Clinical Research
The Cincinnati Children's Center for ADHD is involved in a number of grant funded research projects. These studies are designed to test new and innovative ways to evaluate and treat ADHD. Through the Cincinnati Children's Center for ADHD children and their families have the opportunity to participate in research studies, gaining access to new and potentially more effective interventions before they are available to the general public.
Current Projects
ADHD Collaborative
| PI: |
Jeff Epstein, PhD |
| Collaborators: |
Joshua Langberg, PhD, Phil Lichtenstein, MD, Lori Stark, PhD |
| ADHD Task Force Members: |
John Brewer, MD (Community Physician), Allan Robinson, MD (Community Physician), David Schonfeld, MD (Developmental and Behavioral Pediatrics), Michael Sorter, MD (Psychiatry), Marty Visscher PhD (Parent Advocate) |
Funded by the Patient Innovation Fund (2004-2009), CCHMC developed their own intervention model termed the ADHD Collaborative to promote the adoption of evidence-based practices among community pediatricians. Over 278 physicians at 64 practices throughout the Greater Cincinnati and Northern Kentucky region have voluntarily enrolled in the project. The ADHD Collaborative works with the entire office staff to modify office systems to promote the systematic use of the AAP guidelines across the whole practice. Physicians are informed about the rationale and implementation of the AAP prescribed guidelines for assessing and treating children with ADHD. These teachings are followed by office flow training sessions during which pediatric offices work to modify their own individual office systems to derive systematic office procedures for collecting ADHD rating scales, establishing written care management plans, and monitoring treatment response. ADHD Collaborative staff then work with the physicians and office staff to ensure that the new office flow system is implemented effectively. The adherence of each participating physician to AAP-recommended practice behaviors is monitored by ADHD Collaborative staff through quarterly patient chart reviews. Each physician is provided with summaries of the chart review results. Quality improvement strategies are used to teach practices how to problem-solve systemic glitches and continually improve their office system. Practices use this feedback to derive PDSA cycles to address any practice behaviors that are below established goal levels.
Return to Top
Development of a Multi-faceted Cognitive Training Program for Children with ADHD
After decades of ADHD intervention research, only two intervention approaches (i.e., psychopharmacology, behavioral treatment) have a “well-established” evidence-base supporting their efficacy for children with ADHD. Both of these interventions have inherent limitations. Recently multiple studies have demonstrated that cognitive training may improve neuropsychological and behavioral functioning in children with ADHD. The magnitude of treatment effects for cognitive training has been comparable to treatment effects for behavioral treatment for ADHD (i.e., small to moderate effect sizes). A limitation of existing cognitive training programs that may limit their efficacy is that each has employed a unifaceted approach. Each intervention program has targeted a single cognitive domain (e.g., working memory). This is problematic since as a group, children with ADHD have multiple areas of cognitive deficit (i.e., working memory, attention, response inhibition, delay aversion, intra-individual variability) and thus a unifaceted intervention does not address the multifaceted array of cognitive dysfunction in children with ADHD. Also, because individuals with ADHD each have unique patterns of cognitive deficits, a unifaceted cognitive training approach may target areas which are non-deficient and miss areas of significant deficit in individual patients depending on their ideographic cognitive profile. The primary goal of the proposed research is to develop and test a multifaceted cognitive training intervention that addresses a comprehensive array of ADHD-related cognitive deficits thereby ensuring that children’s unique areas of cognitive deficit are targeted. During Phase I (R21 grant), software and a manual will be developed consisting of four training tasks targeting response inhibition, verbal working memory, attention, and delay aversion. Each task will possess advancing levels of difficulty. On each task, children will receive feedback on performance accuracy as well as on intra-individual variability in reaction times. The software will be pilot tested in Phase I to determine performance thresholds and intervention duration. Also, focus groups will be conducted to obtain patient perceptions of each task’s difficulty and interest level. In Phase II (R33 grant), a preliminary randomized clinical trial will be conducted in order to obtain initial estimates of treatment efficacy. Pre-, post-, and follow up outcomes will be collected on a wide range of neuropsychological, behavioral, and academic measures. Effect size estimates across outcomes will be used to guide sample size determinations for future clinical trials of multifaceted cognitive training.
