Multisite Randomized Control Trial Research Articles

Project STYLE: A Multisite RCT for HIV Prevention Among Youths in Mental Health Treatment

The study examined the efficacy of family-based and adolescent-only HIV prevention programs in decreasing HIV risk and improving parental monitoring and sexual communication among youths in mental health treatment. A randomized controlled trial (RCT) with 721 adolescents (ages 13-18 years) and their caregivers from mental health settings in three U.S. cities were randomly assigned to one of three theory-based, structured group interventions: family-based HIV prevention, adolescent-only HIV prevention, and adolescent-only health promotion. Interventions were delivered during an all-day workshop. Assessments were completed at baseline and three months postintervention. Compared with those in the health intervention, adolescents in the HIV prevention interventions reported fewer unsafe sex acts (adjusted rate ratio=.49, p=.01), greater condom use (adjusted relative change=59%, p=.01), and greater likelihood of avoiding sex (adjusted odds ratio=1.44, p=.05). They also showed improved HIV knowledge (p<.01) and self-efficacy (p<.05). The family-based intervention, compared with the other interventions, produced significant improvements in parent-teen sexual communication (p<.01), parental monitoring (p<.01), and parental permissiveness (p=.05). This RCT found that the HIV prevention interventions reduced sexual risk behavior over three months in a large, diverse sample of youths in mental health treatment and that the family-based intervention improved parental monitoring and communication with teens about sex. These interventions show promise.

Slow-onset and Fast-onset Symptom Presentations In Acute Coronary Syndrome (ACS): New Perspectives on Prehospital Delay in Patients with ACS

BackgroundPatient decision delay is the main reason why many patients fail to receive timely medical intervention for symptoms of acute coronary syndrome (ACS). Study ObjectivesThis study examines the validity of slow-onset and fast-onset ACS presentations and their influence on ACS prehospital delay times. A fast-onset ACS presentation is characterized by sudden, continuous, and severe chest pain, and slow-onset ACS pertains to all other ACS presentations. MethodsBaseline data pertaining to medical profiles, prehospital delay times, and ACS symptoms were recorded for all ACS patients who participated in a large multisite randomized control trial (RCT) in Dublin, Ireland. Patients were interviewed 2–4 days after their ACS event, and data were gathered using the ACS Response to Symptom Index. ResultsOnly baseline data from the RCT, N = 893 patients, were analyzed. A total of 65% (n = 577) of patients experienced slow-onset ACS presentation, whereas 35% (n = 316) experienced fast-onset ACS. Patients who experienced slow-onset ACS were significantly more likely to have longer prehospital delays than patients with fast-onset ACS (3.5 h vs. 2.0 h, respectively, t = −5.63, df 890, p < 0.001). A multivariate analysis of delay revealed that, in the presence of other known delay factors, the only independent predictors of delay were slow-onset and fast-onset ACS (β = −.096, p < 0.002) and other factors associated with patient behavior. ConclusionSlow-onset ACS and fast-onset ACS presentations are associated with distinct behavioral patterns that significantly influence prehospital time frames. As such, slow-onset ACS and fast-onset ACS are legitimate ACS presentation phenomena that should be seriously considered when examining the factors associated with prehospital delay.

Psychosocial interventions for the treatment of perinatal depression

Epidemiological investigations and meta-analyses of predictive studies have consistently demonstrated the importance of psychosocial variables as postpartum depression risk factors. To address this, several psychosocial treatment strategies have been evaluated for the treatment of postpartum depression. The purpose of this paper is to determine the current state of scientific knowledge related to the treatment of postpartum depression from a psychosocial perspective. Thirteen trials were included in the review that evaluated the following interventions: peer support, partner support, non-directive counselling, home visits by mental health nurses, and collaborative models of care. Owing to methodological limitations of the included trials, the effectiveness of most psychosocial approaches for the treatment of postpartum depression is equivocal. Large, multisite randomised-controlled trials are needed to compare different treatment approaches, examine the effectiveness of individual treatment components, and determine which treatments are most useful for women with different risk factors or clinical presentations of postpartum depression.

