Faculty Bibliography

AIMS: Methods for the training and fidelity monitoring of behavioral interventions in multi-site addictions research are reviewed, including five published studies and seven ongoing studies sponsored by the National Institute on Drug Abuse-funded Clinical Trials Network. METHODS: Methods are categorized and reviewed consistent with a technology model of treatment delivery. Topics include: therapist selection, training, certification, and supervision; selection, training, and certification of supervisors; scales and processes used for monitoring of the quality of treatment; and processes followed to provide new training for replacement staff once trials have begun. RESULTS: The review reveals both a wide array of procedures and emerging standards for multi-site trials. Methodological weakness was observed with respect to limited empirical support for many adherence scales, little or no evaluation of supervisory processes, and no evaluation of re-training practices. CONCLUSIONS: Methods used in multi-site trials are important not only to ensure validity of those trials, but also to inform the wider dissemination of empirically based treatment into community agencies. Studies examining noted weaknesses are needed. Training and fidelity models that delegate responsibility to participating sites appear most relevant for establishing best practices for dissemination of behavioral interventions. The effectiveness of these distributed training and supervision models should be subjected to empirical study at a level of rigor comparable to the evaluation of their corresponding treatments

Homeless shelters provide a unique opportunity to intervene with occupants who have substance abuse problems, as not addressing these issues may lead to continuation of problems playing a contributing role in homelessness. Attempts to implement Contingency Management (CM) with this population have often been complex, costly, and not straightforward to replicate in community settings. We conducted a randomized trial evaluating a simple, low-cost 4-week CM program for 30 individuals seeking shelter in a community-based homeless shelter who had both current substance and psychiatric disorders. Behavioral assessments were performed at baseline, weekly, and termination of the study. Overall retention in the trial was high; participants assigned to CM reduced their cocaine and alcohol use more than those in assessment-only. This pilot trial suggests that application of low-cost CM procedures is feasible within this novel setting and may decrease substance use.

The RIFE Grants Program offers funding to individuals in recovery from mental health and substance abuse problems for innovative projects to help them take steps toward achieving their life aspirations. Twenty-one people who received awards participated in an evaluation using the MDS and EPQ with significant increases in items related to empowerment from the beginning to mid study and a decrease in the empowerment factor from mid to end study. Ninety-one percent of participants reported improvements in daily life, 82% in thoughts of self, 80% in belief in capabilities, 60% in social roles, 80% in socializing, and 50% in values

BACKGROUND: Several short-term, controlled trials have documented the efficacy of vitamin E in treating tardive dyskinesia. However, the persistent nature of the disease prompted us to perform a multicenter, longer-term trial of vitamin E. METHODS: The study was a prospective, randomized, 9-site trial of up to 2 years of treatment with d-vitamin E (1600 IU/d) vs matching placebo. One hundred fifty-eight subjects with tardive dyskinesia who were receiving neuroleptic medications were enrolled. The blinded assessments performed were clinical (Abnormal Involuntary Movements Scale, Barnes Akathisia Scale, and Modified Simpson-Angus [for Extrapyramidal Symptoms] Scale) and electromechanical assessments of movement disorders, psychiatric status (Brief Psychiatric Rating Scale), and functioning (Global Assessment of Functioning). There were no significant differences in baseline demographic characteristics or in study assessments between the group that received vitamin E and the group that received placebo. RESULTS: Vitamin E was well tolerated and subject compliance with medication was good and similar between treatment groups. One hundred seven subjects (70% of those receiving vitamin E and 66% of subjects receiving placebo) completed at least 1 year of treatment. There were no significant effects of vitamin E on total scores or subscale scores for the AIMS, electromechanical measures of dyskinesia, or scores from the other 4 scales. CONCLUSION: This long-term, randomized trial of vitamin E vs placebo found no evidence for efficacy of vitamin E in the treatment of tardive dyskinesia

