Promoting early autism detection and intervention in underserved communities: study protocol for a pragmatic trial using a stepped-wedge design.

BACKGROUND: Despite the known benefits of early, specialized intervention for toddlers with Autism Spectrum Disorder (ASD), access to such intervention remains limited. This pragmatic trial examines a novel healthcare delivery model (Screen-Refer-Treat [SRT]), which capitalizes upon existing health care and early intervention (EI) infrastructure to increase community capacity for ASD detection and treatment before age 3, when it is likely to have the greatest impact. This model comprises three components: (1) universal use of Stage 1 ASD screening by primary care providers (PCPs) at 18-month well-child visits (i.e., Screen); (2) immediate referral of positive screens to a community-based EI program (i.e., Refer); and (3) provision of an inexpensive, evidence-based ASD-specialized treatment by EI providers, after verifying ASD risk with a Stage 2 screen (i.e., Treat). This paper describes our research design and the initial successes, challenges, and adaptations made during the early implementation phase. METHOD/DESIGN: A stepped-wedge cluster RCT was used to implement the SRT model sequentially in four diverse Washington State counties ("clusters"). Counties are randomly assigned to the time of receipt of the SRT intervention, which comprises training workshops and technical assistance focused on the use of evidence-based ASD screening and intervention tools. Separate cohorts of families with toddlers (16-35 months old) with and without ASD concerns are recruited before and after the SRT intervention from participating PCP practices and EI programs. PCPs and EI providers complete measures on their screening, referral, and intervention practices before and after the SRT intervention. Each family cohort completes surveys about their well-being, parenting efficacy, health care satisfaction, and toddler's social-communicative behaviors. CONCLUSION: This trial is the first of its kind to work simultaneously with two service delivery systems with the goal of improving early detection and treatment for ASD. Our approach was successful in attaining buy-in from PCPs and EI providers, building and maintaining partnerships with providers, and achieving high levels of retention and survey completion. Fostering provider engagement and problem-solving issues together as partners were integral to overcoming the main challenges. Numerous lessons have been learned thus far, which have applicability for implementation researchers in ASD and those in other fields. TRIAL REGISTRATION: The registration number for this trial is NCT02409303 and it was posted on ClinicalTrials.gov on April 6, 2015.

Best Practices in Videoconferencing-Based Telemental Health April 2018.

Telemental health, in the form of interactive videoconferencing, has become a critical tool in the delivery of mental health care. It has demonstrated the ability to increase access to and quality of care, and in some settings to do so more effectively than treatment delivered in-person. This article updates and consolidates previous guidance developed by The American Telemedicine Association (ATA) and The American Psychiatric Association (APA) on the development, implementation, administration, and provision of telemental health services. The guidance included in this article is intended to assist in the development and delivery of effective and safe telemental health services founded on expert consensus, research evidence, available resources, and patient needs. It is recommended that the material reviewed be contemplated in conjunction with APA and ATA resources, as well as the pertinent literature, for additional details on the topics covered.

Telemental health for children and adolescents.

Most children and adolescents across the USA fail to receive adequate mental health services, especially in rural or underserved communities. The supply of child and adolescent psychiatrists is insufficient for the number of children in need of services and is not anticipated to grow. This calls for novel approaches to mental health care. Telemental health (TMH) offers one approach to increase access. TMH programmes serving young people are developing rapidly and available studies demonstrate that these services are feasible, acceptable, sustainable and likely as effective as in-person services. TMH services are utilized in clinical settings to provide direct care and consultation to primary care providers (PCPs), as well as in non-traditional settings, such as schools, correctional facilities and the home. Delivery of services to young people through TMH requires several adjustments to practice with adults regarding the model of care, cultural values, participating adults, rapport-building, pharmacotherapy and psychotherapy. Additional infrastructure accommodations at the patient site include space and staffing to conduct developmentally appropriate evaluations and treatment planning with parents, other providers, and community services. For TMH to optimally impact young people's access to mental health care, collaborative models of care are needed to support PCPs as frontline mental health-care providers, thereby effectively expanding the child and adolescent mental health workforce.

