Trial of Training to Reduce Driver Inattention in Teens with ADHD.

BACKGROUND: Teens with attention deficit-hyperactivity disorder (ADHD) are at increased risk for motor vehicle collisions. A computerized skills-training program to reduce long glances away from the roadway, a contributor to collision risk, may ameliorate driving risks among teens with ADHD. METHODS: We evaluated a computerized skills-training program designed to reduce long glances (lasting ≥2 seconds) away from the roadway in drivers 16 to 19 years of age with ADHD. Participants were randomly assigned in a 1:1 ratio to undergo either enhanced Focused Concentration and Attention Learning, a program that targets reduction in the number of long glances (intervention) or enhanced conventional driver's education (control). The primary outcomes were the number of long glances away from the roadway and the standard deviation of lane position, a measure of lateral movements away from the center of the lane, during two 15-minute simulated drives at baseline and at 1 month and 6 months after training. Secondary outcomes were the rates of long glances and collisions or near-collisions involving abrupt changes in vehicle momentum (g-force event), as assessed with in-vehicle recordings over the 1-year period after training. RESULTS: During simulated driving after training, participants in the intervention group had a mean of 16.5 long glances per drive at 1 month and 15.7 long glances per drive at 6 months, as compared with 28.0 and 27.0 long glances, respectively, in the control group (incidence rate ratio at 1 month, 0.64; 95% confidence interval [CI], 0.52 to 0.76; P<0.001; incidence rate ratio at 6 months, 0.64; 95% CI, 0.52 to 0.76; P<0.001). The standard deviation of lane position (in feet) was 0.98 SD at 1 month and 0.98 SD at 6 months in the intervention group, as compared with 1.20 SD and 1.20 SD, respectively, in the control group (difference at 1 month, -0.21 SD; 95% CI, -0.29 to -0.13; difference at 6 months, -0.22 SD; 95% CI, -0.31 to -0.13; P<0.001 for interaction for both comparisons). During real-world driving over the year after training, the rate of long glances per g-force event was 18.3% in the intervention group and 23.9% in the control group (relative risk, 0.76; 95% CI, 0.61 to 0.92); the rate of collision or near-collision per g-force event was 3.4% and 5.6%, respectively (relative risk, 0.60, 95% CI, 0.41 to 0.89). CONCLUSIONS: In teens with ADHD, a specially designed computerized simulated-driving program with feedback to reduce long glances away from the roadway reduced the frequency of long glances and lessened variation in lane position as compared with a control program. During real-world driving in the year after training, the rate of collisions and near-collisions was lower in the intervention group. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT02848092.).

Low-intensity transcranial ultrasound stimulation improves memory behavior in an ADHD rat model by modulating cortical functional network connectivity.

Working memory in attention deficit hyperactivity disorder (ADHD) is closely related to cortical functional network connectivity (CFNC), such as abnormal connections between the frontal, temporal, occipital cortices and with other brain regions. Low-intensity transcranial ultrasound stimulation (TUS) has the advantages of non-invasiveness, high spatial resolution, and high penetration depth and can improve ADHD memory behavior. However, how it modulates CFNC in ADHD and the CFNC mechanism that improves working memory behavior in ADHD remain unclear. In this study, we observed working memory impairment in ADHD rats, establishing a corresponding relationship between changes in CFNCs and the behavioral state during the working memory task. Specifically, we noted abnormalities in the information transmission and processing capabilities of CFNC in ADHD rats while performing working memory tasks. These abnormalities manifested in the network integration ability of specific areas, as well as the information flow and functional differentiation of CFNC. Furthermore, our findings indicate that TUS effectively enhances the working memory ability of ADHD rats by modulating information transmission, processing, and integration capabilities, along with adjusting the information flow and functional differentiation of CFNC. Additionally, we explain the CFNC mechanism through which TUS improves working memory in ADHD. In summary, these findings suggest that CFNCs are important in working memory behaviors in ADHD.

Efficacy of a synbiotic in the management of adults with Attention-Deficit and Hyperactivity Disorder and/or Borderline Personality Disorder and high levels of irritability: Results from a multicenter, randomized, placebo-controlled, "basket" trial.

