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We tested the efficacy of a comprehensive intervention program designed for high school students across the autism spectrum, the Center on Secondary Education for Students with Autism (CSESA) model, in a cluster randomized control trial involving 60 high schools in three states (California, North Carolina, Wisconsin), with implementation occurring over a 2-year period. We examined outcomes for the schools, students (N = 547), and families. At the conclusion of the study, CSESA schools had significantly higher program quality than the services-as-usual (SAU) schools. In addition, students in the CSESA schools had significantly higher total attainment of educational goals than students in SAU schools. There were not significant differences between the two groups on standardized assessment outcomes. We discuss implications for intervention implementation and future research with this population in the public school context.

Previous studies have demonstrated evidence of latent skill continuity even in tests intentionally designed for measurement of binary skills. In addition, the assumption of binary skills when continuity is present has been shown to potentially create a lack of invariance in item and latent ability parameters that may undermine applications. In this article, we examine measurement of growth as one such application, and consider multidimensional item response theory (MIRT) as a competing alternative. Motivated by prior findings concerning the effects of skill continuity, we study the relative robustness of cognitive diagnostic models (CDMs) and (M)IRT models in the measurement of growth under both binary and continuous latent skill distributions. We find CDMs to be a less robust way of quantifying growth under misspecification, and subsequently provide a real-data example suggesting underestimation of growth as a likely consequence. It is suggested that researchers should regularly attend to the assumptions associated with the use of latent binary skills and consider (M)IRT as a potentially more robust alternative if unsure of their discrete nature.

IntroductionAvailable evidence is mixed concerning associations between smoking status and COVID-19 clinical outcomes. Effects of nicotine replacement therapy (NRT) and vaccination status on COVID-19 outcomes in smokers are unknown.MethodsElectronic health record data from 104 590 COVID-19 patients hospitalized February 1, 2020 to September 30, 2021 in 21 U.S. health systems were analyzed to assess associations of smoking status, in-hospital NRT prescription, and vaccination status with in-hospital death and ICU admission.ResultsCurrent (n = 7764) and never smokers (n = 57 454) did not differ on outcomes after adjustment for age, sex, race, ethnicity, insurance, body mass index, and comorbidities. Former (vs never) smokers (n = 33 101) had higher adjusted odds of death (aOR, 1.11; 95% CI, 1.06-1.17) and ICU admission (aOR, 1.07; 95% CI, 1.04-1.11). Among current smokers, NRT prescription was associated with reduced mortality (aOR, 0.64; 95% CI, 0.50-0.82). Vaccination effects were significantly moderated by smoking status; vaccination was more strongly associated with reduced mortality among current (aOR, 0.29; 95% CI, 0.16-0.66) and former smokers (aOR, 0.47; 95% CI, 0.39-0.57) than for never smokers (aOR, 0.67; 95% CI, 0.57, 0.79). Vaccination was associated with reduced ICU admission more strongly among former (aOR, 0.74; 95% CI, 0.66-0.83) than never smokers (aOR, 0.87; 95% CI, 0.79-0.97).ConclusionsFormer but not current smokers hospitalized with COVID-19 are at higher risk for severe outcomes. SARS-CoV-2 vaccination is associated with better hospital outcomes in COVID-19 patients, especially current and former smokers. NRT during COVID-19 hospitalization may reduce mortality for current smokers.ImplicationsPrior findings regarding associations between smoking and severe COVID-19 disease outcomes have been inconsistent. This large cohort study suggests potential beneficial effects of nicotine replacement therapy on COVID-19 outcomes in current smokers and outsized benefits of SARS-CoV-2 vaccination in current and former smokers. Such findings may influence clinical practice and prevention efforts and motivate additional research that explores mechanisms for these effects.