A nurse- and peer-led support program to assist women in gynaecological oncology receiving curative radiotherapy, the PeNTAGOn study (Peer and nurse support trial to assist women in gynaecological oncology): study protocol for a randomised controlled trial

BackgroundWomen who undergo radiotherapy for gynaecological cancer (GC) can experience distressing side effects which impact on psychosocial functioning and intimate relationships. Cancer-related distress may be ameliorated by comprehensive preparation for treatment and addressing women’s informational, physical, psychological and psychosexual needs. This paper describes the protocol for a multisite randomised controlled trial (RCT) testing a novel intervention package which combines tailored specialist nursing consultations and telephone peer support with the primary aim to reduce psychological distress. Secondary aims assess patient quality of life, symptom distress, unmet supportive care needs, preparation for treatment, psychosexual functioning and vaginal stenosis.Methods/designThis multifaceted intervention comprises four nurse-led consultations coupled with four phone calls from a peer support volunteer (GC survivor). The evidence-based intervention will be delivered at critical points in the illness trajectory: pre-treatment, mid-treatment, treatment completion and post-treatment. Nurses and peers undergo 2-day intensive training workshops, are guided by comprehensive study intervention manuals and receive ongoing supervision and support. Eligible patients will have a diagnosis of GC, be scheduled to receive curative radiotherapy, be aged 18 years or over and speak English. Three-hundred and six participants will be randomized to receive usual care or usual care with the intervention package. Study outcome measures will be collected at baseline, day 1 of radiotherapy and 1, 6 and 12 months post radiotherapy. Clinical assessments of vaginal toxicity will occur at baseline, and 3, 6, and 12 months post radiotherapy.DiscussionThis timely research has the potential to substantially reduce the physical, psychosexual and supportive care needs of women with GC. Using a telephone peer support model, the intervention package ensures equitable access to support services for geographically isolated patients. The novel intervention engages peer volunteers who liaise with nurses to encourage adherence to professionally-delivered information and provide emotional support. It has been designed to be potentially transferable to a range of treatment settings and diseases. Based on pilot data, the proposed intervention was found to be useful and acceptable to patients and clinicians. If effective and feasible in the multisite RCT, the program could be widely disseminated.Trial registrationAustralian New Zealand Clinical Trial Registry ACTRN12611000744954

1494 – Mindfulness-based cognitive therapy reduces depression symptoms in people who have a traumatic brain injury: results from a randomized controlled trial

Introduction Traumatic brain injuries (TBI) may lead to persistent depression symptoms. We conducted several pilot studies to examine the efficacy of mindfulness-based interventions to deal with this issue; all showed strong effect sizes. The logical next step was to conduct a randomized controlled trial (RCT). Objective We sought to determine the efficacy of mindfulness-based cognitive therapy for people with depression symptoms post-TBI (MBCT-TBI). Methods Using a multi-site RCT design, participants (mean age = 47) were randomized to intervention or control arms. Treatment participants received a group-based, 10-week intervention; control participants waited. Outcome measures, administered pre- and post-intervention, and after three months, included: Beck Depression Inventory-II (BDI-II), Patient Health Questionnaire-9 (PHQ-9), and Symptom Checklist-90-Revised (SCL-90-R). The Philadelphia Mindfulness Scale (PHLMS) captured present moment awareness and acceptance. Results BDI-II scores decreased from 25.47 to 18.84 in treatment groups while they stayed relatively stable in control groups (respectively 27.13 to 25.00; p = .029). We did not find statistically significant differences on the PHQ-9 and SCL-90R post- treatment. However, after three months, all scores were statistically significantly lower than at baseline (ps Conclusions MBCT-TBI may alleviate depression symptoms up to three months post-intervention. Greater mindfulness may have contributed to the reduction in depression symptoms although the association does not confirm causality. More work is required to replicate these findings, identify subgroups that may better respond to the intervention, and refine the intervention to maximize its effectiveness.

The pediatric obsessive compulsive disorder treatment study for young children (POTS Jr): Developmental considerations in the rationale, design, and methods

This paper presents the rationale, design, and methods of the pediatric obsessive compulsive disorder treatment study for young children (POTS Jr). The study is a multi-site randomized controlled trial (RCT) of family-based cognitive behavioral treatment (CBT) vs. family-based relaxation therapy for young children (ages 5–8) with obsessive compulsive disorder (OCD), which examines the effect of treatment on symptom reduction, functional impairment, and quality of life. Secondary aims evaluate: potential moderators and mediators of treatment response, differences in time course of response, retention rates, and maintenance of treatment gains over one year post-treatment. The sample included 127 children (53% female) and their parents. With regard to ethnicity, 89% of the sample described themselves as non-Hispanic, 5% Hispanic/Latino, and 6% did not endorse a category. In terms of race, the sample was predominantly (91%) white. Because the rationale and methods of the multi-site RCT have been well established, we emphasize here the methodological aspects of the study that were tailored to meet the developmental needs of young children with OCD. Aspects that are highlighted include: choice of control group, inclusion/exclusion criteria, assessment/measurement issues, treatment adaptations, training, and recruitment.