Irritability worsens prognosis and increases mortality in individuals with Attention-Deficit and Hyperactivity Disorder (ADHD) and/or Borderline Personality Disorder (BPD). However, treatment options are still insufficient. The aim of this randomized, double blind, placebo-controlled study was to investigate the superiority of a synbiotic over placebo in the management of adults with ADHD and/or BPD and high levels of irritability. The study was conducted between February 2019 and October 2020 at three European clinical centers located in Hungary, Spain and Germany. Included were patients aged 18-65 years old diagnosed with ADHD and/or BPD and high levels of irritability (i.e., an Affectivity Reactivity Index (ARI-S) ≥ 5, plus a Clinical Global Impression-Severity Scale (CGI-S) score ≥ 4). Subjects were randomized 1(synbiotic):1(placebo); the agent was administered each day, for 10 consecutive weeks. The primary outcome measure was end-of-treatment response (i.e., a reduction ≥ 30 % in the ARI-S total score compared to baseline, plus a Clinical Global Impression-Improvement (CGI-I) total score of < 3 (very much, or much improved) at week 10). Between-treatment differences in secondary outcomes, as well as safety were also investigated. Of the 231 included participants, 180 (90:90) were randomized and included in the intention-to-treat-analyses. Of these, 117 (65 %) were females, the mean age was 38 years, ADHD was diagnosed in 113 (63 %), BPD in 44 (24 %), both in 23 (13 %). The synbiotic was well tolerated. At week 10, patients allocated to the synbiotic experienced a significantly higher response rate compared to those allocated to placebo (OR: 0.2, 95 % CI:0.1 to 0.7; P = 0.01). These findings suggest that that (add-on) treatment with a synbiotic may be associated with a clinically meaningful improvement in irritability in, at least, a subgroup of adults with ADHD and/or BPD. A superiority of the synbiotic over placebo in the management of emotional dysregulation (-3.6, 95 % CI:-6.8 to -0.3; P = 0.03), emotional symptoms (-0.6, 95 % CI:-1.2 to -0.05; P = 0.03), inattention (-1.8, 95 % CI: -3.2 to -0.4; P = 0.01), functioning (-2.7, 95 % CI: -5.2 to -0.2; P = 0.03) and perceived stress levels (-0.6, 95 % CI: -1.2 to -0.05; P = 0.03) was also suggested. Higher baseline RANK-L protein levels were associated with a significantly lower response rate, but only in the synbiotic group (OR: 0.1, 95 % CI: -4.3 to - 0.3, P = 0.02). In the placebo group, higher IL-17A levels at baseline were significantly associated with a higher improvement in in particular, emotional dysregulation (P = 0.04), opening a door for new (targeted) drug intervention. However, larger prospective studies are warranted to confirm the findings. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03495375.

The impact of transcranial direct current stimulation on attention bias modification in children with ADHD.

Individuals with attention deficit-hyperactivity disorder (ADHD) struggle with the interaction of attention and emotion. The ventromedial prefrontal cortex (vmPFC) and dorsolateral prefrontal cortex (dlPFC) are assumed to be involved in this interaction. In the present study, we aimed to explore the effect of stimulation applied over the dlPFC and vmPFC on attention bias in individuals with ADHD. Twenty-three children with ADHD performed the emotional Stroop and dot probe tasks during transcranial direct current stimulation (tDCS) in 3 conditions: anodal dlPFC (F3)/cathodal vmPFC (Fp2), anodal vmPFC (Fp2)/cathodal dlPFC (F3), and sham stimulation. Findings suggest reduction of attention bias in both real conditions based on emotional Stroop task and not dot probe task. These results were independent of emotional states. The dlPFC and vmPFC are involved in attention bias in ADHD. tDCS can be used for attention bias modification in children with ADHD.

Attention-deficit/hyperactivity disorder in pregnancy and the postpartum period.