Teletherapy delivery of caregiver behavior training for children with attention-deficit hyperactivity disorder.

BACKGROUND: Preliminary studies suggest that videoteleconferencing (VTC) may be an effective means to deliver behavioral interventions to families. Subjects consisted of a subsample of children (n=37) and caregivers who participated in the Children's Attention-Deficit Hyperactivity Disorder (ADHD) Telemental Health Treatment Study (CATTS) (n=223), a randomized trial testing the effectiveness of delivering treatments for ADHD to families residing in their home communities using distant technologies. Families randomized to the CATTS intervention arm received pharmacotherapy and caregiver behavior training. MATERIALS AND METHODS: Thirty-seven families from the CATTS intervention arm participated. All families received pharmacotherapy through VTC. Twelve families received the caregiver behavior training through VTC, or teletherapy, and 25 received the intervention in-person. We assessed children's outcomes at 25 weeks with the Vanderbilt ADHD Parent Rating Scale and the Columbia Impairment Scale. We assessed caregivers' outcomes using measures of distress in caring for a child with ADHD, including depression, stress, strain, and empowerment. We used analysis of covariance to assess outcomes from baseline to 25 weeks. RESULTS: Families in the two conditions showed comparable attendance at sessions and satisfaction with their care. Caregivers in both conditions reported comparable outcomes for their children's ADHD-related behaviors and functioning, but caregivers in the teletherapy group did not report improvement in their own distress. CONCLUSIONS: Findings support the feasibility, acceptability, and effectiveness of treating children with ADHD through teletherapy. Future work should investigate how teletherapy may improve caregivers' distress. Teletherapy is a promising modality for delivering behavioral interventions for children with ADHD.

Methodology for conducting the children's attention-deficit hyperactivity disorder telemental health treatment study in multiple underserved communities.

BACKGROUND: Children living in nonmetropolitan communities are underserved by evidence-based mental health care and are underrepresented in clinical trials. PURPOSE: In this article, we describe lessons learned in conducting the Children's Attention-Deficit Hyperactivity Disorder (ADHD) Telemental Health (TMH) Treatment Study (CATTS), a randomized controlled trial testing the effectiveness of TMH in improving outcomes of children with ADHD living in underserved communities. METHODS: Children were referred by primary care providers (PCPs). The test intervention group received six telepsychiatry sessions with each session followed by an caregiver behavior training session delivered in-person by a local therapist. A secure website was used to support decision making by the telepsychiatrists and to facilitate real-time collaboration between the telepsychiatrists and community therapists. The control group received a single telepsychiatry consultation. Questionnaires tapping ADHD symptoms and other outcomes were administered to parents and teachers online through a secure portal from personal computers. RESULTS: total of 88 PCPs in seven communities referred the 223 children who participated in the trial. Attrition in treatment sessions and research assessments was very low. Lessons learned TMH proved to be a viable means of providing evidence-based pharmacological services to children and training to local therapists. Recruitment was enhanced by offering the control group a telepsychiatry consultation. Site-specific strategies were needed to meet recruitment targets. CONCLUSIONS: The CATTS trial used methods designed to optimize inclusion of children living in multiple dispersed and underserved areas. The study will serve as a model for other research projects aiming at reducing geographic disparities in access to quality mental health care.

Telemental health: responding to mandates for reform in primary healthcare.

Telemental health (TMH) has established a niche as a feasible, acceptable, and effective service model to improve the mental healthcare and outcomes for individuals who cannot access traditional mental health services. The Accountability Care Act has mandated reforms in the structure, functioning, and financing of primary care that provide an opportunity for TMH to move into the mainstream healthcare system. By partnering with the Integrated Behavioral Healthcare Model, TMH offers a spectrum of tools to unite primary care physicians and mental health specialist in a mind-body view of patients' healthcare needs and to activate patients in their own care. TMH tools include video-teleconferencing to telecommute mental health specialists to the primary care setting to collaborate with a team in caring for patients' mental healthcare needs and to provide direct services to patients who are not progressing optimally with this collaborative model. Asynchronous tools include online therapies that offer an efficient first step to treatment for selected disorders such as depression and anxiety. Patients activate themselves in their care through portals that provide access to their healthcare information and Web sites that offer on-demand information and communication with a healthcare team. These synchronous and asynchronous TMH tools may move the site of mental healthcare from the clinic to the home. The evolving role of social media in facilitating communication among patients or with their healthcare team deserves further consideration as a tool to activate patients and provide more personalized care.