Return to Top
Disseminating a Model Intervention to Promote Improved ADHD Care in the Community
The American Academy of Pediatrics (AAP) has established a set of consensus guidelines for pediatricians to follow. These guidelines can be challenging to implement in typical community-based practices. Cincinnati Children’s Hospital Medical Center (CCHMC) has developed a program called the ADHD Collaborative to promote the adoption of these guidelines among community pediatricians. The program focuses on modifying the office system using academic detailing and quality improvement (QI) methodology to accommodate prescribed practice changes. The ADHD Collaborative has been very successful at recruiting practices in the Greater Cincinnati area, changing practice behaviors, and sustaining these practice behaviors over time at minimal cost to the project and to the office practice. Now that sustainability and effectiveness have been established, the next step is to modify the ADHD Collaborative model to make it amenable to widespread dissemination. The primary goal of the proposed study is to modify the ADHD Collaborative intervention to make it transportable and then evaluate this version in terms of effectiveness, consumer satisfaction, and costs. A transportable intervention is described that utilizes telehealth video-conferencing, a web portal, and long-distance data collection. Initially, three pediatric practices will be recruited to test and refine the distal intervention delivery methodology. Then, eight new pediatric practices will be randomly assigned to receive the distal intervention or to a control group (treatment as usual). Information about pediatric practice behavior will be collected at baseline, 6-months, and 1-year post-baseline. The study design will allow for a preliminary assessment of the feasibility and effectiveness of the distal intervention in terms of rates of evidence-based practice behaviors to patients, change in pediatrician attitudes, consumer satisfaction, and costs.
Significance: The proposed research has high public health significance since it addresses a core issue in community mental health delivery, the promotion of evidence-based care to children. This research proposes an innovative set of intervention techniques that will allow the delivery of an effective intervention model to a greater number and more geographically diverse set of pediatric practices than is currently feasible using existing methods.
Return to Top
Response Variability in Children with ADHD
| Grant Number: |
1R01MH074770 |
| PI: |
Jeff Epstein, PhD |
| Collaborators: |
Joshua Langberg, PhD, Bill Brinkman, MD, Tanya Froehlich, MD, Robert Kahn, MD, Mekibib Altaye, PhD |
Children with Attention Deficit Hyperactivity Disorder (ADHD) have numerous areas of neuropsychological dysfunction including response inhibition, working memory, and attention. One neuropsychological outcome measure that consistently reveals between-group differences is response variability. However, until recently, differences in response variability have been reported as an ancillary finding or viewed as a nuisance in the analyses. The specific aims of the present study are to 1) Examine response variability in ADHD patients across neuropsychological tasks to understand the breadth of this specific deficit and to understand the relation between response variability and other neuropsychological outcome measures; 2) Assess whether response variability deficits are specific to either or both of the two most prevalent ADHD subtypes (i.e., Combined Type [CT] and Predominantly Inattentive Type [PIT]); 3) Determine whether response variability in ADHD patients is affected by either medication or a variety of environmental manipulations (e.g., reward); and 4) Understand the relationship between neuropsychological measures of response variability and naturalistic instances of variable performance. Forty-five children (aged 7-11) with ADHD-CT, 45 children with ADHD-PIT, and 45 normal controls will be recruited to examine response variability across a wide range of neuropsychological tests. Task parameters such as event rate, stimulus saliency, and the presence of operant reward will be modified on each test to determine the conditions under which response variability is manifested in children with ADHD. In addition, all children with ADHD will participate in a placebo-controlled, randomized medication trial with a psychostimulant medication to assess the effects of medication on response variability. Advanced analytic methods utilizing non-Gaussian distributions and fast Fourier Transforms of the reaction time data will be used to conduct detailed analyses of RT patterns across the ADHD and normal control groups. Further, the effects of task parametric manipulations and medication on response variability will be examined. Finally, relations between response variability on neuropsychological tests and response variability in a variety of real-world analog situations will be examined to evaluate the ecological validity of these deficits.
