Do Research Intermediaries Reduce Perceived Coercion to Enter Research Trials Among Criminally Involved Substance Abusers?

We examined the efficacy of including a research intermediary (RI) during the consent process in reducing participants' perceptions of coercion to enroll in a research study. Eighty-four drug court clients being recruited into an ongoing study were randomized to receive a standard informed consent process alone (standard condition) or with an RI (intermediary condition). Before obtaining consent, RIs met with clients individually to discuss remaining concerns. Findings provided preliminary evidence that RIs reduced client perceptions that their participation might influence how clinical and judicial staff view them. This suggests that using RIs may improve participant autonomy in clinical studies.

Corrected Feedback: A Procedure to Enhance Recall of Informed Consent to Research among Substance Abusing Offenders.

This study examined the efficacy of corrected feedback for improving consent recall throughout the course of an ongoing longitudinal study. Participants (N = 135) were randomly assigned to either a corrected feedback or a no-feedback control condition. Participants completed a consent quiz 2-weeks after consenting to the host study and at months 1, 2, and 3. The corrected feedback group received corrections to erroneous responses and the no-feedback control group did not. The feedback group displayed significantly greater recall overall and in specific content areas (i.e., procedures, protections, risks/benefits). Results support the use of corrected feedback for improving consent recall.

Adaptive interventions may optimize outcomes in drug courts: a pilot study.

Adaptive interventions apply a priori decision rules for adjusting treatment services in response to participants' clinical presentation or performance in treatment. This pilot study (n = 30) experimentally examined an adaptive intervention in a misdemeanor drug court. The participants were primarily charged with possession of marijuana (73%) or possession of drug paraphernalia (23%). Results revealed that participants in the adaptive condition had higher graduation rates and required significantly less time to graduate from the program and achieve a final resolution of the case. It took an average of nearly 4 fewer months for participants in the adaptive intervention to resolve their cases compared with those participating in drug court as usual. Participants in the adaptive condition also reported equivalent satisfaction with the program and therapeutic alliances with their counselors. These data suggest that adaptive interventions may enhance the efficiency and effectiveness of drug courts and justify examining adaptive interventions in large-scale drug court studies.

Monetary incentives improve recall of research consent information: it pays to remember.

Research participants often fail to recall substantial amounts of informed consent information after delays of only a few days. Numerous interventions have proven effective at improving consent recall; however, virtually all have focused on compensating for potential cognitive deficits and have ignored motivational factors. In this pilot study, the authors randomly assigned 31 drug court clients participating in a clinical research trial to a control group that received a standard informed consent procedure or to a group that received the same procedure plus incentives for correctly recalling consent information. The incentive group was told they would receive $5 for each of the 15 consent items they could answer correctly 1 week later. At the follow-up, the incentive group recalled a significantly greater percentage of consent information overall than the control group (65% vs. 42%, p<.01). Findings from this study have important implications for the ethical conduct of human subject research. The incentivized consent procedure may be useful for improving consent recall in research studies, particularly those involving potentially serious side effects. The results also provide an important "proof of concept" regarding the utility of motivational procedures for improving recall of consent information.

Outcome Trajectories in Drug Court: Do All Participants Have Drug Problems?

Graduation rates in drug courts average 50% to 70%, but it is unclear what proportion of graduates responded to the drug court services and what proportion might not have had serious drug problems upon entry. This study cluster-analyzed urine drug screen results during the first 14 weeks of treatment on 284 participants from three misdemeanor drug courts. A four-cluster solution (R(2) > .75) produced distinct subgroups characterized by (1) consistently drug-negative urine specimens (34% of the sample), (2) consistently drug-positive specimens (21%), (3) consistently missed urine specimens (26%), and (4) urine specimens that began as drug-positive but became progressively drug-negative over time (19%). These data suggest that approximately one-third of the participants might not have had serious drug problems upon entry. Approximately one-fifth appeared to respond to drug court services, and nearly one-half continued to exhibit problems after 14 weeks. Implications for adaptive programming in drug courts are discussed.

Higher magnitude cash payments improve research follow-up rates without increasing drug use or perceived coercion.

In a prior study [Festinger, D.S., Marlowe, D.B., Croft, J.R., Dugosh, K.L., Mastro, N.K., Lee, P.A., DeMatteo, D.S., Patapis, N.S., 2005. Do research payments precipitate drug use or coerce participation? Drug Alcohol Depend. 78 (3) 275-281] we found that neither the mode (cash vs. gift card) nor magnitude ($10, $40, or $70) of research follow-up payments increased rates of new drug use or perceptions of coercion. However, higher payments and payments in cash were associated with better follow-up attendance, reduced tracking efforts, and improved participant satisfaction with the study. The present study extended those findings to higher payment magnitudes. Participants from an urban outpatient substance abuse treatment program were randomly assigned to receive $70, $100, $130, or $160 in either cash or a gift card for completing a follow-up assessment at 6 months post-admission (n congruent with 50 per cell). Apart from the payment incentives, all participants received a standardized, minimal platform of follow-up efforts. Findings revealed that neither the magnitude nor mode of payment had a significant effect on new drug use or perceived coercion. Consistent with our previous findings, higher payments and cash payments resulted in significantly higher follow-up rates and fewer tracking calls. In addition participants receiving cash vs. gift cards were more likely to use their payments for essential, non-luxury purchases. Follow-up rates for participants receiving cash payments of $100, $130, and $160 approached or exceeded the FDA required minimum of 70% for studies to be considered in evaluations of new medications. This suggests that the use of higher magnitude payments and cash payments may be effective strategies for obtaining more representative follow-up samples without increasing new drug use or perceptions of coercion.

An effectiveness trial of contingency management in a felony preadjudication drug court.

This study evaluated a contingency management (CM) program in a drug court. Gift certificates for compliance were delivered at 4- to 6-week intervals (total value = $390.00). Participants in one condition earned gift certificates that escalated by $5.00 increments. Participants in a second condition began earning higher magnitude gift certificates, and the density of reinforcement was gradually decreased. No main effects of CM were detected, which appears to be attributable to a ceiling effect from the intensive contingencies already delivered in the drug court and the low density of reinforcement. Preplanned interaction analyses suggested that participants with more serious criminal backgrounds might have performed better in the CM conditions. This suggests that CM programs may be best suited for more incorrigible drug offenders.

Adaptive Interventions in Drug Court: A Pilot Experiment.

This pilot study (N = 30) experimentally examined the effects of an adaptive intervention in an adult misdemeanor drug court. The adaptive algorithm adjusted the frequency of judicial status hearings and clinical case-management sessions according to pre-specified criteria in response to participants' ongoing performance in the program. Results revealed the adaptive algorithm was acceptable to both clients and staff, feasible to implement with greater than 85% fidelity, and showed promise for eliciting clinically meaningful improvements in drug abstinence and graduation rates. Estimated effect sizes ranged from 0.40 to 0.60 across various dependent measures. Compared to drug court as-usual, participants in the adaptive condition were more likely to receive responses from the drug court team for inadequate performance in the program and received those responses after a substantially shorter period of time. This suggests the adaptive algorithm may have more readily focused the drug court team's attention on poorly-performing individuals, thus allowing the team to "nip problems in the bud" before they developed too fully. These preliminary data justify additional research evaluating the effects of the adaptive algorithm in a fully powered experimental trial.