What Is Light in Dark Times?

Alisse Waterston and Charlotte Corden's Light in Dark Times (2020) began as an address by the president of the American Anthropological Association and was transformed into "a work of art and anthropology" by a member of the audience. The result was a coauthored book-length graphic essay that is expansive in subject matter, and in the representation of ideas, scholars, and questions about what it means to be human and how we will pass the time that is given us on earth. Light and dark are central to the visual representations that serve as the background to a story about what is necessary to become a person who is honest. This critical assessment reflects on the content and form of that story, which predated the COVID pandemic, widespread political unrest, and assaults on truth, evidence, language, categories, education, and "others" in the US and elsewhere. The format is both challenging to read and interesting to think with. As teaching and learning increasingly become animated and visualized, Light in Dark Times is a worthy introduction to these ways of apprehending the vexing questions and conundrums presently in such abundant supply.

Unheard Voices: African American Fathers Speak about their Parenting Practices.

Researchers have called for qualitative investigations into African American fathers' parenting practices that consider their social context and identify specific practices. Such investigations can inform the way we conceptualize African American fathers' parenting practices, which can in turn contribute to prevention interventions with at-risk youth. We conducted semi-structured, qualitative interviews about parenting with 30 self-identified, African American, biological fathers of pre-adolescent sons at-risk for developing aggressive behaviors, depressive symptoms, or both. Fathers provided descriptions of their parenting practices, which were at times influenced by their environmental context, fathers' residential status, and masculine ideologies. Our systematic analysis revealed four related themes that emerged from the data: managing emotions, encouragement, discipline, and monitoring. Of particular note, fathers in the current sample emphasized the importance of teaching their sons to manage difficult emotions, largely utilized language consistent with male ideologies (i.e., encouragement rather than love or nurturance), and engaged in high levels of monitoring and discipline in response to perceived environmental challenges and the developmental needs of their sons. The findings provide deeper insight into the parenting practices of African American fathers who are largely understudied, and often misunderstood. Further, these findings highlight considerations that may have important implications for father-focused prevention interventions that support African American fathers, youth, and families.

Outcomes During and After Early Intervention Services for First-Episode Psychosis: Results Over 5 Years From the RAISE-ETP Site-Randomized Trial.

To examine long-term effects of early intervention services (EIS) for first-episode psychosis, we compared Heinrichs-Carpenter Quality of Life (QLS) and Positive and Negative Syndrome Scale (PANSS) scores and inpatient hospitalization days over 5 years with data from the site-randomized RAISE-ETP trial that compared the EIS NAVIGATE (17 sites; 223 participants) and community care (CC) (17 sites; 181 participants). Inclusion criteria were: age 15-40 years; DSM-IV diagnoses of schizophrenia, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, or psychotic disorder not otherwise specified; first psychotic episode; antipsychotic medication taken for ≤6 months. NAVIGATE-randomized participants could receive NAVIGATE from their study entry date until NAVIGATE ended when the last-enrolled NAVIGATE participant completed 2 years of treatment. Assessments occurred every 6 months. 61% of participants had assessments conducted ≥2 years; 31% at 5 years. Median follow-up length was CC 30 months and NAVIGATE 38 months. Primary analyses assumed data were not-missing-at-random (NMAR); sensitivity analyses assumed data were missing-at-random (MAR). MAR analyses found no significant treatment-by-time interactions for QLS or PANSS. NMAR analyses revealed that NAVIGATE was associated with a 13.14 (95%CI:6.92,19.37) unit QLS and 7.73 (95%CI:2.98,12.47) unit PANSS better improvement and 2.53 (95%CI:0.59,4.47) fewer inpatient days than CC (all comparisons significant). QLS and PANSS effect sizes were 0.856 and 0.70. NAVIGATE opportunity length (mean 33.8 (SD = 5.1) months) was not associated (P = .72) with QLS outcome; duration of untreated psychosis did not moderate (P = .32) differential QLS outcome. While conclusions are limited by the low rate of five-year follow-up, the data support long-term benefit of NAVIGATE compared to community care.

Toward an Anti-Racist Curriculum: Incorporating Art into Medical Education to Improve Empathy and Structural Competency.

