A randomized study of a method for optimizing adolescent assent to biomedical research.

Purpose: Voluntary consent/assent with adolescents invited to participate in research raises challenging problems. No studies to date have attempted to manipulate autonomy in relation to assent/consent processes. This study evaluated the effects of an autonomy-enhanced individualized assent/consent procedure embedded within a randomized pediatric asthma clinical trial.

A Conceptual Model and Clinical Framework for Integrating Mindfulness into Family Therapy with Adolescents.

Individual and group-based psychotherapeutic interventions increasingly incorporate mindfulness-based principles and practices. These practices include a versatile set of skills such as labeling and attending to present-moment experiences, acting with awareness, and avoiding automatic reactivity. A primary motivation for integrating mindfulness into these therapies is compelling evidence that it enhances emotion regulation.

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 affects of various social context variables on adolescent research participation decision making; and the inter-relatedness of these psychological and social factors.

Predicting adolescent asthma research participation decisions from a structural equations model of protocol factors.

Purpose: To examine similarities and differences in the process that parents and adolescents use to make decisions concerning participation in an asthma clinical trial. We hypothesized that a single conceptual model, tested through structural equations modeling, could explain adolescent assent and parent consent for adolescent research participation.

Methods: One hundred nine adolescents enrolled with at least one parent and received an asthma evaluation from a pediatric asthma specialist and then evaluated a hypothetical asthma research protocol.

Conceptualizing the role of research literacy in advancing societal health.

'Research literacy' is proposed as a key concept for advancing societal health. To examine whether improvements in research literacy would affect knowledge of and ethical participation in research, parents of young children received a brief educational intervention designed to enhance their understanding of child research. Results demonstrated that the intervention improved research-related knowledge and increased parents' comfort with their research participation decisions.

Enrolling adolescents in asthma research: adolescent, parent, and physician influence in the decision-making process.

Background: The factors influencing family decisions to participate in adolescent asthma research are not well understood. Legal and ethical imperatives require adolescent research participation to be voluntary. While parents and adolescents often agree about research decisions, disagreements may also occur with relative frequency.

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.

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.

Comparisons of adolescent and parent willingness to participate in minimal and above-minimal risk pediatric asthma research protocols.

Purpose: Through the processes of permission and assent, parents and adolescents have a shared involvement in decision-making about adolescent research participation. Yet little empirical data exists examining the prevalence and contexts in which adolescents and parents disagree on research participation decisions. The purpose of this study was to compare parent and adolescent willingness to participate in minimal and above-minimal risk pediatric asthma research protocols.

Financial compensation to adolescents for participation in biomedical research: adolescent and parent perspectives in seven studies.

Objective: To examine the impact of financial compensation on pediatric asthma research participation decision-making and determine whether perceptions of fair compensation differed for parents and adolescents, lower and higher income participants, and compensation-informed and uninformed participants in minimal and above minimal risk research.

Study Design: Adolescents (n = 36) with asthma and their parents reviewed 7 pediatric asthma research protocols, decided whether they would choose to participate, and provided estimates of "fair" compensation for their participation. Chi-square, analysis of variance, and analysis of covariance were used to determine the affects of compensation on participation and whether various respondents differed in the perceptions of fair compensation.

Perception of risk associated with asthma research procedures among adolescents, parents, and pediatricians.

Background: Little empirical data exist about how adolescents with asthma, their parents, and pediatricians view the risks and benefits associated with asthma clinical research.

Objective: Two studies examined similarities and differences in the perception of risks and benefits associated with asthma research.

Methods: In study I questionnaires were completed by adolescents with asthma and parents at the end of an audio and written presentation of a hypothetical research vignette.

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.