Development and Usability of an Endoscopist Report Card Assessing ERCP Quality.

BACKGROUND AND AIMS: Audit and feedback (A&F) for endoscopic retrograde cholangiopancreatography (ERCP) is relatively understudied despite the demonstrated effectiveness of A&F for endoscopic procedures such as colonoscopy. Endoscopist 'report cards' are one A&F tool. We aimed to develop an ERCP report card and assess its appropriateness, acceptability and feasibility through usability testing. METHODS: A prototype report card was designed using a combination of published quality indicators and established predictors of adverse events (AE). Exploratory analyses from a prospective multi-center registry were performed to further identify novel and/or understudied parameters for possible inclusion. Semi-structured interviews with ERCP endoscopists were conducted and framework analysis performed. Validated post-interview usability instruments were administered. Feedback was incorporated to create a final report card. RESULTS: The report card included domains of technical parameters, AE rates/prevention, and patient-reported experience measures (PREMs). Qualitative feedback was positive, with respondents agreeing with inclusion of relevant content in most domains. Post-interview instruments revealed adequate appropriateness and acceptability. PREMs were felt by respondents to be poorly actionable and were replaced with appropriateness of indication and fluoroscopy usage parameters in the final report card. Concerns were raised regarding the feasibility of implementation due to reliance on difficult-to-obtain granular intraprocedural data. CONCLUSIONS: We designed and tested an ERCP report card that has potential to be an effective A&F intervention for endoscopists in clinical practice. Though feasibility of data capture and implementation are currently limitations, advances in video recording and artificial intelligence technologies could accelerate widespread adoption of such a tool.

Provider perspectives and recommendations on standardized sexual function screening intervention in adolescent/young adult oncology patients.

BACKGROUND: Sexual function (SF) concerns are common among adolescent and young adult (AYA) cancer survivors, are underrecognized and undertreated. This study sought AYA oncology provider input on the implementation of an SF screening tool to address this unmet need. PROCEDURE: Semi-structured interviews were completed with oncology providers (n = 25) who care for AYAs at a single institution. Interviews sought to understand barriers to addressing SF, elicit perspectives on use of an established screening tool, and obtain recommendations for SF screening intervention development and implementation. Interviews were developed using the Consolidated Framework for Implementation Research (CFIR); thematic analysis-guided interpretation. RESULTS: AYA oncology providers were in favor of using an SF screening tool, but confirmed previously identified barriers and implementation considerations within multiple CFIR domains, including concerns about privacy, patient comfort, provider buy-in, provider knowledge, resource needs, and workflow/capacity constraints. They identified numerous strategies to address barriers through screening intervention design and implementation approaches. For example, provider buy-in could be optimized through education, availability of clinical resources, creation of a dedicated sexual healthcare team, provider engagement in intervention development, and leadership involvement. CONCLUSIONS: Development and implementation of an effective SF screening intervention is necessary to improve diagnosis and treatment of sexual dysfunction, with the ultimate goal of improving sexual health-related quality of life in AYA cancer survivors. AYA oncology providers identified numerous intervention and implementation design strategies for the development and implementation of an SF screening intervention, which must be integrated with patient recommendations.

Unmeasured factors are associated with the use of completion lymph node dissection (CLND) in melanoma.

BACKGROUND: Completion lymph node dissection (CLND) was the standard treatment for patients with melanoma with positive sentinel lymph nodes (SLN) until 2017 when data from the DeCOG-SLT and MLST-2 randomized trials challenged the survival benefit of this procedure. We assessed the contribution of patient, tumor and facility factors on the use of CLND in patients with surgically resected Stage III melanoma. METHODS: Using the National Cancer Database, patients who underwent surgical excision and were found to have a positive SLN from 2012 to 2017 were included. A multivariable mixed-effects logistic regression model with a random intercept for the facility was used to determine the effect of patient, tumor, and facility variables on the risk of CLND. Reference effect measures (REMs) were used to compare the contribution of contextual effects (unknown facility variables) versus measured variables on the variation in CLND use. RESULTS: From 2012 to 2017, the overall use of CLND decreased from 59.9% to 26.5% (p < 0.0001). Overall, older patients and patients with government-based insurance were less likely to undergo CLND. Tumor factors associated with a decreased rate of CLND included primary tumor location on the lower limb, decreasing depth, and mitotic rate <1. However, the contribution of contextual effects to the variation in CLND use exceeded that of the measured facility, tumor, time, and patient variables. CONCLUSIONS: There was a decrease in CLND use during the study period. However, there is still high variability in CLND use, mainly driven by unmeasured contextual effects.