The Transition of Academic Mental Health Clinics to Telehealth During the COVID-19 Pandemic.

OBJECTIVE: A consortium of 8 academic child and adolescent psychiatry programs in the United States and Canada examined their pivot from in-person, clinic-based services to home-based telehealth during the COVID-19 pandemic. The aims were to document the transition across diverse sites and to present recommendations for future telehealth service planning. METHOD: Consortium sites completed a Qualtrics survey assessing site characteristics, telehealth practices, service use, and barriers to and facilitators of telehealth service delivery prior to (pre) and during the early stages of (post) the COVID-19 pandemic. The design is descriptive. RESULTS: All sites pivoted from in-person services to home-based telehealth within 2 weeks. Some sites experienced delays in conducting new intakes, and most experienced delays establishing tele-group therapy. No-show rates and use of telephony versus videoconferencing varied by site. Changes in telehealth practices (eg, documentation requirements, safety protocols) and perceived barriers to telehealth service delivery (eg, regulatory limitations, inability to bill) occurred pre-/post-COVID-19. CONCLUSION: A rapid pivot from in-person services to home-based telehealth occurred at 8 diverse academic programs in the context of a global health crisis. To promote ongoing use of home-based telehealth during future crises and usual care, academic programs should continue documenting the successes and barriers to telehealth practice to promote equitable and sustainable telehealth service delivery in the future.

Implementing a low-cost web-based clinical trial management system for community studies: a case study.

BACKGROUND: Clinical trials with multiple intervention locations and a single research coordinating center can be logistically difficult to implement. Increasingly, web-based systems are used to provide clinical trial support with many commercial, open source, and proprietary systems in use. New web-based tools are available which can be customized without programming expertise to deliver web-based clinical trial management and data collection functions. PURPOSE: To demonstrate the feasibility of utilizing low-cost configurable applications to create a customized web-based data collection and study management system for a five intervention site randomized clinical trial establishing the efficacy of providing evidence-based treatment via teleconferencing to children with attention-deficit hyperactivity disorder. The sites are small communities that would not usually be included in traditional randomized trials. A major goal was to develop database that participants could access from computers in their home communities for direct data entry. METHODS: Discussed is the selection process leading to the identification and utilization of a cost-effective and user-friendly set of tools capable of customization for data collection and study management tasks. RESULTS: An online assessment collection application, template-based web portal creation application, and web-accessible Access 2007 database were selected and customized to provide the following features: schedule appointments, administer and monitor online secure assessments, issue subject incentives, and securely transmit electronic documents between sites. Each tool was configured by users with limited programming expertise. As of June 2011, the system has successfully been used with 125 participants in 5 communities, who have completed 536 sets of assessment questionnaires, 8 community therapists, and 11 research staff at the research coordinating center. LIMITATIONS: Total automation of processes is not possible with the current set of tools as each is loosely affiliated, creating some inefficiency. This system is best suited to investigations with a single data source e.g., psychosocial questionnaires. CONCLUSIONS: New web-based applications can be used by investigators with limited programming experience to implement user-friendly, efficient, and cost-effective tools for multi-site clinical trials with small distant communities. Such systems allow the inclusion in research of populations that are not usually involved in clinical trials.

Editorial: For Adolescents With Subthreshold Depression, Is an Ounce of Prevention Worth a Pound of Cure?