BACKGROUND: There is an urgent need for medical school curricula that address the effects of structural influences, particularly racism, on health, healthcare access, and the quality of care for people of color. Underrepresented racial minorities in the United States receive worse health care relative to their White counterparts. Structural competency, a framework for recognizing and understanding social influences on health, provides a means for understanding the structural violence that results from and perpetuates racism in classroom and clinical education. Some medical schools have incorporated art into their curricula to increase empathy generally, yet few programs use art to address racial disparities in medicine specifically. OBJECTIVE: "Can We Talk About Race?" (CWTAR) aims to increase medical students' empathy for racial minorities and increase the ease and ability of students to address racial issues. CWTAR also provides a unique context for ongoing conversations about racism and structural inequality within the health care system. METHODS: Sixty-four first-year medical students were randomly selected to participate in CWTAR. The on-campus Ackland Art Museum staff and trained student facilitators lead small group discussions on selected artworks. A course evaluation was sent to all participants consisting of 4 questions: (1) Likert scale rating the quality of the program, (2) the most important thing learned from the program, (3) any differences between discussion at this program versus other conversations around race, and (4) suggestions for changes to the program. Free text responses were content coded and analyzed to reveal common themes. RESULTS: Out of 64 students, 63 (98%) responded to at least one course evaluation question. The majority (89%) of participants rated the program quality as either "Very Good" or "Excellent." Of the 37 students who responded to the free text question regarding the most important thing they learned from the program, 16 (44%) responses revealed students felt that they were exposed to perspectives that differed from their own, and 19% of respondents reported actively viewing a subject through another's perspective. Of the 33 students who responded to the free text question regarding any differences between discussion at this program versus other conversations around race, 48% noted an increased comfort level discussing race during the program. A common theme in responses to the question regarding suggested changes to the program was a more explicit connection to medicine in the discussion around race. CONCLUSIONS: Student responses to CWTAR suggest that the program is effective in engaging students in discussions of racial issues. More investigation is needed to determine whether this methodology increases empathy among medical students for racial minorities specifically.

Client predictors of the therapeutic alliance in individual resiliency training for first episode psychosis.

Individuals experiencing their first episode of psychosis (FEP) are often reluctant to seek treatment, and are difficult to engage and retain in mental health services. The therapeutic alliance (TA), or the affective and collaborative bond between therapist and client, is predictive of better treatment outcomes for clients with FEP; thus, it is important to understand the predictors of the TA in order to determine how best to foster a positive alliance with these individuals. The primary aim of the present study was to examine whether baseline client characteristics, including severity of symptoms, social functioning, and insight, were associated with the TA. The exploratory aim was to examine associations between demographic variables (age, race, and gender) and the TA. The present study included a subsample of participants (n = 134) who received Individual Resiliency Training (IRT) as part of the NAVIGATE treatment in the Recovery After An Initial Schizophrenia Episode Early Treatment Program study. Four trained research assistants rated the TA from early audiotaped sessions of IRT. Multilevel modeling was utilized given the nested data structure. Results indicated that more severe positive and less severe negative symptoms were significantly and uniquely associated with a better therapeutic alliance, as was female gender. The findings suggest that client symptom profiles should be considered when developing a TA with FEP clients.

The therapeutic alliance in individual resiliency training for first episode psychosis: Relationship with treatment outcomes and therapy participation.

OBJECTIVE: The therapeutic alliance has long been considered an essential part of treatment. Despite a large body of work examining the alliance-outcome relationship, very few studies have examined it within individuals with first episode psychosis (FEP). METHOD: The present study examined the alliance at Session 3, 4, or 5 and its relationship to 2-year treatment outcomes and therapy participation in a sample of 144 FEP clients who received specialized FEP treatment at U.S. clinics. Furthermore, we examined between-therapist and within-therapist (client) effects of the alliance on outcomes. RESULTS: Results indicated that a better alliance was related to improved mental health recovery, psychological well-being, quality of life, total symptoms, negative symptoms, and disorganized symptoms at the end of treatment. In addition, the between-therapist effect of the alliance was significantly related to better mental health recovery whereas the within-therapist (client) effect of the alliance was related to better quality of life, total symptoms, and negative symptoms at the end of treatment. CONCLUSIONS: A stronger alliance was related to improved treatment outcomes in FEP. Future work should consider examining mediators of the alliance-outcome relationship as well as how changes in the alliance relate to changes in outcomes over time. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

Implementation and fidelity assessment of the NAVIGATE treatment program for first episode psychosis in a multi-site study.

