Effectiveness of public deliberation methods for gathering input on issues in healthcare: Results from a randomized trial.

UNLABELLED: Public deliberation elicits informed perspectives on complex issues that are values-laden and lack technical solutions. This Deliberative Methods Demonstration examined the effectiveness of public deliberation for obtaining informed public input regarding the role of medical evidence in U.S. healthcare. We conducted a 5-arm randomized controlled trial, assigning participants to one of four deliberative methods or to a reading materials only (RMO) control group. The four deliberative methods reflected important differences in implementation, including length of the deliberative process and mode of interaction. The project convened 76 groups between August and November 2012 in four U.S. LOCATIONS: Chicago, IL; Sacramento, CA; Silver Spring, MD; and Durham, NC, capturing a sociodemographically diverse sample with specific attention to ensuring inclusion of Hispanic, African-American, and elderly participants. Of 1774 people recruited, 75% participated: 961 took part in a deliberative method and 377 participants comprised the RMO control group. To assess effectiveness of the deliberative methods overall and of individual methods, we evaluated whether mean pre-post changes on a knowledge and attitude survey were statistically different from the RMO control using ANCOVA. In addition, we calculated mean scores capturing participant views of the impact and value of deliberation. Participating in deliberation increased participants' knowledge of evidence and comparative effectiveness research and shifted participants' attitudes regarding the role of evidence in decision-making. When comparing each deliberative method to the RMO control group, all four deliberative methods resulted in statistically significant change on at least one knowledge or attitude measure. These findings were underscored by self-reports that the experience affected participants' opinions. Public deliberation offers unique potential for those seeking informed input on complex, values-laden topics affecting broad public constituencies.

Knowledge and behavioral effects in cardiovascular health: Community Health Worker Health Disparities Initiative, 2007-2010.

INTRODUCTION: Cardiovascular disease is the leading cause of death in the United States, and disparities in cardiovascular health exist among African Americans, American Indians, Hispanics, and Filipinos. The Community Health Worker Health Disparities Initiative of the National Heart, Lung, and Blood Institute (NHLBI) includes culturally tailored curricula taught by community health workers (CHWs) to improve knowledge and heart-healthy behaviors in these racial/ethnic groups. METHODS: We used data from 1,004 community participants in a 10-session curriculum taught by CHWs at 15 sites to evaluate the NHLBI's health disparities initiative by using a 1-group pretest-posttest design. The curriculum addressed identification and management of cardiovascular disease risk factors. We used linear mixed effects and generalized linear mixed effects models to examine results. RESULTS: Average participant age was 48; 75% were female, 50% were Hispanic, 35% were African American, 8% were Filipino, and 7% were American Indian. Twenty-three percent reported a history of diabetes, and 37% reported a family history of heart disease. Correct pretest to posttest knowledge scores increased from 48% to 74% for heart healthy knowledge. The percentage of participants at the action or maintenance stage of behavior change increased from 41% to 85%. CONCLUSION: Using the CHW model to implement community education with culturally tailored curricula may improve heart health knowledge and behaviors among minorities. Further studies should examine the influence of such programs on clinical risk factors for cardiovascular disease.

The impact of the Good Behavior Game, a universal classroom-based preventive intervention in first and second grades, on high-risk sexual behaviors and drug abuse and dependence disorders into young adulthood.

The Good Behavior Game (GBG), a method of teacher classroom behavior management, was tested in first- and second-grade classrooms in 19 Baltimore City Public Schools beginning in the 1985-1986 school year. The intervention was directed at the classroom as a whole to socialize children to the student role and reduce aggressive, disruptive behaviors, confirmed antecedents of a profile of externalizing problem outcomes. This article reports on the GBG impact on the courses and interrelationships among aggressive, disruptive behavior through middle school, risky sexual behaviors, and drug abuse and dependence disorders through ages 19-21. In five poor to lower-middle class, mainly African American urban areas, classrooms within matched schools were assigned randomly to either the GBG intervention or the control condition. Balanced assignment of children to classrooms was made, and teachers were randomly assigned to intervention or control. Analyses involved multilevel growth mixture modeling. By young adulthood, significant GBG impact was found in terms of reduced high-risk sexual behaviors and drug abuse and dependence disorders among males who in first grade and through middle school were more aggressive, disruptive. A replication with the next cohort of first-grade children with the same teachers occurred during the following school year, but with minimal teacher mentoring and monitoring. Findings were not significant but generally in the predicted direction. A universal classroom-based prevention intervention in first- and second-grade classrooms can reduce drug abuse and dependence disorders and risky sexual behaviors.

Study protocol for a group randomized controlled trial of a classroom-based intervention aimed at preventing early risk factors for drug abuse: integrating effectiveness and implementation research.