Return to Top
Follow-up of the Multimodal Treatment Study of Children with ADHD
| Grant Number: |
N01MH12012 |
| PI: |
Karen Wells, PhD
(Duke University Medical Center) |
| Co-I: |
Jeff Epstein, PhD |
This contract is to follow adolescents with Attention Deficit Hyperactivity Disorder (ADHD) who – when they were 7.0 to 9.9 years old - had been randomized into intensive, 14-month-duration treatment study, the NIMH Multimodal Treatment Study of Children with Attention-Deficit / Hyperactivity Disorder (MTA Study). During the follow-up period, the majority of these children will enter and traverse the critical years between 13 and 23 years when ADHD exerts its maximum risks for teenage academic failure, delinquency, substance use and abuse and traffic accidents.
Return to Top
Medication Response in Children with Predominantly Inattentive Type ADHD
Proposed Research: Robust data show that stimulant medications reduce ADHD symptoms and impairment, but it is unclear whether their efficacy differs across the ADHD subtypes. Predominantly inattentive type (PIT) is the most prevalent ADHD subtype in U.S. population-based studies, but few studies have examined stimulant response in this subtype. Instead, PIT medication guidelines have largely been extrapolated from studies enrolling all or mostly ADHD-combined type (CT). Thus, this proposal seeks to further understanding of stimulant response and its predictors in children with PIT. We will evaluate participants’ response to methylphenidate (MPH), the most widely prescribed stimulant, via a prospective, double-blind, placebo-controlled crossover trial with 3 dose conditions. Our first specific aim is to examine MPH medication and dose response in children with PIT (n=120) and CT (n=45) to test the hypotheses that participants with PIT have a diminished MPH response (amount of symptom change on the most effective dose) and derive less benefit from higher doses compared to those with CT. Since only one prior study has examined genetic predictors of MPH response within a PIT-only sample, our second specific aim (exploratory) is to determine the potential role of genetic polymorphisms (i.e., DRD4 and ADRA2A) on MPH response in children with PIT (n=120), examining both magnitude of symptom change and dose response curves.
Return to Top
Multisite Study of School-Based Treatment Approaches for ADHD Adolescents
Goals The long term objective of this study is to determine the value of adding treatment programs like the Challenging Horizons Program (CHP) to the services available to youth with ADHD in a community. There continues to be a lack of data on effective psychosocial treatments for adolescents with ADHD. This is problematic, as medication is inadequate for most youth as a sole form of treatment and adolescence is a time where the impairment associated with ADHD becomes increasingly dangerous, life-altering, and serious. Specifically, this study aims to: 1) Evaluate the efficacy of the after-school program model and the consultation model of CHP as compared to each other and as compared to community care, 2) Estimate cost-effectiveness ratios for each of the two levels of services, and 3) Identify moderators and mediators of treatment response for the two CHP intervention models. In addition, the findings should inform treatment decisions about which children need which level of care.
Methods Treatment services are delivered either through an after-school program (CHP-AS) or through teachers employed by the school who are trained and provided with ongoing consultation on the CHP methods (CHP-C). Over five years 315 participants who meet criteria for ADHD will be recruited at seven middle schools across two sites and randomly assigned to receive either the CHP-AS, CHP-C or community care. Costs of providing the services for all three conditions will be measured as well as symptom and impairment outcomes. Data collection will occur on an ongoing basis over the academic year of a child’s participation in the project. In addition, formal evaluations will occur at baseline, immediately post-treatment, and 6 months post-treatment. Consistent with findings from preliminary studies it is expected that response to both active treatment conditions will vary across participants. Assessments will be collected that identify potential moderators and mediators of treatment response and these will be included in the analyses in order to identify child and parent characteristics that may predict response to treatment as well as variables related to the treatment process (e.g., attendance) that predicts response.