RE-AIM implementation outcomes and service outcomes: what's the connection? results of a cross-sectional survey.

BACKGROUND: Implementation science and health services outcomes research each focus on many constructs that are likely interrelated. Both fields would be informed by increased understanding of these relationships. However, there has been little to no investigation of the relationships between implementation outcomes and service outcomes, despite general acknowledgement that both types of outcomes are important in the pathway to individual and population health outcomes. Given the lack of objective data about the links between implementation and service outcomes, an initial step in elucidating these relationships is to assess perceptions of these relationships among researchers and practitioners in relevant fields. The purpose of this paper is to assess perceived relationships between Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework outcomes and service outcomes, testing five a priori hypotheses about which perceived relationships may be strongest. METHODS: A cross-sectional online survey was administered to a convenience sample of implementation scientists, health services researchers, and public health and medical practitioners from a variety of settings. Respondents provided information on their discipline, training, practice and research settings, and levels of experience in health service outcomes research, implementation science, and the RE-AIM framework. Next, they rated perceived relationships between RE-AIM and service outcomes. Repeated measures analysis of variance were used to test a priori hypotheses. Exploratory analyses assessed potential differences in mean ratings across groups of respondents categorized by discipline, setting, and levels of implementation science, health services, and RE-AIM experience. RESULTS: Surveys were completed by 259 respondents, most of whom were employed in academic and medical settings. The majority were doctoral-level researchers and educators or physicians. Reported levels of experience with implementation research, health services research, and the RE-AIM framework varied. The strongest perceived relationships overall were between Implementation/Fidelity and Effectiveness (as a service outcome); Maintenance and Efficiency; Reach and Equity; Adoption and Equity; Implementation/Adaptation and Patient-Centeredness; Adoption and Patient-Centeredness; and Implementation/Fidelity and Safety. All but one of the a priori hypotheses were supported. No significant differences in ratings of perceived relationships were observed among subgroups of respondents. CONCLUSIONS: This study is an initial step in developing conceptual understanding of the links between implementation outcomes, health services outcomes, and health outcomes. Our findings on perceived relationships between RE-AIM and services outcomes suggest some areas of focus and identify several areas for future research to advance both implementation science and health services research toward common goals of improving health outcomes.

Universal, School-Based Mental Health Program Implemented Among Racially and Ethnically Diverse Youth Yields Equitable Outcomes: Building Resilience for Healthy Kids.

Although suicide is a leading cause of mortality among racial and ethnic minority youth, limited data exists regarding the impact of school-based mental health interventions on these populations, specifically. A single-arm pragmatic trial design was utilized to evaluate the equity of outcomes of the universal, school-based mental health coaching intervention, Building Resilience for Healthy Kids. All sixth-grade students at an urban middle school were invited to participate. Students attended six weekly sessions with a health coach discussing goal setting and other resilience strategies. 285 students (86%) participated with 252 (88%) completing both pre- and post-intervention surveys. Students were a mean age of 11.4 years with 55% identifying as girls, 69% as White, 13% as a racial minority, and 18% as Hispanic. Racial minority students exhibited greater improvements in personal and total resilience compared to White students, controlling for baseline scores.

Ranked determinants of telemedicine diabetic retinopathy screening performance in the United States primary care safety-net setting: an exploratory CART analysis.

