Participation bias among suicidal adults in a randomized controlled trial

Although individuals who attempt suicide have poor compliance rates with treatment recommendations, the nature and degree of participation bias in clinical treatment research among these individuals is virtually unknown. The purpose of this study was to examine participation bias by comparing the demographic and diagnostic characteristics of adult suicide attempters who participated in a randomized controlled trial to a sample of nonparticipants. Results indicated that males and individuals with a diagnosis of substance abuse or dependence were more likely to be participants in the randomized controlled trial. The implications of these findings for suicide intervention research are discussed.     

Clinical and Non-Clinical Characteristics Associated with Medication Use Among Children with Serious Emotional Disturbance

Our study explores the clinical and non-clinical characteristics associated with medication use among children with serious emotional disturbance who are referred into community-based family-driven system of care settings. Using data collected as part of the Comprehensive Community Mental Health Services for Children and Their Families Program initiative, our study provides results from analyses completed on 7,009 children and adolescents with serious emotional disturbance. Using both bivariate and multivariate statistical analyses, the researchers found that females entering systems of care were less likely to have received medication in the 6-months prior to entry, as were children of African-American and Native-American heritage compared to children from non-Hispanic White heritage. Children referred from mental health, child welfare or who were self-referred were more likely to use medications than those referred from juvenile justice. Children with histories of prior inpatient, outpatient, day treatment, or school-based services were between 2 and 4 times more likely to use medications than children without such histories. Children with family histories of mental illness and those who were Medicaid recipients were also more likely to use medications. Family income was also positively related to medication use and younger children were more likely to use medications than older children. Implications of the findings are discussed.     

Comparison of Informed Consent Preferences for Multiplex Genetic Carrier Screening among a Diverse Population

Multiplex genetic carrier screening is increasingly being integrated into reproductive care. Obtaining informed consent becomes more challenging as the number of screened conditions increases. Implementing a model of generic informed consent may facilitate informed decision-making. Current Wayne State University students and staff were invited to complete a web-based survey by blast email solicitation. Participants were asked to determine which of two generic informed consent scenarios they preferred: a brief versus a detailed consent. They were asked to rank the importance of different informational components in making an informed decision and to provide demographic information. Comparisons between informational preferences, demographic variables and scenario preferences were made. Six hundred ninety three participants completed the survey. When evaluating these generic consents, the majority preferred the more detailed consent (74.5 %), and agreed that it provided enough information to make an informed decision (89.5 %). Those who thought it would be more important to know the severity of the conditions being screened (p?=?.002) and range of symptoms (p?=?.000) were more likely to prefer the more detailed consent. There were no significant associations between scenario preferences and demographic variables. A generic consent was perceived to provide sufficient information for informed decision making regarding multiplex carrier screening with most preferring a more detailed version of the consent. Individual attitudes rather than demographic variables influenced preferences regarding the amount of information that should be included in the generic consent. The findings have implications for how clinicians approach providing tailored informed consent.     

The Effect of Emotion on Visual Attention to Information and Decision Making in the Context of Informed Consent Process for Clinical Trials

The aim of this study was to examine the influence of emotion on visual information processing and decision making in the context of informed consent. Researchers are ethically obligated to ensure informed consent in clinical trials; however, many volunteers have unrealistic expectations about the value of an experimental therapy. Moreover, suboptimal participation rates for clinical trials may be partially attributable to perceptions that ethical obligations to volunteers are not met. This study examines whether discrete negative emotions (fear, anger, and sadness) differentially influence information processing, visual attention, and decisions in the context of clinical trial informed consent. Community participants completed a standard emotion induction (or control) and then read an actual consent form from a clinical trial while eye movements were tracked. Fear and anger produced the most prominently different patterns of systematic processing and visual attention, such that fear induced longer fixations to information presented, whereas anger induced shorter fixations. Moreover, among women only, fear increased decisions to participate, compared with anger and neutral emotion. Examinations of associations between eye‐tracking variables and self‐reported outcomes indicated that for angry participants only, less systematic processing was associated with greater decisions to participate. Negative emotions of any kind decreased accurate perceptions of trial benefit. These patterns suggest a complex interplay among emotion, processing style, and decision making. Future research is necessary to further probe these effects among potential clinical trial volunteers. Published 2016. This article is a U.S Government work and is in the public domain in the USA.     

