A Scoping Review of the Intersectionality of Autism and Intellectual and Developmental Disability with Social Inequity on Diagnosis and Treatment of Youth.

Objective: To describe how the intersectionality of race, ethnicity, and language with autism and intellectual and developmental disability (IDD) impacts mental health inequities in psychopharmacological management of youth. Method: This was a scoping review in which a series of searches were conducted in PubMed, Web of Science, Google Scholar, and manual review of the articles collected. Results: Although autism and/or IDD increases the risk for poor physical and mental health, social determinants of health such as race, ethnicity, and language account for approximately a third of poor outcomes. Minoritized children with autism/IDD experience significantly greater delays to diagnosis and misdiagnosis and are less likely to receive appropriate services. Access to psychological testing and psychosocial services is often limited by availability, skilled practitioners, a shortage of non-English-language providers or interpreters, and poor reimbursement. Conclusion: The intersectionality of autism and/or IDD with race, ethnicity, and language compounds the health inequities associated with either of these challenges independently.

An Open-Label Study of a Wearable Device Targeting ADHD, Executive Function, and Academic Performance.

OBJECTIVE: This was an open-label pilot study to test the feasibility and preliminary efficacy of a wearable digital intervention developed to improve on-task behavior. This was an exploratory study to test for specificity of response on parent- and teacher-reported symptom outcomes in attention and hyperactive/impulsive symptoms, as well as domains of functional impairment, including school behavior and learning and executive function. METHOD: Participants included 38 children aged 8-12 years with a parent-reported past diagnosis of ADHD. Following baseline ratings from parents (N = 38) and teachers (N = 26), participants wore the device to school for four weeks. Parent and teacher ratings of ADHD symptoms, executive function, and functional impairment were repeated at the end of the four-week intervention period. RESULTS: Statistically significant improvement was seen in the total scores for all parent and nearly all teacher outcomes, with moderate effect size improvements in attention, organization and planning, self-monitoring, school functioning, and teacher-reported academic performance. CONCLUSIONS: Preliminary evidence from this open-label pilot study suggests that having a child interact with a wearable device to self-monitor attention is feasible. This exploratory, open-label pilot study found real-world improvement in functional domains, including academic performance. Future research will require a blinded, randomized, controlled trial using an appropriate sham comparator to confirm these findings.

The Impact of School Closures on Service Utilization in School-Based Health Centers.

BACKGROUND: The pandemic was followed by a severe mental health crisis in youth with both an increase in the prevalence of mental health problems and a decrease in requests for and access to care. METHODS: data were extracted from the school-based health center records in three large public high schools that include under-resourced and immigrant communities. Data from 2018/2019 (pre-pandemic), 2020 during the pandemic, and then in 2021 after the return to in-person school were compared regarding the impact of in-person, telehealth, and hybrid care. RESULTS: Despite the increase in mental health needs globally, there was a dramatic decrease in referrals, evaluations, and the total number of students seen for behavioral health care. The time course of this decrease in care was specifically associated with the transition to telehealth, although treatment did not return to pre-pandemic levels, even after in-person care became available. CONCLUSIONS: Despite ease of access and increased need, these data suggest that telehealth has unique limitations when delivered in school-based health centers.

A Paradigm for Targeting Functional Impairment as an Outcome in Attention-Deficit/Hyperactivity Disorder.

Although functional impairment is required for a diagnosis in the DSM 5, the time frame and definition of functional impairment is ambiguous. We present a conceptual review clarifying the difference between functional impairment as a stable trait representing strength or disability in various domains, and functional impairment as secondary to emotional or behavior problems, which is a state sensitive to change with treatment intervention. Functional impairment as a measure of treatment outcome includes both change from baseline and status at the endpoint of treatment. When using a validated measure of function, functional improvement can be defined as the percentage of patients who achieve the Minimal Important Clinical Difference (MCID) and functional remission as the percentage of patients who normalize at treatment endpoint. True treatment remission should be defined as both symptomatic and functional remission.

Measurement Informed Care in Attention-Deficit/Hyperactivity Disorder (ADHD).

Measurement-informed care is a cornerstone of evidence-based practice and shared decision-making. A structured diagnostic interview specific to ADHD provides a globally agreed-on standard of evaluation. These interviews are accessible in the public domain in multiple languages and are helpful to clinicians new to the diagnosis of ADHD. Broad-based rating scales looking at multiple domains of psychopathology are critical to assuring recognition of comorbid diagnoses, which might otherwise be missed, differential diagnoses, and identification of the most prominent or treatable diagnosis. Recent innovations in computerized adaptive testing have improved the efficiency and accuracy of diagnostic screening. Rating scales specific to ADHD and disruptive behavior disorders establish the severity of the disorder and response to intervention. Age- and gender-normed symptom rating scales for ADHD capture clinically salient differences between what is normative in different demographic groups. An evaluation of functional impairment in ADHD has been critical to understanding the patient's perspective of the presenting problem. Best practice care for ADHD treatment goes beyond improvement to well-defined standards for both symptom and functional remission. Studies of executive function, emotional regulation, mind-wandering, and sluggish cognitive tempo have led to a richer understanding of the breadth and depth of associated deficits commonly experienced by ADHD patients. Psychometrically validated tools are available to complement every aspect of ADHD care and provide global standards for research.

