Latent classes of oppositional defiant disorder in adolescence and prediction to later psychopathology.

Current conceptualizations of oppositional defiant disorder (ODD) place the symptoms of this disorder within three separate but related dimensions (i.e., angry/irritable mood, argumentative/defiant behavior, vindictiveness). Variable-centered models of these dimensions have yielded discrepant findings, limiting their clinical utility. The current study utilized person-centered latent class analysis based on self and parent report of ODD symptomatology from a community-based cohort study of 521 adolescents. We tested for sex, race, and age differences in the identified classes and investigated their ability to predict later symptoms of depression and conduct disorder (CD). Diagnostic information regarding ODD, depression, and CD were collected annually from adolescents (grades 6-9; 51.9% male; 48.7% White, 28.2% Black, 18.5% Asian) and a parent. Results provided evidence for three classes of ODD (high, medium, and low endorsement of symptoms), which demonstrated important developmental differences across time. Based on self-report, Black adolescents were more likely to be in the high and medium classes, while according to parent report, White adolescents were more likely to be in the high and medium classes. Membership in the high and medium classes predicted later increases in symptoms of depression and CD, with the high class showing the greatest risk for later psychopathology.

Associations between Sex, Rumination, and Depressive Symptoms in Late Adolescence: A Four-Year Longitudinal Investigation.

OBJECTIVE: The literature on the association between sex, rumination, and depression indicates significant variability from childhood to adulthood. Although this variability indicates the need for a developmental lens, a surprising lack of research has been conducted on the association between these variables from middle to late adolescence. METHOD: The present study seeks to bridge this gap using structured equation modeling (SEM) to evaluate the reciprocal associations between sex, brooding rumination, reflective rumination, and depressive symptoms in a sample of students measured at 8th grade, 9th grade, and 12th grade time points. RESULTS: In line with findings across the lifespan, female participants indicated significantly higher average levels of both subtypes of rumination and depressive symptoms versus males. Novel results of this study include the findings that for male participants in this age range, brooding rumination predicted later depressive symptoms, while for female participants, early depressive symptoms predicted later brooding. For female participants, early reflective rumination predicted later depressive symptoms. CONCLUSIONS: This is the first investigation of its kind to demonstrate deleterious longitudinal effects of self-reflective rumination. Findings are interpreted through an ecological framework and mark the transition to high school as a potential risk for interrupted problem-solving of circumstances related to adolescents' distress.

Emergence of Depressive Symptoms from Kindergarten to Sixth Grade.

This study documents the emergence of symptoms of anxiety and depression in a community sample of school-age children and describes the temporal progression of symptoms leading to depressive episodes. Caregivers of 468 seventh graders reported retrospectively the manifestation of 14 symptoms of depression and anxiety in their children from kindergarten through sixth grade. The sample was balanced by sex and reflected the racial and economic diversity of the urban school district. Childhood period prevalence was calculated for each symptom, and discrete time survival analyses compared likelihoods of early symptom emergence in children who did and did not meet diagnostic criteria for major depressive disorder (MDD) by ninth grade. Symptom prevalence ranged between 20% (excessive guilt) and 50% (concentration problems) during the elementary school years. The 4-year period prevalence of MDD was 8.9%, 95% confidence interval [6.5%, 12.1%]. Low energy, excessive worry, excessive guilt, anhedonia, social withdrawal, and sadness or depressed mood were each associated with a significantly higher likelihood of onset of MDD. Compared to girls, boys were more likely to exhibit sad mood, fatigue, and trouble concentrating. Children who later met criteria for MDD demonstrated a significantly higher likelihood of showing core features of depressive and anxiety disorders during their elementary school years. The findings underscore the importance of recognizing early signs and developing interventions to help children manage early symptoms and prevent later psychiatric illness.

The impact of exposure to parental intimate partner violence on adolescent precocious transitions to adulthood.

INTRODUCTION: Precocious transitions can create stress by placing excessive demands on adolescents and are associated with adverse outcomes that extend into adulthood. The current study assessed whether exposure to parental intimate partner violence (IPV) is associated with adolescent precocious transitions to adulthood. METHODS: Data come from 33,360 individuals aged 18+ years in the United States who participated in the National Epidemiologic Surveys of Alcohol and Related Conditions. Six precocious transitions (leaving home early, early sex, early marriage, early parenthood, early full-time employment, and dropping out of high school) were examined. Robust Poisson regression was used to calculate relative risks for the association between IPV exposure and each precocious transition, adjusting for confounders. We assessed effect modification by gender and by exposure to childhood abuse or neglect. RESULTS: Participants exposed to IPV in childhood were at higher risk of engaging in early sex; dropping out of high school; entering into early full-time employment; entering into early marriage; and entering into early parenthood relative to participants not exposed to IPV. Significant interactions between gender and exposure to IPV were detected for early sex and early full-time work outcomes, such that the associations were stronger for females compared to males. Participants exposed to more frequent or more severe IPV in childhood were at even higher risk for experiencing precocious transitions. CONCLUSIONS: Individuals exposed to IPV in childhood are more likely to experience precocious transitions to adulthood. Findings highlight the need for interventions to mitigate adverse outcomes in adolescence for children exposed to IPV.

