Negative versus withdrawn maternal behavior: Differential associations with infant gray and white matter during the first 2 years of life.

Distinct neural effects of threat versus deprivation emerge by childhood, but little data are available in infancy. Withdrawn versus negative parenting may represent dimensionalized indices of early deprivation versus early threat, but no studies have assessed neural correlates of withdrawn versus negative parenting in infancy. The objective of this study was to separately assess the links of maternal withdrawal and maternal negative/inappropriate interaction with infant gray matter volume (GMV), white matter volume (WMV), amygdala, and hippocampal volume. Participants included 57 mother-infant dyads. Withdrawn and negative/inappropriate aspects of maternal behavior were coded from the Still-Face Paradigm at four months infant age. Between 4 and 24 months (M age = 12.28 months, SD = 5.99), during natural sleep, infants completed an MRI using a 3.0 T Siemens scanner. GMV, WMV, amygdala, and hippocampal volumes were extracted via automated segmentation. Diffusion weighted imaging volumetric data were also generated for major white matter tracts. Maternal withdrawal was associated with lower infant GMV. Negative/inappropriate interaction was associated with lower overall WMV. Age did not moderate these effects. Maternal withdrawal was further associated with reduced right hippocampal volume at older ages. Exploratory analyses of white matter tracts found that negative/inappropriate maternal behavior was specifically associated with reduced volume in the ventral language network. Results suggest that quality of day-to-day parenting is related to infant brain volumes during the first two years of life, with distinct aspects of interaction associated with distinct neural effects.

Testing the Outcomes of a Smoking Cessation Smartphone App for Nondaily Smokers: Protocol for a Proof-of-concept Randomized Controlled Trial.

BACKGROUND: Nondaily smoking is a widespread, increasingly prevalent pattern of smoking, particularly in ethnic minority and vulnerable populations. To date, no effective treatment approach for this type of smokers has been identified. OBJECTIVE: This study aims to use a randomized controlled trial to evaluate proof-of-concept markers of the Smiling instead of Smoking (SiS) app, a smoking cessation smartphone app designed specifically for nondaily smokers. This app was developed iteratively and is now in its third version. Previous studies have demonstrated acceptability and feasibility when participants were onboarded in person (study 1) and remotely (study 2) and showed within-person changes in line with hypothesized mechanisms of change. This is the first randomized test of this app. METHODS: In total, 225 adult nondaily smokers will be asked to undertake a quit attempt while using smoking cessation support materials for a period of 7 weeks. Participants will be randomized to use the SiS smartphone app, the National Cancer Institute smartphone app QuitGuide, or the National Cancer Institute smoking cessation brochure "Clearing the Air." Participants will take part in a 15-minute scripted onboarding phone call during which study staff will introduce participants to their support materials. Survey links will be sent 2, 6, 12, and 24 weeks after the participants' initially chosen quit date. The primary outcome is self-efficacy to remain abstinent from smoking at treatment end, measured using the Smoking Self-Efficacy Questionnaire. Secondary outcomes cover several domains relevant to treatment development and implementation: treatment acceptability (eg, satisfaction with smoking cessation support, measured using the Client Satisfaction Questionnaire, and app usability, measured using the System Usability Scale); treatment feasibility (eg, measured using the number of days participants used the SiS or QuitGuide app during the prescribed treatment period); and, in an exploratory way, treatment efficacy assessed using self-reported 30-day point prevalence abstinence. RESULTS: Recruitment began in January 2021 and ended June 2022. The final 24-week follow-up was completed in January 2023. This trial is funded by the American Cancer Society. CONCLUSIONS: This study is designed to test whether the prescribed use of the SiS app results in greater self-efficacy to abstain from smoking in nondaily smokers than commonly recommended alternative treatments and whether the SiS app treatment is acceptable and feasible. Positive results will mean that the SiS app warrants testing in a large-scale randomized controlled trial to test its effectiveness in supporting smoking cessation in nondaily smokers. The design of this study also provides insights into issues pertinent to smoking cessation smartphone app treatment development and implementation by measuring, in a randomized design, markers of treatment satisfaction, engagement with the technology and content of the treatment, and adherence to the treatment plan. TRIAL REGISTRATION: ClinicalTrials.gov NCT04672239; https://clinicaltrials.gov/ct2/show/NCT04672239. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/40867.

Impact of COVID-19 on alcohol use disorder recovery: A qualitative study.