Attention-deficit/hyperactivity disorder is a childhood-onset neurodevelopmental disorder that frequently persists into adulthood with 3% of adult women having a diagnosis of attention-deficit/hyperactivity disorder. Many women are diagnosed and treated during their reproductive years, which leads to management implications during pregnancy and the postpartum period. We know from clinical practice that attention-deficit/hyperactivity disorder symptoms frequently become challenging to manage during the perinatal period and require additional support and attention. There is often uncertainty among healthcare providers about the management of attention-deficit/hyperactivity disorder in the perinatal period, particularly the safety of pharmacotherapy for the developing fetus. This guideline is focused on best practices in managing attention-deficit/hyperactivity disorder in the perinatal period. We recommend (1) mitigating the risks associated with attention-deficit/hyperactivity disorder that worsen during the perinatal period via individualized treatment planning; (2) providing psychoeducation, self-management strategies or coaching, and psychotherapies; and, for those with moderate or severe attention-deficit/hyperactivity disorder, (3) considering pharmacotherapy for attention-deficit/hyperactivity disorder, which largely has reassuring safety data. Specifically, providers should work collaboratively with patients and their support networks to balance the risks of perinatal attention-deficit/hyperactivity disorder medication with the risks of inadequately treated attention-deficit/hyperactivity disorder during pregnancy. The risks and impacts of attention-deficit/hyperactivity disorder in pregnancy can be successfully managed through preconception counselling and appropriate perinatal planning, management, and support.

Attention-Deficit/Hyperactivity Disorder Diagnosis, Treatment, and Telehealth Use in Adults - National Center for Health Statistics Rapid Surveys System, United States, October-November 2023.

Attention-deficit/hyperactivity disorder (ADHD) is a neurodevelopmental disorder that develops during childhood and can last into adulthood. Data from the National Center for Health Statistics Rapid Surveys System collected during October-November 2023 were used to estimate the prevalence of ADHD diagnosis and treatment among U.S. adults. In 2023, an estimated 15.5 million U.S. adults (6.0%) had a current ADHD diagnosis based on self-report; approximately one half received the diagnosis at age ≥18 years. Approximately one third of adults with ADHD took a stimulant medication to treat their ADHD in the previous year, 71.5% of whom had difficulty getting their ADHD prescription filled because it was unavailable. Approximately one half of adults with ADHD have ever used telehealth for ADHD-related services. Telehealth might have benefits for persons with ADHD, including helping them access behavioral treatment or medication prescriptions for ADHD. This report provides national estimates of the prevalence and treatment of ADHD among U.S. adults to help guide clinical care and regulatory decision-making for ADHD among U.S. adults.

The efficacy of weighted blankets for sleep in children with attention-deficit/hyperactivity disorder-A randomized controlled crossover trial.

Weighted blankets are a non-pharmacological intervention for treating sleep and anxiety problems in children with attention-deficit/hyperactivity disorder. However, research on the efficacy of weighted blankets is sparse. The aim of this randomized controlled trial with a crossover design (4 + 4 weeks) was to evaluate the efficacy of weighted blankets on sleep among children with attention-deficit/hyperactivity disorder and sleeping problems. Children diagnosed with uncomplicated Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition attention-deficit/hyperactivity disorder with verified sleep problems were randomized to start with either a weighted blanket or a lighter control blanket. Data collection was performed at weeks 0, 4 and 8 using actigraphy, questionnaires and a daily sleep diary. T-tests were used to evaluate efficacy. The study included 94 children with attention-deficit/hyperactivity disorder (mean age 9.0 [sd 2.2] years; 54 [57.4%] boys). Weighted blankets had a significant effect on total sleep time (mean diff. 7.72 min, p = 0.027, Cohen's d = 0.24), sleep efficiency (mean diff. 0.82%, p = 0.038, Cohen's d = 0.23) and wake after sleep onset (mean diff. -2.79 min, p = 0.015, Cohen's d = -0.27), but not on sleep-onset latency (p = 0.432). According to our exploratory subgroup analyses, weighted blankets may be especially beneficial for improving total sleep time in children aged 11-14 years (Cohen's d = 0.53, p = 0.009) and in children with the inattentive attention-deficit/hyperactivity disorder subtype (Cohen's d = 0.58, p = 0.016). Our results suggest that weighted blankets may improve children's sleep and could be used as an alternative to pharmacological sleep interventions.

Economic Burden and Service Utilization of Children With Attention-Deficit/Hyperactivity Disorder: A Systematic Review and Meta-Analysis.

