Development of a Self-report Measure of Dual Diagnosis Capability for Addiction and Mental Health Programs

The purpose of this study is to develop and test the psychometrics of a self-report version of a measure of the capacity of addiction and mental health programs to deliver dual-diagnosis treatment, that is, to provide treatment for both addiction problems and mental health problems. Traditionally these services are provided by very different service providers that did not until recently interact very well, if at all. The increasing recognition that patients who suffer from both kinds of problems – who are dually diagnosed – would benefit from integrated delivery of addiction and mental health services has led to efforts to encourage provision of such integrated services in programs that have tended to focus primarily on the delivery of either addiction or mental health services to the exclusion of the other. In order to assess how well the integration of these services is progressing, various measures have been developed, one of which is the original Dual Diagnosis Capability in Addiction Treatment (DDCAT) Index. The DDCAT, as it now stands, however, is a very time-intensive tool. It requires a rater to visit a site and spend one half to a full day there interviewing administrators, therapists, and patients, reviewing medical records, and attending meetings. The purpose of this study is to test a self-report version of the DDCAT that will be administered to administrators and therapists to see how well it performs compared to the more time- intensive procedures of the original DDCAT

An Observational Descriptive Study of IRB Decision Making

Background: Institutional Review Boards (IRBs) are the primary organizations designed to protect research subjects from harm and assure that they participate voluntarily. At the same time, many researchers feel that they intrude into the research process without making research safer. Goals: • Identify which issues about applications are the focus of IRB attention; e.g., the scientific validity of a protocol, issues of risk, informed consent • Clarify how, if at all, the occupants of different roles (chair, community member, attorney, scientific expert, etc.) differ in their discussion of applications • Describe how IRB members identify problems in applications; what information resources they use and how they use them • Identify how IRBs organize the work of application review through the use of staff, pre-meeting review, and formatl meeting

Genomic Relationships, Novel Loci, and Pleiotropic Mechanisms across Eight Psychiatric Disorders

Genetic influences on psychiatric disorders transcend diagnostic boundaries, suggesting substantial pleiotropy of contributing loci. However, the nature and mechanisms of these pleiotropic effects remain unclear. We performed analyses of 232,964 cases and 494,162 controls from genome-wide studies of anorexia nervosa, attention-deficit/hyper-activity disorder, autism spectrum disorder, bipolar disorder, major depression, obsessive-compulsive disorder, schizophrenia, and Tourette syndrome. Genetic correlation analyses revealed a meaningful structure within the eight disorders, identifying three groups of inter-related disorders. Meta-analysis across these eight disorders detected 109 loci associated with at least two psychiatric disorders, including 23 loci with pleiotropic effects on four or more disorders and 11 loci with antagonistic effects on multiple disorders. The pleiotropic loci are located within genes that show heightened expression in the brain throughout the lifespan, beginning prenatally in the second trimester, and play prominent roles in neurodevelopmental processes. These findings have important implications for psychiatric nosology, drug development, and risk prediction.Peer reviewe

Internet-based, randomized, controlled trial of omega-3 fatty acids for hyperactivity in autism.

ObjectivePreliminary evidence suggests that omega-3 fatty acids may reduce hyperactivity in children with autism spectrum disorder (ASD). We sought to examine the feasibility of a novel, Internet-based clinical trial design to evaluate the efficacy of this supplement.MethodE-mail invitations were sent to parents of children aged 5 to 8 years enrolled in the Interactive Autism Network. All study procedures, including screening, informed consent, and collection of outcome measures took place over the Internet. The primary outcome measures were parent- and teacher-rated changes in hyperactivity on the Aberrant Behavior Checklist (ABC-H).ResultsDuring the 6-week recruitment period, 57 children from 28 states satisfied all eligibility criteria and were randomly assigned to 1.3 grams of omega-3 fatty acids or an identical placebo daily for 6 weeks. Outcome assessments were obtained from all 57 participants and 57 teachers, and the study was completed in 3 months. Children in the omega-3 fatty acid group had a greater reduction in hyperactivity (-5.3 points) compared to the placebo group (-2.6 points), but the difference was not statistically significant (1.9-point greater improvement in the omega-3 group, 95% CI = -2.2 to 5.2). Adverse events were rare and not associated with omega-3 fatty acids. Participant feedback was positive.ConclusionInternet-based, randomized controlled trials of therapies in children with ASD are feasible and may lead to marked reductions in the time and cost of completing trials. A larger sample size is required to definitively determine the efficacy of omega-3 fatty acids. Clinical trial registration information-Omega-3 Fatty Acids for Hyperactivity Treatment in Autism Spectrum Disorder; http://clinicaltrials.gov; NCT01694667

Common Data Element Collection in Underserved School Communities: Challenges and Recommendations

OBJECTIVESTo provide recommendations for future common data element (CDE) development and collection that increases community partnership, harmonizes data interpretation, and continues to reduce barriers of mistrust between researchers and underserved communities. METHODSWe conducted a cross-sectional qualitative and quantitative evaluation of mandatory CDE collection among Rapid Acceleration of Diagnostics-Underserved Populations Return to School project teams with various priority populations and geographic locations in the United States to: (1) compare racial and ethnic representativeness of participants completing CDE questions relative to participants enrolled in project-level testing initiatives and (2) identify the amount of missing CDE data by CDE domain. Additionally, we conducted analyses stratified by aim-level variables characterizing CDE collection strategies. RESULTSThere were 15 study aims reported across the 13 participating Return to School projects, of which 7 (47%) were structured so that CDEs were fully uncoupled from the testing initiative, 4 (27%) were fully coupled, and 4 (27%) were partially coupled. In 9 (60%) study aims, participant incentives were provided in the form of monetary compensation. Most project teams modified CDE questions (8/13; 62%) to fit their population. Across all 13 projects, there was minimal variation in the racial and ethnic distribution of CDE survey participants from those who participated in testing; however, fully uncoupling CDE questions from testing increased the proportion of Black and Hispanic individuals participating in both initiatives. CONCLUSIONSCollaboration with underrepresented populations from the early study design process may improve interest and participation in CDE collection efforts