of Medicine in 2001 were invited to participate. After a single half-hour educational session, a written posttest of ability to detect ethical problems in hypothetical protocol vignettes was administered. The authors analyzed responses to ten protocol vignettes that had been evaluated independently by experts. For each vignette, a global assessment of the perceived significance of ethical problems and the identification of specific ethical problems were evaluated. Results Eighty-three medical students (27%) volunteered: 50 (60%) were women and 55 (66%) were first- and second-year students. On global assessments, the criteria-focused group perceived ethical problems as more significant than did the other two groups (p < .02). Students in the criteria-focused group were better able than students in the control group (p < .03) to discern specific ethical problems, more closely resembling expert assessments. Unexpectedly, the group focused on clinical research participants identified fewer problems than did the control group (p < .05). Conclusions The criteria-focused intervention produced enhanced ethical evaluation skills. This work supports the potential value of empirically derived methods for preparing professionals to discern ethical aspects of human studies.

Empirically Derived Knowledge on Adolescent Assent to Pediatric Biomedical Research

Background: There has been a recent growth in empirical research on assent with pediatric populations, due in part to the demand for increased participation of this population in biomedical research. Despite methodological limitations, studies of adolescent capacities to assent have advanced and identified a number of salient psychological and social variables that are key to understanding assent. Methods: The authors review a subsection of the empirical literature on adolescent assent focusing primarily on asthma and cancer therapeutic research; adolescent competencies to assent to these studies; perceptions of protocol risk and benefit; the effects of various social context variables on adolescent research participation decision making; and the interrelatedness of these psychological and social factors. Results: Contemporary studies of assent, using multivariate methods and updated approaches to statistical modeling, have revealed the importance of studying the intercorrelation between adolescents’ psychological capacities and their ability to employ these capacities in family and medical decision-making contexts. Understanding these dynamic relationships will enable researchers and ethicists to develop assent procedures that respect the authority of parents, while at the same time according adolescents appropriate decision-making autonomy. Conclusions: Reviews of empirical literature on the assent process reveal that adolescents possess varying capacities for biomedical research participation decision making depending on their maturity and the social context in which the decision is made. The relationship between adolescents and physician-investigators can be used to attenuate concerns about research protocols and clarify risk and benefit information so adolescents, in concert with their families, can make the most informed and ethical decisions. Future assent researchers will be better able to navigate the complicated interplay of contextual and developmental factors and develop the empirical bases for research enrollment protocols that will support increased involvement of adolescents in biomedical research.

Ethical Issues in Adolescent and Parent Informed Consent for Pediatric Asthma Research Participation

This article reviews the empirical literature related to knowledge, competence, volition, and financial compensation in the biomedical research decision-making of children, adolescents, and parents. Research findings indicate there are differences in adolescent and parent understanding and appreciation of research risks and procedures, that opinions about decision-making authority and physician influence for research participation are different in adolescents and parents, and that financial compensation can be a salient factor in the research-related decision-making process. Pediatric asthma researchers can consider these psychological factors involved in adolescent and parent research participation decision-making processes to develop effective informed consent procedures.

Using Structural Equation Modeling to Understand Child and Parent Perceptions of Asthma Quality of Life

OBJECTIVE Using structural equation modeling, test a conceptual model of associations between constructs predicting parent and child asthma quality of life. METHODS Children with a confirmed asthma diagnosis and their parents completed measures of health status and independently reported on psychological functioning, family functioning, and quality of life. RESULTS Measurement and structural models for predicting parent and child quality of life provided a good fit of data to the conceptual model. Parent and child independent reports of quality of life are dependent upon family functioning and child psychological functioning. Long-term asthma symptom control is the only health status variable that impacts quality of life. CONCLUSIONS With minor modifications, both parent and child data fit the conceptual model. Child psychological functioning and long-term asthma control jointly contribute to quality of life outcomes. Findings suggest that both acute and long-term asthma health status outcomes have different determinants.