OBJECTIVES: Attention-deficit/hyperactivity disorder (ADHD) is one of the most common neurodevelopmental disorders in children. This study aims to systematically synthesize the literature on service utilization and costs for children with ADHD. METHODS: The search included 9 databases for peer-reviewed primary studies in English from 2007 to 2023. Two independent reviewers conducted title/abstract and full-text screenings and quality assessment. Meta-analysis was conducted on direct medical costs. RESULTS: Thirty-two studies were included. Children with ADHD have used more pharmaceuticals, mental health, and special education services than children without ADHD (counterparts). Nevertheless, one study found that children with ADHD were twice as likely to have unmet health needs than their counterparts. Annual health system costs per patient were highly varied and higher in children with ADHD ($722-$11 555) than their counterparts ($179-$3646). From a societal perspective, children with ADHD were associated with higher costs ($162-$18 340) than their counterparts ($0-2540). The overall weighted mean direct medical cost was $5319 for children with ADHD compared with $1152 for their counterparts when all studies with different sample sizes were considered together, with the difference being $4167. Limited literature on productivity losses associated with ADHD reported them as a substantial cost. ADHD in children had a "large" effect on the increment of direct medical costs. CONCLUSIONS: ADHD was associated with increased service utilization and costs. However, unmet health needs or underuse among children with ADHD was also evident. Governments should endeavor to improve access to effective services for children with ADHD to mitigate the impact of ADHD.

Transcranial photobiomodulation for neurodevelopmental disorders: a narrative review.

BACKGROUND: Neurodevelopmental disorders (NDDs) such as autism spectrum disorder (ASD), attention-deficit/hyperactivity disorder (ADHD), and Down syndrome (DS) significantly impact social, communicative, and behavioral functioning. Transcranial photobiomodulation (t-PBM) with near-infrared light is a promising non-invasive neurostimulation technique for neuropsychiatric disorders, including NDDs. This narrative review aimed to examine the preclinical and clinical evidence of photobiomodulation (PBM) in treating NDDs. METHODS: A comprehensive search across six databases was conducted, using a combination of MeSH terms and title/abstract keywords: "photobiomodulation", "PBM", "neurodevelopmental disorders", "NDD", and others. Studies applying PBM to diagnosed NDD cases or animal models replicating NDDs were included. Protocols, reviews, studies published in languages other than English, and studies not evaluating clinical or cognitive outcomes were excluded. RESULTS: Nine studies were identified, including one preclinical and eight clinical studies (five on ASD, two on ADHD, and one on DS). The reviewed studies encompassed various t-PBM parameters (wavelengths: 635-905 nm) and targeted primarily frontal cortex areas. t-PBM showed efficacy in improving disruptive behavior, social communication, cognitive rigidity, sleep quality, and attention in ASD; in enhancing attention in ADHD; and in improving motor skills and verbal fluency in DS. Minimal adverse effects were reported. Proposed mechanisms involve enhanced mitochondrial function, modulated oxidative stress, and reduced neuroinflammation. CONCLUSIONS: t-PBM emerges as a promising intervention for NDDs, with potential therapeutic effects across ASD, ADHD, and DS. These findings underscore the need for further research, including larger-scale, randomized sham-controlled clinical trials with comprehensive biomarker analyses, to optimize treatment parameters and understand the underlying mechanisms associated with the effects of t-PBM.

Novel and complementary treatment approaches in attention-deficit/hyperactivity disorder.

PURPOSE OF REVIEW: To provide an updated review of novel and complementary treatment approaches for children and adolescents with attention-deficit/hyperactivity disorder. RECENT FINDINGS: The evidence for complementary attention-deficit/hyperactivity disorder treatments is often promising, but limited to small, unblinded studies. Recent evidence from larger, more rigorous studies reveals that most of these treatments have modest efficacy. Omega-3 polyunsaturated fatty acids, saffron, broad spectrum micronutrients, and physical exercise have potential benefits that seem to outweigh known risks. However, neurofeedback, cognitive training, and trigeminal nerve stimulation need further research to determine whether specific sub-groups of children/adolescents with attention-deficit/hyperactivity disorder would benefit long-term with their associated tolerable risks. SUMMARY: There is not sufficient evidence for complementary treatments to be recommended as substitutes for first-line pharmacological and psychosocial treatment options. Nonetheless, some adjuvant therapies to currently recommended attention-deficit/hyperactivity disorder treatments can be safe. Physicians should be familiar with existing and emerging complementary treatments to help guide families.

Sex Differences in ADHD: Review and Priorities for Future Research.