Research strategy for health sciences: Facebook friend request is non-differentially accepted in a diverse, young adult population.

Social media is being used for recruitment and the study of health-care choices and behavior, and could be particularly helpful to reach young adult populations outside of a 4 year college setting. The aim of this study was to report on overall success of recruiting young adults in diverse settings with respect to education and employment into a study using Facebook (FB). Young adults (n = 380, 50% male, 44% white) who had been involved in a longitudinal research project received a friend request from the research study group's profile. Acceptance rates of friend requests and sociodemographic and mental health factors associated with acceptance were evaluated. Approximately 67% of 318 participants who received a friend request accepted the request. Sociodemographic and mental health characteristics were similar between those who did and did not accept friend requests, suggesting non-differential recruitment through FB. Friending through FB is a feasible way to reach young adults involved in health and behavioral research, and could be a way to expand the populations that are studied in health science research to maximize generalizability of the conclusions drawn.

Correction to: Depression during pregnancy and preterm delivery: a prospective cohort study among women attending antenatal clinic at Pumwani Maternity Hospital.

[This corrects the article DOI: 10.1186/s12991-018-0202-6.].

Depression during pregnancy and preterm delivery: a prospective cohort study among women attending antenatal clinic at Pumwani Maternity Hospital.

BACKGROUND: Preterm birth occurs among 9.6% of births worldwide and is the leading cause of long-term neurodevelopmental disabilities among children and also responsible for 28% of neonatal deaths. No single etiological factor is responsible for preterm birth, but various risk factors have been identified. Prior studies have reported that compromised maternal mental health occurring during pregnancy may lead to various adverse obstetric outcomes. OBJECTIVE: To determine whether antenatal depression is significantly associated with preterm delivery in a low resource hospital sample from suburbs of Nairobi. METHODS: 292 women attending the antenatal clinic at Pumwani Maternity Hospital in Nairobi meeting the study criteria were recruited. The Edinburgh Postnatal Depression Scale was administered to screen for depression. A clinical cutoff score of 10 and above was regarded as possible depression. Thereafter, a clinical interview together with the Patient Health Questionnaire-9 was administered to evaluate the participants on DSM-V criteria for major depressive disorder. Only 255 of the women were successfully followed-up to delivery with an attrition rate of 12.7%. Records of gestation at delivery and birth weight were collected at second contact. DATA ANALYSIS: Preterm birth was associated with various demographic, psychosocial and medical variables. Relative risks were estimated via log binomial regression analysis to determine whether depression was a risk factor for preterm birth. RESULTS: Of the 255 participants, 98(38.4%) found to have depressive symptoms and 27(10.7%) delivered preterm. The risk of delivering preterm was 3.8 times higher among those with depressive symptoms. CONCLUSION: There is a positive association between antenatal depression and preterm delivery. This highlights the importance of screening for mental health challenges in the antenatal period as a means to reduce adverse obstetric outcomes.

Suicidal ideation in early to middle adolescence: sex-specific trajectories and predictors.

BACKGROUND: The present study examined developmental trajectories of suicidal ideation (SI) and predictors of the course of SI across early to middle adolescence in a sample of 521 children utilizing a prospective longitudinal design. METHOD: A baseline assessment including structured interviews and parent- and adolescent-reported measures was conducted at age 11-12 years, with follow-up assessments occurring 6, 12, 18, and 36 months later. RESULTS: Group-based trajectory analyses revealed three groups of individuals, one group that remained at low ideation scores throughout the time period examined, another group with moderate ideation scores and a minority of children who had fluctuating SI. Sex differences in SI trajectories were revealed with the highest SI scores at age 12 for boys. For boys in this group, high ideation followed by a steady decline in the slope over time. SI in girls demonstrated a quadratic function increasing from age 12 to 13, and decreasing from age 14 to 15. Factors that predicted SI group membership were identified. Depression, externalizing problems, family and friend support discriminated SI trajectories for both boys and girls. History of a suicide attempt was associated with moderate- and high-declining ideation groups for boys, and moderate and high ideation group for girls. CONCLUSIONS: Assessment of SI in adolescents should occur in early adolescents, particularly around the time of school transitions.