BackgroundThere is mixed evidence about the relations of current versus past cancer with severe COVID-19 outcomes and how they vary by patient and cancer characteristics.MethodsElectronic health record data of 104,590 adult hospitalized patients with COVID-19 were obtained from 21 United States health systems from February 2020 through September 2021. In-hospital mortality and ICU admission were predicted from current and past cancer diagnoses. Moderation by patient characteristics, vaccination status, cancer type, and year of the pandemic was examined.Results6.8% of the patients had current (n = 7,141) and 6.5% had past (n = 6,749) cancer diagnoses. Current cancer predicted both severe outcomes but past cancer did not; adjusted odds ratios (aOR) for mortality were 1.58 [95% confidence interval (CI), 1.46-1.70] and 1.04 (95% CI, 0.96-1.13), respectively. Mortality rates decreased over the pandemic but the incremental risk of current cancer persisted, with the increment being larger among younger vs. older patients. Prior COVID-19 vaccination reduced mortality generally and among those with current cancer (aOR, 0.69; 95% CI, 0.53-0.90).ConclusionsCurrent cancer, especially among younger patients, posed a substantially increased risk for death and ICU admission among patients with COVID-19; prior COVID-19 vaccination mitigated the risk associated with current cancer. Past history of cancer was not associated with higher risks for severe COVID-19 outcomes for most cancer types.ImpactThis study clarifies the characteristics that modify the risk associated with cancer on severe COVID-19 outcomes across the first 20 months of the COVID-19 pandemic. See related commentary by Egan et al., p. 3.

Person misfit and person reliability indices in item response theory (IRT) can play an important role in evaluating the validity of a test or survey instrument at the respondent level. Prior empirical comparisons of these indices have been applied to binary item response data and suggest that the two types of indices return very similar results. In this paper, however, we demonstrate an important applied distinction between these methods when applied to polytomously-scored rating scale items, namely their varying sensitivities to response style tendencies. Using several empirical datasets, we illustrate settings in which these indices are in one case highly correlated and in two other cases weakly correlated. In the datasets showing a weak correlation between indices, the primary distinction appears due to the effects of response style behavior, whereby respondents whose response styles are less common (e.g. a disproportionate selection of the midpoint response) are found to misfit using Drasgow et al's l[subscript z] person misfit index, but often show high levels of reliability from a person reliability perspective; just the opposite frequently occurs for respondents that over-select the rating scale extremes. It is suggested that person misfit reporting should be supplemented with an evaluation of person reliability to best understand the validity of measurement at the respondent level when using IRT models with rating scale measures.

Main objectiveThere is limited information on how patient outcomes have changed during the COVID-19 pandemic. This study characterizes changes in mortality, intubation, and ICU admission rates during the first 20 months of the pandemic.Study design and methodsUniversity of Wisconsin researchers collected and harmonized electronic health record data from 1.1 million COVID-19 patients across 21 United States health systems from February 2020 through September 2021. The analysis comprised data from 104,590 adult hospitalized COVID-19 patients. Inclusion criteria for the analysis were: (1) age 18 years or older; (2) COVID-19 ICD-10 diagnosis during hospitalization and/or a positive COVID-19 PCR test in a 14-day window (+/- 7 days of hospital admission); and (3) health system contact prior to COVID-19 hospitalization. Outcomes assessed were: (1) mortality (primary), (2) endotracheal intubation, and (3) ICU admission.Results and significanceThe 104,590 hospitalized participants had a mean age of 61.7 years and were 50.4% female, 24% Black, and 56.8% White. Overall risk-standardized mortality (adjusted for age, sex, race, ethnicity, body mass index, insurance status and medical comorbidities) declined from 16% of hospitalized COVID-19 patients (95% CI: 16% to 17%) early in the pandemic (February-April 2020) to 9% (CI: 9% to 10%) later (July-September 2021). Among subpopulations, males (vs. females), those on Medicare (vs. those on commercial insurance), the severely obese (vs. normal weight), and those aged 60 and older (vs. younger individuals) had especially high mortality rates both early and late in the pandemic. ICU admission and intubation rates also declined across these 20 months.ConclusionsMortality, intubation, and ICU admission rates improved markedly over the first 20 months of the pandemic among adult hospitalized COVID-19 patients although gains varied by subpopulation. These data provide important information on the course of COVID-19 and identify hospitalized patient groups at heightened risk for negative outcomes.Trial registrationClinicalTrials.gov Identifier: NCT04506528 (https://clinicaltrials.gov/ct2/show/NCT04506528).

Four-parameter models have received increasing psychometric attention in recent years, as a reduced upper asymptote for item characteristic curves can be appealing for measurement applications such as adaptive testing and person-fit assessment. However, applications can be challenging due to the large number of parameters in the model. In this article, we demonstrate in the context of mathematics assessments how the slip and guess parameters of a four-parameter model may often be empirically related. This observation also has a psychological explanation to the extent that both asymptote parameters may be manifestations of a single item complexity characteristic. The relationship between lower and upper asymptotes motivates the consideration of an asymmetric item response theory model as a three-parameter alternative to the four-parameter model. Using actual response data from mathematics multiple-choice tests, we demonstrate the empirical superiority of a three-parameter asymmetric model in several standardized tests of mathematics. To the extent that a model of asymmetry ultimately portrays slips and guesses not as purely random but rather as proficiency-related phenomena, we argue that the asymmetric approach may also have greater psychological plausibility.

