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. Research also demonstrates that family relationships have a profound influence on emotion regulation capacities, which are central to family functioning and prosocial behavior more broadly. Despite this evidence, no framework exists to describe how mindfulness might integrate into family therapy. This paper describes the benefits of mindfulness-based interventions, highlighting how and why informal mindfulness practices might enhance emotion regulation when integrated with family therapy. We provide a clinical framework for integrating mindfulness into family therapy, particularly as it applies to families with adolescents. A brief case example details sample methods showing how incorporating mindfulness practices into family therapy may enhance treatment outcomes. A range of assessment modalities from biological to behavioral demonstrates the breadth with which the benefits of a family-based mindfulness intervention might be evaluated.

Depression Change Profiles in Adolescents Treated for Comorbid Depression/Substance Abuse and Profile Membership Predictors.

Using data from a randomized trial in which adolescents with depressive and substance use disorders (SUD) received treatments for both disorders in either a sequenced or coordinated manner, we (a) determine the number and nature of depression response profiles through 1-year posttreatment and (b) examine whether 8 previously identified factors predict profile membership. There were 170 adolescents (M age = 16.4 years; 22% female; 28% Hispanic, 61% Non-Hispanic White) with comorbid depressive disorder/SUD randomized to one of three sequences of receiving the Adolescent Coping With Depression Course and Functional Family Therapy for SUD (depression treatment followed by SUD treatment; SUD treatment followed by depression treatment; coordinated treatment). Depression was assessed at 7 points from baseline to 1-year follow-up. A 4-class solution fit the data best, with groups labeled Mildly Depressed Responders (57.1%), Depressed Responders (18.8%), Depressed Non-Responders (12.9%), and Depressed with Recurrence (11.2%). The 4 change profiles differed on indices of all but 1 predictor (age); most differences were driven by lower scores among Mildly Depressed Responders. Profile membership was most strongly predicted by depression severity, cognitive distortions, hopelessness, and global functioning. The strongest predictor of Nonresponse was low family cohesion, whereas Recurrence was associated with hopelessness, suicide attempts, and starting treatment near the end of the school year. Most depressed adolescents experienced a positive response that was maintained. Understanding the most common profiles of depression change during and following treatment and the variables that predict change can help improve treatment outcomes and advance tailoring efforts.

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. METHODS: Families were randomly assigned to remain together or separated during a consent/assent process; the latter we characterize as an autonomy-enhanced assent/consent procedure. We hypothesized that separating adolescents from their parents would improve adolescent assent by increasing knowledge and appreciation of the clinical trial and willingness to participate. RESULTS: Sixty-four adolescent-parent dyads completed procedures. The together versus separate randomization made no difference in adolescent or parent willingness to participate. However, significant differences were found in both parent and adolescent knowledge of the asthma clinical trial based on the assent/consent procedure and adolescent age. The separate assent/consent procedure improved knowledge of study risks and benefits for older adolescents and their parents but not for the younger youth or their parents. Regardless of the assent/consent process, younger adolescents had lower comprehension of information associated with the study medication and research risks and benefits, but not study procedures or their research rights and privileges. CONCLUSIONS: The use of an autonomy-enhanced assent/consent procedure for adolescents may improve their and their parent's informed assent/consent without impacting research participation decisions. Traditional assent/consent procedures may result in a "diffusion of responsibility" effect between parents and older adolescents, specifically in attending to key information associated with study risks and benefits.

A Conceptual Framework for the Expansion of Behavioral Interventions for Youth Obesity: A Family-Based Mindful Eating Approach.

BACKGROUND: Currently, over 30% of US youth are overweight and 1 in 6 have metabolic syndrome, making youth obesity one of the major global health challenges of the 21st century. Few enduring treatment strategies have been identified in youth populations, and the majority of standard weight loss programs fail to adequately address the impact of psychological factors on eating behavior and the beneficial contribution of parental involvement in youth behavior change. METHODS: A critical need exists to expand treatment development efforts beyond traditional education and cognitive-behavioral programs and explore alternative treatment models for youth obesity. Meditation-based mindful eating programs represent a unique and novel scientific approach to the current youth obesity epidemic given that they address key psychological variables affecting weight. RESULTS: The recent expansion of mindfulness programs to include family relationships shows the immense potential for broadening the customarily individual focus of this intervention to include contextual factors thought to influence youth health outcomes. CONCLUSIONS: This article provides an overview of how both mindful eating and family systems theory fits within a conceptual framework in order to guide development of a comprehensive family-based mindful eating program for overweight youth.

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. 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 accord 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.

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. Family members independently evaluated the protocol and made research participation decisions. RESULTS: Perceived risk, benefit, and compensation were direct predictors of participation decisions for parents and adolescents. Adolescents perceived direct study benefit from the relationship with the physician, however parents did not. Parent decisions were most strongly associated with perceived risk, and parents associated discomfort with risk more strongly than did adolescents. Protocol procedures contributed to perceptions of benefit and discomfort for parents and adolescents. CONCLUSIONS: Parent and adolescent research participation decisions are influenced by protocol variables in similar ways, although there are differences that account for disagreements within families. Findings may help investigators develop protocols that appeal to parents and adolescents and highlight issues of particular importance to address during the process of informed consent.

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. Moreover, enhanced understanding of child volition increased parents' willingness to enrol their children in research. The proposed research literacy model identifies methods to enhance population knowledge and appreciation of research, strengthening links between scientific advancement and health.

Adolescent health-risk sexual behaviors: effects of a drug abuse intervention.