BACKGROUND: Diabetic retinopathy (DR) is a leading cause of blindness worldwide, despite easy detection and effective treatment. Annual screening rates in the USA remain low, especially for the disadvantaged, which telemedicine-based DR screening (TDRS) during routine primary care has been shown to improve. Screening rates from such programs have varied, however, pointing to inconsistent implementation and unaddressed barriers. This work seeks to identify and prioritize modifiable barriers for targeted intervention. METHODS: In this final phase of an exploratory mixed-methods study, we developed, validated, and administered a 62-item survey to multilevel stakeholders involved with TDRS in primary care safety-net clinics. Survey items were aligned with previously identified determinants of clinic-level screening and mapped to the Consolidated Framework for Implementation Research (CFIR). Classification and Regression Tree (CART) analyses were used to identify and rank independent variables predictive of individual-level TDRS screening performance. RESULTS: Overall, 133 of the 341 invited professionals responded (39%), representing 20 safety-net clinics across 6 clinical systems. Respondents were predominately non-Hispanic White (77%), female (94%), and between 31 and 65 years of age (79%). Satisfaction with TDRS was high despite low self-reported screening rates. The most important screening determinants were: provider reinforcement of TDRS importance; explicit instructions by providers to staff; effective reminders; standing orders; high relative priority among routine diabetic measures; established TDRS workflows; performance feedback; effective TDRS champions; and leadership support. CONCLUSIONS: In this survey of stakeholders involved with TDRS in safety-net clinics, screening was low despite high satisfaction with the intervention. The best predictors of screening performance mapped to the CFIR constructs Leadership Engagement, Compatibility, Goals & Feedback, Relative Priority, Champions, and Available Resources. These findings facilitate the prioritization of implementation strategies targeting determinants of TDRS performance, potentially increasing its public health impact.

Identifying Unbiased Items for Screening Preschoolers for Disruptive Behavior Problems.

Objective: Efficient identification and referral to behavioral services are crucial in addressing early-onset disruptive behavior problems. Existing screening instruments for preschoolers are not ideal for pediatric primary care settings serving diverse populations. Eighteen candidate items for a new brief screening instrument were examined to identify those exhibiting measurement bias (i.e., differential item functioning, DIF) by child characteristics. Method: Parents/guardians of preschool-aged children ( N = 900) from four primary care settings completed two full-length behavioral rating scales. Items measuring disruptive behavior problems were tested for DIF by child race, sex, and socioeconomic status using two approaches: item response theory-based likelihood ratio tests and ordinal logistic regression. Results: Of 18 items, eight were identified with statistically significant DIF by at least one method. Conclusions: The bias observed in 8 of 18 items made them undesirable for screening diverse populations of children. These items were excluded from the new brief screening tool.

Female Sexual Function Index Short Version: A MsFLASH Item Response Analysis.

The Female Sexual Function Index (FSFI) is a psychometrically sound and popular 19-item self-report measure, but its length may preclude its use in studies with multiple outcome measures, especially when sexual function is not a primary endpoint. Only one attempt has been made to create a shorter scale, resulting in the Italian FSFI-6, later translated into Spanish and Korean without further psychometric analysis. Our study evaluated whether a subset of items on the 19-item English-language FSFI would perform as well as the full-length FSFI in peri- and postmenopausal women. We used baseline data from 898 peri- and postmenopausal women recruited from multiple communities, ages 42-62 years, and enrolled in randomized controlled trials for vasomotor symptom management. Goals were to (1) create a psychometrically sound, shorter version of the FSFI for use in peri- and postmenopausal women as a continuous measure and (2) compare it to the Italian FSFI-6. Results indicated that a 9-item scale provided more information than the FSFI-6 across a spectrum of sexual functioning, was able to capture sample variability, and showed sufficient range without floor or ceiling effects. All but one of the items from the Italian 6-item version were included in the 9-item version. Most omitted FSFI items focused on frequency of events or experiences. When assessment of sexual function is a secondary endpoint and subject burden related to questionnaire length is a priority, the 9-item FSFI may provide important information about sexual function in English-speaking peri- and postmenopausal women.

The Perceived Stigma of Mental Health Services Among Rural Parents of Children With Psychosocial Concerns.

OBJECTIVE: To examine parents' perceptions of stigma regarding mental health services for their child, consider stigma in the context of novel service delivery settings (e.g., telehealth, primary care, and schools), and evaluate stigma with other factors known to influence service access. METHODS: 347 caregivers of children with psychosocial concerns completed surveys regarding their perceptions of stigma, service delivery settings, and barriers to care. RESULTS: Parents endorsed low levels of stigma around services. Greater perceived stigma was related to less willingness to seek services in a mental/behavioral health center or schools but not in other settings, even when other barriers were considered. Having a younger child and a history of prior services was associated with greater willingness to seek services. CONCLUSIONS: Stigma does appear to present as a barrier, but only for some parents. Providing mental health services to young children and their parents in some nontraditional settings may increase access.