PURPOSE OF REVIEW: In childhood, attention-deficit/hyperactivity disorder (ADHD) is diagnosed three to 16 times more frequently in males compared to females, yet in adulthood, nearly equivalent numbers of males and females are diagnosed with ADHD. Relatively few studies have prioritized examination of sex differences in ADHD even though sex differences may have critical implications for the identification and treatment of ADHD in females and males. This review highlights current research on sex differences in ADHD across the lifespan that has emerged from cross-sectional and prospective longitudinal studies of youth, adult-ascertained samples, and registry studies. RECENT FINDINGS: Accumulating research suggests that both males and females with ADHD experience widespread impairment across the lifespan. Some evidence of sex differences emerged, although effects have generally been modest in size. Continued research that includes females and males with ADHD is needed to clarify the nature of sex differences in ADHD. Research that focuses on equitable identification of ADHD in males and females, disentangles the effects of sex and gender, probes underlying mechanisms of sex differences, and addresses the clinical impact of sex differences in ADHD must be prioritized.

Low-intensity ultrasound stimulation modulates cortical neurovascular coupling in an attention deficit hyperactivity disorder rat model.

Attention deficit hyperactivity disorder is accompanied by changes in cranial nerve function and cerebral blood flow (CBF). Low-intensity ultrasound stimulation can modulate brain neural activity in attention deficit hyperactivity disorder. However, to date, the modulatory effects of low-intensity ultrasound stimulation on CBF and neurovascular coupling in attention deficit hyperactivity disorder have not been reported. To address this question, Sprague-Dawley, Wistar-Kyoto, and spontaneously hypertensive (attention deficit hyperactivity disorder (ADHD) rat model) rats were divided into the control and low-intensity ultrasound stimulation (LIUS) groups. Cortical electrical stimulation was used to induce cortical excitability in different types of rats, and a penetrable laser speckle contrast imaging (LSCI) system and electrodes were used to evaluate the electrical stimulation-induced CBF, cortical excitability, and neurovascular coupling in free-moving rats. The CBF, cortical excitability, and neurovascular coupling (NVC) under cortical electrical stimulation in the attention deficit hyperactivity disorder rats were significantly different from those in the Sprague-Dawley and Wistar-Kyoto rats. We also found that low-intensity ultrasound stimulation significantly interfered with the cortical excitability and neurovascular coupling induced by cortical electrical stimulation in rats with attention deficit hyperactivity disorder. Our findings suggest that neurovascular coupling is a potential biomarker for attention deficit hyperactivity disorder. Furthermore, low-intensity ultrasound stimulation can improve abnormal brain function in attention deficit hyperactivity disorder and lay a research foundation for its application in the clinical treatment of attention deficit hyperactivity disorder.

Modernizing behavioral parent training program for ADHD with mHealth strategies, telehealth groups, and health behavior curriculum: a randomized pilot trial.

OBJECTIVE: Parent behavior management training (BMT) is an evidence-based yet underutilized tool to treat children with ADHD and address related health disparities. This pilot study investigated the acceptability and feasibility of a novel, health behavior-, and technology-adapted BMT (LEAP) vs. standard BMT. METHODS: The weekly 9-session LEAP telemedicine group program is based on a standard BMT curriculum enhanced with strategies for supporting optimal child sleep, problematic media use (PMU), and physical activity, including wrist-worn activity trackers. Children ages 6-10 years with ADHD and their caregivers were randomized to LEAP or standard BMT. Acceptability and feasibility were tracked. Caregivers completed standardized measures, and children wore hip-worn accelerometers for 1 week at baseline, postintervention (10 weeks), and follow-up (20 weeks). RESULTS: 84 parent/child dyads were randomized to LEAP or standard BMT, with high and comparable acceptability and feasibility. Both treatment groups demonstrated decreased ADHD symptoms and improved executive functions postintervention (p < .0001), maintained at follow-up. Average accelerometer-measured MVPA decreased and sleep duration remained unchanged, while PMU and bedtime resistance improved for both groups. CONCLUSIONS: LEAP is highly feasible and acceptable, and yielded similar initial clinical and health behavior improvements to standard BMT. Innovative and targeted supports are needed to promote healthy behaviors in children with ADHD.

Psychoeducation for adult ADHD: a scoping review about characteristics, patient involvement, and content.