Globally, depression is among the leading neuropsychiatric disorders of adolescence. Conventional wisdom indicates that an "ounce of prevention is worth a pound of cure," a perspective bolstered by some studies demonstrating that psychological interventions for subthreshold depression reduce acute symptoms and prevent the onset of major depressive disorder (MDD) over short-term follow-up. However, the meta-analysis by Cuijpers et al.,1 the first to pool results from all available relevant studies in the field, provides evidence that would seem to challenge this conventional wisdom. The meta-analysis included 12 randomized controlled trials of children and adolescents. This editorial focuses on the 10 studies with adolescents (age range, 13.5-17.4 years), who were recruited from schools (n = 6), medical settings (n = 3), and mass mailings (n = 1). The youths received short-term psychotherapies ranging from 6 to 16 sessions, primarily cognitive-behavioral therapy or interpersonal therapy, or inactive control/care as usual. Results showed significant short-term benefits in reducing acute depression symptoms, even though effect size was small to medium (number needed to treat = 8.4). At 6-18 months of follow-up, however, the likelihood of meeting full criteria for MDD was not significantly different between the intervention and control conditions. We child and adolescent psychiatrists have difficulty yielding our commitment to conventional wisdom and look for evidence that this meta-analysis is not the last word on the value of early interventions for subthreshold depression to prevent MDD in adolescents.

Home-Based Telemental Health: A Proposed Privacy and Safety Protocol and Tool.

Objectives: To describe the development of a protocol and practical tool for the safe delivery of telemental health (TMH) services to the home. The COVID-19 pandemic forced providers to rapidly transition their outpatient practices to home-based TMH (HB-TMH) without existing protocols or tools to guide them. This experience underscored the need for a standardized privacy and safety tool as HB-TMH is expected to continue as a resource during future crises as well as to become a component of the routine mental health care landscape. Methods: The authors represent a subset of the Child and Adolescent Psychiatry Telemental Health Consortium. They met weekly through videoconferencing to review published safety standards of care, existing TMH guidelines for clinic-based and home-based services, and their own institutional protocols. They agreed on three domains foundational to the delivery of HB-TMH: environmental safety, clinical safety, and disposition planning. Through multiple iterations, they agreed upon a final Privacy and Safety Protocol for HB-TMH. The protocol was then operationalized into the Privacy and Safety Assessment Tool (PSA Tool) based on two keystone medical safety constructs: the World Health Organization (WHO) Surgical Safety Checklist/Time-Out and the Checklist Manifesto.Results: The PSA Tool comprised four modules: (1) Screening for Safety for HB-TMH; (2) Assessment for Safety During the HB-TMH Initial Visit; (3) End of the Initial Visit and Disposition Planning; and (4) the TMH Time-Out and Reassessment during subsequent visits. A sample workflow guides implementation. Conclusions: The Privacy and Safety Protocol and PSA Tool aim to prepare providers for the private and safe delivery of HB-TMH. Its modular format can be adapted to each site's resources. Going forward, the PSA Tool should help to facilitate the integration of HB-TMH into the routine mental health care landscape.

Developing home-based telemental health services for youth: Practices from the SUAY Study.

INTRODUCTION: There are no published procedural or safety guidelines for home-based telemental health (TMH) therapy with youth, despite the unique challenges and risks of providing services to this population outside of a traditional clinic setting. We developed clinical, logistical, and safety procedures for home-based TMH with youth in the context of a large clinical trial. METHODS: A Targeted Approach to Safer Use of Antipsychotics in Youth (SUAY) study identifies youth ages 3-17 who are prescribed second-generation antipsychotic medication for non-psychotic disorders within large healthcare systems. Prescribing physicians receive psychopharmacology consultation. Patients receive a "navigator" to coordinate treatments and access to TMH if they do not have a local therapist. We optimized access by allowing TMH sessions to take place in the family's home, while providing guidelines for privacy, safety, and in-session crises. RESULTS: Clinical issues included providing flexibility in the treatment modality and engaging families. Logistical issues included remote consenting for treatment and troubleshooting technological problems. Safety issues included crisis and safety planning with the youth and family before and during treatment. DISCUSSION: The provision of home-based TMH therapy for youth requires adaptations to existing TMH procedural and safety guidelines to optimize clinical care, technology coordination, and safety.Trial registration number and trial register: Clinicaltrials.gov: NCT03448575.