Purpose: The aim of this study was to determine how the speech disorder profiles in Down syndrome (DS) relate to reduced intelligibility, atypical overall quality, and impairments in the subsystems of speech production (phonation, articulation, resonance, and prosody). Method: Auditory-perceptual ratings of intelligibility, overall quality, and features associated with the subsystems of speech production were obtained from recordings of 79 children and adults with DS. Ratings were made for sustained vowels (62 of 79 speakers) and short sentences (79 speakers). The data were analyzed to determine the severity of the affected features in each speaking task and to detect patterns in the group data by means of principal components analysis. Results: Reduced intelligibility was noted in 90% of the speakers, and atypical overall speech quality was noted in 100%. Affected speech features were distributed across the speech production subsystems. Principal components analysis revealed four components each for the vowel and sentence tasks, showing that individuals with DS are not homogeneous in the features of their speech disorder. Discussion: The speech disorder in DS is complex in its perceptual features and reflects impairments across the subsystems of speech production, but the pattern is not uniform across individuals, indicating that attention must be given to individual variation in designing treatments.

This paper presents a mixture item response tree (IRTree) model for extreme response style. Unlike traditional applications of single IRTree models, a mixture approach provides a way of representing the mixture of respondents following different underlying response processes (between individuals), as well as the uncertainty present at the individual level (within an individual). Simulation analyses reveal the potential of the mixture approach in identifying subgroups of respondents exhibiting response behavior reflective of different underlying response processes. Application to real data from the Students Like Learning Mathematics (SLM) scale of Trends in International Mathematics and Science Study (TIMSS) 2015 demonstrates the superior comparative fit of the mixture representation, as well as the consequences of applying the mixture on the estimation of content and response style traits. We argue that methodology applied to investigate response styles should attend to the inherent uncertainty of response style influence due to the likely influence of both response styles and the content trait on the selection of extreme response categories.

We revisit the empirically observed positive correlation between DIF and difficulty studied by Freedle and commonly seen in tests of verbal proficiency when comparing populations of different mean latent proficiency levels. It is shown that a positive correlation between DIF and difficulty estimates is actually an expected result (absent any true DIF) in the presence of systematically negative ICC asymmetry. Under such conditions, conditional upon sum score, correct responses to easier items are indicative of higher latent proficiency than correct responses to more difficult items. Negative ICC asymmetry, which can occur as a result of disjunctively interacting latent subprocesses (including disjunctive combinations of proficiency-based guessing and problem-solving processes, for example), is suggested to be widely present among items used in many verbal tests due to their general lack of problem-solving complexity and the anticipated presence of proficiency-related guessing. When systematic, negative ICC asymmetries result in a shrinkage of units at the lower end of the IRT metric when traditional symmetric IRT models are applied. We demonstrate by simulation an ensuing DIF-difficulty correlation artifact in application of a model-based DIF approach, as well as for the Mantel-Haenszel and Standardization DIF detection methods. A sensitivity analysis illustration demonstrates how assuming a fixed level of negative asymmetry in the ICCs effectively makes an observed positive correlation between DIF and difficulty seen when fitting symmetric ICCs go away.

IntroductionThere are no population-level estimates in the United States for achievement of blood pressure goals in patients with diabetes and hypertension by obesity weight class.AimWe sought to examine the relationship between the extent of obesity and the achievement of guideline-recommended blood pressure goals and other quality of care metrics among patients with diabetes.MethodsWe conducted an observational population-based cohort study of electronic health data of three large health systems from 2010-2012 in rural, urban and suburban settings of 51,229 adults with diabetes. Outcomes were achievement of diabetes quality of care metrics: blood pressure, A1c, and LDL control, and A1c and LDL testing. Two blood pressure goals were examined given the recommendation for adults with diabetes of 130/80 mmHg from JNC7 and the recommendation of 140/90 mmHg from JNC8 in 2014.ResultsPatients in obesity classes I, II, and III with diagnosed hypertension were less likely to achieve blood pressure control at both the 140/90 mmHg and 130/80 mmHg control levels. The patients from obesity class III had the lowest likelihood of achieving control at the 130/80 mmHg goal, and control was markedly worse for the 130/80 mmHg threshold in all weight classes. There were minimal to no differences by weight class in LDL and A1c control and LDL and A1c testing.ConclusionsAlthough the cardiovascular risk for patients with obesity and diabetes is greater than for non-obese patients with diabetes, we found that patients with obesity are even further behind in achieving blood pressure control.

