Advancing Inclusive Research (AIR) Site Alliance: Facilitating the inclusion of historically underrepresented people in oncology and ophthalmology clinical research.

BACKGROUND: The Advancing Inclusive Research (AIR) Site Alliance is composed of clinical research centers that partner with Genentech, a biotechnology company, to advance the representation of diverse patient populations in its oncology and ophthalmology clinical trials, test recruitment, and retention approaches and establish best practices to leverage across the industry to achieve health equity. METHODS: Through a data-driven selection process, Genentech identified 6 oncology and 3 ophthalmology partners that focus on reaching historically underrepresented patients in clinical trials and worked collaboratively to share knowledge and explore original ways of increasing clinical study access for every patient, including sites co-creation of a Protocol Entry Criteria Guideline with inclusion principles. RESULTS: For patients, three publicly available educational videos about clinical trials were created in multiple languages. The AIR Site Alliance has also defined invoiceable services for sites to enhance patient support; this has been built into the new study budget templates for sustainability. For healthcare professionals (HCPs), the first-of-its-kind AIR Educational Program was developed to focus on identifying and addressing bias and engaging historically underrepresented patient populations in trials. The sites also co-created videos for HCPs and patients on why advancing inclusive research matters. Over 16 regional health equity symposia have been delivered for patients, HCPs, and community leaders. CONCLUSIONS: This AIR Site Alliance is a model for other site alliances, including Kenya, South Africa, the United Kingdom, and Canada. Such alliances will build a robust and sustainable research ecosystem that includes diverse patient groups and encourages change across the healthcare system.

Adaptation of the Drug and Drug Problems Perception Questionnaire to assess healthcare provider attitudes toward adolescent substance use.

Although preventive screening, brief intervention and referral to treatment for adolescent substance use is recommended by the American Academy of Pediatrics, primary care providers inconsistently address substance use with their pediatric patients (AAP Committee on Practice and Ambulatory Medicine and AAP Bright Futures Periodicity Schedule Workgroup, 2017). Further research on provider perceptions about addressing adolescent substance use may help identify and address some barriers to screening. However, there are few validated measures of provider perceptions toward patient substance, and none are specific to pediatric patients. This study (conducted in Maryland, 2015-2017) examines the internal consistency and factor structure of an adapted measure to assess perceptions of adolescent substance use. Internal consistency was assessed using responses from a sample of 276 healthcare practitioners (87.7% women, 12.3% men). Their professions included the following: Certified Medical Assistants (10.9%), Registered Nurses (17.8%), Nurse Practitioners (8.3%), Physician Assistants (3.6%), Medical Doctors (13.8%), Clinical Therapists (10.9%) and Other (21.0%). A four-factor solution was identified and initial evidence suggests the adapted measure is appropriate for use with health care providers. A subsample of 181 participants who reported direct interaction with adolescent patients in a provider role was also used to assess convergent validity with self-reported screening practices and effectiveness. Provider-reported frequency of alcohol and drug use assessment for pediatric patients was significantly related to positive perceptions about adolescent substance use on all subscales. The adapted measure could prove useful for assessing provider readiness to receive adolescent substance use screening training and could be further adapted to include items unique to adolescent care, including parental involvement.

The Core Components of Evidence-Based Social Emotional Learning Programs.

Implementing social emotional learning (SEL) programs in school settings is a promising approach to promote critical social and emotional competencies for all students. However, there are several challenges to implementing manualized SEL programs in schools, including program cost, competing demands, and content that is predetermined and cannot be tailored to individual classroom needs. Identifying core components of evidence-based SEL programs may make it possible to develop more feasible approaches to implementing SEL in schools. The purpose of this study was to systematically identify the core components in evidence-based elementary school SEL programs, using the five interrelated sets of competencies identified by the Collaborative for Academic, Social, and Emotional Learning (CASEL) as an organizing framework. We present the components that were identified, and the rates at which each component was included in the sample of evidence-based SEL programs. The core components that occurred most frequently across programs were Social Skills (100% of programs), Identifying Others' Feelings (100% of programs), Identifying One's Own Feelings (92.3% of programs), and Behavioral Coping Skills/Relaxation (91.7% of programs). These findings illustrate the feasibility of systematically identifying core components from evidence-based SEL programs and suggest potential utility of developing and evaluating modularized SEL programs.

Narcissism and Callous-Unemotional Traits Prospectively Predict Child Conduct Problems.

Although narcissism and callous-unemotional (CU) traits are separable facets of psychopathy, their independent prediction of conduct problems (CP) among young children is not well known. In addition, above-average IQ was central to the original conceptualization of psychopathy, yet IQ is typically inversely associated with youth CP. We examined narcissism and CU traits as independent and prospective predictors of oppositional defiant disorder (ODD), conduct disorder (CD), and youth self-reported antisocial behavior, as well as their moderation by IQ. At baseline, parents and teachers separately rated narcissism and CU traits in 188 6-to-10-year-old children (47.9% non-White; 69.1% male; M = 7.34 years, SD = 1.09) with (n = 99) and without (n = 89) attention-deficit/hyperactivity disorder (ADHD). Approximately 2 years later, parents and teachers separately rated youth ODD and CD symptoms, and youth self-reported antisocial behavior. With control of baseline ADHD and ODD/CD symptoms, narcissism and CU traits independently and positively predicted ODD and CD symptoms at follow-up. IQ did not moderate any CP predictions from baseline narcissism or CU traits. These preliminary findings suggest that individual differences in narcissism and CU traits, even relatively early in development, are uniquely associated with emergent CP. Findings are considered within a developmental framework and the multiple pathways underlying the heterogeneity of CP are discussed.

Cognitive ability and psychopathic traits: independent and interactive associations with youth conduct problems.

Although average or high IQ was central to initial conceptualizations of psychopathy, IQ is typically negatively associated with oppositional defiant disorder (ODD) and conduct disorder (CD). Few studies have simultaneously considered narcissism and callous-unemotional (CU) traits with respect to ODD and CD symptoms, including potential interactive associations with IQ. Participants were 221 ethnically-diverse (45 % non-White) 6-9 year-old children with (n = 114) and without (n = 107) attention-deficit/hyperactivity disorder (ADHD) with separate parent and teacher ratings of narcissism, CU traits, ODD, and CD. To minimize shared method variance, we conservatively examined the association of parent-rated psychopathic traits with teacher-rated ODD and CD as well as the association of teacher-rated psychopathic traits with parent-rated ODD and CD. Controlling for age, sex, and the number of child ADHD symptoms, narcissism, but not CU traits, uniquely and positively predicted parent- and teacher-rated ODD and CD symptoms. We also observed a significant IQ × narcissism interaction where narcissism was more strongly associated with ODD and CD among children with high IQ relative to average and low IQ youth. Whereas studies of youth psychopathic traits focus almost exclusively on CU traits, narcissism independently predicted separate parent and teacher ratings of ODD and CD, particularly among children with high IQ. These preliminary data persuasively suggest that early narcissism is a critical facet of psychopathy and in conjunction with IQ, may suggest a unique profile associated with emergent conduct problems.