A National Pediatric Telepsychiatry Curriculum for Graduate Medical Education and Continuing Medical Education.

Objectives: Our goal was to develop an open access nationally disseminated online curriculum for use in graduate and continuing medical education on the topic of pediatric telepsychiatry to enhance the uptake of telepsychiatry among child psychiatry training programs and improve access to mental health care for youth and families. Methods: Following Kern's 6-stage model of curriculum development, we identified a core problem, conducted a needs assessment, developed broad goals and measurable objectives in a competency-based model, and developed educational content and methods. The curriculum was reviewed by experts and feedback incorporated. Given the urgent need for such a curriculum due to the COVID-19 pandemic, the curriculum was immediately posted on the American Academy of Child and Adolescent Psychiatry and American Association of Directors of Psychiatric Residency Training websites. Further evaluation will be conducted over the next year. Results: The curriculum covers the six areas of core competence adapted for pediatric telepsychiatry and includes teaching content and resources, evaluation tools, and information about other resources. Conclusion: This online curriculum is available online and provides an important resource and set of standards for pediatric telepsychiatry training. Its online format allows for ongoing revision as the telepsychiatry landscape changes.

Attention-deficit/hyperactivity disorder and telemental health.

Attention-deficit/hyperactivity disorder (ADHD) is one of the most prevalent psychiatric disorders diagnosed in children and adolescents (youth). ADHD is equally distributed geographically, but services are not. Access to expert evaluation and treatment remains limited for youth with ADHD living in rural areas, as well as for ethnic and racial minority youth. Telepsychiatry is a service delivery model with the potential to reach these youth and to develop collaborative models of care among local primary care physicians, remote telepsychiatrists, and local families. Care delivered through telepsychiatry can readily adhere to the practice parameters of the American Academy of Child and Adolescent Psychiatry. Work to date indicates that ADHD is the most common disorder treated through telepsychiatry. This article reviews the status of child and adolescent telepsychiatry, with particular focus on its potential to improve the care and outcomes of underserved populations of youth diagnosed with ADHD.

Implementation of Home-Based Telemental Health in a Large Child Psychiatry Department During the COVID-19 Crisis.

Objective: Telemental health (TMH) is not well described for mental health service delivery during crises. Most child and adolescent psychiatry training programs have not integrated TMH into their curricula and are ill equipped to respond during crises to their patients' needs. In this study, we present the implementation of a home-based TMH (HB-TMH) service during the COVID-19 pandemic. Methods: We describe the technological, administrative, training, and clinical implementation components involved in transitioning a comprehensive outpatient child and adolescent psychiatry program to a HB-TMH virtual clinic. Results: The transition was accomplished in 6 weeks. Most in-clinic services were rapidly moved off campus to the home. Owing to challenges encountered with each implementation component, phone sessions bridged the transition from in-clinic to reliable virtual appointments. Within 3 weeks (March 20, 2020) of planning for HB-TMH, 67% of all appointments were conducted at home, and within 4 weeks (March 27, 2020), 90% were conducted at home. By week 6 (April 3, 2020), reliable HB-TMH appointments were implemented. Conclusions: The COVID-19 pandemic crisis created the opportunity to innovate a solution to disrupted care for our established patients and to create a resource for youth who developed problems during the crisis. Our department was experienced in providing TMH services that facilitated the transition to HB-TMH, yet still had to overcome known and unanticipated challenges. Our experience provides a roadmap for establishing a HB-TMH service with focus on rapid implementation. It also demonstrates a role for TMH during (rather than after) future crises when usual community resources are not available.

Primary Care Management of Children with Attention-Deficit/Hyperactivity Disorder Appears More Assertive Following Brief Psychiatric Intervention Compared with Single Session Consultation.

