Faculty Bibliography

OBJECTIVE:Physical activity (PA) interventions are part of many interdisciplinary programs for the management of children and adolescents with or without physical or psychological conditions or disabilities. Aiming to summarize the available evidence, we conducted an umbrella review of meta-analyses of PA interventions that included psychosocial outcomes in populations of children and adolescents. METHOD/METHODS:Literature searches were conducted in PubMed, Cochrane Central, Web of Science, Medline, SPORTDiscus, and PsychInfo from January 1, 2010, to May 6, 2022. Meta-analyses of randomized and quasi-randomized studies investigating the efficacy of PA interventions for psychosocial outcomes in children and adolescents were included. Summary effects were recalculated using common metric and random-effects models. We assessed between-study heterogeneity, predictive intervals, publication bias, small study effects, and whether the results of the observed positive studies were greater than expected due to chance. On the basis of these calculations, strength of associations was assessed using quantitative umbrella review criteria, and credibility of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Quality was assessed using the AMSTAR 2 tool. This study is registered with the Open Science Framework, https://osf.io/ap8qu. RESULTS:A total of 112 studies from 18 meta-analyses generating 12 new meta-analyses comprising 21,232 children and adolescents in population groups including attention-deficit/hyperactivity disorder, cancer, cerebral palsy, chronic respiratory diseases, depression, neuromotor impairment, and obesity and in general populations were included. PA interventions were efficacious in reducing psychological symptoms in all meta-analyses across the different population groups using random-effects models. However, umbrella review criteria suggested a weak strength of association for this outcome, and GRADE credibility of evidence ranged from moderate to very low. For psychological well-being, 3 out of 5 meta-analyses identified significant effects, but the strength of these associations was weak, and GRADE credibility of evidence ranged from moderate to very low. Similarly, for social outcomes, meta-analyses reported a significant summary effect, but the strength of association was weak, and GRADE credibility of evidence ranged from moderate to very low. For self-esteem, one meta-analysis in children with obesity failed to show any effect. CONCLUSION/CONCLUSIONS:Even though existing meta-analyses suggested a beneficial effect of PA interventions on psychosocial outcomes across different population groups, the strength of associations was weak, and the credibility of evidence was variable depending on the target population, outcome, and condition or disability. Randomized studies of PA interventions in children and adolescents with and without different physical and psychological conditions or disabilities should always include psychosocial outcomes as an important dimension of social and mental health. STUDY PREREGISTRATION INFORMATION/UNASSIGNED:Prenatal Maternal Infection and Adverse Neurodevelopment: A Structural Equation Modelling Approach to Downstream Environmental Hits; https://osf.io/; cp85a.

OBJECTIVE/UNASSIGNED:Studies show adult ADHD presents differently in men and women, however few studies contrast ADHD in cisgender and gender diverse adults. We assessed care differences between these groups using previously identified quality measures (QMs). METHODS/UNASSIGNED:Using EHR data, we matched a group of male ADHD patients to a female group. We followed the same procedure with a cisgender group and one identified as gender diverse through a gender dysphoria diagnosis. QM achievement was measured using logistic regression models. RESULTS/UNASSIGNED:Most QMs exhibited increasing achievement over time for all groups. Variations in care quality between males and females persisted, with female patients achieving QMs more often. There were no appreciable differences between the cisgender and gender diverse groups. CONCLUSION/UNASSIGNED:Though quality care for adult ADHD improved from 2010 to 2020, differences between male and female patients lingered. This effect was not observed in cisgender and gender diverse patients.