Adolescents who abuse substances are more likely to engage in health-risking sexual behavior (HRSB) and are at particularly high risk for HIV/AIDS. Thus, substance abuse treatment presents a prime opportunity to target HIV-risk behaviors. The present study evaluated a one-session HIV-risk intervention embedded in a controlled clinical trial for drug-abusing adolescents. The trial was conducted in New Mexico and Oregon with Hispanic and Anglo adolescents. Youths were randomly assigned to individual cognitive behavior therapy (CBT) or to an integrated behavioral and family therapy (IBFT) condition, involving individual and family sessions. The HIV-specific intervention was not associated with change. IBFT and CBT were both efficacious in reducing HIV-risk behaviors from intake to the 18-month follow-up for high-risk adolescents. For low-risk adolescents, CBT (versus IBFT) was more efficacious in suppressing HRSB. These data suggest that drug abuse treatments can have both preventative and intervention effects for adolescents, depending on their relative HIV-risk.

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.

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. Physician recommendations are also known to influence research participation decisions. Little attention has been given to how these dynamics may affect adolescents' involvement in decisions to participate in research. OBJECTIVE: To examine the influence of family and physician-investigator relationships and recommendations on adolescent asthma clinical research participation decisions. METHODS: A statewide community sample of 111 adolescents 11 to 17 years of age, with a diagnosis of asthma, and their parents participated in this study. Adolescents received a medical evaluation from an asthma specialist and then the family was offered participation in a hypothetical asthma clinical trial. By random assignment, the research study was presented by either the same or an unknown asthma specialist, and half the families in each group also received affirmative recommendations from the asthma specialist to participate in the hypothetical asthma clinical trial. Parents and adolescents made initial private decisions about participating in the trial. Then, following a family discussion of the clinical trial, a final research participation decision was made. RESULTS: Thirty-three percent of parents and adolescents initially disagreed about the research participation decision. When disagreements occurred, final decisions followed the parents' initial views except when the physician-investigator was known and a recommendation was made. Families with initial disagreement about participating were less likely to enroll when the investigator was unknown or when no recommendation was made. Adolescents who initially disagreed with parents' views were less likely to concur with the final research participation decision, felt less comfortable, and were less likely to feel they influenced the decision. CONCLUSIONS: Parents' views on research decisions take precedence over adolescents' views in most circumstances. Physician-investigator relationships may reduce parental resistance to participation and enhance adolescent decision-making autonomy when research participation is desired by the adolescent.

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.

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.

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. 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.

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.

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. METHOD: Thirty-six adolescents diagnosed with asthma and a parent of each, independently rated their willingness to participate in nine pediatric asthma research protocol vignettes. The selected protocols were chosen by an expert panel as representative of typical minimal and above-minimal risk pediatric asthma studies. RESULTS: Parents and adolescents were significantly less likely to enroll in above-minimal risk studies. However, this was qualified by a finding that adolescents were significantly more willing than parents to enroll in above-minimal risk research. Across all nine studies, parents and adolescents held concordant views on participation decisions 60% of the time, on average. Perception of potential study benefit was the most frequent reason provided for participation decisions by both parents and adolescents. CONCLUSION: Parents and their adolescents report substantial discordance in their views about participating in asthma research across a variety of protocols. These differences of opinion highlight the need to carefully consider the process by which families are offered the option of adolescent research participation. Investigators may want to adopt recruitment procedures that involve adolescents in initial discussions, especially for above-minimal risk studies.

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. RESULTS: Financial compensation did not affect participation decisions. Estimates of fair compensation were lower for adolescents, lower income respondents, and participants who were naive about potential compensation. Fair compensation estimates were higher than actual compensation for minimal risk studies and lower for above minimal risk studies. CONCLUSIONS: Financial compensation may be a minor consideration in pediatric research participation decision-making. Still, differences in how pediatric researchers and their prospective participants judge fair compensation create the potential for undue influence. Pediatric researchers should use caution when determining a reasonable financial compensation for research participation.

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. In study II adolescents with asthma, their parents, and pediatricians rated the risks and benefits associated with discreet asthma research procedures. RESULTS: In study I adolescents and parents made distinctions in riskiness among the asthma research procedures ( P < .001 and P < .001, respectively). With the exception of venipuncture, rank orders of risk ratings among procedures were similar for both groups. In study II significant differences in risk and benefit ratings for individual procedures were found among respondent groups, including experimental medication, placebo, and venipuncture. Overall, asthma research procedures were viewed as more beneficial than risky ( P < .001). CONCLUSION: Participants generally viewed asthma research procedures as more beneficial than risky. Overall, the relative risk rankings among all respondents were similar. However, there were between-group difference in ratings of risk associated with venipuncture and experimental medication. Parents and adolescents rated the benefit of placebo significantly higher than did pediatricians.

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 world's 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 the key findings and outline the implications for safeguards in mental illness research.

What is ethically important in clinical research? A preliminary study of attitudes of 73 psychiatric faculty and residents.

The ethical caliber of psychiatric research ultimately rests upon the shoulders of psychiatric clinicians and investigators who perform protocols and are directly responsible for the welfare of study volunteers. Little is known, however, about ethically relevant attitudes of psychiatrists toward human research. Working as part of a larger study, we surveyed all psychiatry faculty and residents at one institution in 1999 regarding the relative importance of 12 elements in the ethical conduct of human research. Responses of 73 participants were analyzed, and three factors emerged: Safeguards and Scientific Merit, Investigator Integrity and Relationship, and Patient Benefit. Safeguards and Scientific Merit, as a set, were the most salient considerations for both psychiatry faculty and residents. We found that residents placed greater importance on all factors and nearly every element than did faculty. Future research is needed to clarify the understanding of the perspectives and priorities of different stakeholders involved in human studies.