Characterizing opioid overdose hotspots for place-based overdose prevention and treatment interventions: A geo-spatial analysis of Rhode Island, USA.

OBJECTIVE: Examine differences in neighborhood characteristics and services between overdose hotspot and non-hotspot neighborhoods and identify neighborhood-level population factors associated with increased overdose incidence. METHODS: We conducted a population-based retrospective analysis of Rhode Island, USA residents who had a fatal or non-fatal overdose from 2016 to 2020 using an environmental scan and data from Rhode Island emergency medical services, State Unintentional Drug Overdose Reporting System, and the American Community Survey. We conducted a spatial scan via SaTScan to identify non-fatal and fatal overdose hotspots and compared the characteristics of hotspot and non-hotspot neighborhoods. We identified associations between census block group-level characteristics using a Besag-York-Mollié model specification with a conditional autoregressive spatial random effect. RESULTS: We identified 7 non-fatal and 3 fatal overdose hotspots in Rhode Island during the study period. Hotspot neighborhoods had higher proportions of Black and Latino/a residents, renter-occupied housing, vacant housing, unemployment, and cost-burdened households. A higher proportion of hotspot neighborhoods had a religious organization, a health center, or a police station. Non-fatal overdose risk increased in a dose responsive manner with increasing proportions of residents living in poverty. There was increased relative risk of non-fatal and fatal overdoses in neighborhoods with crowded housing above the mean (RR 1.19 [95 % CI 1.05, 1.34]; RR 1.21 [95 % CI 1.18, 1.38], respectively). CONCLUSION: Neighborhoods with increased prevalence of housing instability and poverty are at highest risk of overdose. The high availability of social services in overdose hotspots presents an opportunity to work with established organizations to prevent overdose deaths.

Psychometric properties of the family assessment task parental monitoring scenario among adolescents receiving substance use treatment.

INTRODUCTION: The Family Assessment Task (FAsTask) is an observer-rated parent-child interaction task used in adolescent substance use intervention. The parental monitoring component of the FAsTask is thought to provide an objective assessment of parental monitoring that can guide treatment planning and circumvent the potential limitations of self-report measures. Yet, the factor structure, measurement invariance, and concurrent validity of the parental monitoring FAsTask has not been evaluated; doing so is essential to effectively guide clinical care. This study examined if the parental monitoring FAsTask can be reliably administered across adolescent age and sex, and to identify which components of the parental monitoring FAsTask are most consistently associated with adolescent substance use. METHODS: The study pooled data from 388 adolescent-caregiver dyads across six separate clinical trials (adolescents [Mage = 15.7, 57.5% male, 61.9% White, 31.2% Latine]; caregivers [Mage = 42.14, 88.7% female, 72.7% White, 24.2% Latine]). Dyads completed the FAsTask and the Timeline Followback at baseline, prior to randomization. Analyses proceeded in three steps. First, exploratory factor analysis (EFA) was conducted in half of the sample, followed by a confirmatory factor analysis (CFA) in the second half of the sample. Second, measurement invariance was tested as a function of adolescent age and biological sex. Third, a series of structural equation models were used to assess the associations of each factor with alcohol use, binge drinking, and cannabis use. RESULTS: EFA and CFA indicated the presence of four factors (labeled Supervised/Structured, Active Monitoring, Task Engagement, and Parental Rules/Strategies). Evidence of measurement invariance was found across adolescent age and sex. The Supervision/Structure was negatively associated with adolescent alcohol use, binge drinking, and cannabis use. CONCLUSIONS: The parental monitoring FAsTask demonstrates validity and retains its structure across adolescent age and sex. Items focused on parental supervision and structure are most strongly associated with adolescent substance use and may best inform clinical care for adolescent substance use.

From court to the community: improving access to evidence-based treatment for underserved youth involved in the juvenile legal system at-risk for suicide.