OBJECTIVE:To systematically investigate if there is a significant association between markers of autonomic functioning and emotional dysregulation (ED) in children and adolescents. METHOD/METHODS:April 2021) and included empirical studies reporting indices of autonomic nervous system (ANS) functioning in youths meeting DSM/ICD criteria for any psychopathological/neurodevelopmental condition and assessed for ED with a validated scale. Eligible outcomes included correlation coefficients between ED and ANS measures or differences in ANS measures between youths with and without ED. Study quality was assessed with the Appraisal tool for Cross-Sectional Studies (AXIS) and the Newcastle-Ottawa Scale (NOS) for cohort studies. Random-effects meta-analyses were used for data synthesis. RESULTS:Twelve studies (1016 participants) were included in the descriptive review and nine (567 participants) in the meta-analyses. We did not find evidence of a significant association between ED and altered cardiac or electrodermal functioning. However, exploratory meta-regressions suggested a possible association between reduced resting-state cardiac vagal control and increased ED. CONCLUSION/CONCLUSIONS:Our study did not find evidence of an association between ED and autonomic dysfunction. However, we found preliminary evidence that reduced vagal control at rest might be a transdiagnostic marker of ED in young people. Additional future studies comparing autonomic measures in youths with and without ED are needed, and should also assess the effects of interventions for ED on ANS functioning.

OBJECTIVE/UNASSIGNED:State mental health systems are retraining their workforces to deliver services supported by research. Knowledge about evidence-based therapies (EBTs) for child and adolescent disorders is robust, but the feasibility of their statewide scaling has not been examined. The authors reviewed implementation feasibility for 12 commonly used EBTs, defining feasibility for statewide scaling as an EBT having at least one study documenting acceptability, facilitators and barriers, or fidelity; at least one study with a racially and ethnically diverse sample; an entity for training, certification, or licensing; and fiscal data reflecting the costs of implementation. METHODS/UNASSIGNED:The authors reviewed materials for 12 EBTs being scaled in New York State and conducted a literature review with search terms relevant to their implementation. Costs and certification information were supplemented by discussions with treatment developers and implementers. RESULTS/UNASSIGNED:All 12 EBTs had been examined for implementation feasibility, but only three had been examined for statewide scaling. Eleven had been studied in populations reflecting racial-ethnic diversity, but few had sufficient power for subgroup analyses to demonstrate effectiveness with these samples. All had certifying or licensing entities. The per-clinician costs of implementation ranged from $500 to $3,500, with overall ongoing costs ranging from $100 to $6,000. A fiscal analysis of three EBTs revealed hidden costs ranging from $5,000 to $24,000 per clinician, potentially limiting sustainability. CONCLUSIONS/UNASSIGNED:The evidence necessary for embedding EBTs in state systems has notable gaps that may hinder sustainability. Research-funding agencies should prioritize studies that focus on the practical aspects of scaling to assist states as they retrain their workforces.

BACKGROUND:Numerous interventions for irritability in autism spectrum disorder (ASD) have been investigated. We aimed to appraise the magnitude of pharmacological and non-pharmacological interventions for irritability in ASD without any restrictions in terms of eligible interventions. METHODS:We systematically searched PubMed/MEDLINE, Scopus, and Web of Science until April 15, 2023. We included randomized controlled trials (RCTs) with a parallel design that examined the efficacy of interventions for the treatment of irritability in patients of any age with ASD without any restrictions in terms of eligible interventions. We performed a random-effects meta-analysis by pooling effect sizes as Hedges' g. We classified assessed interventions as follows: pharmacological monotherapy, risperidone plus adjuvant therapy versus risperidone monotherapy, non-pharmacological intervention, and dietary intervention. We utilized the Cochrane tool to evaluate the risk of bias in each study and the GRADE approach to assess the certainty of evidence for each meta-analyzed intervention. RESULTS:Out of 5640 references, we identified 60 eligible articles with 45 different kinds of interventions, including 3531 participants, of which 80.9% were males (mean age [SD] = 8.79 [3.85]). For pharmacological monotherapy, risperidone (Hedges' g - 0.857, 95% CI - 1.263 to - 0.451, certainty of evidence: high) and aripiprazole (Hedges' g - 0.559, 95% CI - 0.767 to - 0.351, certainty of evidence: high) outperformed placebo. Among the non-pharmacological interventions, parent training (Hedges' g - 0.893, 95% CI - 1.184 to - 0.602, certainty of evidence: moderate) showed a significant result. None of the meta-analyzed interventions yielded significant effects among risperidone + adjuvant therapy and dietary supplementation. However, several novel molecules in augmentation to risperidone outperformed risperidone monotherapy, yet from one RCT each. LIMITATIONS/CONCLUSIONS:First, various tools have been utilized to measure the irritability in ASD, which may contribute to the heterogeneity of the outcomes. Second, meta-analyses for each intervention included only a small number of studies and participants. CONCLUSIONS:Only risperidone, aripiprazole among pharmacological interventions, and parent training among non-pharmacological interventions can be recommended for irritability in ASD. As an augmentation to risperidone, several novel treatments show promising effects, but further RCTs are needed to replicate findings. Trial registration PROSPERO, CRD42021243965.