Some previous studies suggest that response times (RTs) on rating scale items can be informative about the content trait, but a more recent study suggests they may also be reflective of response styles. The latter result raises questions about the possible consideration of RTs for content trait estimation, as response styles are generally viewed as nuisance dimensions in the measurement of noncognitive constructs. In this article, we extend previous work exploring the simultaneous relevance of content and response style traits on RTs in self-report rating scale measurement by examining psychometric differences related to fast versus slow item responses. Following a parallel methodology applied with cognitive measures, we provide empirical illustrations of how RTs appear to be simultaneously reflective of both content and response style traits. Our results demonstrate that respondents may exhibit different response behaviors for fast versus slow responses and that both the content trait and response styles are relevant to such heterogeneity. These findings suggest that using RTs as a basis for improving the estimation of noncognitive constructs likely requires simultaneously attending to the effects of response styles. [ABSTRACT FROM AUTHOR]

The purpose of this study was to examine middle school outreach to families about student behavior and its relationship with student school behavior, conduct problems, emotional symptoms, prosocial behavior, as well as school safety. In addition, the role of school implementation of positive behavioral interventions and supports (PBIS) was examined as a systems-level approach that could promote school outreach to families. Participants were 653 teachers and 12,912 students across 41 public middle schools in the Northwest region of the United States. The longitudinal data were examined using multilevel regression models in which repeated measures at the school level were nested within schools. Residualized change in school-level outcome was modeled as a function of current and prior measures. Findings suggested that teacher report of school proactive outreach to families predicted greater teacher report of school safety, as well as declines in student report of conduct problems and emotional symptoms. In addition, results suggested that school outreach was associated with teacher report of student school behavior. Implications for continued research on school-home communication, as well as implications for embedding proactive school-home communication approaches in school systems and practices, are discussed.

ObjectiveTo find clinically relevant combinations of chronic conditions among patients with diabetes and to examine their relationships with six diabetes quality metrics.Data sources/study settingTwenty-nine thousand five hundred and sixty-two adult patients with diabetes seen at eight Midwestern U.S. health systems during 2010-2011.Study designWe retrospectively evaluated the relationship between six diabetes quality metrics and patients' combinations of chronic conditions. We analyzed 12 conditions that were concordant with diabetes care to define five mutually exclusive combinations of conditions ("classes") based on condition co-occurrence. We used logistic regression to quantify the relationship between condition classes and quality metrics, adjusted for patient demographics and utilization.Data collectionWe extracted electronic health record data using a standardized algorithm.Principal findingsWe found the following condition classes: severe cardiac, cardiac, noncardiac vascular, risk factors, and no concordant comorbidities. Adjusted odds ratios and 95 percent confidence intervals for glycemic control were, respectively, 1.95 (1.7-2.2), 1.6 (1.4-1.9), 1.3 (1.2-1.5), and 1.3 (1.2-1.4) compared to the class with no comorbidities. Results showed similar patterns for other metrics.ConclusionsPatients had distinct quality metric achievement by condition class, and those in less severe classes were less likely to achieve diabetes metrics.

Purpose: The aim of this study was to determine how the speech disorder profiles in Down syndrome (DS) relate to reduced intelligibility, atypical overall quality, and impairments in the subsystems of speech production (phonation, articulation, resonance, and prosody). Method: Auditory-perceptual ratings of intelligibility, overall quality, and features associated with the subsystems of speech production were obtained from recordings of 79 children and adults with DS. Ratings were made for sustained vowels (62 of 79 speakers) and short sentences (79 speakers). The data were analyzed to determine the severity of the affected features in each speaking task and to detect patterns in the group data by means of principal components analysis. Results: Reduced intelligibility was noted in 90% of the speakers, and atypical overall speech quality was noted in 100%. Affected speech features were distributed across the speech production subsystems. Principal components analysis revealed four components each for the vowel and sentence tasks, showing that individuals with DS are not homogeneous in the features of their speech disorder. Discussion: The speech disorder in DS is complex in its perceptual features and reflects impairments across the subsystems of speech production, but the pattern is not uniform across individuals, indicating that attention must be given to individual variation in designing treatments., Down syndrome (DS) is a genetic defect caused by trisomy of whole or part of chromosome 21. Worldwide, it is the most prevalent genetic disorder and the most common genetic [...]