Research Participants’ Preferences for Hypothetical Secondary Results from Genomic Research

Secondary or incidental results can be identified in genomic research that increasingly uses whole exome/genome sequencing. Understanding research participants’ preferences for secondary results and what influences these decisions is important for patient education, counseling, and consent, and for the development of policies regarding return of secondary results. Two hundred nineteen research participants enrolled in genomic studies were surveyed regarding hypothetical preferences for specific types of secondary results, and these preferences were correlated with demographic information and psychosocial data. The majority of research participants (73%) indicated a preference to learn about all results offered, with no clear pattern regarding which results were not desired by the remaining participants. Participants who reported greater interest in genetic privacy were less likely to indicate a preference to learn all results, as were individuals who self-identified as Jewish. Although most research participants preferred to receive all secondary results offered, a significant subset preferred to exclude some results, suggesting that an all-or-none policy would not be ideal for all participants. The correlations between preferences to receive secondary results, religious identification, and privacy concerns demonstrate the need for culturally sensitive counseling and educational materials accessible to all education levels to allow participants to make the best choices for themselves.     

Power, propensity to negotiate, and moving first in competitive interactions

Five experiments investigated how the possession and experience of power affects the initiation of competitive interaction. In Experiments 1a and 1b, high-power individuals displayed a greater propensity to initiate a negotiation than did low-power individuals. Three additional experiments showed that power increased the likelihood of making the first move in a variety of competitive interactions. In Experiment 2, participants who were semantically primed with power were nearly 4 times as likely as participants in a control condition to choose to make the opening arguments in a debate competition scenario. In Experiment 3, negotiators with strong alternatives to a negotiation were more than 3 times as likely to spontaneously express an intention to make the first offer compared to participants who lacked any alternatives. Experiment 4 showed that high-power negotiators were more likely than low-power negotiators to actually make the first offer and that making the first offer produced a bargaining advantage.     

Factors Associated with Recruitment and Retention in Randomized Controlled Trials of Behavioral Interventions for Patients with Pediatric Type 1 Diabetes

The purpose of this study is to describe recruitment and retention experiences from three behavioral randomized controlled trials conducted among youth with type 1 diabetes. Eligibility, recruitment, and retention data were examined. Study-specific differential study participation and loss-to-follow-up analyses assessed the relations of patient characteristics with treatment completion and 6-month retention. Multivariable logistic regression identified factors independently associated with 6-month retention among all participants. Approximately 70–92 % of randomized participants completed treatment and 58–90 % were retained for follow-up. Older patients and non-Caucasian patients were less likely to enroll. Treatment completion and 6-month retention were less likely among youth who were older, had worse baseline glycemic control, lower household income, and/or unmarried parents. Some subgroups of patients are less likely to participate in research and are more susceptible to loss-to-follow-up. More work is needed to understand the facilitators and barriers to research participation.     

Family characteristics of children who self-select into a prevention program for children of alcoholics

Evaluated the efficacy of a self-selection recruitment process designed to attract fourth-, fifth-, and sixth-grade children into a school-based prevention program for children of alcoholics. Participants were 296 families comprising one child and either one or both parents. Family members' self- and collateral reports were used to assess parental problem drinking, family characteristics, and individual pathology. Analyses revealed that the recruitment process was not effective in recruiting children of alcohol-abusing parents. Furthermore, families in which children received parental consent to participate in the prevention program were indistinguishable from families whose children either showed interest without obtaining consent or showed no interest at all. Implications for recruitment strategies for future prevention programs for children of alcoholics are discussed.     

Determinants and Barriers to Participation in an Internet Based Recovery Program for Cardiac Patients

Patients hospitalized for coronary heart disease were offered a home recovery program utilizing the Internet. About one-half of the patients interviewed chose to enlist in this program. Participants and non-participants did not differ significantly according to medical risk and diagnostic factors, lifestyle and some demographic variables (principally marital status, sex, and race). However, those who owned personal computers and/or were familiar with the Internet, who were in higher socioeconomic strata, and were younger than age 65 were strongly more likely to participate. Internet instruction and computers (for those who had none) were provided to participants. Those who were lent computers—29% of the program participants—were more often female, without any college training, and less confident about using the Internet. As the public becomes increasingly more familiar with personal computer technology these potential barriers to its use may eventually disappear. The present study evaluated a fairly resolute method to introduce an Internet program to many recovering patients who were unfamiliar with this technology. However, other innovative and perhaps more aggressive ways of making those most in need of such valuable health-related information and resources can be tested in the near future.     

