Background Unemployment is associated with negative outcomes both during and after drug abuse treatment. Interventions designed to increase rates of employment may also improve drug abuse treatment outcomes. The purpose of this multi-site clinical trial was to evaluate the Job Seekers’ Workshop (JSW), a three session, manualized program designed to train patients in the skills needed to find and secure a job. Method Study participants were recruited through the NIDA Clinical Trials Network (CTN) from six psychosocial counseling (n=327) and five methadone maintenance (n=301) drug treatment programs. Participants were randomly assigned to either standard care (program-specific services plus brochure with local employment resources) (SC) or standard care plus JSW. Three 4-hr small group JSW sessions were offered weekly by trained JSW facilitators with ongoing fidelity monitoring. Results JSW and SC participants had similar 12- and 24-week results for the primary outcome measure (i.e., obtaining a new taxed job or enrollment in a training program), Specifically, one-fifth of participants at 12 weeks (20.1 – 24.3%) and nearly one-third at 24 weeks (31.4–31.9%) had positive outcomes, with “obtaining a new taxed job” accounting for the majority of cases. Conclusion JSW group participants did not have higher rates of employment/training than SC controls. Rates of job acquisition were modest for both groups, suggesting more intensive interventions may be needed. Alternate targets (e.g., enhancing patient motivation, training in job-specific skills) warrant further study as well.

A substantial number of women who enter substance abuse treatment have a history of trauma and meet criteria for Post Traumatic Stress Disorder (PTSD). Fear regarding the extent to which PTSD treatment can evoke negative consequences remains a research question. This study explored adverse events related to the implementation of an integrated treatment for women with trauma and substance use disorder (Seeking Safety) compared with a non-trauma focused intervention (Women's Health Education). Three hundred fifty-three women enrolled in community substance abuse treatment were randomized to one of the two study groups and monitored weekly for adverse events. There were no differences between the two intervention groups in the number of women reporting study-related adverse events (28 [9.6%] for the Seeking Safety group, 21 [7.2%] for the Women's Health Education group). Implementing PTSD treatment in substance abuse treatment programs appears to be safe, with minimal impact on intervention-related adverse HHS Public Access

Background: Quality assurance (QA) of clinical trials is essential to protect the welfare of trial participants and the integrity of the data collected. However, there is little detailed information available on specific procedures and outcomes of QA monitoring for clinical trials.

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Intensive care units were developed in response to the perceived need for increased monitoring in critically ill medical patients. The same principle applies to elderly patients with severe agitated behaviors. These patients can be served by the Geriatric Behavioral Intensive Care Unit (BICU). The uniqueness of the program results from the application of a behavioral and environmental approach to the treatment of agitated behavior. The underlying strategy in the treatment process is to enhance the patient's ability to adapt to his or her home environment. Preliminary results have been encouraging, showing positive outcomes in diverse areas such as low level of institutional placement, patient quality of life, and caregiver symptoms of burden and depression.