BACKGROUND: Juvenile legal involved youth (JLIY) experience disproportionately high rates of suicidal and self-injurious thoughts and behaviors (SSITB). Many JLIY lack access to evidence-based treatment specifically designed to treat SSITB, thereby increasing the overall risk of suicide. The overwhelming majority of JLIY are not placed in secure facilities and almost all incarcerated youth are eventually released to the community. Consequently, SSITB are a major concern of JLIY residing in the community and it is critical that this population has access to evidence-based treatment for SSITB. Unfortunately, most community mental health providers who treat JLIY have not been trained in evidence-based interventions that are specifically designed to SSITB, which often leads to youth experiencing prolonged periods of SSITB. Training community mental health providers who serve JLIY in the detection and treatment of SSITB shows promise for decreasing the overall suicide risk for JLIY. METHODS: The current proposal aims to reduce SSITB among JLIY, and thus reduce mental health disparities in this vulnerable and underserved youth population, by increasing access to evidence-based treatment strategies specifically designed to treat SSITB behaviors. We will implement an agency-wide training among at least 9 distinct community mental health agencies that serve JLIY referred to treatment by a statewide court system in the Northeast. Agencies will be trained in an adapted version of the COping, Problem Solving, Enhancing life, Safety, and Parenting (COPES+) intervention. Training will be implemented via a cluster-randomized stepped wedge trial that proceeds through multiple phases. DISCUSSION: This research engages multiple systems (i.e., juvenile legal and mental health systems) serving JLIY and has the potential to directly inform treatment practices in juvenile legal and mental health systems. The current protocol has significant public health implications as the primary goals are to reduce SSITB among adolescents involved in the juvenile legal system. By implementing a training protocol with community-based providers to help them learn an evidence-based intervention, this proposal aims to reduce mental health disparities in a marginalized and underserved population. TRIAL REGISTRATION: osf.io/sq9zt.

Virtual Training Is More Cost-Effective Than In-Person Training for Preparing Staff to Implement Contingency Management.

Behavior therapy implementation relies in part on training to foster counselor skills in preparation for delivery with fidelity. Amidst Covid-19, the professional education arena witnessed a rapid shift from in-person to virtual training, yet these modalities' relative utility and expense is unknown. In the context of a cluster-randomized hybrid type 3 trial of contingency management (CM) implementation in opioid treatment programs (OTPs), a multi-cohort design presented rare opportunity to compare cost-effectiveness of virtual vs. in-person training. An initial counselor cohort (n = 26) from eight OTPs attended in-person training, and a subsequent cohort (n = 31) from ten OTPs attended virtual training. Common training elements were the facilitator, learning objectives, and educational strategies/activities. All clinicians submitted a post-training role-play, independently scored with a validated fidelity instrument for which performances were compared against benchmarks representing initial readiness and advanced proficiency. To examine the utility and expense of in-person and virtual trainings, cohort-specific rates for benchmark attainment were computed, and per-clinician expenses were estimated. Adjusted between-cohort differences were estimated via ordinary least squares, and an incremental cost effectiveness ratio (ICER) was calculated. Readiness and proficiency benchmarks were attained at rates 12-14% higher among clinicians attending virtual training, for which aggregated costs indicated a $399 per-clinician savings relative to in-person training. Accordingly, the ICER identified virtual training as the dominant strategy, reflecting greater cost-effectiveness across willingness-to-pay values. Study findings document greater utility, lesser expense, and cost-effectiveness of virtual training, which may inform post-pandemic dissemination of CM and other therapies.

Ho'ouna Pono implementation: applying concept mapping to a culturally grounded substance use prevention curriculum in rural Hawai'i schools.