Acceptability and Feasibility of Physical Activity Assessment Methods for an Appalachian Population.

Nowhere is improving understanding and accurate assessment of physical activity more important for disease prevention and health promotion than among health disparities populations such as those residing in rural and Appalachian regions. To enhance accurate assessment of physical activity and potentially improve intervention capacity, we conducted a mixed-methods study examining the acceptability and feasibility of self-report physical activity questionnaires, pedometers, and accelerometers among rural Appalachian children, adolescents, and adults. Most participants reported positive experiences with all three physical activity assessment tools. Several acceptability ratings differed by age group and by sex within each age group. With very few exceptions, no significant differences in acceptability were found by race, education, employment status, health status, BMI categories, income levels, or insurance status within age groups or overall. Several factors may impact the choice of the physical activity assessment method, including target population age, equipment cost, researcher burden, and potential influence on physical activity levels. Children and adolescents appear to have more constraints on when they can wear pedometers and accelerometers. While pedometers are inexpensive and convenient, they may influence physical activity levels, rather than simply measure them. Accelerometers, while less influential on behavior, consume extensive resources, including high purchase costs and researcher burden.

A rural Appalachian faith-placed smoking cessation intervention.

Although health promotion programming in faith institutions is promising, most faith-based or placed health projects focus on diet, exercise, or cancer screening and many have been located in urban environments. This article addresses the notable absence of faith programming for smoking cessation among underserved rural US residents who experience tobacco-related health inequities. In this article, we describe our faith-oriented smoking cessation program in rural Appalachia, involving 590 smokers in 26 rural churches randomized to early and delayed intervention groups. We present three main themes that account for participants' positive evaluation of the program; the program's ability to leverage social connections; the program's convenience orientation; and the program's financial support for smoking cessation. We also present themes on the roles of faith and church in smoking cessation programming, including some mixed perceptions on smoking stigma and comfort in church settings; challenges in faith-placed smoking cessation recruitment; and the positive perception of such programming by church leaders. We conclude that faith-placed smoking cessation programs offer great potential, although they must be administered with great sensitivity to individual and community norms.

Testing effectiveness and implementation of a standardized approach to sexual dysfunction screening among adolescent and young adult-aged survivors of childhood cancer: A type I hybrid, mixed methods trial protocol.

BACKGROUND: Approximately 20-50% of adolescent and young adult-aged childhood cancer survivors (AYA-CCS) experience sexual dysfunction (SD), although this healthcare need is widely underrecognized. Previous research from both AYA-CCS patients and their providers report that SD needs are unaddressed despite patient desires for SD discussions to be incorporated as part of their care. Patients and providers agree that standardized use of a patient-reported outcome measure may facilitate SD discussions; an SD screening approach was developed with patient and provider input. This study will measure the effectiveness of a standardized SD screening intervention and assess implementation outcomes and multilevel barriers and facilitators to guide future research. METHODS: This multi-site, mixed methods, type 1 effectiveness-implementation hybrid trial will be evaluated using a pre-post design (NCT05524610). The trial will enroll 86 AYA-CCS (ages 15-39) from two cancer centers in the United States. The SD intervention consists of core fundamental functions with a "menu" of intervention options to allow for flexibility in delivery and tailoring in variable contexts. Effectiveness of the intervention on facilitating SD communication will be measured through patient surveys and clinical data; multivariable logistic regression will be used for the binary outcome of self-reported SD screening, controlling for patient-level predictors. Implementation outcomes will be assessed using mixed methods (electronic health record abstraction, patient and provider surveys, and provider interviews. Quantitative and qualitative findings will be merged using a joint display to understand factors affecting intervention success. IMPLICATIONS: Identification and treatment of SD in AYA-CCS is an important and challenging quality of life concern. The type 1 hybrid design will facilitate rapid translation from research to practice by testing the effects of the intervention while simultaneously identifying multilevel barriers and facilitators to real-world implementation. This approach will inform future testing and dissemination of the SD screening intervention.

