Faculty Bibliography

OBJECTIVE/UNASSIGNED:To examine the effects of triple beaded mixed amphetamine salts (TB MAS) on ADHD and executive dysfunction symptoms throughout the day in adults with DSM-5 ADHD. METHOD/UNASSIGNED:This was a 6 week, single-blind, placebo-lead in trial of TB MAS (12.5-37.5 mg/day); all participants received 2 weeks of single-blind placebo); one individual was a placebo responder and was discontinued. One of these 18 dropped after 1 week on 12.5 mg/day, while all others completed the trial and received 37.5 mg/day TB MAS. RESULTS/UNASSIGNED:There were significant effects of TB MAS on all clinical measures, including investigator overall symptoms (AISRS); self-report overall (ASRS), time-sensitive ADHD (TASS) scores throughout the day, impairment (CGI) and executive function scores (BRIEF-A). TB MAS was generally well tolerated. CONCLUSIONS/UNASSIGNED:This study extends prior findings of TB MAS to adults with DSM-5 ADHD; it further re-validates findings of efficacy of TB MAS throughout the day.

Objective: To examine the effects of triple beaded mixed amphetamine salts (TB MAS) on ADHD and executive dysfunction symptoms throughout the day in adults with DSM-5 ADHD. Method: This was a 6 week, single-blind, placebo-lead in trial of TB MAS (12.5"“37.5 mg/day); all participants received 2 weeks of single-blind placebo); one individual was a placebo responder and was discontinued. One of these 18 dropped after 1 week on 12.5 mg/day, while all others completed the trial and received 37.5 mg/day TB MAS. Results: There were significant effects of TB MAS on all clinical measures, including investigator overall symptoms (AISRS); self-report overall (ASRS), time-sensitive ADHD (TASS) scores throughout the day, impairment (CGI) and executive function scores (BRIEF-A). TB MAS was generally well tolerated. Conclusions: This study extends prior findings of TB MAS to adults with DSM-5 ADHD; it further re-validates findings of efficacy of TB MAS throughout the day.

IMPORTANCE/OBJECTIVE:Pregnancy induces unique physiologic changes to the immune response and hormonal changes leading to plausible differences in the risk of developing post-acute sequelae of SARS-CoV-2 (PASC), or Long COVID. Exposure to SARS-CoV-2 during pregnancy may also have long-term ramifications for exposed offspring, and it is critical to evaluate the health outcomes of exposed children. The National Institutes of Health (NIH) Researching COVID to Enhance Recovery (RECOVER) Multi-site Observational Study of PASC aims to evaluate the long-term sequelae of SARS-CoV-2 infection in various populations. RECOVER-Pregnancy was designed specifically to address long-term outcomes in maternal-child dyads. METHODS:RECOVER-Pregnancy cohort is a combined prospective and retrospective cohort that proposes to enroll 2,300 individuals with a pregnancy during the COVID-19 pandemic and their offspring exposed and unexposed in utero, including single and multiple gestations. Enrollment will occur both in person at 27 sites through the Eunice Kennedy Shriver National Institutes of Health Maternal-Fetal Medicine Units Network and remotely through national recruitment by the study team at the University of California San Francisco (UCSF). Adults with and without SARS-CoV-2 infection during pregnancy are eligible for enrollment in the pregnancy cohort and will follow the protocol for RECOVER-Adult including validated screening tools, laboratory analyses and symptom questionnaires followed by more in-depth phenotyping of PASC on a subset of the overall cohort. Offspring exposed and unexposed in utero to SARS-CoV-2 maternal infection will undergo screening tests for neurodevelopment and other health outcomes at 12, 18, 24, 36 and 48 months of age. Blood specimens will be collected at 24 months of age for SARS-CoV-2 antibody testing, storage and anticipated later analyses proposed by RECOVER and other investigators. DISCUSSION/CONCLUSIONS:RECOVER-Pregnancy will address whether having SARS-CoV-2 during pregnancy modifies the risk factors, prevalence, and phenotype of PASC. The pregnancy cohort will also establish whether there are increased risks of adverse long-term outcomes among children exposed in utero. CLINICAL TRIALS.GOV IDENTIFIER/BACKGROUND:Clinical Trial Registration: http://www.clinicaltrials.gov. Unique identifier: NCT05172011.