Aim: To compare effects of three post‐relapse interventions on smoking abstinence. Design: Sequential three‐phase multiple assignment randomized trial (SMART). Setting: Eighteen Wisconsin, USA, primary care clinics. Participants: A total of 1154 primary care patients (53.6% women, 81.2% White) interested in quitting smoking enrolled from 2015 to 2019; 582 relapsed and were randomized to relapse recovery treatment. Interventions: In phase 1, patients received cessation counseling and 8 weeks nicotine patch. Those who relapsed and agreed were randomized to a phase 2 relapse recovery group: (1) reduction counseling + nicotine mini‐lozenges + encouragement to quit starting 1 month post‐randomization (preparation); (2) repeated encouragement to quit starting immediately post‐randomization (recycling); or (3) advice to call the tobacco quitline (control). The first two groups could opt into phase 3 new quit treatment [8 weeks nicotine patch + mini‐lozenges plus randomization to two treatment factors (skill training and supportive counseling) in a 2 × 2 design]. Phase 2 and 3 interventions lasted ≤ 15 months. Measurements The study was powered to compare each active phase 2 treatment with the control on the primary outcome: biochemically confirmed 7‐day point‐prevalence abstinence 14 months post initiating phase 2 relapse recovery treatment. Exploratory analyses tested for phase 3 counseling factor effects. Findings Neither skill training nor supportive counseling (each on versus off) increased 14‐month abstinence rates; skills on versus off 9.3% (14/151) versus 5.2% (8/153), P = 0.19; support on versus off 6.6% (10/152) versus 7.9% (12/152), P = 0.73. Phase 2 preparation did not produce higher 14‐month abstinence rates than quitline referral; 3.6% (8/220) versus 2.1% [3/145; risk difference = 1.5%, 95% confidence interval (CI) = −1.8−5.0%, odds ratio (OR) = 1.8, 95% CI = 0.5–6.9]. Recycling, however, produced higher abstinence rates than quitline referral; 6.9% (15/217) versus 2.1% (three of 145; risk difference, 4.8%, 95% CI = 0.7–8.9%, OR = 3.5, 95% CI = 1.0–12.4). Recycling produced greater entry into new quit treatment than preparation: 83.4% (181/217) versus 55.9% (123/220), P < 0.0001. Conclusions: Among people interested in quitting smoking, immediate encouragement post‐relapse to enter a new round of smoking cessation treatment ('recycling') produced higher probability of abstinence than tobacco quitline referral. Recycling produced higher rates of cessation treatment re‐engagement than did preparation/cutting down using more intensive counseling and pharmacotherapy. [ABSTRACT FROM AUTHOR]

Traditional approaches to the modeling of multiple‐choice item response data (e.g., 3PL, 4PL models) emphasize slips and guesses as random events. In this paper, an item response model is presented that characterizes both disjunctively interacting guessing and conjunctively interacting slipping processes as proficiency‐related phenomena. We show how evidence for this perspective is seen in the systematic form of invariance violations for item slip and guess parameters under four‐parameter IRT models when compared across populations of different mean proficiency levels. Specifically, higher proficiency populations tend to show higher guess and lower slip probabilities than lower proficiency populations. The results undermine the use of traditional models for IRT applications that require invariance and would suggest greater attention to alternatives. [ABSTRACT FROM AUTHOR]

ObjectiveMultimorbidity affects 26 million persons with diabetes, and care for comorbid chronic conditions may impact diabetes care quality. The aim of this study was to determine which chronic conditions were related to lack of achievement or achievement of diabetes care quality goals to determine potential targets for future interventions.Research design and methodsThis is an exploratory retrospective analysis of electronic health record data for 23 430 adults, aged 18-75, with diabetes who were seen at seven Midwestern US health systems. The main outcome measures were achievement of six diabetes quality metrics in the reporting year, 2011 (glycated haemoglobin (HbA1c) control and testing, low-density lipoprotein control and testing, blood pressure control, kidney testing). Explanatory variables were 62 chronic condition indicators. Analyses were adjusted for baseline patient sociodemographic and healthcare utilization factors.ResultsThe 62 chronic conditions varied in their relationships to diabetes care goal achievement for specific care goals. Congestive heart failure was related to lack of achievement of cholesterol management goals. Obesity was related to lack of HbA1c and BP control. Mental health conditions were related to both lack of achievement and achievement of different care goals. Three conditions were related to lack of cholesterol testing, including congestive heart failure and substance-use disorders. Of 17 conditions related to achieving control goals, 16 were related to achieving HbA1c control. One-half of the comorbid conditions did not predict diabetes care quality.ConclusionsFuture interventions could target patients at risk for not achieving diabetes care for specific care goals based on their individual comorbidities.