Testing effectiveness and implementation of a standardized approach to sexual dysfunction screening among adolescent and young adult-aged survivors of childhood cancer: A type I hybrid, mixed methods trial protocol: Effectiveness of sexual dysfunction screening among AYA cancer survivors: a study protocol.

Background: Approximately 20-50% of adolescent and young adult-aged childhood cancer survivors (AYA-CCS) experience sexual dysfunction (SD), although this healthcare need is widely underrecognized. Previous research from both AYA-CCS patients and their providers report that SD needs are unaddressed despite patient desires for SD discussions to be incorporated as part of their care. Patients and providers agree that standardized use of a patient-reported outcome measure may facilitate SD discussions; an SD screening approach was developed with patient and provider input. This study will measure the effectiveness of a standardized SD screening intervention and assess implementation outcomes and multilevel barriers and facilitators to guide future research. Methods: This multi-site, mixed methods, type 1 effectiveness-implementation hybrid trial will be evaluated using a pre-post design (NCT05524610). The trial will enroll 86 AYA-CCS (ages 15-39) from two cancer centers in the United States. The SD intervention consists of core fundamental functions with a "menu" of intervention options to allow for flexibility in delivery and tailoring in variable contexts. Effectiveness of the intervention on facilitating SD communication will be measured through patient surveys and clinical data; multivariable logistic regression will be used for the binary outcome of self-reported SD screening, controlling for patient-level predictors. Implementation outcomes will be assessed using mixed methods (electronic health record abstraction, patient and provider surveys, and provider interviews. Quantitative and qualitative findings will be merged using a joint display to understand factors affecting intervention success. Implications: Identification and treatment of SD in AYA-CCS is an important and challenging quality of life concern. The type 1 hybrid design will facilitate rapid translation from research to practice by testing the effects of the intervention while simultaneously identifying multilevel barriers and facilitators to real-world implementation. This approach will inform future testing and dissemination of the SD screening intervention.

A Digital Intervention to Improve Skin Self-Examination Among Survivors of Melanoma: Protocol for a Type-1 Hybrid Effectiveness-Implementation Randomized Trial.

BACKGROUND: Although melanoma survival rates have improved in recent years, survivors remain at risk of recurrence, second primary cancers, and keratinocyte carcinomas. The National Comprehensive Cancer Network recommends skin examinations by a physician every 3 to 12 months. Regular thorough skin self-examinations (SSEs) are recommended for survivors of melanoma to promote the detection of earlier-stage, thinner melanomas, which are associated with improved survival and lower treatment costs. Despite their importance, less than a quarter of survivors of melanoma engage in SSEs. OBJECTIVE: Previously, our team developed and evaluated a web-based, fully automated intervention called mySmartSkin (MSS) that successfully improved SSE among survivors of melanoma. Enhancements were proposed to improve engagement with and outcomes of MSS. The purpose of this paper is to describe the rationale and methodology for a type-1 hybrid effectiveness-implementation randomized trial evaluating the enhanced MSS versus control and exploring implementation outcomes and contextual factors. METHODS: This study will recruit from state cancer registries and social media 300 individuals diagnosed with cutaneous malignant melanoma between 3 months and 5 years after surgery who are currently cancer free. Participants will be randomly assigned to either enhanced MSS or a noninteractive educational web page. Surveys will be collected from both arms at baseline and at 3, 6, 12, and 18 months to assess measures of intervention engagement, barriers, self-efficacy, habit, and SSE. The primary outcome is thorough SSE. The secondary outcomes are the diagnosis of new or recurrent melanomas and sun protection practices. RESULTS: Multilevel modeling will be used to examine whether there are significant differences in survivor outcomes between MSS and the noninteractive web page over time. Mixed methods will evaluate reach, adoption, implementation (including costs), and potential for maintenance of MSS, as well as contextual factors relevant to those outcomes and future scale-up. CONCLUSIONS: This trial has the potential to improve outcomes in survivors of melanoma. If MSS is effective, the results could guide its implementation in oncology care and nonprofit organizations focused on skin cancers. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/52689.

Barriers to cervical cancer screening among middle-aged and older rural Appalachian women.