BACKGROUND: Despite their potential to ameliorate health disparities and address youth substance use, prevention programs have been poorly disseminated and implemented across Hawai'i, which begs the question: Why are effective prevention programs not being used in communities most in need of them? Implementing and sustaining culturally grounded prevention programs is critical to address equitable healthcare and minimize health disparities in communities. The field of implementation science provides frameworks, theories, and methods to examine factors associated with community adoption of these programs. METHOD: Our project applies concept mapping methods to a culturally grounded youth drug prevention program with state level educational leadership in rural Hawai'i schools. The goal is to integrate barrier and facilitator salience collected through teacher and school staff surveys and specific implementation strategies to regionally tailored implementation plans on Hawai'i island. This protocol paper describes the concept mapping steps and how they will be applied in public and public-charter schools. DISCUSSION: Improving prevention program implementation in rural schools can result in sustained support for populations that need it most. The project will integrate implementation science and culturally grounded methods in rural Hawai'i, where most youth are of Native Hawaiian and Pacific Islander descent. This project addresses health disparities among Native Hawaiian and Pacific Islander youth and provides actionable plans for rural Hawai'i communities to implement effective prevention programming.

The measurement-based care to opioid treatment programs project (MBC2OTP): a study protocol using rapid assessment procedure informed clinical ethnography.

BACKGROUND: Psychosocial interventions are needed to enhance patient engagement and retention in medication treatment within opioid treatment programs. Measurement-based care (MBC), an evidence-based intervention structure that involves ongoing monitoring of treatment progress over time to assess the need for treatment modifications, has been recommended as a flexible and low-cost intervention for opioid treatment program use. The MBC2OTP Project is a two-phase pilot hybrid type 1 effectiveness-implementation trial that has three specific aims: (1) to employ Rapid Assessment Procedure Informed Clinical Ethnography (RAPICE) to collect mixed methods data to inform MBC implementation; (2) to use RAPICE data to adapt an MBC protocol; and (3) to conduct a hybrid type 1 trial to evaluate MBC's preliminary effectiveness and implementation potential in opioid treatment programs. METHODS: This study will be conducted in two phases. Phase 1 will include RAPICE site visits, qualitative interviews (N = 32-48 total), and quantitative surveys (N = 64-80 total) with staff at eight programs to build community partnerships and evaluate contextual factors impacting MBC implementation. Mixed methods data will be analyzed using immersion/crystallization and thematic analysis to inform MBC adaptation and site selection. Four programs selected for Phase 2 will participate in MBC electronic medical record integration, training, and ongoing support. Chart reviews will be completed in the 6 months prior-to and following MBC integration (N = 160 charts, 80 pre and post) to evaluate effectiveness (patient opioid abstinence and treatment engagement) and implementation outcomes (counselor MBC exposure and fidelity). DISCUSSION: This study is among the first to take forward recommendations to implement and evaluate MBC in opioid treatment programs. It will also employ an innovative RAPICE approach to enhance the quality and rigor of data collection and inform the development of an MBC protocol best matched to opioid treatment programs. Overall, this work seeks to enhance treatment provision and clinical outcomes for patients with opioid use disorder. Trial registration This study will be registered with Clinicaltrials.gov within 21 days of first participant enrollment in Phase 2. Study Phase 1 (RAPICE) does not qualify as a clinical trial, therefore Phase 2 clinical trial registration has not yet been pursued because all elements of Phase 2 will be dependent on Phase 1 outcomes.

You have an effective brief intervention (BI) for young adults, now what? Concrete strategies to advance BI implementation in usual care settings.

Objective: Risky drinking remains high among young adults and is associated with negative health-related consequences. Brief interventions (BIs) are an evidence-based practice for risky drinking that are particularly well suited for young adults. However, the widespread implementation of BIs remains challenging. This article highlights guiding principles for researchers and clinicians seeking to implement BI for young adults. Method: Five guiding principles for the implementation of BIs for young adults with risky drinking are introduced as follows: (a) selecting an implementation model; (b) considering contextual factors; (c) specifying an implementation strategy; (d) assessing implementation outcomes; and (e) embracing hybrid effectiveness-implementation designs. Advancing health equity is considered a key crosscutting theme. Results: Multiple implementation models are discussed including process models, determinant frameworks, classic theories, implementation theories, and evaluation frameworks. Contextual factors impacting BI implementation are then considered across multiple levels within an organization. Next, we present methods for selecting implementation strategies and discuss implementation outcomes that can be measured during preimplementation, implementation, and sustainability phases. Finally, we encourage employing hybrid effectiveness-implementation designs to reduce the BI science-practice gap. Guiding principles are illustrated with examples from two National Institute on Alcohol Abuse and Alcoholism-funded studies exploring BI implementation domestically and internationally. Conclusions: This article introduces foundational principles and emerging strategies to nonspecialist researchers, clinicians, and policymakers seeking to enhance the dissemination and implementation of BIs. Advancing the dissemination and implementation of BIs is essential to ensure that investments in BI research are fully realized to equitably improve public health. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Project MIMIC (Maximizing Implementation of Motivational Incentives in Clinics): A cluster-randomized type 3 hybrid effectiveness-implementation trial.

