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Objective: The Before School Functioning Questionnaire and Parent Rating of Evening and Morning Behavior–Revised assess early morning (BSFQ, PREMB-R AM subscale) and late afternoon/evening (PREMB-R PM subscale) functional impairment in children with ADHD. Clinically meaningful improvements were identified and applied to a trial of delayed-release and extended-release methylphenidate (DR/ER-MPH) in children with ADHD (NCT02520388) to determine if the statistically-determined improvements in functional impairment were also clinically meaningful. Method: Clinically meaningful improvements in BSFQ/PREMB-R were established post hoc by receiver operating characteristics curves, using anchors of Clinical Global Impression–Improvement (CGI-I) = 1 and CGI-I ≤ 2. Percentages of participants achieving these thresholds were calculated. Results: Thresholds for CGI-I = 1/CGI-I ≤ 2, respectively, were 27/20 (BSFQ), 5/3 (PREMB-R AM), and 9/5 (PREMB-R PM)-point decreases. More children achieved clinically meaningful improvements with DR/ER-MPH versus placebo (all p Conclusion: DR/ER-MPH increased proportions of children achieving clinically meaningful improvements in BSFQ and PREMB-R.

Objective: We compared the placebo response (PR) as measured by the Test of Variables of Attention (TOVA) and the Conners’ Adult ADHD Rating Scale (CAARS) scores. Method: A retrospective data analysis from a double-blind placebo-controlled study of metadoxine-ER in adults with ADHD. An additional database was used for comparison to TOVA response after methylphenidate challenge (TOVA-MPH-R). Results: PR was highest when calculated from the TOVA-Attention Composite Score (ACS). The PR showed significantly fewer variables improving concomitantly compared with MPH-R. The most prominent correlation between the CAARS-PR and the TOVA-PR was in the Omissions score ( p = .032), which was age-dependent ( b = .0007, p

Background: The objective of this study was to examine changes in the activation of the brain reward system following treatment with lisdexamfetamine (LDX) vs. placebo (PL) as a function of clinical improvement in attention deficit/hyperactivity disorder (ADHD) symptoms. Methods: Twenty adults with ADHD were included in a randomized cross-over study. Participants underwent two functional magnetic resonance imaging (fMRI) scans, after receiving 3 to 5 weeks of treatment with both LDX and PL. During scanning, participants performed the passive-avoidance learning task to assess reward-related learning using computational variables (e.g., estimated value and prediction error). Pre-treatment to post-treatment symptom change was assessed via the ADHD Rating Scale (ADHD-RS). The imaging contrasts were Object Choose or Object Refuse during the object choice component of the task, modulated by expected value (reward vs. nonreward cue), and Reward vs. Punishment during feedback, modulated by prediction error (expected vs. actual outcome). To address the primary objective, we performed group-level mass univariate analyses between pre-treatment to post-treatment percent change of the ADHD-RS total scores and the four contrast images under the choice and feedback conditions, with significance set at a whole-brain voxel-wise threshold of p < .05 with family-wise error (FWE) correction and an extent (cluster) threshold of 50 contiguous voxels. Results: Improvement in ADHD symptoms was accompanied by significant increases of brain activation during the Object Refuse, Reward and Punishment contrasts in a widespread network including left caudate and putamen, and right orbitofrontal cortex (i.e., reward-related signaling) and left middle frontal, superior frontal, and precentral gyri (i.e., executive control). Conclusions: These findings are the first to show that the increase in responsiveness of systems engaged in reward processing with LDX treatment is positively related to symptom improvement. Results support the hypothesis that LDX treatment may restore balance to dysfunction (e.g., hypoactivation) within the brain reward circuitry in adults with ADHD.

Objective: The purpose of the present study was to characterize prescription stimulant non-medical use (NMU) in adolescents between the ages of 13 and 18 years seeking treatment for substance use disorder (SUD) with the Comprehensive Health Assessment Tool for Teens (CHAT™). Method: Adolescents being evaluated for SUD treatment between Q1 2010 and Q3 2017 ( n = 20,189) completed the CHAT™. Results: About 4.3% of the sample ( N = 867) of adolescents in SUD treatment reported past 30-day prescription stimulant NMU. Compared to those without past 30-day prescription stimulant NMU, more reported a lifetime diagnosis of learning disorder or ADHD, more took medication for emotional, behavioral, or learning disorders, received past-month inpatient treatment, or were currently not enrolled in school. Prescription stimulants were most often taken orally for NMU, however, approximately half reported using alternate routes of administration, the most prominent of which was intranasal use. Conclusion: About 4.3% of adolescents in SUD treatment evaluation reported past 30-day prescription stimulant NMU. Greater percentages of lifetime learning disorder, medication use, past-month inpatient treatment, school unenrollment, and overall substance misuse were associated with prescription stimulant NMU, as were alternate routes of administration. These data reveal an ongoing, persistent level of past-30-day NMU of prescription stimulants among adolescents being evaluated for SUD treatment.