Nine VA Medical Centers are participating in a 2-year double-blind placebo controlled study of antioxidant treatment for tardive dyskinesia (TD) conducted by the Department of Veteran Affairs Cooperative Studies Program. One of the principal outcome measures of this study is the score derived from the instrumental assessment of upper extremity dyskinesia. Dyskinetic hand movements are quantified by assessing the variability associated with steady-state isometric force generated by the patient. In the present report, we describe the training procedures and results of a multi-center reliability assessment of this procedure. Data from nine study centers comprising 45 individual patients with six trials each (three from left hand and three from right hand) were reanalyzed by an independent investigator and the results were subjected to reliability assessment. For the statistic of interest (average coefficient of variation over trials 2 and 3 for each hand, then take the larger of these two values), we found very high intraclass correlation coefficients for reliability over all patients across sites (ICC = 0.995). We also calculated the reliability of the measures across trials within patient for each combination of hand (right, left, dominant), rater group (site, control), and trials set (all three, trials 2 and 3). For a given hand and trial set, the reliability of the site raters was similar to that of the control. This study demonstrates that instrumental measures for the assessment of dyskinesia are reliable and can be implemented in multi-center studies with minimal training

This article describes a standardized method for establishing and maintaining desired levels of interrater reliability (IRR) in multicenter trials. The procedure involves six steps: distribution of procedural guides, distribution of an introduction tape, initial distribution of patient interviews to rate, training at the study kickoff meeting, ongoing IRR monitoring, and group training throughout the study. This method is being used in a national Veterans Affairs Cooperative Study (CS #394), involving nine sites to examine the treatment effects of vitamin E on tardive dyskinesia. The six-step standardized process allowed for early detection of areas of concern in assessment administration. When comparing intraclass correlation coefficients (ICCs) at different points in the initial training, the Barnes Akathisia Scale and Anchored Brief Psychiatric Rating Scale reliability improved from 0.68 to 0.74 and from 0.54 to 0.87, respectively. After analyzing the ratings collected prior to the start of CS #394, data were collected to conduct the first check on Abnormal Involuntary Movement Scale (AIMS) IRR during enrollment; the estimated ICC for the AIMS had decreased from 0.87 to 0.60. Raters were instructed to re-assess the subjects from the first videotape on the AIMS and received additional training. The re-rating indicated very good reliability, 0.84, IRR was measured once for the Global Assessment of Functioning Scale resulting in an ICC of 0.90. The companion article (Part II: Edson et al. 1997, page 59 of this issue) describes the statistical procedures used to measure IRR

The primary goal of Veterans Affairs (VA) Cooperative Study (CS) #394 is to determine if vitamin E is a safe and efficacious treatment for tardive dyskinesia (TD). The study uses various instruments to assess subjects for movement disorders (Abnormal Involuntary Movement Scale [AIMS], and Barnes Akathisia Scale [BAS]), psychopathology (Anchored Brief Psychiatric Rating Scale [BPRS]), and level of functioning (Global Assessment of Functioning scale [GAF]). Since the study involves nine sites, each with its own set of raters, it is important to establish and maintain high interrater reliability (IRR) on these instruments throughout the study and to identify raters who differ significantly from the others. To make this determination, personnel at each site assessed subjects from standardized videotapes on the AIMS, BAS, and Anchored BPRS, and rated written vignettes on the GAF. We fit these data to a two-way additive model to identify nonstandardized raters (i.e., those whose average ratings were significantly lower or higher than the others, or those whose scores, after adjusting for subject and rater effects, were highly variable). The proportion of nonstandardized raters ranged from 7 percent (Anchored BPRS) to 33 percent (AIMS). The estimated intraclass correlation coefficients (ICCs) indicated moderate reliability for the AIMS, BAS, and Anchored BPRS (0.73 to 0.75) and excellent agreement for the GAF (0.90). The companion article (Part I: Tracy et al. 1997, page 53 of this issue) describes the procedures used to train the raters for this study