BACKGROUND: Opioid-related overdoses and harms have been declared a public health emergency in the United States, highlighting an urgent need to implement evidence-based treatments. Contingency management (CM) is one of the most effective behavioral interventions when delivered in combination with medication for opioid use disorder, but its implementation in opioid treatment programs is woefully limited. Project MIMIC (Maximizing Implementation of Motivational Incentives in Clinics) was funded by the National Institute on Drug Abuse to identify effective strategies for helping opioid treatment programs improve CM implementation as an adjunct to medication. Specific aims will test the impact of two different strategies on implementation outcomes (primary aim) and patient outcomes (secondary aims), as well as test putative mediators of implementation effectiveness (exploratory aim). METHODS: A 3-cohort, cluster-randomized, type 3 hybrid design is used with the opioid treatment programs as the unit of randomization. Thirty programs are randomized to one of two conditions. The control condition is the Addiction Technology Transfer Center (ATTC) Network implementation strategy, which consists of three core approaches: didactic training, performance feedback, and on-going consultation. The experimental condition is an enhanced ATTC strategy, with the same core ATTC elements plus two additional theory-driven elements. The two additional elements are Pay-for-Performance, which aims to increase implementing staff's extrinsic motivations, and Implementation & Sustainment Facilitation, which targets staff's intrinsic motivations. Data will be collected using a novel, CM Tracker tool to document CM session delivery, session audio recordings, provider surveys, and patient surveys. Implementation outcomes include CM Exposure (number of CM sessions delivered per patient), CM Skill (ratings of CM fidelity), and CM Sustainment (number of patients receiving CM after removal of support). Patient outcomes include self-reported opioid abstinence and opioid-related problems (both assessed at 3- and 6-months post-baseline). DISCUSSION: There is urgent public health need to improve the implementation of CM as an adjunct to medication for opioid use disorder. Consistent with its hybrid type 3 design, Project MIMIC is advancing implementation science by comparing impacts of these two multifaceted strategies on both implementation and patient outcomes, and by examining the extent to which the impacts of those strategies can be explained by putative mediators. TRIAL REGISTRATION: This clinical trial has been registered with clinicaltrials.gov (NCT03931174). Registered April 30, 2019. https://clinicaltrials.gov/ct2/show/NCT03931174?term=project+mimic&draw=2&rank=1.

Substance Use Workforce Training Needs during Intersecting Epidemics: An Analysis of Events Offered by a Regional Training Center from 2017-2020.

Background: Intersecting opioid overdose, COVID-19, and systemic racism epidemics havebrought unprecedented challenges to the addiction treatment and recovery workforce. From 2017-2020, the New England Addiction Technology Transfer Center (ATTC) collected data in real-time on the training and technical assistance (TA) requested and attended by the front-line workforce. This article synthesizes practice-based evidence on the types of TA requests, topics of TA, attendance numbers, and socio-demographics of TA attendees over a 3-year period spanning an unprecedented public health syndemic. Methods: We assessed TA events hosted by the New England ATTC using SAMHSA’s Performance Accountability and Reporting System post-event survey data from 2017-2020. Events were coded by common themes to identify the most frequently requested training types/topics and most frequently attended training events. We also evaluated change in training topics and attendee demographics over the three-year timeline. Results: A total of 258 ATTC events reaching 10,143 participants were analyzed. The number of TA events and attendance numbers surged in the 2019-2020 fiscal year as TA events shifted to fully virtual during the COVID-19 pandemic. The absolute number of opioid-related events increased, but the relative proportion remained stable over time. The relative proportions of events and attendance rates focused on evidence-based practice and health equity both increased over the 3-year period, with the largest increase after the onset of the pandemic and the murder of George Floyd. As events shifted to virtual, events were attended by providers with a broader range of educational backgrounds. Conclusions: Results of the current analysis indicate that the demand for TA increased during the pandemic, with a prioritization of TA focused on evidence-based practice and health equity. The practice-based evidence generated from the New England ATTC may help other training and TA centers to anticipate and nimbly respond to the needs of the workforce in the face of the intersecting epidemics.