An EMR-based tool to support collaborative planning for medication use among adults with diabetes: Design of a multi-site randomized control trial

Patients with type II diabetes often struggle with self-care, including adhering to complex medication regimens and managing their blood glucose levels. Medication nonadherence in this population reflects many factors, including a gap between the demands of taking medication and the limited literacy and cognitive resources that many patients bring to this task. This gap is exacerbated by a lack of health system support, such as inadequate patient–provider collaboration. The goal of our project is to improve self-management of medications and related health outcomes by providing system support. The Medtable™ is an Electronic Medical Record (EMR)-integrated tool designed to support patient–provider collaboration needed for medication management. It helps providers and patients work together to create effective medication schedules that are easy to implement. We describe the development and initial evaluation of the tool, as well as the process of integrating it with an EMR system in general internal medicine clinics. A planned evaluation study will investigate whether an intervention centered on the Medtable™ improves medication knowledge, adherence, and health outcomes relative to a usual care control condition among type II diabetic patients struggling to manage multiple medications.

Recruitment and retention in an adolescent anorexia nervosa treatment trial

To investigate recruitment and retention for a randomized controlled trial (RCT) of adolescent anorexia nervosa (AN), as prior studies suggest that these are significant hurdles to completing meaningful RCTs in this population. Retrospective analyses of recruitment and retention rates were conducted for a multisite RCT of family-based treatment (FBT) versus adolescent-focused therapy (AFT) recruiting adolescents between 12 and 18 years of age with AN. Adolescent participants were recruited from a variety of both medical and nonmedical sources. Recruitment goals were met in time (October 2004-March 2007). Percent retention rates were high across both treatment types (84% for FBT and 92% for AFT), and these rates did not differ significantly. These results reveal that recruitment and retention of adolescent patients with AN to RCTs are feasible in contrast to the experience in adult studies. It is likely that characteristics of our clinical programs make recruitment easier than in other settings, e.g., child and adolescent focused, specialized eating disorders program with an emphasis on outpatient treatment, recognized leaders in the field, and a history of clinical excellence with this population.

Multicenter Randomized Controlled Trial of Pediatric Constraint-Induced Movement Therapy: 6-Month Follow-Up

Pediatric constraint-induced movement therapy (CIMT) is a promising intervention for children with unilateral cerebral palsy (CP). This multisite randomized controlled trial (RCT) tested the hypothesis that 6 hr versus 3 hr per day for 21 days would produce larger maintenance of gains 6 mo posttreatment. Three sites recruited 18 children (6 per site) ages 3-6 yr with unilateral CP. Children were randomly assigned 3 to 6 hr/day of CIMT for 21 days and wore a cast on the unaffected extremity the first 18 days. Occupational therapists applied a standardized pediatric CIMT protocol. Evaluators blinded to condition administered the ASsisted Hand Assessment and the Quality of Upper Extremity Skills Test, and parents completed the Pediatric Motor Activity Log pre- and posttreatment (1 wk, 1 mo, and 6 mo). Both CIMT dosage groups showed significant gains on all five assessments with no significant group differences at 6 mo follow-up. Effect sizes (n = 15) comparing preintervention to postintervention measures (partial η2) ranged from .33 to .80. The first multisite RCT of pediatric CIMT confirmed the maintenance of positive effects at 6 mo follow-up across multiple functional performance measures. The hypothesis that maintenance of effects would differ for children who received 6 versus 3 hr/day of CIMT (126 vs. 63 total hr) was not supported.

Healthy babies through infant-centered feeding protocol: an intervention targeting early childhood obesity in vulnerable populations.