Objective: Several ADHD pharmacological trials reported high placebo response (PR) rates. This study aims to characterize the PR in adult ADHD. Method: A retrospective cohort analysis of the placebo arm (140 adults with ADHD, 18-55 yrs, M:F 46.4%-53.6%) of a 6-week randomized, multicenter, double-blind metadoxine study, using Conners’ Adult ADHD Rating Scale (CAARS) and the Adult ADHD Self-Report Scale (ASRS), was conducted. Results: Pre–post changes in placebo-treated adults were significant for both the CAARS and ASRS, F(2.9, 404.5) = 61.2, p < .00001, F(2.8, 383.0) = 43.1, p < .00001, respectively. Less than half of the participants had a PR which began early in treatment and persisted; almost 50% had a variable, inconsistent PR. Conclusion: In the current sample, PR in adult ADHD was prominent on both symptom scales and the investigator–rater instrument. Therefore, using investigator ratings as a primary endpoint does not necessarily attenuate PR. Of note, about half of the PR is variable, suggesting unreliable determination of efficacy.

Objective: The objective of this study is to evaluate efficacy and safety of SPN-812 (extended-release viloxazine) for ADHD in children aged 6 to 12 years. Method: In an 8-week study, 222 participants were randomized to placebo or SPN-812 100, 200, 300, or 400 mg/day. Measurements included ADHD Rating Scale (RS)-IV total score and Clinical Global Impression-Severity (CGI-S) and Clinical Global Impression-Improvement (CGI-I) scores. Safety assessments included laboratory and electrocardiogram (ECG) measurements, suicidality monitoring (Columbia-Suicide Severity Rating Scale), and adverse event (AE) reporting. Results: Significant improvements in ADHD-RS-IV total score were observed for 200, 300, and 400 mg dose groups versus placebo ( p < .05; effect size [ES] = 0.547, 0.596, and 0.623). CGI-I score for the 300 mg group and CGI-S score for all SPN-812 groups except for 100 mg improved significantly ( p < .05) versus placebo. The most frequent AEs (≥15%) were somnolence, headache, and decreased appetite. Conclusion: SPN-812 significantly reduced the severity of ADHD symptoms and was well tolerated. The efficacy and safety of SPN-812 are being investigated in Phase III trials.

Objective: This longitudinal study examines the recall accuracy of childhood ADHD symptoms in late adolescence and early adulthood by youth and their parents, compared with reports obtained during childhood. Method: Participants ( N = 94) are initially evaluated when they are aged between 7 and 11 and reassessed when they are aged between 16 and 22 years. All participants meet full DSM-IV diagnostic criteria for ADHD in childhood. Assessments at baseline and follow-up include clinical interviews and ADHD checklists. Results: Results indicate that both youth and their parents have limited retrospective recall of childhood symptoms. Current ADHD symptoms improve accuracy of recall. Specifically, when current symptoms are endorsed, participants are more likely to recall clinically significant childhood ADHD symptoms. Conclusion: These results suggest that late adolescents and young adults with ADHD and their parents have limited ability to accurately recall childhood symptoms, with reporting of past symptoms influenced by reports of severity of current symptoms. (J. of Att. Dis. 2010; 14(1) 7-14)

While considerable attention has been paid to discriminating attention-deficit/hyperactivity and anxiety disorders, there are as yet no published confirmatory factor analytic studies of any self-report anxiety scale in ADHD youth. The Multidimensional Anxiety Scale for Children (MASC) is a 39-item, 4-point Likert self-report scale that robustly represents the factor structure of anxiety in children aged 8 to 18 years. Using confirmatory factor analytic methods, the present paper reports a replication of the four-factor measurement model for the MASC in a large sample of ADHD youth aged 7 to 10 years. The fit indices proved to be comparable to those obtained in the MASC clinical and non-clinical (normative) samples. Clinically, therefore, this report strengthens confidence that the MASC is a valid measure of anxiety in diverse populations. With respect to research, it provides supporting evidence that results obtained using the MASC in the MTA and other research studies reflect valid estimates of anxiety in those samples. Presumably because pathological anxiety is associated with significant suffering, disruption in normal psychosocial and academic development and family functioning, and increased utilization of medical services, "worry" is among the more common causes of referral to children's mental health care providers (Black, 1995; Simon, Ormel, VonKorff, & Barlow, 1995). Nonetheless, the prevalence of childhood-onset fears in the population, the structure of