A Prospective Study of Intimate Partner Violence as a Risk Factor for Detectable Plasma Viral Load in HIV-Positive Women Engaged in Transactional Sex in Mombasa, Kenya.

We conducted a prospective cohort study to evaluate intimate partner violence (IPV) as a risk factor for detectable plasma viral load in HIV-positive female sex workers (FSWs) on antiretroviral therapy (ART) in Kenya. IPV in the past year was defined as ≥1 act of physical, sexual, or emotional violence by the index partner (i.e. boyfriend/husband). The primary outcome was detectable viral load (≥180 copies/ml). In-depth interviews and focus groups were included to contextualize results. Analyses included 195 women (570 visits). Unexpectedly, IPV was associated with significantly lower risk of detectable viral load (adjusted relative risk 0.21, 95 % CI 0.05-0.84, p-value = 0.02). Qualitative findings revealed that women valued emotional and financial support from index partners, despite IPV. IPV was not a major barrier to ART adherence. The observed association between IPV and lower risk of detectable viral load in FSWs may be due to unmeasured personal and relationship factors, warranting further research.

A Prospective Cohort Study of Intimate Partner Violence and Unprotected Sex in HIV-Positive Female Sex Workers in Mombasa, Kenya.

We conducted a prospective cohort study to test the hypothesis that intimate partner violence (IPV) is associated with unprotected sex in HIV-positive female sex workers in Mombasa, Kenya. Women completed monthly visits and quarterly examinations. Any IPV in the past year was defined as ≥1 act of physical, sexual, or emotional violence by the current or most recent emotional partner ('index partner'). Unprotected sex with any partner was measured by self-report and prostate specific antigen (PSA) test. Recent IPV was associated with significantly higher risk of unprotected sex (adjusted relative risk [aRR] 1.91, 95 % CI 1.32, 2.78, p = 0.001) and PSA (aRR 1.54, 95 % CI 1.17, 2.04, p = 0.002) after adjusting for age, alcohol use, and sexual violence by someone besides the index partner. Addressing IPV in comprehensive HIV programs for HIV-positive women in this key population is important to improve wellbeing and reduce risk of sexual transmission of HIV.

Risk factors for postpartum depression in women living with HIV attending prevention of mother-to-child transmission clinic at Kenyatta National Hospital, Nairobi.

Mothers with HIV are at high risk of a range of psychosocial issues that may impact HIV disease progression for themselves and their children. Stigma has also become a substantial barrier to accessing HIV/AIDS care and prevention services. The study objective was to determine the prevalence and severity of postpartum depression (PPD) among women living with HIV and to further understand the impact of stigma and other psychosocial factors in 123 women living with HIV attending prevention of mother-to-child transmission (PMTCT) clinic at Kenyatta National Hospital located in Nairobi, Kenya. We used the Edinburgh Postnatal Depression Scale and HIV/AIDS Stigma Instrument - PLWHA (HASI - P). Forty-eight percent (N = 59) of women screened positive for elevated depressive symptoms. Eleven (9%) of the participants reported high levels of stigma. Multivariate analyses showed that lower education (OR = 0.14, 95% CI [0.04-0.46], p = .001) and lack of family support (OR = 2.49, 95% CI [1.14-5.42], p = .02) were associated with the presence of elevated depressive symptoms. The presence of stigma implied more than ninefold risk of development of PPD (OR = 9.44, 95% CI [1.132-78.79], p = .04). Stigma was positively correlated with an increase in PPD. PMTCT is an ideal context to reach out to women to address mental health problems especially depression screening and offering psychosocial treatments bolstering quality of life of the mother-baby dyad.

Modeling the Impact of School-Based Universal Depression Screening on Additional Service Capacity Needs: A System Dynamics Approach.

Although it is widely known that the occurrence of depression increases over the course of adolescence, symptoms of mood disorders frequently go undetected. While schools are viable settings for conducting universal screening to systematically identify students in need of services for common health conditions, particularly those that adversely affect school performance, few school districts routinely screen their students for depression. Among the most commonly referenced barriers are concerns that the number of students identified may exceed schools' service delivery capacities, but few studies have evaluated this concern systematically. System dynamics (SD) modeling may prove a useful approach for answering questions of this sort. The goal of the current paper is therefore to demonstrate how SD modeling can be applied to inform implementation decisions in communities. In our demonstration, we used SD modeling to estimate the additional service demand generated by universal depression screening in a typical high school. We then simulated the effects of implementing "compensatory approaches" designed to address anticipated increases in service need through (1) the allocation of additional staff time and (2) improvements in the effectiveness of mental health interventions. Results support the ability of screening to facilitate more rapid entry into services and suggest that improving the effectiveness of mental health services for students with depression via the implementation of an evidence-based treatment protocol may have a limited impact on overall recovery rates and service availability. In our example, the SD approach proved useful in informing systems' decision-making about the adoption of a new school mental health service.