The NAVIGATE program was developed for the Recovery After Initial Schizophrenia Episode-Early Treatment Program (RAISE-ETP) study, which compared NAVIGATE to usual Community Care in a cluster randomized design involving 34 sites and 404 patients. This article describes the approach to training and implementing the NAVIGATE program at the 17 sites (including 134 practitioners) randomized to provide it, and to evaluating the fidelity of service delivery to the NAVIGATE model. Fidelity was evaluated to five different components of the program, all of which were standardized in manuals in advance of implementation. The components included four interventions (Individualized Resiliency Training, Family Education Program, Supported Employment and Education, Personalized Medication Management) and the overall organization (staffing and structure) of the NAVIGATE team. Most of the sites demonstrated acceptable or higher levels of fidelity in their implementation of the four interventions and the organization of the program, with all 17 sites demonstrating at least acceptable overall fidelity to the NAVIGATE program. The results indicate that the NAVIGATE program can be implemented with good fidelity to the treatment model in a diverse array of community mental health care settings serving persons with a first episode psychosis.

Recognizing and responding to early psychosis: a qualitative analysis of individual narratives.

OBJECTIVE: The ways in which individuals recognize and respond to emerging psychotic illness remain poorly understood. This retrospective study explored when and how individuals recognized changes in themselves and responded to these changes. METHODS: This study used qualitative methods to explore when and how 15 individuals recognized changes and identified how they responded. Standardized information on the onset of psychosis was also collected. RESULTS: Themes relating to recognizing and responding to emerging psychosis were identified through qualitative analysis of interview transcripts. Themes included normalization, explanatory models, withdrawal, avoiding help, and coming to terms with psychosis. CONCLUSIONS: Participants recognized changes in themselves but tended not to understand the observed changes as part of a mental illness. Individuals avoided professional help because of stigma concerns and identified domains of recovery beyond the management of symptoms and medication. Qualitative methods offer a promising strategy for understanding subjective illness experience and suggesting psychosocial treatment approaches.

Character strengths of individuals with first episode psychosis in Individual Resiliency Training.

Positive psychology interventions that integrate a person's strengths into treatment result in improvements in life satisfaction and well-being. Character strengths classified within six core virtues (wisdom/knowledge, courage, humanity, justice, temperance, and transcendence) have been the subject of substantial research. Though a number of studies have been conducted in the general population, little is known about the character strengths of individuals with first episode psychosis (FEP). Moreover, positive psychology principles, in particular a focus on personal strengths, have been increasingly integrated into FEP treatment and was a core component of Individual Resiliency Training (IRT), the individual therapy component of NAVIGATE tested in the Recovery After an Initial Schizophrenia Episode Early Treatment Program. As such, the present study offers an examination of character strengths among 105 FEP clients in specialized early intervention treatment. The present study included two primary aims: 1) to conduct a descriptive analysis of character strengths of FEP individuals and 2) to examine exploratory associations between character strengths and changes in symptomatic and recovery variables over six months. Results revealed that the most commonly identified strengths were: Honesty, Authenticity, and Genuineness (40.95%), Kindness and generosity (37.14%), Fairness, equity, and justice (29.52%), Gratitude (29.52%), and Humor and playfulness (29.52%). Three virtues (Humanity, Justice, and Transcendence) were significantly associated with improvements in symptoms, psychological well-being, and interpersonal relations over six months. Overall, the present study offers a glimpse into how persons with FEP view their strengths and how certain clusters of strengths are related to important outcomes.

Demographic, psychosocial, clinical, and neurocognitive baseline characteristics of Black Americans in the RAISE-ETP study.

This study compared baseline characteristics of Black Americans and Caucasians with first-episode psychosis in the Recovery After an Initial Schizophrenia Episode Early Treatment Program (RAISE-ETP). Black American (N=152) and Caucasian (N=218) participants were compared on demographic, psychosocial, clinical, and neurocognitive measures. Results indicated several notable racial differences in baseline characteristics: a greater proportion of Black Americans than Caucasians were female, and Black Americans reported less personal and parental education than Caucasians. Black Americans were also less likely to have private insurance, more likely to be homeless or transient, had significantly poorer quality of life, more severe disorganized symptoms, worse neurocognition, and were less likely to abuse alcohol than Caucasians. The implications of these findings are discussed, and suggestions are provided for future avenues of treatment and research on racial disparities in first-episode psychosis.

Demographic and clinical correlates of substance use disorders in first episode psychosis.