BACKGROUND/UNASSIGNED:Growing clinical interest in psychedelic-assisted therapies has led to a second wave of research involving psilocybin, lysergic acid diethylamide (LSD), 3,4-methylenedioxymethamphetamine (MDMA) and other substances. Data suggests that these compounds have the potential to treat mental health conditions that are especially prevalent in older adults such as depression, anxiety, existential distress, and posttraumatic stress disorder. AIMS/UNASSIGNED:The goal of this study was to quantify the prevalence of older adults enrolled in psychedelic clinical trials and explore safety data in this population. METHODS/UNASSIGNED:A systematic review was conducted following the 2020 PRISMA guidelines. Search criteria included all trials published in English using psychedelic substances to treat psychiatric conditions, including addiction as well as existential distress related to serious illness. Articles were identified from literature searches on PubMed, EBSCO, and EMBASE. RESULTS/UNASSIGNED:4376 manuscripts were identified, of which 505 qualified for further review, with 36 eventually meeting eligibility criteria. Of the 1400 patients enrolled in the 36 studies, only 19 were identified as 65 or older, representing less than 1.4% of all trial participants. For 10 of these 19 older adults, detailed safety data was obtained. No serious adverse events (AEs) occurred in any older adults and only transient mild-to-moderate AEs related to anxiety, gastrointestinal upset, and hypertension were reported during the psychedelic dosing sessions. CONCLUSIONS/UNASSIGNED:While existing data in older adults is limited, it suggests that psychedelic-assisted psychotherapy can be safe and well tolerated in older adults. Therefore, psychedelic-assisted psychotherapy should be more rigorously investigated for the treatment of psychiatric conditions in this population.

This study examines the effect of volunteering within a Professional Association of Therapeutic Horsemanship International (PATH Intl) premiere accredited center by exploring the experiences of volunteers leading horses in adaptive riding lessons. Adaptive Riding lessons are horseback riding lessons for individuals ages four through the lifespan, with special needs, varying from cognitive, physical, social-emotional, or other challenges. Volunteers directly impact the rider-horse bond by increasing accessibility to horseback riding for individuals with disabilities, fostering a meaningful bond between the rider and horse. The research questions were as follows: (1) do saliva measures of cortisol and alpha-amylase (stress), and oxytocin (affiliative bonding) change over time for volunteers; and (2) how satisfied are volunteers with volunteering for Equine Assisted Services (EAS)? Forty-one volunteers participated in Reining in Anxiety, an intervention combining adaptive riding and cognitive behavioral therapy. Physiological data (i.e., pooled saliva, saliva combined from various glands throughout the mouth, resting under the tongue prior to collection) were collected pre/post riding session at four time points during the 10-session intervention, measuring oxytocin, cortisol, and alpha-amylase. Post-intervention, volunteers completed a survey about their experiences as volunteers and as participants in the study. All saliva samples were collected successfully. There was a non-significant, positive trend in oxytocin and alpha-amylase, while cortisol remained level. The responses in the survey suggested that volunteers perceive their role positively, with nuanced experiences of a sense of responsibility to ensure safety, and enjoyment in assisting the riders. Volunteers are vital to the safety of the rider and horse. While their perceived and internalized responsibility is evidenced by an increase in stress (e.g., cortisol remaining level and an increase in alpha-amylase), it is not necessarily negative stress, as there is simultaneously affiliative bonding expressed (oxytocin). The complex emotions and experiences of volunteers are important to understand to create meaningful, sustainable volunteer engagement. This is particularly important in the EAS industry, which is reliant on volunteerism.