Although cervical cancer rates in the United States have declined sharply in recent decades, certain groups of women remain at elevated risk, including middle-aged and older women in central Appalachia. Cross-sectional baseline data from a community-based randomized controlled trial were examined to identify barriers to cervical cancer screening. Questionnaires assessing barriers were administered to 345 Appalachian women aged 40-64, years when Papanicolaou (Pap) testing declines and cervical cancer rates increase. Consistent with the PRECEDE/PROCEED framework, participants identified barriers included predisposing, enabling, and reinforcing factors. Descriptive and bivariate analyses are reported, identifying (a) the most frequently endorsed barriers to screening, and (b) significant associations of barriers with sociodemographic characteristics in the sample. Recommendations are provided to decrease these barriers and, ultimately, improve rates of Pap tests among this traditionally underserved and disproportionately affected group.

Patterns and determinants of breast and cervical cancer non-screening among Appalachian women.

Breast and cervical cancer account for nearly one-third of new cancer cases and one-sixth of cancer deaths. Cancer, the second leading cause of all deaths in the United States, will claim the lives of nearly 800,000 women this year, which is particularly unfortunate because effective modes of early detection could significantly reduce mortality from breast and cervical cancer. Researchers examined patterns of non-screening among Appalachian women. In-person interviews were conducted with 222 Appalachian women who fell outside of screening recommendations for timing of Pap tests and mammograms. These women, from six Appalachian counties, were participating in a group-randomized, multi-component trial aimed at increasing adherence to cancer screening recommendations. Results indicated that participants who were rarely or never screened for breast cancer were also likely to be rarely or never screened for cervical cancer. In addition, four key barriers were identified as independently and significantly associated with being rarely or never screened for both cervical and breast cancer. An improved understanding of cancer screening patterns plus the barriers underlying lack of screening may move researchers closer to developing effective interventions that facilitate women's use of screening.

Randomized-controlled trial of a whole-family obesity prevention and treatment intervention designed for low-income Hispanic families: HeLP the healthy living program.

BACKGROUND: Low-income Hispanic families face marked disparities in obesity, but interventions for obesity prevention and treatment have rarely been designed with this population as a focus. Hispanic culture is characterized by Familism, a value that prioritizes familial respect, cooperation, and togetherness. We describe the rationale and design of a trial of the Healthy Living Program (HeLP), a bilingual whole-family behavioral obesity prevention and treatment intervention designed around the value Familism and addressing food insecurity. METHODS/DESIGN: This two-group randomized comparative effectiveness trial will compare the effects of HeLP versus a primary care counseling intervention (Recommended Treatment of Obesity in Primary Care, or RTOP) on decreasing body mass index (BMI; kg/m2) in Hispanic children 2-16 years of age with obesity and preventing BMI increase among siblings without obesity. 164 families per arm will be recruited from primary care practices. Families randomized to HeLP will participate in 12 two-hour sessions, followed by booster sessions. HeLP sessions include family meals and instruction in parenting skills, nutrition, culinary skills, fitness, and mindfulness delivered at community recreation centers by bilingual health educators and athletic trainers. Families randomized to RTOP will be offered individual visits in primary care every 3 months throughout the 18-month follow-up period. Secondary outcomes include changes to objectively measured child fitness, the home environment related to nutrition, physical activity, and media usage, food insecurity, child eating behaviors, quality of life, parent BMI and waist circumference, and implementation outcomes. DISCUSSION: This protocol paper describes the rationale and planned methods for the comparative effectiveness trial. TRIAL REGISTRATION: Clinicaltrials.gov Identifier NCT05041855 (6/13/2023).

The Impact of a Universal Mental Health Intervention on Youth with Elevated Negative Affectivity: Building Resilience for Healthy Kids.