BackgroundPoor feeding practices during infancy contribute to obesity risk. As infants transition from human milk and/or formula-based diets to solid foods, these practices interfere with infant feeding self-regulation and healthy growth patterns. Compared with other socioeconomic groups, lower-income mothers are more likely to experience difficulty feeding their infants. This may include misinterpreting feeding cues and using less-than-optimal feeding styles and practices, such as pressuring infants during mealtimes and prematurely introducing solid food and sweetened beverages. The Healthy Babies trial aims to determine the efficacy of a community-based randomized controlled trial of an in-home intervention with economically and educationally disadvantaged mother-infant dyads. The educational intervention is being conducted during the infant's first 6 months of life to promote healthy transition to solids during their first year and is based on the theory of planned behavior.Methods/DesignWe will describe our study protocol for a multisite randomized control trial being conducted in Colorado and Michigan with an anticipated sample of 372 economically and educationally disadvantaged African American, Hispanic, and Caucasian mothers with infants. Participants are being recruited by county community agency staff. Participants are randomly assigned to the intervention or the control group. The intervention consists of six in-home visits by a trained paraprofessional instructor followed by three reinforcement telephone contacts when the baby is 6, 8, and 10 months old. Main maternal outcomes include a) maternal responsiveness, b) feeding style, and c) feeding practices. Main infant outcome is infant growth pattern. All measures occur at baseline and when the infant is 6 and 12 months old.DiscussionIf this project is successful, the expected outcomes will address whether the home-based early nutrition education intervention is effective in helping mothers develop healthy infant feeding practices that contribute to improving infant health and development and reducing the risk of early-onset childhood obesity.Trial RegistrationCurrent Controlled Trials ACTRN126100000415000

A multi-site randomized controlled trial of a cognitive skills programme for male mentally disordered offenders: social–cognitive outcomes

Cognitive skills programmes have been associated with improvements on psychometric measures and reductions in antisocial behaviour in mentally disordered offenders (MDOs). However, to date there have been no randomized controlled trials (RCTs) of such programmes with this population. In the first RCT of a cognitive skills programme with MDOs we aimed to determine if participation in the Reasoning and Rehabilitation (R&R) programme was associated with improvements in social-cognitive skills and thinking styles. A total of 84 men with a primary diagnosis of psychotic disorder and a history of violence were recruited from medium-secure forensic units and allocated to receive R&R (n=44) or treatment as usual (TAU; n=40). At baseline and post-treatment interviews, participants completed questionnaires to assess social problem-solving, criminal attitudes, anger experience, blame externalizing and perspective-taking. Researchers were not blind to group status. The R&R group demonstrated significant improvements on measures of social problem-solving relative to the TAU group, some of which were maintained at 12 months post-treatment. Only half of those allocated to receive R&R completed the full programme. In post-hoc analyses programme completers showed improvements in social problem-solving at the end of treatment and changes in criminal attitudes at 12 months post-treatment. Among male MDOs, R&R participation was associated with improvements in social-cognitive skills, some of which were maintained for up to 12 months post-treatment. Our finding that programme completers do better may reflect pre-treatment patient characteristics. This study establishes that multi-site RCTs can be conducted in medium-secure forensic units.

Changing Healthcare Providers' Behavior during Pediatric Inductions with an Empirically Based Intervention

Each year more than 4 million children experience significant levels of preoperative anxiety, which has been linked to poor recovery outcomes. Healthcare providers (HCPs) and parents represent key resources for children to help them manage their preoperative anxiety. The current study reports on the development and preliminary feasibility testing of a new intervention designed to change HCP and parent perioperative behaviors that have been reported previously to be associated with children's coping and stress behaviors before surgery. An empirically derived intervention, Provider-Tailored Intervention for Perioperative Stress, was developed to train HCPs to increase behaviors that promote children's coping and decrease behaviors that may exacerbate children's distress. Rates of HCP behaviors were coded and compared between preintervention and postintervention. In addition, rates of parents' behaviors were compared between those that interacted with HCPs before training to those interacting with HCPs after the intervention. Effect sizes indicated that HCPs who underwent training demonstrated increases in rates of desired behaviors (range: 0.22-1.49) and decreases in rates of undesired behaviors (range: 0.15-2.15). In addition, parents, who were indirectly trained, also demonstrated changes to their rates of desired (range: 0.30-0.60) and undesired behaviors (range: 0.16-0.61). The intervention successfully modified HCP and parent behaviors. It represents a potentially new clinical way to decrease anxiety in children. A multisite randomized control trial funded by the National Institute of Child Health and Development will examine the efficacy of this intervention in reducing children's preoperative anxiety and improving children's postoperative recovery.

Allegiance Bias and Therapist Effects: Results of a Randomized Controlled Trial of Binge Eating Disorder.