Both the statistical and interpretational shortcomings of the three-parameter logistic (3PL) model in accommodating guessing effects on multiple-choice items are well documented. We consider the use of a residual heteroscedasticity (RH) model as an alternative, and compare its performance to the 3PL with real test data sets and through simulation analyses. Our results suggest advantages to the RH approach, including closer fit to real data, more interpretable parameter estimates, and greater psychological plausibility.

Cognitive diagnosis models (CDMs) typically assume skill attributes with discrete (often binary) levels of skill mastery, making the existence of skill continuity an anticipated form of model misspecification. In this article, misspecification due to skill continuity is argued to be of particular concern for several CDM applications due to the lack of invariance it yields in CDM skill attribute metrics, or what in this article are viewed as the "thresholds" applied to continuous attributes in distinguishing masters from nonmasters. Using the deterministic input noisy and (DINA) model as an illustration, the effects observed in real data are found to be systematic, with higher thresholds for mastery tending to emerge in higher ability populations. The results are shown to have significant implications for applications of CDMs that rely heavily upon the parameter invariance properties of the models, including, for example, applications toward the measurement of growth and differential item functioning analyses.

This randomized controlled trial examined the efficacy of peer network interventions to improve the social connections of 47 high school students with severe disabilities. School staff invited, trained, and supported 192 peers without disabilities to participate in individualized social groups that met throughout one semester. Compared to adolescents in the "business-as-usual" control group (n = 48), students receiving peer networks gained significantly more new social contacts and friendships. Although many peer relationships maintained one and two semesters later, their spill over beyond the school day was limited. Students and staff affirmed the social validity of the interventions. We offer recommendations for research and practice aimed at improving the implementation and impact of peer network interventions in secondary schools.

BackgroundA growing number of randomized controlled trials (RCTs) suggest psychological benefits associated with meditation training delivered via mobile health. However, research in this area has primarily focused on mindfulness, only one of many meditative techniques. ObjectiveThis study aims to evaluate the efficacy of 2 versions of a self-guided, smartphone-based meditation app—the Healthy Minds Program (HMP)—which includes training in mindfulness (Awareness), along with practices designed to cultivate positive relationships (Connection) or insight into the nature of the self (Insight). MethodsA three-arm, fully remote RCT compared 8 weeks of one of 2 HMP conditions (Awareness+Connection and Awareness+Insight) with a waitlist control. Adults (≥18 years) without extensive previous meditation experience were eligible. The primary outcome was psychological distress (depression, anxiety, and stress). Secondary outcomes were social connection, empathy, compassion, self-reflection, insight, rumination, defusion, and mindfulness. Measures were completed at pretest, midtreatment, and posttest between October 2019 and April 2020. Longitudinal data were analyzed using intention-to-treat principles with maximum likelihood. ResultsA total of 343 participants were randomized and 186 (54.2%) completed at least one posttest assessment. The majority (166/228, 72.8%) of those assigned to HMP conditions downloaded the app. The 2 HMP conditions did not differ from one another in terms of changes in any outcome. Relative to the waitlist control, the HMP conditions showed larger improvements in distress, social connectedness, mindfulness, and measures theoretically linked to insight training (d=–0.28 to 0.41; Ps≤.02), despite modest exposure to connection- and insight-related practice. The results were robust to some assumptions about nonrandom patterns of missing data. Improvements in distress were associated with days of use. Candidate mediators (social connection, insight, rumination, defusion, and mindfulness) and moderators (baseline rumination, defusion, and empathy) of changes in distress were identified. ConclusionsThis study provides initial evidence of efficacy for the HMP app in reducing distress and improving outcomes related to well-being, including social connectedness. Future studies should attempt to increase study retention and user engagement. Trial RegistrationClinicalTrials.gov NCT04139005; https://clinicaltrials.gov/ct2/show/NCT04139005