Objectives: Organizational skills training (OST) for youth with ADHD is an efficacious treatment that addresses impairments at home and in school. Modifications of OST were conducted to treat children with or without ADHD, to reduce treatment barriers, and to respond to changes in school demands during the COVID-19 pandemic.
Method(s): After an initial RCT documenting OST efficacy, 3 further studies involved: 1) an open replication of the original RCT confirming improvements in organization, time management, and planning (OTMP) in children diagnosed with ADHD (N = 15) using twice-weekly in-person visits; 2) a subsequent open trial investigating children with deficient organizational skills with or without ADHD and altering delivery to involve a combination of in-person and virtual meetings (N = 29); and 3) a third study with subjects with low OTMP skills who do not necessarily have ADHD, receive treatment with combined in-person and virtual delivery or, in response to COVID-19 restrictions, fully virtual delivery (N = 27, thus far), and, in response to remote school delivery, have altered OST content to fit varied school instruction demands (eg, use of electronic documents instead of papers) while adhering to the principles of OST. Change was measured on the Children's Organizational Skills Scales (COSS).
Result(s): 1) Improvements in OTMP skills (parent ratings d = 3.73; teacher ratings d = 1.12) in the first open study were comparable to the initial RCT findings. 2) In study 2, parents also reported substantial improvements (d = 3.04), and teachers reported large changes (d = 0.88) in pre-post comparisons. 3) In the ongoing RCT, subjects who received treatment immediately were reported to have large changes by parents (d = 2.17) and moderate changes by teachers (d = 0.47) when compared to waitlist controls.
Conclusion(s): Initial analyses indicate that OST leads to OTMP improvements in children struggling with disorganization with and without ADHD diagnosis. Improvements are found when treatment is delivered fully in-person, delivered in hybrid in-person and virtual meetings, or delivered fully virtually. OST could help children with or without ADHD improve behavioral and emotional adjustment at home and in school, when treatment delivery is modified to increase treatment availability, and when school demands are varied. ADHD, CBT, EBP
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Pediatric brain imaging holds significant promise for understanding neurodevelopment. However, the requirement to remain still inside a noisy, enclosed scanner remains a challenge. Verbal or visual descriptions of the process, and/or practice in MRI simulators are the norm in preparing children. Yet, the factors predictive of successfully obtaining neuroimaging data remain unclear. We examined data from 250 children (6-12 years, 197 males) with autism and/or attention-deficit/hyperactivity disorder. Children completed systematic MRI simulator training aimed to habituate to the scanner environment and minimize head motion. An MRI session comprised multiple structural, resting-state, task and diffusion scans. Of the 201 children passing simulator training and attempting scanning, nearly all (94%) successfully completed the first structural scan in the sequence, and 88% also completed the following functional scan. The number of successful scans decreased as the sequence progressed. Multivariate analyses revealed that age was the strongest predictor of successful scans in the session, with younger children having lower success rates. After age, sensorimotor atypicalities contributed most to prediction. Results provide insights on factors to consider in designing pediatric brain imaging protocols.

Effective organizational skills (e.g., time management, materials management, and task planning) are associated with academic success, yet some children struggle to gain these skills without intervention. While evidence-based organizational skills interventions for pediatric clinical populations exist, none target organizationally impaired general populations in a primary school setting. In Organizational Skills Training-School (OST-S), school professionals teach small groups of 4th"“5th grade organizationally impaired elementary school students skills associated with tracking assignments, managing materials, time management, and planning. This open pilot study of 33 students examined: a. the feasibility of adapting and implementing an established clinic-based, individualized treatment (OST-C) to a group format in a school setting, b. the program's acceptability among children, parents, and school partners, and c. whether participating children improved in the same functional areas that OST-C positively influenced. Results indicated that we could adapt the intervention, school partners could implement it, and participants could accept it. Pre-post improvements in organizational skills (as rated by parents, teachers, and children), homework problems, and academic performance demonstrated the potential effectiveness of OST-S, suggesting the need for further efficacy work.

News of a videogame that received FDA clearance to treat youth with attention-deficit hyperactivity disorder (ADHD) garnered a great deal of media attention and raised questions about the role of digital cognitive training programs for treatment. In order for clinicians and clients to understand this news for the purposes of making treatment decisions one must have an understanding of what it means for a treatment to be considered evidence-based and an understanding of what is required to obtain FDA clearance. Finally, in order to fully inform decisions about treatment, clinicians and parents must be able to consider the evidence supporting cognitive training programs in relation to other treatments available for children with ADHD. A review of these standards and the evidence supporting cognitive training in general, and the new videogame that received recent FDA clearance (EndeavorRX^TM) specifically, revealed an overall lack of support for this approach to treatment. There are multiple psychosocial and pharmacological treatment options with much more evidence supporting their effectiveness than any commercially available cognitive training program. The contrast between receiving FDA clearance without evidence of any observable benefits to the child is explained within a description of the FDA process for clearance and approval. Finally, these conclusions are described in the context of clinicians' decisions regarding services offered and procedures for explaining this to families who may have seen the media attention related to FDA clearance.
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Objectives: Replicated findings indicate that those with ADHD frequently demonstrate deficits in executive functions (EF) (eg, problems with attention control, behavior control, working memory, and planning). Clinicians should have a clear understanding of the impact that these deficits have upon individual, family, and school functioning. This presentation will: 1) summarize investigations of EF deficits in ADHD; 2) show how EF deficits can affect daily functioning; 3) discuss limitations when broad and abstract methods for building skills in EF have been tried; and 4) review the findings of emerging treatments that address practical EF deficits that have contributed to improvements in organizational skills, family functioning, and school performance. Attendees will learn how to incorporate this work in assessment, referral, and treatment practices.
Method(s): Based upon findings, some teams have developed methods to train core EF skills, including working memory, attention control, and impulse control. Using varied designs, the impact of these methods on ADHD symptoms, family interactions, and school behavior has been tested. Other research groups have created and tested interventions to address behavioral deficits in organization, time management, and planning (which are found to be present in more than 50 percent of youth with ADHD). These latter interventions, tested in randomized controlled trials, look to increase organizational skills as functional impairments that emerge from deficient EF.
Result(s): The first set of studies, testing the training in core EF skills, have found significant changes on tasks similar to training tasks but with limited improvements in ADHD symptoms, home interactions, and school performance. On the other hand, the other interventions targeting related behavioral deficits have found substantial improvements in home and school functioning. Improved organizational skills, improved family relations, and improved academics have resulted and have led to more positive views of teachers and school, in general. The interventions contribute to persistent home and school success.
Conclusion(s): Broad and abstract methods for addressing EF deficits have proven to be ineffective. However, by addressing practical reflections of EF deficits, some relatively new but sound interventions are changing the course for youth with ADHD. ADHD, EBP, TREAT
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