"Allegiance bias" has been hypothesized to compromise the findings of randomized controlled trials (RCTs). In contrast, our multi-site RCT involving the collaboration of investigators with different allegiances regarding interpersonal psychotherapy (IPT), guided self-help cognitive behavior therapy (CBTgsh), and behavioral weight loss therapy (BWL) for binge eating disorder showed no evidence of any differential site × treatment effects. The findings indicate that "allegiance bias" does not necessarily occur in well-controlled RCTS with appropriate therapist training. We also examined the role of individual therapist differences that have been alleged to be more important than treatment effects. No individual therapist effects emerged on any measure in either IPT or CBTgsh, both of which were significantly more effective than BWL at two-year follow-up.

S09-01 - Discharge planning, an intervention study - and where to go next?

BackgroundProcess evaluation should be an integral part of randomised controlled trials (RCTs), and this is important in examining complex interventions with a number of active ingredients.ObjectiveTo analyse effectiveness and effect moderators in a multi-centre RCT of needs-oriented discharge planning vs. treatment as usual (TAU) for high utilisers of mental health care.MethodFrom April 2006 to July 2007, 491 adults with high utilisation of mental health care for psychotic disorders gave informed consent to participate in a multi-site RCT at five German psychiatric inpatient services. Subjects allocated to the intervention group were offered a manualised needs-led discharge planning intervention of two 45 minute sessions delivered by a trained study worker. Outcomes (service use, needs, psychopathology, depression, quality of life, direct costs) were assessed at four measurement points during 18-month follow-up. Latent class modelling was used to scrutinise differential effectiveness. Characteristics of subgroups of participants showing variable treatment response will be described.ResultsThere was improvement both in the intervention and (TAU) control group but no differential effectiveness of the discharge planning intervention. Only few variables significantly moderated effects. Effect moderators pertained to quality of delivery and intervention dose.ConclusionsStudy results could help to tailor interventions to local conditions and guide future implementation of discharge planning in routine care. Further research should focus on scrutinising study process, ensuring ecological suitability of interventions and on head-to-head comparison studies.

Improving Child Protection in the Emergency Department: A Systematic Review of Professional Interventions for Health Care Providers

This systematic review evaluated the effectiveness of professional and organizational interventions aimed at improving medical processes, such as documentation or clinical assessments by health care providers, in the care of pediatric emergency department (ED) patients where abuse was suspected. A search of electronic databases, references, key journals, and conference proceedings was conducted and primary authors were contacted. Studies whose purpose was to evaluate a strategy aimed at improving ED clinical care of suspected abuse were included. Study methodologic quality was assessed by two independent reviewers. One reviewer extracted the data, and a second checked for completeness and accuracy. Six studies met the inclusion criteria: one randomized controlled trial (RCT), one quasi-RCT, and four observational studies. Study quality ranged from modest (observational studies) to good (trials). Variation in study interventions and outcomes limited between-study comparisons. The quasi-RCT supported self-instructional education kits as a means to improve physician knowledge for both physical abuse (mean +/- standard deviation [SD] pretest score = 13.12 +/- 2.36; mean +/- SD posttest score = 18.16 +/- 1.64) and sexual abuse (mean +/- SD pretest score = 10.81 +/- 3.20; mean +/- SD posttest score = 18.45 +/- 1.79). Modest-quality observational studies evaluated reminder systems for physician documentation with similar results across studies. Compared to standard practice, chart checklists paired with an educational program increased physician consideration of nonaccidental burns in burn cases (59% increase), documentation of time of injury (36% increase), and documentation of consistency (53% increase) and compatibility (55% increase) of reported histories. Decisional flow charts for suspected physical abuse also increased documentation of nonaccidental physical injury (69.5% increase; p < 0.0001) and had a similar significant effect as checklists on increasing documentation of history consistency and compatibility (69.5 and 70.0% increases, respectively; p < 0.0001) when compared to standard practice. No improvements were noted in these studies for documentation of consultations or current status with child protective services. The introduction of a specialized team and crisis center to standardize practice had little effect on physician documentation, but did increase documentation of child protective services involvement (22.7% increase; p < 0.005) and discharge status (23.7% increase; p < 0.02). Referral to social services increased in one study following the introduction of a chart checklist (8.6% increase; p = 0.018). A recently conducted multisite RCT did not support observational findings, reporting no significant effect of educational sessions and/or a chart checklist on ED practices. The small number of studies identified in this review highlights the need for future quality studies that address care of a vulnerable clinical population. While moderate-quality observational studies suggest that education and reminder systems increase clinical knowledge and documentation, these findings are not supported by a multisite randomized trial. The limited theoretical base for conceptualizing change in health care providers and the influence of the ED environment on clinical practice are limitations to this current evidence base.