BACKGROUND: While a number of preventive interventions delivered within schools have shown both short-term and long-term impact in epidemiologically based randomized field trials, programs are not often sustained with high-quality implementation over time. This study was designed to support two purposes. The first purpose was to test the effectiveness of a universal classroom-based intervention, the Whole Day First Grade Program (WD), aimed at two early antecedents to drug abuse and other problem behaviors, namely, aggressive, disruptive behavior and poor academic achievement. The second purpose--the focus of this paper--was to examine the utility of a multilevel structure to support high levels of implementation during the effectiveness trial, to sustain WD practices across additional years, and to train additional teachers in WD practices. METHODS: The WD intervention integrated three components, each previously tested separately: classroom behavior management; instruction, specifically reading; and family-classroom partnerships around behavior and learning. Teachers and students in 12 schools were randomly assigned to receive either the WD intervention or the standard first-grade program of the school system (SC). Three consecutive cohorts of first graders were randomized within schools to WD or SC classrooms and followed through the end of third grade to test the effectiveness of the WD intervention. Teacher practices were assessed over three years to examine the utility of the multilevel structure to support sustainability and scaling-up. DISCUSSION: The design employed in this trial appears to have considerable utility to provide data on WD effectiveness and to inform the field with regard to structures required to move evidence-based programs into practice. CLINICAL TRIALS REGISTRATION NUMBER: NCT00257088.

Effects of a universal classroom behavior management program in first and second grades on young adult behavioral, psychiatric, and social outcomes.

BACKGROUND: The Good Behavior Game (GBG), a method of classroom behavior management used by teachers, was tested in first- and second-grade classrooms in 19 Baltimore City Public Schools beginning in the 1985-1986 school year. The intervention was directed at the classroom as a whole to socialize children to the student role and reduce aggressive, disruptive behaviors, confirmed antecedents of later substance abuse and dependence disorders, smoking, and antisocial personality disorder. This article reports on impact to ages 19-21. METHODS: In five poor to lower-middle class, mainly African American urban areas, three or four schools were matched and within each set randomly assigned to one of three conditions: (1) GBG, (2) a curriculum-and-instruction program directed at reading achievement, or (3) the standard program. Balanced assignment of children to classrooms was made, and then, within intervention schools, classrooms and teachers were randomly assigned to intervention or control. RESULTS: By young adulthood significant impact was found among males, particularly those in first grade who were more aggressive, disruptive, in reduced drug and alcohol abuse/dependence disorders, regular smoking, and antisocial personality disorder. These results underline the value of a first-grade universal prevention intervention. REPLICATION: A replication was implemented with the next cohort of first-grade children with the same teachers during the following school year, but with diminished mentoring and monitoring of teachers. The results showed significant GBG impact for males on drug abuse/dependence disorders with some variation. For other outcomes the effects were generally smaller but in the predicted direction.

Methods for testing theory and evaluating impact in randomized field trials: intent-to-treat analyses for integrating the perspectives of person, place, and time.

Randomized field trials provide unique opportunities to examine the effectiveness of an intervention in real world settings and to test and extend both theory of etiology and theory of intervention. These trials are designed not only to test for overall intervention impact but also to examine how impact varies as a function of individual level characteristics, context, and across time. Examination of such variation in impact requires analytical methods that take into account the trial's multiple nested structure and the evolving changes in outcomes over time. The models that we describe here merge multilevel modeling with growth modeling, allowing for variation in impact to be represented through discrete mixtures--growth mixture models--and nonparametric smooth functions--generalized additive mixed models. These methods are part of an emerging class of multilevel growth mixture models, and we illustrate these with models that examine overall impact and variation in impact. In this paper, we define intent-to-treat analyses in group-randomized multilevel field trials and discuss appropriate ways to identify, examine, and test for variation in impact without inflating the Type I error rate. We describe how to make causal inferences more robust to misspecification of covariates in such analyses and how to summarize and present these interactive intervention effects clearly. Practical strategies for reducing model complexity, checking model fit, and handling missing data are discussed using six randomized field trials to show how these methods may be used across trials randomized at different levels.

Randomized trial of a statewide home visiting program: impact in preventing child abuse and neglect.