Objective: In response to the rise in mental health needs among youth, a school-based resilience intervention was implemented for sixth graders at an urban middle school. The goal of this analysis is to examine improvements in key mental health parameters among students who endorsed negative affectivity at baseline. Method: A total of 285 11-12-year-olds (72% white, 18% Hispanic, 55% female) participated in a single-arm, non-randomized 6-week 1:1 school-based coaching intervention, Healthy Kids. Youth completed validated surveys at baseline and 6-week follow-up assessing depression/anxiety symptoms, bullying, self-efficacy, academic pressure, grit, and resilience. Participants were determined to have elevated negative affectivity if they reported mild-to-severe symptoms for both depression and anxiety symptoms. General linear models examined differences between groups for each mental health parameter, as well as change in outcomes from baseline to follow-up. Results: A third of participants (38%) at baseline endorsed negative affectivity. Youth who endorsed negative affectivity were more often female (71% vs 29%; p < 0.001) and identified as victims of cyberbullying (25% vs 8%; p < 0.001). Youth with baseline negative affectivity scored lower for self-efficacy (total 70.5 vs 86.8; p < 0.0001). Baseline negative affectivity was a significant moderator for change in mental health parameters. Post-intervention, those who endorsed baseline negative affectivity, medium effect sizes were observed for self-efficacy (g = 0.6; 95%CI 0.3, 0.9; p < 0.001) and anxiety symptoms (g = - 0.70; 95%CI - 1.0, - 0.4; p < 0.001). Among all youth, there were significant medium intervention effects in resilience (g = 0.5; 95%CI 0.3, 0.7; p < 0.001) and self-efficacy (g = 0.7; 95%CI 0.4, 0.9; p < 0.001). Conclusions: A universal resiliency program may improve self-efficacy and symptoms of anxiety among youth experiencing negative affectivity, while improving resilience and self-efficacy among all youth. Our findings suggest a universal school-based coaching program benefits all youth, while also specifically targeting the needs of youth with negative affectivity who are most at risk for mental health concerns.

Facebook Intervention for Young-Onset Melanoma Survivors and Families: Protocol for a Randomized Controlled Trial.

BACKGROUND: Individuals diagnosed with melanoma before the age of 40 years (young-onset melanoma survivors) and their first-degree relatives (FDRs) are a growing population at risk for developing recurrent melanoma or new melanomas. Regular surveillance using clinical skin examination (CSE) and skin self-examination (SSE) and engagement in preventive behaviors including sun protection are recommended. Given the growing population of survivors and their families who are at increased risk, it is surprising that no behavioral interventions have been developed and evaluated to improve risk-reduction behaviors. OBJECTIVE: We describe the rationale and methodology for a randomized controlled trial evaluating the efficacy of a Facebook intervention providing information, goal setting, and peer support to increase CSE, SSE, and sun protection for young-onset melanoma survivors and their FDRs. METHODS: Overall, 577 survivors and 577 FDRs will be randomly assigned to either the Young Melanoma Family Facebook Group or the Melanoma Family Healthy Lifestyle Facebook Group condition. Participants will complete measures of CSE, SSE, and sun protection, and mediator measures of attitudes and beliefs before and after the intervention. The primary aim is to evaluate the impact of the Young Melanoma Family Facebook intervention versus the Melanoma Family Healthy Lifestyle Facebook intervention on CSE, SSE frequency and comprehensiveness, and sun protection among FDRs. The secondary aims examine the efficacy of the Young Melanoma Family Facebook intervention on survivors' SSE frequency and comprehensiveness and sun protection behaviors and mechanisms of intervention efficacy for intervention impact on FDR and survivor outcomes. The exploratory aim is to evaluate the efficacy of the 2 interventions on perceived stress, physical activity, and healthy eating. RESULTS: This project was funded by the National Institutes of Health (R01CA221854). The project began in May 2018, and recruitment started in January 2019. We anticipate completing enrollment by November 2023. Power calculations recommended a sample size of 577 survivors and 577 FDRs. Multilevel modeling treating family as the upper-level sampling unit and individual as the lower-level sampling unit will be the primary data analytic approach. Fixed effect predictors in these models will include condition, role, sex, all 2- and 3-way interactions, and covariates. CONCLUSIONS: The Young Melanoma Family Facebook intervention aims to improve primary and secondary skin cancer prevention for young-onset melanoma survivors and their family members. The intervention's delivery via a popular, freely available social media platform increases its impact because of the potential for dissemination in many contexts. If efficacious, this program could be disseminated by dermatologist practices, public health or nonprofit organizations focused on melanoma, and existing melanoma and skin cancer Facebook groups, thereby expanding its reach. This project will produce a content library of posts and a moderation guide for others. TRIAL REGISTRATION: ClinicalTrials.gov NCT03677739; https://clinicaltrials.gov/ct2/show/NCT03677739. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/39640.