Hospital hypoglycemia: From observation to action

Background: A preponderance of evidence indicates that when treatment of hyperglycemia with insulin is provided for certain hospitalized populations, the attainment of appropriate glycemic targets improves nonglycemic outcomes such as mortality rates, morbidities (eg, wound infection, critical illness polyneuropathy, bacteremia, new renal insufficiency), duration of ventilator dependency, transfusion requirements, and length of hospital stay. Nevertheless, randomized controlled trials (RCTs) of intensive insulin therapy and studies of outcomes before and after implementation of tight glycemic control have consistently recognized an increased incidence of hypoglycemia as a complication associated with the use of lower glycemic targets and higher doses of insulin. Objectives: This commentary compares the quality of the available evidence on the clinical impact of iatrogenic hypoglycemia. We present treatment strategies designed to prevent iatrogenic hypoglycemia in the hospital setting. Methods: The PubMed database and online citations of articles tracked subsequent to publication were searched for articles on the epidemiology, clinical impact, and mechanism of harm of hypoglycemia published since 1986. In addition, we searched the literature for RCTs conducted since 2001 concerning intensive insulin therapy in the hospital critical care setting, including meta-analyses; letters to the editor were excluded. The retrieved studies were scanned and chosen selectively for full-text review based on the study size and design, novelty of findings, and evidence related to the possible clinical impact of hypoglycemia. Reference lists from the retrieved studies were searched for additional studies. Reports were summarized for the purpose of comparing and contrasting the qualitative nature of information about iatrogenic hypoglycemia in the hospital. Results: Eight RCTs of intensive glycemic management, 16 observational studies of hospitalized patients with hypoglycemia (including studies of outcomes before and after implementation of tight glycemic control), and 4 case reports on patients with hypoglycemia were selected for discussion of the incidence of hypoglycemia, significance of hypoglycemia as a marker or cause of poor prognosis, and clinical harm of hypoglycemia. Hypoglycemia was identified in clinical trials as either a category of adverse events or a complication of intensified insulin treatment. For example, a recent meta-analysis found that the incidence of severe hypoglycemia was higher among critically ill patients treated with intensive insulin therapy than among control patients, with a pooled relative risk of 6.0 (95% CI, 4.5–8.0). In the largest multisite RCT on glycemic control among patients in intensive care units (ICUs) conducted to date, deaths were reported for 27.5% (829/3010 patients) in the intensive-treatment group and 24.9% (751/3012 patients) in the conventional-treatment group (odds ratio, 1.14; 95% CI, 1.02–1.28; P = 0.02). In another multisite ICU study, although the intensive and control groups had similar mortality rates, the mortality rate was higher among hypoglycemic participants than among nonhypoglycemic participants (32.2% vs 13.6%, respectively; P < 0.01). Pooled data from 2 singlesite studies in medical and surgical ICUs revealed an increased risk of hypoglycemia in the intensive-treatment group compared with the conventional-treatment group (11.3% [154/1360] and 1.8% [25/1388], respectively; P < 0.001), but the hospital mortality rate was similar for the 2 groups (50.6% [78/154] and 52.0% [13/25], respectively). Specific sequelae of hypoglycemia affecting individual patients were described in the RCTs as well as in the observational studies. New guidelines for glycemic control have recently been issued, but results of the studies using the new targets are not yet available. We propose treatment strategies designed to prevent iatrogenic hypoglycemia in the hospital setting. Conclusions: In response to the growing evidence on the risk of hypoglycemia during intensified glycemic management of hospitalized patients, professional organizations recently revised targets for glycemic control. It is appropriate for institutions to reevaluate hospital protocols for glycemic management with intravenous insulin and, on general wards, to implement standardized order sets for use of subcutaneous insulin to achieve beneficial targets using safe strategies.

Does Cognitive Training Improve Internal Locus of Control Among Older Adults?