OBJECTIVES: To assess the impact of home visiting in preventing child abuse and neglect in the first 3 years of life in families identified as at-risk of child abuse through population-based screening at the child's birth. METHODS: This experimental study focused on Hawaii Healthy Start Program (HSP) sites operated by three community-based agencies. From 11/94 to 12/95, 643 families were enrolled and randomly assigned to intervention and control groups. Child abuse and neglect were measured by observed and self-reported parenting behaviors, all hospitalizations for trauma and for conditions where hospitalization might have been avoided with adequate preventive care, maternal relinquishment of her role as primary caregiver, and substantiated CPS reports. Data were collected through annual maternal interviews (88% follow-up each year of all families with baseline interviews); observation of the home environment; and review of CPS, HSP, and pediatric medical records. RESULTS: HSP records rarely noted home visitor concern about possible abuse. The HSP and control groups were similar on most measures of maltreatment. HSP group mothers were less likely to use common corporal/verbal punishment (AOR=.59, p=.01) but this was attributable to one agency's reduction in threatening to spank the child. HSP group mothers reported less neglectful behavior (AOR=.72, .02), related to a trend toward decreased maternal preoccupation with problems and to improved access to medical care for intervention families at one agency. CONCLUSIONS: The program did not prevent child abuse or promote use of nonviolent discipline; it had a modest impact in preventing neglect. Possible targets for improved effectiveness include the program's implementation system and model.

Randomized trial of a statewide home visiting program to prevent child abuse: impact in reducing parental risk factors.

OBJECTIVES: To assess the impact of a home visiting program in reducing malleable parental risk factors for child abuse in families of newborns identified, through population-based screening, as at-risk of child abuse. METHODS: This randomized trial focused on Healthy Start Program (HSP) sites operated by three community-based organizations on Oahu, HI, USA. From 11/94 to 12/95, 643 families were enrolled and randomly assigned to intervention and control groups. Mothers in both groups were interviewed annually for 3 years (88% follow-up each year) to measure mental health, substance use, and partner violence. HSP records were reviewed to measure home visiting services provided. Home visitors were surveyed annually to measure their perceived competence. RESULTS: Malleable parental risks for child abuse were common at baseline. There was no significant overall program effect on any risk or on at-risk mothers' desire for and use of community services to address risks. There was a significant reduction in one measure of poor mental health at one agency and a significant reduction in maternal problem alcohol use and repeated incidents of physical partner violence for families receiving > or =75% of visits called for in the model. Home visitors often failed to recognize parental risks and seldom linked families with community resources. HSP training programs were under-developed in preparing staff to address risks and to link families with community resources. CONCLUSIONS: Overall, the home visiting program did not reduce major risk factors for child abuse that made families eligible for service. Research is needed to develop and test strategies to improve home visiting effectiveness in reducing parental risks for child abuse.

Risk of mother-reported child abuse in the first 3 years of life.

OBJECTIVE: The purpose of this research was to investigate, within an at-risk population, parent and child characteristics associated with a mother's self-reports of severe physical assault and assault on the self-esteem of the child in the first 3 years of life. DESIGN: The study population consisted of a community-based sample of mothers of newborns identified as at-risk for child maltreatment (n=595). Families were assessed annually from the child's birth through age 3 using instruments with established psychometric properties. Independent variables investigated included: family socio-demographics, parity, mother's social support, maternal depression, maternal problem drug or alcohol use, partner violence, child's age, child's sex, low birth weight/small for gestational age (SGA), and mother's perception of child's demand level. Associations with maltreatment were examined using multivariable methods for longitudinal data. RESULTS: Child severe physical assault was significantly associated with parent characteristics (maternal depression and partner violence); and child characteristics (SGA). Assault to the child's self-esteem was significantly associated with maternal depression, maternal illicit drug use, partner violence and mother's perception of child's demand level. Controlling for family sociodemographic characteristics did not change the associations. Likewise, while mother's perception of child demand level had an independent association with self-esteem assault, the associations described above persisted while demand level was held constant. In this high-risk sample, abuse was not associated with mother's age, education, race, parity, or household income level. CONCLUSIONS: While characteristics such as SGA can serve as markers for increased abuse risk, they are not amenable to intervention after the child is born. However, certain other risk factors, such as maternal depression and domestic violence are malleable and should be targeted for intervention with the goal of preventing child maltreatment.

Evaluating a statewide home visiting program to prevent child abuse in at-risk families of newborns: fathers' participation and outcomes.

This study sought to describe fathers' participation in a statewide home-visiting program to prevent child abuse and to assess program impact on their parenting. This randomized trial followed 643 at-risk families for 3 years. Data were collected through program record review, staff surveys, and annual maternal interviews. Participation in visits varied by the parents' relationship and paternal employment, violence, and heavy drinking at baseline. Overall, the program had no apparent impact on fathers' accessibility to the child, engagement in parenting activities, and sharing of responsibility for the child's welfare. The program promoted parenting involvement for nonviolent fathers in couples who lived together but also for violent fathers in couples with little contact at baseline; it decreased the father's accessibility to the child in couples who lived apart but saw each other frequently at baseline. Infrequent participation in visits and differential program impact on violent versus nonviolent fathers demonstrate the need to consider family context in developing, implementing, and studying home-visiting models.