Arithmetic Errors in Financial Contexts in Parkinson's Disease.

Research on dyscalculia in neurodegenerative diseases is still scarce, despite high impact on patients' independence and activities of daily living function. Most studies address Alzheimer's Disease; however, patients with Parkinson's Disease (PD) also have a higher risk for cognitive impairment while the relation to arithmetic deficits in financial contexts has rarely been studied. Therefore, the current exploratory study investigates deficits in two simple arithmetic tasks in financial contexts administered within the Clinical Dementia Rating in a sample of 100 PD patients. Patients were classified as cognitively normal (PD-NC) or mildly impaired (PD-MCI) according to Level I consensus criteria, and assessed using a comprehensive neuropsychological test battery, neurological motor examination, and sociodemographic and clinical questionnaires. In total, 18% showed arithmetic deficits: they were predominately female, had longer disease duration, more impaired global cognition, but minor signs of depression compared to PD patients without arithmetic deficits. When correcting for clinical and sociodemographic confounders, greater impairments in attention and visuo-spatial/constructional domains predicted occurrence of arithmetic deficits. The type of deficit did not seem to be arbitrary but seemed to involve impaired place × value processing frequently. Our results argue for the importance of further systematic investigations of arithmetic deficits in PD with sensitive tests to confirm the results of our exploratory study that a specific subgroup of PD patients present themselves with dyscalculia.

Evaluating approaches to marketing cognitive behavioral therapy: does evidence matter to consumers?

Direct-to-consumer marketing initiatives may improve utilization of evidence-based therapy.  An important decision in such marketing efforts is how to effectively present scientific evidence supporting these treatments to potential consumers (if at all). This OSF preregistered study experimentally tested whether the language used to describe research evidence supporting cognitive behavioral therapy (CBT) for anxiety disorders affected consumer treatment attitudes and intentions. Adult participants (N = 303) recruited via mTurk were first assessed for their understanding of the term "evidence-based." They were then randomized to read a description of CBT employing either: formal research language (e.g., "large-scale clinical trials have demonstrated…"), informal language about research support derived from prior qualitative work (e.g., "people have better results…"), or no information about research. Perceptions of CBT (including credibility and expectancy) and likelihood of pursuing CBT (pull demand) were assessed. Results indicated that only half the sample understood the meaning of the term "evidence-based." The conditions that discussed research support outperformed the control condition on CBT perceptions, credibility, general expectancies, and perceived effectiveness. Post-hoc comparisons provided some evidence that qualitatively-derived language was more effective than formal research language for promoting positive perceptions of CBT. Implications for marketing content are discussed.

Assessment of cognitive-driven activity of daily living impairment in non-demented Parkinson's patients.