BACKGROUND: Psychosocial interventions such as psychoeducation are increasingly being used to treat adult ADHD, both as an alternative and as a supplement to pharmacotherapy. A thorough overview of the literature on psychoeducation for adult ADHD is lacking. The objectives of this scoping review were therefore to identify the characteristics of psychoeducation interventions designed for adults with ADHD, examine how the patient experience or perspective is considered during the intervention's development and implementation, determine the typical themes covered, and explore how 'psychoeducation' is defined in these interventions. METHODS: A comprehensive search was performed to identify records in MEDLINE, Embase, PsycINFO, Web of Science, Cochrane CENTRAL, AMED, and ClinicalTrials.gov. Two or more reviewers were included in every step of the screening process and the final selection of included studies. The Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) checklist (Supplementary Material 1) was used to report the results, and the framework developed by Arksey and O'Malley was used as a guide throughout the scoping process. RESULTS: A total of 2121 records were identified through the literature search. After screening and full-text analysis, ten studies were included for final analysis. Most studies were conducted in Europe and followed a group format. Seven main themes were identified: Information about the diagnosis, treatment options, somatic health and ADHD, the insider perspective, ADHD and social life, coping and psychological skills, and ADHD and work. There was significant overlap in themes covered, but coverage of each theme varied. Themes deemed important by newer research, such as sexuality and gender-specific issues, were missing. Only one intervention involved patients in its development and implementation, and two interventions involved family members. There was variation in how psychoeducation was defined in the included studies, and the implications of this are discussed. CONCLUSION: The literature on psychoeducation for adult ADHD is not ready for any systematic effect estimation. Before such estimations are conducted, a shared understanding and definition of psychoeducation are needed. The involvement of end users in the development and delivery of interventions may aid reach this goal but results from this review indicate that such practices are rare.

Psychosocial interventions for improving the physical health of young people and adults with attention deficit hyperactivity disorder: a scoping review.

BACKGROUND: Young people and adults with ADHD are at risk of a range of physical health problems. There is limited guidance on how to approach health problems in ADHD, and especially around 16-25 year olds who will be transitioning from paediatric to adult care. The aim of this scoping review was to identify psychosocial interventions that target physical health in young people and adults with ADHD. METHODS: We constructed searches in MEDLINE, PsycInfo, EMBASE of adolescents, young people and adults. Inclusion criteria were; studies of psychosocial interventions examining a component of physical health, applicable to people aged 16-25, with clinical or research diagnoses of ADHD. Data were extracted using a data extraction tool and tabulated, including study intervention framing/aims, population, intervention, and relevant outcomes (including specific statistics where relevant). RESULTS: Our search identified 22 unique papers covering, psychosocial interventions targeting at least one of sleep (n=7), smoking (n=3), substance/alcohol use (n=4), physical health/exercise (n=6) and general health (n=3). Studies examined psychotherapy/behaviour interventions (n=12), psychoeducation (n=4), digital (n=2) and social interventions (n=4). There was significant heterogeneity in intervention framing, outcome measures and population. CONCLUSION: Further work on the impact of targeted physical health interventions, with explicit reference to a conceptual framework of poor health in ADHD is required. Furthermore, future work standardising reporting of physical health outcomes in ADHD is crucial for the development of an evidence base in this field.

The efficacy of real versus sham external Trigeminal Nerve Stimulation (eTNS) in youth with Attention-Deficit/Hyperactivity Disorder (ADHD) over 4 weeks: a protocol for a multi-centre, double-blind, randomized, parallel-group, phase IIb study (ATTENS).

BACKGROUND: Attention Deficit/Hyperactivity Disorder (ADHD), if severe, is usually treated with stimulant or non-stimulant medication. However, users prefer non-drug treatments due to side effects. Alternative non-medication treatments have so far only shown modest effects. External trigeminal nerve stimulation (eTNS) is a minimal risk, non-invasive neuromodulation device, targeting the trigeminal system. It was approved for ADHD in 2019 by the USA Food and Drug administration (FDA) based on a small proof of concept randomised controlled trial (RCT) in 62 children with ADHD showing improvement of ADHD symptoms after 4 weeks of nightly real versus sham eTNS with minimal side effects. We present here the protocol of a larger confirmatory phase IIb study testing efficacy, longer-term persistency of effects and underlying mechanisms of action. METHODS: A confirmatory, sham-controlled, double-blind, parallel-arm, multi-centre phase IIb RCT of 4 weeks of eTNS in 150 youth with ADHD, recruited in London, Portsmouth, and Southampton, UK. Youth with ADHD will be randomized to either real or sham eTNS, applied nightly for 4 weeks. Primary outcome is the change in the investigator-administered parent rated ADHD rating scale. Secondary outcomes are other clinical and cognitive measures, objective hyperactivity and pupillometry measures, side effects, and maintenance of effects over 6 months. The mechanisms of action will be tested in a subgroup of 56 participants using magnetic resonance imaging (MRI) before and after the 4-week treatment. DISCUSSION: This multi-centre phase IIb RCT will confirm whether eTNS is effective in a larger age range of children and adolescents with ADHD, whether it improves cognition and other clinical measures, whether efficacy persists at 6 months and it will test underlying brain mechanisms. The results will establish whether eTNS is effective and safe as a novel non-pharmacological treatment for ADHD. TRIAL REGISTRATION: ISRCTN82129325 on 02/08/2021, https://doi.org/10.1186/ISRCTN82129325 .