BACKGROUND: We assessed the prevalence and correlates of lifetime substance use disorders in people with first episode psychosis using the baseline data from the Recovery After an Initial Schizophrenia Episode (RAISE) Early Treatment Program study. METHODS: Research staff assessed 404 first episode patients at 34 community mental health centers across the United States with the Structured Clinical Interview for DSM-IV for diagnoses of psychotic and substance use disorders. Logistic regression was used to evaluate the relationships between participant characteristics and lifetime substance use disorders, followed with generalized linear mixed-effects regression models to identify unique predictors of lifetime substance use disorders. RESULTS: Approximately one-third of participants reported recent alcohol use (36.6%) and cannabis use (30.7%), and one half (51.7%) met criteria for any lifetime alcohol or drug use disorder. Lifetime substance use disorders were associated with male gender, White race, higher excited (hyperactivity, mood lability, impulsivity, hostility, and uncooperativeness), psychotic and depressive symptoms, less impaired cognition, and greater perceived stigma. Gender, race, and excited symptoms were the most consistent unique predictors of lifetime substance use disorders found in multivariate analyses. CONCLUSIONS: Half of first episode psychosis patients have co-occurring substance use disorders, which are associated with both more severe symptoms and greater perceptions of stigma. Programs aiming to serve these patients must have the skills and clinical strategies to help people with these unique characteristics.

Comparison of Early Intervention Services vs Treatment as Usual for Early-Phase Psychosis: A Systematic Review, Meta-analysis, and Meta-regression.

Importance: The value of early intervention in psychosis and allocation of public resources has long been debated because outcomes in people with schizophrenia spectrum disorders have remained suboptimal. Objective: To compare early intervention services (EIS) with treatment as usual (TAU) for early-phase psychosis. Data Sources: Systematic literature search of PubMed, PsycINFO, EMBASE, and ClinicalTrials.gov without language restrictions through June 6, 2017. Study Selection: Randomized trials comparing EIS vs TAU in first-episode psychosis or early-phase schizophrenia spectrum disorders. Data Extraction and Synthesis: This systematic review was conducted according to PRISMA guidelines. Three independent investigators extracted data for a random-effects meta-analysis and prespecified subgroup and meta-regression analyses. Main Outcomes and Measures: The coprimary outcomes were all-cause treatment discontinuation and at least 1 psychiatric hospitalization during the treatment period. Results: Across 10 randomized clinical trials (mean [SD] trial duration, 16.2 [7.4] months; range, 9-24 months) among 2176 patients (mean [SD] age, 27.5 [4.6] years; 1355 [62.3%] male), EIS was associated with better outcomes than TAU at the end of treatment for all 13 meta-analyzable outcomes. These outcomes included the following: all-cause treatment discontinuation (risk ratio [RR], 0.70; 95% CI, 0.61-0.80; P < .001), at least 1 psychiatric hospitalization (RR, 0.74; 95% CI, 0.61-0.90; P = .003), involvement in school or work (RR, 1.13; 95% CI, 1.03-1.24; P = .01), total symptom severity (standardized mean difference [SMD], -0.32; 95% CI, -0.47 to -0.17; P < .001), positive symptom severity (SMD, -0.22; 95% CI, -0.32 to -0.11; P < .001), and negative symptom severity (SMD, -0.28; 95% CI, -0.42 to -0.14; P < .001). Superiority of EIS regarding all outcomes was evident at 6, 9 to 12, and 18 to 24 months of treatment (except for general symptom severity and depressive symptom severity at 18-24 months). Conclusions and Relevance: In early-phase psychosis, EIS are superior to TAU across all meta-analyzable outcomes. These results support the need for funding and use of EIS in patients with early-phase psychosis.

Relationships and communication in minority participation in research: multidimensional and multidirectional.

We examined the range and nature of investigators' communication and relationship building as they recruit minority participants in their research. Semistructured, in-depth interviews were conducted with 33 investigators conducting research with human participants. The response rate was 77%. Investigators described several kinds of relationships that are formed or called upon when including minority participants in research. The relationships ranged from study-related, short-term interactions geared solely to facilitate recruitment to others that were longer term, extending beyond a particular project. The data suggest that a range of relationships is important as investigators seek to include minority populations in research. These relationships can both facilitate the recruitment process as well as aid in the interpretation of research findings.

Incomes and Outcomes: Social Security Disability Benefits in First-Episode Psychosis.