A Comparison of Enrollees Versus Non-enrollees in a Patient/Family HCV Psychoeducation Study

Despite the seriousness of Hepatitis C (HCV), many patients do not receive treatment. One promising means of addressing these issues for medically ill patients is through participation in support group services. This study examined individual-, treatment- and system-level factors associated with enrolling in a support group intervention (psychoeducation) for persons with HCV. A total of 235 research participants were recruited as part of a NIAAA-funded randomized clinical trial for patients with HCV and their family members, with 172 (73.2 %) agreeing to enroll in the psychoeducation trial and 63 (26.8 %) declining. Factors leading to enrollment indicated that individuals without employment, with certain personality structures (low cooperativeness and self-directedness), and traveling greater distance to their group were more likely to agree to participate. Populations being seen in public settings demonstrate a desire for additional support and education, but at the same time these potential participants are faced with challenges to following through and enrolling in the desired services.     

Family demographics of clinically referred children: What we know and what we need to know

Published empirical studies were reviewed to establish family demographics of clinically referred children and adolescents. Data on parental marital status were collected from studies of referred and nonreferred children and adolescents in six empirical journals. Data on family socioeconomic status (SES) and child race or ethnicity were also collected. Based on 86 studies that presented parental marital status, 56.4% of clinically referred children and adolescents live with both their biological mother and biological father. Family SES data were difficult to summarize because of the different methods of presenting this information. When considering race and ethnicity, 86% of the children and adolescents in the clinical samples were Caucasian American. Of the studies that were originally reviewed, 80.4% did not include parental marital status and 36. 7% did not include SES, race, or ethnicity of the participants. There were no significant differences between journals in the rates of inclusion of family demographic data. In addition to revealing family demographic information about children and adolescents who participate in clinical research, these data highlight the lack of consistency in the presentation of family demographic data in published research. Suggestions are provided to help researchers colled and present meaningful family demographic data in clinical and nonclinical research with children and adolescents.This study was completed with support from the Division of Sponsored Research at the University of South Florida and preparation of this article was supported in part by National Institute of Mental Health Grant R29 49601-02 to the first author. We express our gratitude to Georgetta Bosco and Tracy Burbine for their diligent data collection in the library.     

Hypnotic discontinuation in chronic insomnia: impact of psychological distress, readiness to change, and self-efficacy.

OBJECTIVE: To compare individuals who were successful in discontinuing hypnotic medications against those who were not on measures of insomnia severity, medication withdrawal symptoms, psychological symptoms, perceived health, readiness to change and self-efficacy. DESIGN: Secondary analyses of a randomized clinical trial comparing a hypnotic taper intervention with or without self-help treatment for insomnia. MAIN OUTCOME MEASURES: Self-report measures of insomnia severity, medication withdrawal symptoms, depression and anxiety symptoms, physical and mental health, stages of change, readiness to change, decisional balance, and general and situational self-efficacy. RESULTS: There were no significant differences at baseline between medication-free individuals and those still using sleep medication at the end of a taper intervention. Group differences emerged midway through the 8-week withdrawal program and were accentuated after the intervention; participants who remained medication-free during the next six months had less severe insomnia and anxiety symptoms, a more positive perception of their health and higher self-efficacy to refrain from hypnotic use in various situations. Contrary to expectations, there were no differences between drug-free and nondrug-free participants on both readiness to change and stages of change. CONCLUSIONS: Chronic users of hypnotic medications entered a taper intervention with equal levels of psychological distress, health, self-efficacy, and readiness to change. Successful hypnotic discontinuation was associated with overall improvement of insomnia, anxiety and distress symptoms, perceived health and self-efficacy. More intensive and individualized therapeutic attention may be warranted for individuals experiencing worsening of insomnia symptoms, more withdrawal symptoms and psychological distress, and lower self-efficacy during medication discontinuation.     