One-year follow-up of the effectiveness and mediators of cognitive behavioural therapy among adults with attention-deficit/hyperactivity disorder: secondary outcomes of a randomised controlled trial.

BACKGROUND: The long-term effectiveness of cognitive behavioural therapy (CBT) in medicated attention-deficit/hyperactivity disorder (ADHD) adults with residual symptoms needs to be verified across multiple dimensions, especially with respect to maladaptive cognitions and psychological quality of life (QoL). An exploration of the mechanisms underlying the additive benefits of CBT on QoL in clinical samples may be helpful for a better understanding of the CBT conceptual model and how CBT works in medicated ADHD. METHODS: We conducted a secondary analysis of a randomised controlled trial including 98 medicated ADHD adults with residual symptoms who were randomly allocated to the CBT combined with medication (CBT + M) group or the medication (M)-only group. Outcomes included ADHD-core symptoms (ADHD Rating Scale), depression symptoms (Self-rating Depression Scale), maladaptive cognitions (Automatic Thoughts Questionnaire and Dysfunctional Attitude Scale), and psychological QoL (World Health Organization Quality of Life-Brief Version-psychological domain). Mixed linear models (MLMs) were used to analyse the long-term effectiveness at one-year follow-up, and structural equation modeling (SEM) was performed to explore the potential mechanisms of CBT on psychological QoL. RESULTS: ADHD patients in the CBT + M group outperformed the M-only group in reduction of ADHD core symptoms (d = 0.491), depression symptoms (d = 0.570), a trend of reduction of maladaptive cognitions (d = 0.387 and 0.395, respectively), and improvement of psychological QoL (d = - 0.433). The changes in above dimensions correlated with each other (r = 0.201 ~ 0.636). The influence of CBT on QoL was mediated through the following four pathways: 1) changes in ADHD core symptoms; 2) changes in depressive symptoms; 3) changes in depressive symptoms and then maladaptive cognitions; and 4) changes firstly in depressive symptoms, maladaptive cognitions, and then ADHD core symptoms. CONCLUSIONS: The long-term effectiveness of CBT in medicated ADHD adults with residual symptoms was further confirmed. The CBT conceptual model was verified in clinical samples, which would be helpful for a deeper understanding of how CBT works for a better psychological QoL outcome. TRIAL REGISTRATION: ChiCTR1900021705 (2019-03-05).

Protocols for transitioning to adult mental health services for adolescents with ADHD.

BACKGROUND: For Attention Deficit/Hyperactivity Disorder (ADHD) youth transitioning from child to adult services, protocols that guide the transition process are essential. While some guidelines are available, they do not always consider the effective workload and scarce resources. In Italy, very few guidelines are currently available, and they do not adhere to common standards, possibly leading to non-uniform use. METHODS: The present study analyzes 6 protocols collected from the 21 Italian services for ADHD patients that took part in the TransiDEA (Transitioning in Diabetes, Epilepsy, and ADHD patients) Project. The protocols' content is described, and a comparison with the National Institute for Clinical Health and Excellence (NICE) guidelines is carried out to determine whether the eight NICE fundamental dimensions were present. RESULTS: In line with the NICE guidelines, the dimensions addresses in the 6 analyzed documents are: early transition planning (although with variability in age criteria) (6/6), individualized planning (5/6), and the evaluation of transfer needs (5/6). All protocols also foresee joint meetings between child and adult services. The need to include the families is considered by 4 out of 6 protocols, while monitoring (2/6), and training programs (1/6) are less encompassed. In general, a highly heterogeneous picture emerges in terms of quality and quantity of regulations provided. CONCLUSIONS: While some solid points and core elements are in common with international guidelines, the content's variability highlights the need to standardize practices. Finally, future protocols should adhere more to the patients' needs and the resources available to clinicians.