Objectives: We examined primary care providers' (PCPs') management of attention-deficit/hyperactivity disorder (ADHD) during and following families' participation in two arms of the Children's ADHD Telemental Health Treatment Study. We hypothesized that more intensive treatment during the trial would show an "after-effect" with more assertive PCPs' management during short term follow-up. Methods: We conducted a pragmatic follow-up of PCPs' management of children with ADHD who had been randomized to two service delivery models. In the Direct Service Model, psychiatrists provided six sessions over 22 weeks of pharmacotherapy followed by behavior training. In the Consultation Model, psychiatrists provided a single-session consultation and made treatment recommendations to PCPs who implemented these recommendations at their discretion for 22 weeks. At the end of the trial, referring PCPs for both service delivery models resumed ADHD treatment for 10 weeks. We performed intent-to-treat analysis using all 223 original participants. We applied linear regression models on continuous outcomes, Poisson regression models on count outcomes, and logistic regression models to binary outcomes. Missing data were addressed through imputations. Results: Participants in the Direct Service Model had more ADHD visits than those in the Consultation Model across the full 32 weeks (mean = 7.05 visits vs. 3.36 visits; adjusted rate ratio = 2.1 [1.85-2.38]; p < 0.0001). During follow-up, participants in the DSM were more likely to be taking ADHD-related medications (82% vs. 61%; adjusted odds ratio = 2.44 [1.24-4.81], p = 0.01). At 32 weeks, participants in the Direct Service Model had higher stimulant dosages (adjusted difference = 5.64 [0.12-11.15] mg; p = 0.046). Conclusion: These results from a pragmatic follow-up of a randomized trial suggest an "after-effect" for brief intensive treatment in the Direct Service Model on the short term follow-up management of ADHD in primary care.

Child and adolescent telepsychiatry: utilization and satisfaction.

Access to psychiatric care for children and adolescents is limited outside of urban areas. Telepsychiatry provides one mechanism to bring needed services to youth. This investigation examines whether telepsychiatry could be successful in providing needed services. Using interactive video teleconferencing at 384 kilobits per second, psychiatrists based at a regional childrens hospital provided consultation and management services to patients at 4 sites across Washington State located 75150 miles from the childrens hospital. Twelve-month review of billing records provided utilization data. Surveys of parents satisfaction over 12 months examined whether parents would accept and be satisfied with the care rendered to their children. Over the study year, 387 telepsychiatry visits were provided to 172 youth 221 years old with a mean of 2.25 visits per patient. The demographic and diagnostic profile of this sample was consistent with usual outpatient mental health samples. Parents endorsed high satisfaction with their childrens telepsychiatric care, with an indication of increasing satisfaction upon return appointments. Parents demonstrated some differential satisfaction, tending to higher satisfaction with their school-aged childrens care and lower satisfaction with their adolescents care. Telepsychiatry offered through a regional childrens hospital was well utilized and parents were highly satisfied with their childrens care. The stage is now set for integrating telepsychiatry into a system of care that meets youths overall needs and for controlled studies demonstrating the efficacy of telepsychiatry with youth.

Feasibility, acceptability, and sustainability of telepsychiatry for children and adolescents.

OBJECTIVE: This study examined the feasibility, acceptability, and sustainability of a telepsychiatry service for children and adolescents living in nonmetropolitan communities. METHODS: Using high-bandwidth interactive video teleconferencing, psychiatrists at a children's hospital provided care to patients of primary care physicians at four nonmetropolitan sites. Review of one-year utilization provided feasibility data. Surveys of referring physicians examined acceptability of telepsychiatry. Reimbursement records provided sustainability data. RESULTS: Overall, 387 sessions were provided to 172 youths (mean=2.25 sessions) whose clinical profiles were representative of national samples. Referring providers endorsed high satisfaction with telepsychiatric care, although pediatricians were consistently more satisfied than family physicians. Sustainability of telepsychiatry is challenged by infrastructure costs and low reimbursement by public payers. CONCLUSIONS: Telepsychiatry is a feasible and acceptable approach to providing psychiatric services to youths in underserved communities. Sustainability will depend on developing financial alternatives to fee-for-service, especially if caseloads emphasize publicly funded programs.