OBJECTIVE: Social Security Administration (SSA) disability benefits are an important source of income for people with psychoses and confer eligibility for health insurance. The authors examined the impact of coordinated specialty care on receipt of such benefits in first-episode psychosis, along with the correlates and consequences of receiving them. METHOD: The Recovery After an Initial Schizophrenia Episode-Early Treatment Program (RAISE-ETP) study, a 34-site cluster-randomized trial, compared NAVIGATE, a coordinated specialty care program, to usual community care over 2 years. Receipt of SSA benefits and clinical outcomes were assessed at program entry and every 6 months for 2 years. Piecewise regression analysis was used to identify relative change in outcome trajectories after receipt of disability benefits. RESULTS: Among 399 RAISE-ETP participants, 36 (9%) were receiving SSA disability benefits at baseline; of the remainder, 124 (34.1%) obtained benefits during the 2-year study period. The NAVIGATE intervention improved quality of life, symptoms, and employment but did not significantly reduce the likelihood of receiving SSA disability benefits. Obtaining benefits was predicted by more severe psychotic symptoms and greater dysfunction and was followed by increased total income but fewer days of employment, reduced motivation (e.g., sense of purpose, greater anhedonia), and fewer days of intoxication. CONCLUSIONS: A 2-year coordinated specialty care intervention did not reduce receipt of SSA disability benefits. There were some advantages for those who obtained SSA disability benefits over the 2-year treatment period, but there were also some unintended adverse consequences. Providing income supports without impeding recovery remains an important policy challenge.

Psychological well-being and mental health recovery in the NIMH RAISE early treatment program.

Recovery-oriented practices that promote client-centered care, collaboration, and functional outcome have been recommended to improve treatment engagement, especially for individuals with serious mental illness (SMI). Psychological well-being (PWB) is related to recovery and refers to experiencing purpose and meaning in life through realizing one's potential. The recently completed Recovery After an Initial Schizophrenia Episode Early Treatment Program (RAISE ETP) study sought to improve quality of life, functional outcome, and well-being in individuals with first episode psychosis (FEP). Therefore, the primary aims of the present analysis were: 1) to examine the impact of treatment on PWB and mental health recovery trajectories, 2) to examine the impact of duration of untreated psychosis (DUP) on these outcomes, and 3) to examine the relationships among these outcomes and quality of life. Multilevel modeling was used given the nested data structure. Results revealed that PWB and mental health recovery improved over the course of the 2-year treatment; there were no significant treatment differences. In addition, DUP was associated with the Positive Relationships and Environmental Mastery dimensions of PWB. Finally, PWB, mental health recovery, and quality of life were all significantly correlated at baseline while controlling for depressive symptoms. Overall, the findings indicate that PWB and mental health recovery can improve in FEP, are related to yet distinct from quality of life, and that DUP may play a role in certain facets of these constructs.

Tools to Assess Behavioral and Social Science Competencies in Medical Education: A Systematic Review.

PURPOSE: Behavioral and social science (BSS) competencies are needed to provide quality health care, but psychometrically validated measures to assess these competencies are difficult to find. Moreover, they have not been mapped to existing frameworks, like those from the Liaison Committee on Medical Education (LCME) and Accreditation Council for Graduate Medical Education (ACGME). This systematic review aimed to identify and evaluate the quality of assessment tools used to measure BSS competencies. METHOD: The authors searched the literature published between January 2002 and March 2014 for articles reporting psychometric or other validity/reliability testing, using OVID, CINAHL, PubMed, ERIC, Research and Development Resource Base, SOCIOFILE, and PsycINFO. They reviewed 5,104 potentially relevant titles and abstracts. To guide their review, they mapped BSS competencies to existing LCME and ACGME frameworks. The final included articles fell into three categories: instrument development, which were of the highest quality; educational research, which were of the second highest quality; and curriculum evaluation, which were of lower quality. RESULTS: Of the 114 included articles, 33 (29%) yielded strong evidence supporting tools to assess communication skills, cultural competence, empathy/compassion, behavioral health counseling, professionalism, and teamwork. Sixty-two (54%) articles yielded moderate evidence and 19 (17%) weak evidence. Articles mapped to all LCME standards and ACGME core competencies; the most common was communication skills. CONCLUSIONS: These findings serve as a valuable resource for medical educators and researchers. More rigorous measurement validation and testing and more robust study designs are needed to understand how educational strategies contribute to BSS competency development.

Cost-Effectiveness of Comprehensive, Integrated Care for First Episode Psychosis in the NIMH RAISE Early Treatment Program.