We evaluated the effect of cognitive training among 1,534 participants in the Advanced Cognitive Training for Independent and Vital Elderly (ACTIVE) randomized controlled trial (RCT) on 5-year improvements in 3 cognitive-specific measures of locus of control-internal, chance, and powerful others. ACTIVE was a multisite RCT (age > or = 65), with 4 groups (memory, reasoning, speed of processing, and no-contact control). Complete 5-year follow-up data were available for 1,534 (55%) of the 2,802 participants. A propensity score model was used to adjust for potential attrition bias. Clinically important improvements (and decrements) in the cognitive-specific locus of control scale scores were defined as greater than or equal to 0.5 SD (medium) and greater than or equal to 1.0 SD (large). Multinomial logistic regression was used to simultaneously contrast those who improved and those who declined with those whose locus of control scale score was unchanged. Statistically significant effects reflecting medium-sized (> or = 0.5 SD) improvements in internal locus of control between baseline and the 5-year follow-up were found for the reasoning and speed of processing intervention groups who were 76% (p < .01) and 68% (p < .05) more likely, respectively, to improve than the no-contact control group. No improvement effects were found on the chance or powerful others locus of control measures or for the memory intervention group. Cognitive training that targets reasoning and speed of processing can improve the cognitive-specific sense of personal control over one's life in older adults.

The Family Check-Up in Early Childhood: A Case Study of Intervention Process and Change

This article describes a case study in the use of the Family Check-Up (FCU), a family-based and ecological preventive intervention for children at risk for problem behavior. The FCU is an assessment-driven intervention that utilizes a health maintenance model; emphasizes motivation for change; and offers an adaptive, tailored approach to intervention. This case study follows one Caucasian family through their initial assessment and subsequent treatment for their toddler daughter's conduct problems over a 2-year period. Clinically meaningful improvements in child and family functioning were found despite the presence of child, parent, and neighborhood risk factors. The case is discussed with respect to the findings from a current multisite randomized control trial of the FCU and its application to other populations.

Supervision of Facilitators in a Multisite Study: Goals, Process, and Outcomes

To describe the aims, implementation, and desired outcomes of facilitator supervision for both interventions (treatment and control) in Project Eban and to present the Eban Theoretical Framework for Supervision that guided the facilitators' supervision. The qualifications and training of supervisors and facilitators are also described.This article provides a detailed description of supervision in a multisite behavioral intervention trial. The Eban Theoretical Framework for Supervision is guided by 3 theories: cognitive behavior therapy, the Model of Life-Long Supervision, and the empowerment model of culturally responsive supervision.Supervision is based on the Eban Theoretical Framework for Supervision, which provides guidelines for implementing both interventions using goals, process, and outcomes.Because of effective supervision, the interventions were implemented with fidelity to the protocol and were standard across the multiple sites.Supervision of facilitators is a crucial aspect of multisite intervention research quality assurance. It provides them with expert advice, optimizes the effectiveness of facilitators, and increases adherence to the protocol across multiple sites. Based on the experience in this trial, some of the challenges that arise when conducting a multisite randomized control trial and how they can be handled by implementing the Eban Theoretical Framework for Supervision are described.

STRATEGIES FOR IMPROVING THE PREDICTION OF PSYCHOSIS

Introduction: Over the last fifteen years, valid and reliable criteria have been developed for identifying individuals at ‘ultra-high risk’ (UHR) of imminent onset of psychotic disorder. A number of randomized controlled trials (RCTs) have been conducted in the UHR population. These trials have demonstrated that psychotic disorder can at least be delayed in this population. However, it remains unclear what the most effective type, timing and duration of treatment is for this population is. There is evidence that benign treatments may be sufficient as a first step in the UHR population. Recent research also indicates a reduction in rate of transition to psychotic disorder in the UHR population. Together, these data suggests that a staged approach to treatment, starting with more benign interventions and progressing to more intensive treatments in the case of poor response or deterioration, may be appropriate for the UHR population. Another factor that has been a challenge in UHR intervent ion studies has been to recruit a sufficient number of participants to provide statistical power to address research questions. Methods: This background has provided the impetus for a new multisite RCT being developed in the UHR population. The RCT has a two-stage design. Stage 1 consists of participants being randomized to one of two conditions: cognitive-behavioural case management (CBCM) + placebo or CBCM + eico sapentanoic acid (EPA). Treatment will continue for 3 months. Participants who fail to respond to treatment in Stage 1 will be randomized at Stage 2 to either CBCM + low dose atypical anti-psychotic medication (quetiapine) or CBCM + placebo. Treatment will continue for 6 months. The study will be conducted across 9 international UHR clinics.