The Children's Attention-Deficit Hyperactivity Disorder Telemental Health Treatment Study: Caregiver Outcomes.

The Children's Attention-deficit Hyperactivity Disorder (ADHD) Telemental Health Treatment Study (CATTS) tested the hypotheses that children and caregivers who received guideline-based treatment delivered through a hybrid telehealth service delivery model would experience greater improvements in outcomes than children and caregivers receiving treatment via a comparison delivery model. Here, we present caregiver outcomes. 88 primary care providers (PCPs) in seven geographically underserved communities referred 223 children (ages 5.5 - 12.9 years) to the randomized controlled trial. Over 22 weeks, children randomized to the CATTS service delivery model received six sessions of telepsychiatry and six sessions of caregiver behavior management training provided in person by community therapists who were trained and supervised remotely. Children randomized to the comparison Augmented Primary Care (APC) service model received management in primary care augmented by a single telepsychiatry consultation. Caregiver outcomes included changes in distress, as measured by the Patient Health Questionnaire (PHQ-9), Parenting Stress Index (PSI), Caregiver Strain Questionnaire (CSQ) and Family Empowerment Scale (FES). Caregivers completed five assessments. Multilevel mixed effects regression modeling tested for differences between the two service delivery models in caregiver outcomes from baseline to 25 weeks. Compared to caregivers of children in the APC model, caregivers of children in the CATTS service model showed statistically significantly greater improvements on the PHQ-9 (ß = -1.41, 95 % CI = [-2.74, -0.08], p < .05), PSI (ß = -4.59, 95 % CI = [-7.87, - 1.31], p < .001), CSQ (ß = -5.41, 95 % CI = [- 8.58, -2.24], p < .001) and FES (ß = 6.69, 95 % CI = [2.32, 11.06], p < .01). Improvement in child ADHD symptoms mediated improved caregiver scores on the PSI and CSQ. Improvement in child ODD behaviors mediated caregiver CSQ scores. The CATTS trial supports the effectiveness of a hybrid telehealth service delivery model for reducing distress in caregivers of children with ADHD and suggests a mechanism through which the service model affected caregiver distress.

Enhanced Bulbar Function in Amyotrophic Lateral Sclerosis: The Nuedexta Treatment Trial.

The goal of this randomized, blinded, crossover clinical trial was to determine whether Nuedexta (dextromethorphan and quinidine) enhanced speech, swallowing, and salivation in patients with ALS. Sixty patients with amyotrophic lateral sclerosis (ALS) received either Nuedexta or placebo for 28 to 30 days, followed by a 10 to 15-day washout period. Subsequently, patients were switched to the opposite treatment arm for the remaining days of the trial. The primary endpoint was a reduction in the self-report Center for Neurologic Study Bulbar Function Scale (CNS-BFS) score. The rater-administered ALS Functional Rating Scale Revised was the principal secondary endpoint. The CNS-BFS score improved with active treatment, decreasing from a mean of 59.3 in the placebo arm of the trial to 53.5 during the drug-treatment arm (p < 0.001). Each of the individual domains of bulbar function interrogated by the CNS-BFS responded to treatment with Nuedexta as follows: salivation: 15.8 versus 14.3 (p = 0.004); speech: 24.6 versus 22.2 (p = 0.003); swallowing: 18.9 versus 17.1 (p = 0.009). Similarly, the bulbar component of the ALS Functional Rating Scale Revised improved with active treatment (p = 0.003), although the drug did not affect the motor and respiratory components of this scale. This study is unique for several reasons. Firstly, it was driven by patient reports of improved speech and swallowing while taking Nuedexta for control of emotional lability. Secondly, the study was conducted over a short duration (70 days), and thirdly, a self-report scale was selected as the principle outcome measure. Considering the importance of bulbar functions, these results, if confirmed, point to an additional use of Nuedexta as an adjunct to the management of ALS.