Psychoeducational group interventions for adults diagnosed with attention-deficit/ hyperactivity disorder: a scoping review of feasibility, acceptability, and outcome measures.

INTRODUCTION: Although psychoeducational group interventions are increasingly used for adults diagnosed with attention-deficit/hyperactivity disorder (ADHD), a comprehensive review focused on the feasibility and acceptability indicators of these interventions remains lacking. Furthermore, although previous research has explored various aspects of psychoeducation for ADHD, such as its definition and approaches, limited research has focused on the synthesis for outcome measures and patients' experiences related to these interventions. Therefore, this scoping review aims to map the existing evidence reported on psychoeducational group interventions for adults diagnosed with ADHD. The objective is to provide a comprehensive overview of feasibility indicators, acceptability, and outcome measures used in psychoeducational group interventions. METHOD: A comprehensive structured literature search on the topic was performed in seven bibliographic databases, and the resulting records were independently screened, and their data extracted by two reviewers. We followed the Preferred Reporting Items for Systematic reviews and Meta-Analyses Extension for Scoping Reviews (PRISMA-S) to ensure the transparency and rigor of this scoping review. RESULTS: The searches yielded 7510 records. Eight studies met the inclusion criteria. These included studies were conducted in European countries and the United States. Among these, six studies used a randomized control design, one an open feasibility trial, and one a pre-post intervention design. All the studies reported some feasibility and acceptability indicators. While all the studies reported on the severity of symptoms of ADHD as an outcome measure, some also reported on outcomes related to psychological or mental-health problems, quality of life, changes in knowledge regarding ADHD, or the level of self-esteem, functioning, and impairment. CONCLUSION: This scoping review revealed that psychoeducational group interventions are generally acceptable for patients in terms of patient satisfaction with the group intervention. All included studies reported some feasibility indicators, with some reporting good attendance and relatively low dropout rates. Most studies reported positive effects on ADHD and mental health symptoms, suggesting that these interventions are beneficial for adults with ADHD. However, several gaps exist regarding the reporting on the feasibility indicators, acceptability, and outcome measures employed across studies.

Feasibility, acceptability and preliminary evaluation of a user co-facilitated psychoeducational programme: a feasibility proof-of-concept randomised control trial.

BACKGROUND: Mental health settings are increasingly using co-facilitation of educational group interventions in collaboration with patient partners and service users. However, despite promising results, limited information is available regarding the feasibility and satisfaction levels of these programmes among adults newly diagnosed with attention-deficit hyperactivity/impulsivity disorder (ADHD). Hence, this study aimed to determine the feasibility, acceptability, and preliminary effects of a user co-facilitated psychoeducational group programme for adults diagnosed with ADHD. METHODS: This feasibility proof-of-concept randomised controlled trial recruited outpatients from a Norwegian community mental health centre. Outpatients randomised to the intervention group (IG) received a psychoeducational programme supplementing Treatment As Usual (TAU), while the control group received TAU. Feasibility was determined by the acceptance rate, adherence rate, and dropout rate. Acceptability was measured with the Client Satisfaction Questionnaire and a 3-item scale measuring satisfaction with the received information. To test the preliminary effects, self-efficacy, symptom severity, and quality of life were measured at baseline and pre- and post-intervention. RESULTS: Feasibility was demonstrated; most of the patients were willing to enrol, participants attended 82% of the psychoeducational programme, and only 13% dropped out of the study. The between-group analyses revealed that the IG reported significantly greater mean satisfaction than the CG. Moreover, the intervention group was more satisfied with the information they received during the psychoeducational programme. Concerning the preliminary effects, the linear mixed model showed improvement in quality of life (the subscale relationship); however, other patient-reported outcomes did not show improvements. CONCLUSIONS: This proof-of-concept randomised controlled trial supports the feasibility and acceptability of the user co-facilitated psychoeducational programme for patients newly diagnosed with ADHD in an outpatient setting. While preliminary findings indicate promise in enhancing patient-reported outcomes, a larger study is warranted to assess the intervention's effectiveness rigorously. TRIAL REGISTRATION: NCT03425, 09/11/2017.