The core criterion for Parkinson's disease dementia (PDD) is the impairment in activities of daily living (ADL) function primarily caused by cognitive, not motor symptoms. There is evidence to assume that mild ADL impairments in mild cognitive impairment (PD-MCI) characterize those patients at high risk for dementia. Data of 216 Parkinson's disease (PD) patients assessed with comprehensive motor and neuropsychological assessments were analysed. Based on linear regression models, subscores of the Functional Activities Questionnaire (FAQ) primarily reflecting patients' global cognitive status (FAQC ) or PD-related motor severity (FAQM ) were developed. A quotient (FAQQ ) of both scores was calculated, with values >1 indicating more cognitive- compared to motor-driven ADL impairment. Both FAQC and FAQM scores were higher in PD-MCI than cognitively normal (PD-CN) patients, indicating more severe cognitive- and motor-driven ADL impairments in this group. One third (31.6%) of the PD-MCI group had a FAQQ score >1, which was significantly different from patients with PD-CN (p = .02). PD-MCI patients with an FAQQ score >1 were more impaired on tests assessing attention (p = .019) and language (p = .033) compared to PD-MCI patients with lower FAQQ values. The differentiation between cognitive- and motor-driven ADL is important, as the loss of functional capacity is the defining factor for a diagnosis of PDD. We were able to differentiate the cognitive-driven from the motor-driven ADL impairments for the FAQ. PD-MCI patients with more cognitive- compared to motor-driven ADL impairments may pose a risk group for conversion to PDD and can be targeted for early treatments.

Assessment of Cognitive-Driven Performance-Based Activities of Daily Living Dysfunction in Parkinson's Disease.

OBJECTIVES: Parkinson's disease (PD) patients with mild cognitive impairment (PD-MCI) have an increased risk of developing dementia (PDD). As activities of daily living (ADL) impairment is mandatory for the diagnosis of PDD, assessing early signs of instrumental ADL (iADL) dysfunction, especially in PD-MCI, is essential. In PD, self- and caregiver-reported iADL performance is often confounded by motor dysfunction and mood. Objective and time-efficient performance-based measurements are needed to screen for cognitive-related iADL dysfunction. We evaluated the Erlangen Test of Activities of Daily Living in Mild Dementia and Mild Cognitive Impairment (ETAM) in PD and determined its value for characterizing a subgroup of PD-MCI patients with mild performance-based iADL impairment. METHODS: Twenty-one cognitively normal PD patients (PD-NC), 24 PD-MCI patients, and 18 healthy controls (HC) were analyzed. Assessments included the ETAM, a comprehensive neuropsychological test battery, iADL, mood, and motor measurements. RESULTS: PD-MCI patients scored significantly lower on the ETAM total score compared to PD-NC patients (p = .002), whereas HC and PD-NC patients did not statistically differ. No HC scored lower than 27 points (diagnostic cutoff for mild iADL impairment); only PD-MCI patients scored below this cutoff (29.2%) suggesting the ETAM is able to characterize a PD-MCI subgroup with early iADL impairment. PD-MCI patients below the cutoff were more impaired in the attention domain (p = .04). CONCLUSIONS: The ETAM is a potentially valuable clinical assessment, able to detect first signs of iADL dysfunction in PD-MCI. Further studies in larger cohorts are needed to evaluate the prognostic ability for predicting PDD.

Validation of a novel Montreal Cognitive Assessment scoring algorithm in non-demented Parkinson's disease patients.

INTRODUCTION: The early diagnosis of mild cognitive impairment (PD-MCI) in Parkinson's disease (PD) is essential as it increases the future risk for PD dementia (PDD). Recently, a novel weighting algorithm for the Montreal Cognitive Assessment (MoCA) subtests has been reported, to best discriminate between those with and without cognitive impairment in PD. The aim of our study was to validate this scoring algorithm in a large sample of non-demented PD patients, hypothesizing that the weighted MoCA would have a higher diagnostic accuracy for PD-MCI than the original MoCA. METHODS: In 202 non-demented PD patients, we evaluated cognitive status, clinical and demographic data, as well as the MoCA with a weighted and unweighted score. Receiver operating characteristic (ROC) curve analysis was used to evaluate discriminative ability of the MoCA. Group comparisons and ROC analysis were performed for PD-MCI classifications with a cut-off ≤ 1, 1.5, and 2 standard deviation (SD) below appropriate norms. RESULTS: PD-MCI patients scored lower on the weighted than the original MoCA version (p < 0.001) compared to PD patients with normal cognitive function. Areas under the curve only differed significantly for the 2 SD cut-off, leading to an increased sensitivity of the weighted MoCA score (72.9% vs. 70.5%) and specificity compared to the original version (79.0% vs. 65.4%). CONCLUSIONS: Our results indicate better discriminant power for the weighted MoCA compared to the original for more advanced stages of PD-MCI (2 SD cut-off). Future studies are needed to evaluate the predictive value of the weighted MoCA for PDD.