This study compares the cost-effectiveness of Navigate (NAV), a comprehensive, multidisciplinary, team-based treatment approach for first episode psychosis (FEP) and usual Community Care (CC) in a cluster randomization trial. Patients at 34 community treatment clinics were randomly assigned to either NAV (N = 223) or CC (N = 181) for 2 years. Effectiveness was measured as a one standard deviation change on the Quality of Life Scale (QLS-SD). Incremental cost effectiveness ratios were evaluated with bootstrap distributions. The Net Health Benefits Approach was used to evaluate the probability that the value of NAV benefits exceeded its costs relative to CC from the perspective of the health care system. The NAV group improved significantly more on the QLS and had higher outpatient mental health and antipsychotic medication costs. The incremental cost-effectiveness ratio was $12 081/QLS-SD, with a .94 probability that NAV was more cost-effective than CC at $40 000/QLS-SD. When converted to monetized Quality Adjusted Life Years, NAV benefits exceeded costs, especially at future generic drug prices.

Comprehensive Versus Usual Community Care for First-Episode Psychosis: 2-Year Outcomes From the NIMH RAISE Early Treatment Program.

OBJECTIVE: The primary aim of this study was to compare the impact of NAVIGATE, a comprehensive, multidisciplinary, team-based treatment approach for first-episode psychosis designed for implementation in the U.S. health care system, with community care on quality of life. METHOD: Thirty-four clinics in 21 states were randomly assigned to NAVIGATE or community care. Diagnosis, duration of untreated psychosis, and clinical outcomes were assessed via live, two-way video by remote, centralized raters masked to study design and treatment. Participants (mean age, 23) with schizophrenia and related disorders and ≤6 months of antipsychotic treatment (N=404) were enrolled and followed for ≥2 years. The primary outcome was the total score of the Heinrichs-Carpenter Quality of Life Scale, a measure that includes sense of purpose, motivation, emotional and social interactions, role functioning, and engagement in regular activities. RESULTS: The 223 recipients of NAVIGATE remained in treatment longer, experienced greater improvement in quality of life and psychopathology, and experienced greater involvement in work and school compared with 181 participants in community care. The median duration of untreated psychosis was 74 weeks. NAVIGATE participants with duration of untreated psychosis of <74 weeks had greater improvement in quality of life and psychopathology compared with those with longer duration of untreated psychosis and those in community care. Rates of hospitalization were relatively low compared with other first-episode psychosis clinical trials and did not differ between groups. CONCLUSIONS: Comprehensive care for first-episode psychosis can be implemented in U.S. community clinics and improves functional and clinical outcomes. Effects are more pronounced for those with shorter duration of untreated psychosis.

The RAISE early treatment program for first-episode psychosis: background, rationale, and study design.

OBJECTIVE: The premise of the National Institute of Mental Health Recovery After an Initial Schizophrenia Episode Early Treatment Program (RAISE-ETP) is to combine state-of-the-art pharmacologic and psychosocial treatments delivered by a well-trained, multidisciplinary team in order to significantly improve the functional outcome and quality of life for first-episode psychosis patients. The study is being conducted in non-academic (ie, real-world) treatment settings, using primarily extant reimbursement mechanisms. METHOD: We developed a treatment model and training program based on extensive literature review and expert consultation. Our primary aim is to compare the experimental intervention to "usual care" on quality of life. Secondary aims include comparisons on remission, recovery, and cost-effectiveness. Patients 15-40 years old with a first episode of schizophrenia, schizoaffective disorder, schizophreniform disorder, psychotic disorder not otherwise specified, or brief psychotic disorder according to DSM-IV and no more than 6 months of treatment with antipsychotic medications were eligible. Patients are followed for a minimum of 2 years, with major assessments conducted by blinded, centralized raters using live, 2-way video. We selected 34 clinical sites in 21 states and utilized cluster randomization to assign 17 sites to the experimental treatment and 17 to usual care. Enrollment began in July 2010 and ended in July 2012 with 404 subjects. The results of the trial will be published separately. The goal of the article is to present both the overall development of the intervention and the design of the clinical trial to evaluate its effectiveness. CONCLUSIONS: We believe that we have succeeded in both designing a multimodal treatment intervention that can be delivered in real-world clinical settings and implementing a controlled clinical trial that can provide the necessary outcome data to determine its impact on the trajectory of early phase schizophrenia. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01321177.