Namibian prisoners describe barriers to HIV antiretroviral therapy adherence.

Little is available in scholarly literature about how HIV-positive prisoners, especially in low-income countries, access antiretroviral therapy (ART) medication. We interviewed 18 prisoners at a large prison in Namibia to identify barriers to medication adherence. The lead nurse researcher was a long-standing clinic employee at the prison, which afforded her access to the population. We identified six significant barriers to adherence, including (1) the desire for privacy and anonymity in a setting where HIV is strongly stigmatized; (2) the lack of simple supports for adherence, such as availability of clocks; (3) insufficient access to food to support the toll on the body of ingesting taxing ART medications; (4) commodification of ART medication; (5) the brutality and despair in the prison setting, generally leading to discouragement and a lack of motivation to strive for optimum health; and (6) the lack of understanding about HIV, how it is transmitted, and how it is best managed. Because most prisoners eventually transition back to communitysettings when their sentences are served, investments in prison health represent important investments in public health.

Using modular psychotherapy in school mental health: provider perspectives on intervention-setting fit.

The "fit" or appropriateness of well-researched interventions within usual care contexts is among the most commonly cited, but infrequently researched, factors in the successful implementation of new practices. The current study was initiated to address two exploratory research questions: How do clinicians describe their current school mental health service delivery context? and How do clinicians describe the fit between modular psychotherapy and multiple levels of the school mental health service delivery context? Following a year-long training and consultation program in an evidence-based, modular approach to psychotherapy, semistructured qualitative interviews were conducted with 17 school-based mental health providers to evaluate their perspectives on the appropriateness of implementing the approach within a system of school-based health centers. Interviews were transcribed and coded for themes using conventional and directed content analysis. Findings identified key elements of the school mental health context including characteristics of the clinicians, their practices, the school context, and the service recipients. Specific evaluation of intervention-setting appropriateness elicited many comments about both practical and value-based (e.g., cultural considerations) aspects at the clinician and client levels but fewer comments at the school or organizational levels. Results suggest that a modular approach may fit well with the school mental health service context, especially along practical aspects of appropriateness. Future research focused on the development of methods for routinely assessing appropriateness at different stages of the implementation process is recommended.

Depression and its associated factors in pediatric chronic kidney disease.

BACKGROUND: Few studies on the occurrence of depression in pediatric patients with chronic kidney disease (CKD) have been conducted and none have identified associated clinical and demographic factors. METHODS: This was a cross-sectional study in which we administered the Child Depression Inventory-2 (CDI-2) to 44 patients aged 9-18 years with CKD stages III-V. Criteria for depression were CDI-2 scores of ≥65 or an established diagnosis of depression recorded in the medical chart. Relative risks (RR) and 95 % confidence intervals (CI) were calculated to determine associations between patient characteristics and depression status. RESULTS: Of the 44 patients enrolled in the study, 13 (30 %) met our criteria for depression, representing 18 % of patients aged <13 years and 34 % of those aged ≥13 years. Although not reaching statistical significance, the adjusted risk of depression was lower for patients with CKD duration of ≤3 years than for those with longer CKD duration (RR 0.19, 95 % CI 0.02, 1.53), and for those with CKD stage IV (RR 0.23, 95 % CI 0.05, 1.09) and CKD stage V (RR 0.13, 95 % CI 0.01, 1.07) compared to those with CKD stage III. CONCLUSIONS: Our results indicate that depression is common in children with CKD, particularly for those with longstanding renal disease and at CKD stage III.

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.

Associations between household and neighborhood income and anxiety symptoms in young adolescents.