A Randomized Controlled Pilot Study of Motivational Interviewing to Change Attitudes about Adherence to Medications for Asthma

The day-to-day management of asthma relies on patient self-care practices; in particular, adherent use of asthma medications is fundamental for asthma management. However, most persons with asthma do not use their medications to clinically acceptable standards. The purpose of this study was to test the efficacy of a brief educational intervention to enhance knowledge and skills relevant to asthma self-care, and the efficacy of motivational interviewing to improve attitudes toward taking medications as prescribed. Twenty-five adults with asthma were randomly assigned to receive a brief educational intervention alone, or education plus motivational interviewing. Over time, all participants improved their knowledge of asthma and skills using a metered dose inhaler. Participants who received education alone showed a decreased level of readiness to adhere with their medications over time, whereas participants who received motivational interviewing were more likely to show a stable or increased level of readiness to adhere over time. Among participants who described themselves as not consistently adhering with their medications at the first evaluation, those who received motivational interviewing endorsed more positive attitudes toward taking medications over time. The results are supportive of the utility of motivational interviewing in enhancing participants' attitudes toward adherent medication use. Future research should test if attitude change is reflected in change in medication use.     

Evaluating the Effectiveness of Cognitive-Behavioral Teletherapy in Depressed Adults

Telephone psychotherapy is an emerging form of delivery of care that has recently demonstrated utility and efficacy for adult depression when provided as an adjunct to antidepressant treatment in primary care trials. This study constitutes one of the initial evaluations of cognitive behavioral therapy-telephone treatment (CBT-TT) as a stand-alone treatment for adult depression in specialty care. Thirty adults initiating psychotherapy for depression at a mental health clinic participated in the trial. The majority of participants (69%) were very satisfied with the 8-session CBT-TT, reduction in depression severity was significant over 3 and 6 months, and 42% of participants were considered recovered at termination. These outcomes closely parallel the findings from an earlier primary care trial, despite specialty care participants beginning treatment with more severe depression and without adjunctive antidepressant medication. These findings suggest that CBT-TT for adult depression is feasible and has potential as a stand-alone treatment. Implementation of this telephone-based delivery approach in primary and specialty care settings is discussed.     

Perspectives on Focus Group Participation and Remuneration

Recruiting participants from underserved and marginalized communities for behavioral research is an essential yet challenging task. We examined participants' motivation to participate in a focus group about health communication and their beliefs about appropriate remuneration for participation. Twelve focus groups were conducted with low-income African American and Latina adolescent girls and African American women. We utilized a grounded theory approach and thematic analysis to examine views about research participation and remuneration. This study can inform important considerations about the consent process, study recruitment, and remuneration.     

Sign on the Dotted Line: The Informed Consent Process (ICP) as Induced Compliance1

We investigated the social implications of signing an informed consent form (ICF) on participant behavior. ICF research fails to consider that the decision to participate in research is a process that occurs in a social and cultural context. Understanding the meaning of giving consent in this social context is critical. In separate experiments, we found significantly greater agreement to return to complete a study and persistence at a task in participants who signed the ICF versus those who did not. Signing the ICF may be putting participants at risk of induced compliance with study protocols, rather than empowering them to withhold consent or withdraw. Future research should investigate the psychosocial factors affecting participants' decision making in the informed consent process.     

Comprehension of Online Informed Consents: Can It Be Improved?

This study examined possible ways to ensure that participants provide fully informed consent for online surveys. Participants were randomly assigned to read either a traditional informed consent or one of three modified versions: enhanced (e.g., images, bullet points), consent for each key element, or a combination of these two. Those who read the combination version scored higher on a comprehension quiz, guessed at fewer questions, and were more likely to read all of the informed consent than those who received the traditional version. These findings suggest that comprehension can be improved by adopting alternatives to the traditional informed consent.     

Examining attitudes about and influences on research participation among forensic psychiatric inpatients

Although a growing body of research has examined various types of coercive practices that may occur among psychiatric patients over the years, almost no attention has been given to coercive influences that may occur specifically in the context of recruitment into research projects. Particularly for those who are institutionalized (e.g., in-patient insanity acquittees), there are significant concerns that their autonomous decision-making to consent or not may be significantly impaired due to the highly restrictive and controlled environment in which they live. This exploratory study sought to examine patients' perceptions of coercive influences by presenting them with hypothetical research vignettes regarding possible recruitment into either a biomedical or social-behavioral research project. Among 148 multi-ethnic male and female participants across two facilities, participants reported relatively minimal perceptions that their autonomous decision-making would be impacted or that various potentially coercive factors (e.g., pressures from staff) would impair their free choice to participate (or not) in such research. To the extent that such perceptions of coercion did occur, they were moderately associated with patients' more general personality traits and attitudinal variables, such as alienation and external locus of control. Limitations of this study and their implications for future research are discussed.