Evaluating whether direct-to-consumer marketing can increase demand for evidence-based practice among parents of adolescents with substance use disorders: rationale and protocol.

BACKGROUND: Fewer than one in 10 adolescents with substance use disorders (ASUDs) will receive specialty treatment, and even fewer will receive treatment designated as evidence-based practice (EBP). Traditional efforts to increase the utilization of EBP by ASUDs typically focus on practitioners-either in substance use clinics or allied health settings. Direct-to-consumer (DTC) marketing that directly targets parents of ASUDs represents a potentially complementary paradigm that has yet to be evaluated. The current study is the first to evaluate the relevance of a well-established marketing framework (the Marketing Mix) and measurement approach (measurement of perceived service quality [PSQ]) with parents of ASUDs in need of treatment. METHODS/DESIGN: A mixed-methods design is employed across three study phases, consistent with well-established methods used in the field of marketing science. Phase 1 consists of formative qualitative research with parents (and a supplementary sample of adolescents) in order to evaluate and potentially adapt a conceptual framework (Marketing Mix) and measure of PSQ. Phase 2 is a targeted survey of ASUD parents to elucidate their marketing preferences, using the adapted Marketing Mix framework, and to establish the psychometric properties of the PSQ measure. The survey will also gather data on parents' preferences for different targeted marketing messages. Phase 3 is a two-group randomized controlled trial comparing the effectiveness of targeted marketing messages versus standard clinical information. Key outcomes will include parents' ratings of PSQ (using the new measure), behavioral intentions to seek out information about EBP, and actual information-seeking behavior. DISCUSSION: The current study will inform the field whether a well-established marketing framework and measurement approach can be used to increase demand for EBP among parents of ASUDs. Results of this study will have the potential to immediately inform DTC marketing efforts by professional organizations, federal agencies, clinicians, and clinical researchers.

Simultaneous development of the Pediatric GERD Caregiver Impact Questionnaire (PGCIQ) in American English and American Spanish.

BACKGROUND: The objective of this study was to develop simultaneously a new questionnaire, the Pediatric GERD Caregiver Impact Questionnaire (PGCIQ), in American English and American Spanish in order to elucidate the impact of caring for a child with GERD. METHODS: Two focus group discussions were conducted in American English and American Spanish to develop a relevant conceptual model. Focus group participants were the primary caregivers of children with GERD (newborn through 12 years of age). Participant responses were qualitatively analyzed to identify potential differences in caregiver perspectives by the caregiver's language, socio-economic status and demographic profile as well as the child's age and disease severity level. Items in the PGCIQ were generated simultaneously in English and Spanish by reviewing results of qualitative analysis from focus groups in each language. The PGCIQ was finalized in both languages after testing content validity and conducting an in-depth translatability assessment. RESULTS: Analysis of focus group comments resulted in the development of a first draft questionnaire consisting of 58 items in 10 domains. Content validity testing and an in-depth translatability assessment resulted in wording modification of 37 items, deletion of 14 items and the addition of a domain with five items. Feedback from the content validity testing interviews indicated that the instrument is conceptually relevant in both American English and American Spanish, clear, comprehensive and easy to complete within 10 minutes. The final version of the PGCIQ contains 49 items assessing ten domains. An optional module with nine items is available for investigative research purposes and for use only at baseline. CONCLUSION: The PGCIQ was developed using simultaneous item generation, a process that allows for consideration of concept relevance in all stages of development and in all languages being developed. The PGCIQ is the first questionnaire to document the multidimensional impact of caring for an infant or young child with GERD. Linguistic adaptation of the PGCIQ in multiple languages is ongoing. A validation study of the PGCIQ is needed to examine its psychometric properties, further refine the items and develop an appropriate scoring model.