BACKGROUND: A better understanding of the role of both family- and neighborhood-level socioeconomic characteristics in the development of anxiety disorders is important for identifying salient target populations for intervention efforts. Little research has examined the question of whether associations between anxiety and socioeconomic status (SES) differ depending upon the level at which SES is measured or way in which anxiety manifests. We studied associations between both household- and neighborhood-level income and four different manifestations of anxiety in a community sample of young adolescents. METHODS: We conducted a cross-sectional analysis of data on 498 subjects aged 11-13 from a cohort study of Seattle-area middle school students. Generalized estimating equations were used to examine the association between both annual household income and neighborhood median income and each of four anxiety subscale scores from the multidimensional anxiety scale for children (MASC): physical symptoms, harm avoidance, social anxiety, and separation/panic anxiety. RESULTS: A negative association was found between household income and scores on two of the four MASC subscales--physical symptoms and separation/panic anxiety. In contrast, at equivalent levels of household income, adolescents living in higher income neighborhoods reported higher physical and harm avoidance symptom scores. CONCLUSION: The role that SES plays in the development of childhood anxiety appears to be complex and to differ depending on the specific type of anxiety that is manifest and whether income is evaluated at the household or neighborhood level.

Mother's and Father's Serious Mental Illness and Risk of Child Injury in a Taiwanese Birth Cohort.

Objective: Parental serious mental illness (SMI) is associated with childhood injury. This study investigated whether child injury risk differs according to which parent is affected, SMI diagnosis, or timing of SMI onset.Methods: This cohort study included 1,999,322 singletons born in 2004-2014 identified from the national Taiwanese registries. General estimating equation Poisson models were used to estimate incidence rate ratios (IRRs) of injury events and hospitalizations before the age of 5 years among children according to which parent was affected, SMI diagnosis (schizophrenia [ICD-9-CM codes: 295, 297, 298.3, 298.4, 298.9], bipolar disorder [296.00-296.16, 296.40-296.81, 296.89-296.99, 298.1, 648.4], or major depressive disorder [MDD; 296.20-296.36, 296.82, 298.0]), and timing of diagnosis (before or after childbirth, as a proxy of timing of onset). Data analysis was performed on data obtained from April 20, 2017, to May 6, 2020.Results: Relative to unexposed children, the IRRs of injury hospitalizations for children with two SMI-affected parents, maternal SMI only, and paternal SMI only were 1.85 (95% CI, 1.38-2.48), 1.58 (95% CI, 1.48-1.68), and 1.34 (95% CI, 1.23-1.46), respectively. The IRRs of injury hospitalizations for maternal schizophrenia, bipolar disorder, and MDD were 2.09 (95% CI, 1.82-2.40), 1.77 (95% CI, 1.56-2.00), and 1.38 (95% CI, 1.26-1.50), respectively. The IRRs for paternal schizophrenia, bipolar disorder, and MDD were 1.39 (95% CI, 1.20-1.60), 1.61 (95% CI, 1.39-1.87), and 1.19 (95% CI, 1.05-1.36), respectively. The magnitude of excess risk was similar for children whose parent(s) experienced SMI diagnosed before and after childbirth.Conclusions: We found children with two SMI-affected parents or at least one parent with schizophrenia or bipolar disorder to be at greatest risk of severe injury requiring hospitalization. These parents may benefit from extra parenting support and injury prevention coaching.

Baseline situational analysis in Bangladesh, Jordan, Paraguay, the Philippines, Ukraine, and Zimbabwe for the WHO Special Initiative for Mental Health: Universal Health Coverage for Mental Health.

INTRODUCTION: Mental, neurological and substance use conditions lead to tremendous suffering, yet globally access to effective care is limited. In line with the 13th General Programme of Work (GPW 13), in 2019 the World Health Organization (WHO) launched the WHO Special Initiative for Mental Health: Universal Health Coverage for Mental Health to advance mental health policies, advocacy, and human rights and to scale up access to quality and affordable care for people living with mental health conditions. Six countries were selected as 'early-adopter' countries for the WHO Special Initiative for Mental Health in the initial phase. Our objective was to rapidly and comprehensively assess the strength of mental health systems in each country with the goal of informing national priority-setting at the outset of the Initiative. METHODS: We used a modified version of the Program for Improving Mental Health Care (PRIME) situational analysis tool. We used a participatory process to document national demographic and population health characteristics; environmental, sociopolitical, and health-related threats; the status of mental health policies and plans; the prevalence of mental disorders and treatment coverage; and the availability of resources for mental health. RESULTS: Each country had distinct needs, though several common themes emerged. Most were dealing with crises with serious implications for population mental health. None had sufficient mental health services to meet their needs. All aimed to decentralize and deinstitutionalize mental health services, to integrate mental health care into primary health care, and to devote more financial and human resources to mental health systems. All cited insufficient and inequitably distributed specialist human resources for mental health as a major impediment. CONCLUSIONS: This rapid assessment facilitated priority-setting for mental health system strengthening by national stakeholders. Next steps include convening design workshops in each country and initiating monitoring and evaluation procedures.

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.