Effect of a Multilayer, Extended-Release Methylphenidate Formulation (PRC-063) on Sleep in Adolescents with Attention-Deficit/Hyperactivity Disorder: A Randomized, Double-Blind, Fixed-Dose, Placebo-Controlled Trial Followed by a 6-Month Open-Label Follow-Up.

Objectives: We analyzed patient-reported sleep parameters for an extended-release methylphenidate formulation (PRC-063) in adolescents with attention-deficit/hyperactivity disorder. Methods: Clinical efficacy and long-term safety/tolerability data from a 4-week, double-blind, placebo-controlled, fixed-dose study (NCT02139111) and a subsequent 6-month, optimized-dose, open-label extension (OLE) study (NCT02168127) were used. In the double-blind study, participants were randomly assigned 1:1:1:1:1 to one of four doses of PRC-063 (25, 45, 70, or 85 mg/day) or placebo. In both the double-blind and OLE studies, sleep outcomes were assessed using the Pittsburgh Sleep Quality Index (PSQI). Results: During double-blind treatment, no statistically significant least-squares mean difference in change from baseline between PRC-063 (all doses combined; N = 293) and placebo (N = 74) was found for either global PSQI score (-0.3 vs. -0.5; p = 0.6110) or scores for any of the seven PSQI subscales. Compared with the placebo group, a marginally higher proportion of patients in the PRC-063 group (all doses combined) went from being poor to good sleepers (global PSQI score ≤5; 14.4% vs. 11.3%). In a logistic regression analysis, study treatment was not a predictor of poor sleep (p = 0.5368) at the end of the double-blind study. In the OLE study, there was a trend of improvement in sleep after 1 month of individualized dosing that was maintained through 6 months. Sleep efficiency (time asleep as a proportion of time in bed) showed improvement at the end of the OLE study. Conclusion: While individual patients may experience changes in sleep as an adverse event, group data evaluating sleep as an outcome found there were no differences between PRC-063 and placebo in self-reported sleep outcomes on the PSQI.

Effect of a Multi-Layer, Extended-Release Methylphenidate Formulation (PRC-063) on Sleep in Adults with ADHD: A Randomized, Double-Blind, Forced-Dose, Placebo-Controlled Trial Followed by a 6-month Open-Label Extension.

BACKGROUND: The effects of stimulant treatment on sleep in adults with attention-deficit/hyperactivity disorder (ADHD) are complex and varied, with some individuals experiencing worsening of sleep but others experiencing improvement. METHODS: Data from previously reported trials of the clinical efficacy and safety of the long-acting methylphenidate formulation PRC-063 (Adhansia XR® in the USA; Foquest® in Canada) in adults with ADHD were used to evaluate patient-reported sleep outcomes, as captured using the Pittsburgh Sleep Quality Index (PSQI) and adverse events of insomnia. The trials comprised 4 weeks of randomized, forced-dose PRC-063 treatment at a dose of 0 (placebo), 25, 45, 70, or 100 mg/day followed by an optional 6 months of open-label PRC-063 treatment at an individually optimized dose of 25-100 mg/day. RESULTS: At the end of double-blind treatment, PRC-063 (all doses combined; N = 297) showed no significant difference versus placebo (N = 78) in least squares mean change in global PSQI score from baseline (- 0.7 vs. - 1.3; P = 0.0972) or in scores for each of the seven subscales of the PSQI. For patients enrolled in the open-label extension (N = 184), mean ± standard deviation global PSQI score improved from 7.8 ± 3.55 at the end of double-blind treatment to 5.8 ± 3.11 at 1 month and 5.4 ± 3.21 at 6 months (P < 0.0001). A greater proportion of patients were good sleepers (global PSQI score ≤ 5) at the end of the open-label extension (57.3%) than at baseline (20.9%) or at the end of double-blind treatment (26.0%). In a logistic regression analysis, baseline global PSQI score (odds ratio 1.491; P < 0.0001), but not randomized study treatment (P = 0.1428), was a significant predictor of poor sleep (global PSQI score > 5) at the end of double-blind treatment. Adverse event rates for insomnia (15.8 vs. 3.8%) and initial insomnia (6.1 vs. 1.3%) during double-blind treatment were higher for PRC-063 (all doses combined) than for placebo. Two patients receiving PRC-063 in the double-blind study and one patient in the open-label study were withdrawn because of insomnia adverse events. CONCLUSIONS: Our findings indicate that, on average, PRC-063 had no significant impact on overall sleep quality in adults with ADHD. Although insomnia was observed as an adverse event, when sleep was measured over time as an outcome in its own right for patients receiving dose-optimized PRC-063 open-label, more patients showed improvement in sleep than deterioration. CLINICALTRIALS. GOV IDENTIFER: NCT02139124 and NCT02168127.