In March 2020, restrictions on in-person gatherings were introduced due to the coronavirus disease (COVID-19) pandemic, requiring alcohol use disorder (AUD) recovery resources to migrate to virtual platforms. This study investigated how these restrictions impacted recovery attempts and explored participant experiences with virtual resources using a qualitative approach. Participants attempting recovery from AUD (N = 62; Mage = 48.2; F = 53.2%; 71% White) completed virtual semistructured interviews from July 2020 to August 2020 on their experience during the COVID-19 lockdown, impacts on recovery, and experiences with online resources. Interviews were recorded, transcribed, and analyzed using a thematic coding process. Three overarching themes were identified: Effect on Recovery, Virtual Recovery Resources, and Effect on General Life. Within each overarching theme, lower order parent themes and subthemes reflected varied participant experiences. Specifically, one group of participants cited negative impacts due to COVID-19, a second group reported positive impacts, and a third group reported experiencing both positive and negative impacts. Participants reported both positive and negative experiences with virtual resources, identifying suggestions for improvement and other resources. Findings suggest that while individuals in AUD recovery experienced significant hardships, a proportion experienced positive impacts as well, and the positive and negative consequences were not mutually exclusive. Additionally, the results highlight the limitations of existing virtual resources. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Impacts of the COVID-19 public health restrictions on substance use, mental health, and psychosocial functioning among individuals with alcohol use disorder.

Background: The COVID-19 pandemic has been associated with major psychosocial disruptions and there is particular concern for individuals with substance use disorders.Objectives: This study characterized the psychosocial and experiential impacts of the pandemic on individuals seeking alcohol use disorder (AUD) recovery, including pandemic impacts on self-reported drinking, heavy drinking, tobacco, cannabis, and stimulant use.Methods: Participants were 125 AUD+ individuals (% males: 57.60; Mage = 49.11, SD = 12.13) reporting on substance use from January 1st-24th March, 2020 (pre-pandemic) and since the stay-at-home orders commenced, 24th March-June 28th 2020 (intra-pandemic). Within-subjects changes were examined and a latent profile analysis was performed to identify subgroups differentially impacted by the pandemic.Results: Large proportions reported psychosocial impacts of COVID-19, but drinking and other substance use did not reveal significant changes. Latent profile analyses revealed two subgroups: Profile 1 (n = 41/125), "Moderately Impacted") and Profile 2 (n = 84/125), "Severely Impacted"). Compared to the pre-pandemic period, the group that was moderately impacted by the pandemic exhibited significantly fewer heavy drinking days (p = .02) during the intra-pandemic period, but no other substance use changes. The group showing severe pandemic impacts did not exhibit changes in alcohol or other drug use but evidenced more severe anxiety and depression (ps < .001).Conclusions: We found heterogeneous subtypes of pandemic-related impacts in AUD recovery patients. There is need to provide psychosocial support to this particular population and further monitoring substance use and mental health.

Randomized Evaluation of TriGuard 3 Cerebral Embolic Protection After Transcatheter Aortic Valve Replacement: REFLECT II.

OBJECTIVES: The REFLECT II (Randomized Evaluation of TriGuard 3 Cerebral Embolic Protection After Transcatheter Aortic Valve Implantation) trial was designed to investigate the safety and efficacy of the TriGUARD 3 (TG3) cerebral embolic protection in patients undergoing transcatheter aortic valve replacement. BACKGROUND: Cerebral embolization occurs frequently following transcatheter aortic valve replacement and procedure-related ischemic stroke occurs in 2% to 6% of patients at 30 days. Whether cerebral protection with TriGuard 3 is safe and effective in reducing procedure-related cerebral injury is not known. METHODS: This prospective, multicenter, single-blind, 2:1 randomized (TG3 vs. no TG3) study was designed to enroll up to 345 patients. The primary 30-day safety endpoint (Valve Academic Research Consortium-2 defined) was compared with a performance goal (PG). The primary hierarchical composite efficacy endpoint (including death or stroke at 30 days, National Institutes of Health Stroke Scale score worsening in hospital, and cerebral ischemic lesions on diffusion-weighted magnetic resonance imaging at 2 to 5 days) was compared using the Finkelstein-Schoenfeld method. RESULTS: REFLECT II enrolled 220 of the planned 345 patients (63.8%), including 41 roll-in and 179 randomized patients (121 TG3 and 58 control subjects) at 18 US sites. The sponsor closed the study early after the U.S. Food and Drug Administration recommended enrollment suspension for unblinded safety data review. The trial met its primary safety endpoint compared with the PG (15.9% vs. 34.4% (p < 0.0001). The primary hierarchal efficacy endpoint at 30 days was not met (mean scores [higher is better]: -8.58 TG3 vs. 8.08 control; p = 0.857). A post hoc diffusion-weighted magnetic resonance imaging analysis of per-patient total lesion volume above incremental thresholds showed numeric reductions in total lesion volume >500 mm3 (-9.7%) and >1,000 mm3 (-44.5%) in the TG3 group, which were more pronounced among patients with full TG3 coverage: -51.1% (>500 mm3) and -82.9% (>1,000 mm3). CONCLUSIONS: The REFLECT II trial demonstrated that the TG3 was safe compared with a historical PG but did not meet its pre-specified primary superiority efficacy endpoint.