Return to Top
Organizational Skills Intervention for Children with ADHD
This proposal, “Organizational Skills Interventions for Children with ADHD” is submitted in response to RFA-84.305A “Social and Behavioral Context for Academic Learning”, Goal 2 – Intervention Development.” Attention-Deficit/Hyperactivity Disorder (ADHD) is one of the most commonly diagnosed childhood disorders, with prevalence rates estimated at 8% (Froehlich et al. 2007). Several of the primary symptoms of ADHD relate to problems with temporal and materials organization (i.e. often has difficulty organizing tasks and activities, often loses things, is often forgetful, and often fails to finish school-work, chores, or duties; APA, 2000). In the school setting, problems with organization manifest as forgetting to complete or losing homework assignments, difficulties planning for the completion of long-term projects and tests, and problems keeping class materials organized. These difficulties become particularly problematic with the increased academic demands of middle school (Evans, Serpell & White, 2005; Langberg, Epstein, Altaye et al., 2008). Problems with organizational skills ultimately lead to negative educational outcomes such as poor class grades, retention and school dropout (DuPaul & Stoner, 2003).
Langberg and colleagues developed and evaluated an intervention that directly targets the organizational difficulties of children with ADHD. Participants are taught to implement and self-monitor structured systems of bookbag, locker and binder organization and to effectively plan and manage time for the completion of homework, tests, and projects. In the context of an after-school program delivered by research personnel, the intervention was found to be highly effective at improving organizational skills, decreasing homework problems, and raising grade point average (Langberg, Epstein, Urbanowicz et al., 2008). The primary goal of this Goal II proposal is to modify and refine the intervention protocol to create a product that is feasible for school counselors/psychologists to implement during the school day. An in-school delivery model developed with direct input from school personnel will facilitate widespread dissemination upon proof of efficacy.
In Phase I of the proposed research, middle school counselors, psychologists, teachers, middle school students with ADHD and their parents will consult with the intervention developers to modify the after-school treatment protocol for in-school implementation. An intervention protocol will be developed. The intervention will be piloted with ten children in order to identify barriers to implementation. Measures of treatment fidelity, skills acquisition, and satisfaction will be completed. These data will inform additional modifications of the protocol and further improve feasibility/acceptability of the intervention procedures.
In Phase II of the study, ten school counselors/psychologists from four separate school districts will implement the protocol developed in Phase I. Thirty children with ADHD in grades 6 and 8 will receive the intervention. Organizational skills, grade point average, and academic impairment will be evaluated at baseline, post intervention and at 8-week follow-up. After implementing the intervention, all participants (i.e., teachers, counselors, psychologists, children and parents) will participate in a series of focus groups and will complete intervention satisfaction questionnaires. These data will inform final revisions to the intervention protocol. The resulting product will be an intervention that targets organizational skills in children with ADHD that has potential for widespread school-based dissemination. The final intervention protocol and effect size estimates from the proposed research will lay the foundation for an IES Goal III test of efficacy.
Return to Top
Shared Decision Making to Improve Care for Children with ADHD
There is evidence to support treating ADHD with 1) behavioral treatment alone, 2) stimulant medication treatment alone, or 3) a combination of both. However, the potential benefits (e.g. ADHD symptom reduction) and harms (e.g. side effects, costs) differ among these options. Decisional conflict is an important construct for people facing decisions that involve risk, uncertain outcomes, or value tradeoffs. Decreasing decisional conflict increases the likelihood that treatment will be implemented. Shared decision-making interventions that include decision aids have been effective in reducing decision conflict among adult patients but have not been implemented in pediatrics. We propose to study and optimize the implementation of a shared decision-making intervention that includes 1) a one-page paper-based decision aid for use by physicians during visits with children newly diagnosed with ADHD and 2) an informational booklet that parents can review before the visit. We will partner with 10 community-based pediatricians in four practices to video-record encounters at baseline (phase I), during implementation and optimization of the intervention (phase II), and post-optimization (phase III). The project aims to improve care for children with ADHD and produce a successful model for implementing shared decision making that can adapted for use with children with other chronic conditions.
Return to Top