We conducted a prospective, single arm, multisite, multinational, open label trial assessing the safety and efficacy of a novel amygdala derived neurofeedback treatment, designated Amygdala-Derived-EFP, for chronic PTSD. Participants, including veterans and civilians, underwent screening, training, 15 neurofeedback sessions over 8 weeks and; baseline, termination (8 weeks) and 3 month post treatment assessments with validated measures. The primary endpoint was more than 50 % of the participants demonstrating a Minimally Clinically Important Difference (MCID) defined as a 6-point reduction, on the Clinician Administered PTSD Scale (CAPS-5) total score at 3 months. Secondary measures included the PCL-5, ERQ, PHQ-9, and CGI. Statistical analyses were performed using SAS®V9.4. The primary endpoint was met, with a CAPS-5 MCID response rate of 66.7 %. The average reduction in CAPS-5 total scores at 3 month follow up was 13.5 points, more than twice the MCID. Changes from baseline in CAPS-5, PCL-5, PHQ-9 scores at 8 weeks and the 3 month follow-up demonstrated statistically significant improvements in response and; demonstrated effect sizes ranging from 0.46 to 1.07. Adverse events were mild and resolved after treatment. This study builds on prior research demonstrating similar outcomes using amygdala-derived neurofeedback. Positive attributes of this therapy include monitoring by non-physician personnel, affordability, accessibility, and tolerability.

BACKGROUND/UNASSIGNED:Precision medicine has led to the development of targeted treatment strategies tailored to individual patients based on their characteristics and disease manifestations. Although precision medicine often focuses on a single health outcome for individualized treatment decision rules (ITRs), relying only on a single outcome rather than all available outcomes information leads to suboptimal data usage when developing optimal ITRs. METHODS/UNASSIGNED:To address this limitation, we propose a Bayesian multivariate hierarchical model that leverages the wealth of correlated health outcomes collected in clinical trials. The approach jointly models mixed types of correlated outcomes, facilitating the "borrowing of information" across the multivariate outcomes, and results in a more accurate estimation of heterogeneous treatment effects compared to using single regression models for each outcome. We develop a treatment benefit index, which quantifies the relative treatment benefit of the experimental treatment over the control treatment, based on the proposed multivariate outcome model. RESULTS/UNASSIGNED:We demonstrate the strengths of the proposed approach through extensive simulations and an application to an international Coronavirus Disease 2019 (COVID-19) treatment trial. Simulation results indicate that the proposed method reduces the occurrence of erroneous treatment decisions compared to a single regression model for a single health outcome. Additionally, the sensitivity analysis demonstrates the robustness of the model across various study scenarios. Application of the method to the COVID-19 trial exhibits improvements in estimating the individual-level treatment efficacy (indicated by narrower credible intervals for odds ratios) and optimal ITRs. CONCLUSION/UNASSIGNED:The study jointly models mixed types of outcomes in the context of developing ITRs. By considering multiple health outcomes, the proposed approach can advance the development of more effective and reliable personalized treatment.

The non-reporting of negative studies results in a scientific record that is incomplete, one-sided and misleading. The consequences of this range from inappropriate initiation of further studies that might put participants at unnecessary risk to treatment guidelines that may be in error, thus compromising day-to-day clinical practice.