The steering committee of the collaborative six-site Multimodal Treatment Study of Children with Attention-Deficit/Hyperactivity Disorder (the MTA) had to develop a common protocol consistent with public health goals and with scientific and clinical state of the art. With the aid of statistical, educational, and public health consultation, the steering committee balanced the stated objectives of the RFA against budgetary, clinical, ethical, and logistical practicalities. Two primary questions will be addressed: (1) What is the relative long-term effectiveness of excellent medication vs. excellent behavioral treatment vs. the combination? (2) What is the relative long-term effective ness of each of these state-of-the art intense treatments vs. routine community care? In a parallel-group design, 576 children (96 at each site) age 7-9 in grades 1-4 are thoroughly assessed in multiple domains from multiple informants and randomized to 4 treatment conditions: a medication-alone strategy, a psychosocial-treatment-alone strategy, a combination strategy, and community comparison (assessment and referral). The first three groups are treated for 14 months and all are re-assessed periodically for 24 months. Each treatment strategy is multi-component, with compromises between clinical flexibility and cross-site uniformity supported by a multi-tiered supervisory/fidelity structure, including 10 manuals, weekly teleconference panels, site visits, circuit-riding consultants, and feedback loops from therapists and supervisors to the steering committee about clinical realities. The resulting data should not only answer the primary questions above, but also support secondary data analyses about the effect of comorbidity, sex, SES, and other subject characteristics on treatment outcome. The MTA should both provide conclusions useful to the practicing clinician and define questions for the next generation of investigations.

As the largest randomized clinical trial conducted by the National Institute of Mental Health, the Multimodal Treatment Study of Children with ADHD (MTA) will yield data on a diverse sample of 576 7.0- to 9.9-year-old children with attention-deficit hyperactivity disorder (ADHD), Combined type, regarding the relative and combined effectiveness of psychosocial and pharmacologic interventions. After delineating key challenges posed by such a multi-site investigation, we describe the MTA's multiple-gating procedures for recruitment, screening, and diagnosis of a diverse sample. We then discuss the cross-domain assessment battery for tracking the sample before, during, and after 14 months of active intervention. Throughout, we emphasize the guiding principles that shaped pertinent decision making. Highlighted are issues of psychometric adequacy; dimensional vs. categorical measurement; multi-method, multi-agent, and multi-domain coverage; plotting of individual trajectories of development and change; respondent bias and burden; appraisal of treatment processes as well as outcomes; and con struction of composite indices.

Attention, impulse control, activity level, and motor decision/response organization were assessed in 70 child psychiatric outpatients, using a continuous performance test (CPT), a solid-state actigraph, and a response incompatibility task. Subjects were divided based on the presence or absence of attention-deficit hyperactivity disorder (ADHD) and/or reading disability (RD). Two-way ANOVAs yielded significant main effects for ADHD, but not RD, on objective measures of impulsivity and overactivity. No significant differences were found on a CPT measure of inattention. The response incompatibility task revealed differential performance between ADHD subgroups with and without comorbid RD. Deficits in motor decision/response organization were observed in the ADHD-only subgroup, but not in the comorbid ADHD+RD subgroup. These findings suggest that children with ADHD, RD and comorbid ADHD+RD have at least partially distinct underlying cognitive and neuropsychological disturbances, and that executive function deficits may be present primarily in ADHD children without RD.

Objective: To examine cognitive and psychosocial factors associated with high school dropout in urban adolescents with and without childhood ADHD. Method: In a longitudinal study, 49 adolescents/young adults with childhood ADHD and 44 controls who either dropped out or graduated from high school are included. Risk factors examined as potential correlates of dropout were intelligence, reading skills, socioeconomic status, marijuana use, and paternal contact. Results: Lower IQ, reading ability, socioeconomic status, frequent marijuana use, and limited paternal contact significantly differentiated dropouts from graduates, irrespective of childhood ADHD. Follow-up analyses determined that IQ, marijuana use, and paternal contact independently contribute to the likelihood of dropout. Conclusion: Selected cognitive and psychosocial factors appear independently associated with the likelihood of high school dropout irrespective of ADHD. Notably, childhood ADHD did not increase this risk, suggesting that previous reports of increased dropout because of ADHD may become negated in urban areas when matched with similar community controls. (J. of Att. Dis. 2009; 13(2) 127-136)