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Abstract: The effectiveness of motivational enhancement therapy (MET) in comparison with counseling as usual (CAU) for increasing retention and reducing substance use was evaluated in the National Drug Abuse Treatment Clinical Trials Network protocol CTN-0004, a multisite randomized clinical trial. Participants were 461 outpatients treated by 31 therapists within 1 of 5 outpatient substance abuse programs. Contrary to the study hypothesis, MET did not appear to be more effective than CAU for either retention measure or urine drug outcome. However, though both 3-session interventions resulted in reductions in substance use during the 4-week therapy phase, MET resulted in sustained reductions during the subsequent 12 weeks whereas CAU was associated with significant increases in substance use over this follow-up period. MET also resulted in more sustained substance use reductions than CAU among primary alcohol users, but no difference was found for primary drug users. An independent evaluation of session audiotapes indicated that MET and CAU were highly and comparably discriminable across sites. Although the researchers did not directly assess the efficacy of their training model, the results of this study and its companion single-session protocol (Carroll et al, 2006) indicated that community-based therapists can learn to deliver MET effectively even in the absence of a priori allegiance, interest, or training in the model. Future analyses will evaluate the relationship between therapist experience, skill, adherence, and treatment outcomes.

Abstract:

High levels of missing outcome data for biologically confirmed substance use (BCSU) threaten the validity of substance use disorder (SUD) clinical trials. Underlying attributes of clinical trials could explain BCSU missingness and identify targets for improved trial design.

We reviewed 21 clinical trials funded by the NIDA National Drug Abuse Treatment Clinical Trials Network (CTN) and published from 2005 to 2018 that examined pharmacologic and psychosocial interventions for SUD. We used configurational analysis-a Boolean algebra approach that identifies an attribute or combination of attributes predictive of an outcome-to identify trial design features and participant characteristics associated with high levels of BCSU missingness. Associations were identified by configuration complexity, consistency, coverage, and robustness. We limited results using a consistency threshold of 0.75 and summarized model fit using the product of consistency and coverage.

For trial design features, the final solution consisted of two pathways: psychosocial treatment as a trial intervention OR larger trial arm size (complexity=2, consistency=0.79, coverage=0.93, robustness score=0.71). For participant characteristics, the final solution consisted of two pathways: interventions targeting individuals with poly- or nonspecific substance use OR younger age (complexity=2, consistency=0.75, coverage=0.86, robustness score=1.00).

Conclusions: Psychosocial treatments, larger trial arm size, interventions targeting individuals with poly- or nonspecific substance use, and younger age among trial participants were predictive of missing BCSU data in SUD clinical trials. Interventions to mitigate missing data that focus on these attributes may reduce threats to validity and improve utility of SUD clinical trials.

Related protocols: CTN-0002, CTN-0003, CTN-0004, CTN-0006, CTN-0007, CTN-0009. CTN-0013, CTN-0014, CTN-0015, CTN-0017, CTN-0021, CTN-0029, CTN-0030, CTN-0031, CTN-0037, CTN-0044, CTN-0046, CTN-0048, CTN-0051, CTN-0053

Abstract:

The extent to which behavioral drug abuse treatments affect sexual risk behaviors is largely unknown. This study examined the impact of behavioral drug abuse treatments on sexual risk behaviors using an integrative data analysis approach across eight trials conducted within the NIDA Clinical Trials Network (CTN-0004, 0005, 0006, 0007, 0009, 0013, 0015, and 0021). Participants (N=1305) from eight randomized controlled trials who were sexually active at baseline were included in the pooled dataset; 48.7% were female, 64.1% self-identified as a racial/ethnic minority, with M (SD) age of 34.9 (9.6). Longitudinal logistic regression estimated the probability of risky sexual behavior (i.e., inconsistent condom use and/or > 1 sexual partner in past 30 days) post-intervention with an indicator variable (1 for post-intervention), study condition (control, intervention), and their interaction as predictors; the analysis employed random effects for each trial and included relevant control variables. Time-varying differences in effects based on weeks post-intervention were incorporated using interacted linear and quadratic terms with condition status. Approximately 84.2% reported risky sexual behaviors at baseline. The control and intervention conditions were 18.5 and 17.3 percentage points less likely to report risky sexual behavior post-intervention, respectively.

Conclusions: Results suggest decreasing rates of risky sex engagement until 8 weeks (control) or 9 weeks (intervention post-intervention; risky sexual behavior subsequently increased. Behavioral CTN trial participation was associated with decreased sexual risk behaviors in both the intervention and control trial conditions. Given the heterogeneity of treatment approaches employed across the 8 CTN trials, these results point to the effectiveness of behavioral drug abuse treatment to reduce sexual risk behaviors. To bolster further reductions in sexual risk behavior engagement, there is a need to identify HIV risk reduction interventions that can best be integrated within existing resource-limited substance use disorder treatment programs.

Related protocols: CTN-0004, CTN-0005, CTN-0006, CTN-0007, CTN-0009, CTN-0013, CTN-0015, CTN-0021

Abstract:

African Americans are less likely than other racial groups to engage in and complete outpatient substance abuse treatment. This secondary analysis of CTN-0004 examined whether Readiness to Change (RTC) over time influences retention and whether gender moderates the relationship between changes in RTC and retention among 194 African American women and men.

Participants completed the University of Rhode Island Change Assessment at baseline and at the end of the 16-week study. Positive increases in RTC from baseline to week 16 were associated with higher retention rates among African American substance users. This finding is consistent with the stage-of-change model suggesting that the emergence of positive behaviors may be associated with an increasing motivation (i.e., readiness) to change maladaptive behaviors. While previous research supports the stage-of-change model by demonstrating a link between initial readiness to change and retention, these findings further contribute to the model by providing convincing evidence that an increase in readiness to change is also associated with treatment retention.

The study also suggests that change in RTC is another factor that differentially influences retention for African American women and men. Nevertheless, additional research is needed to examine why change in RTC is more strongly associated with retention among African American men.

Conclusions: Consideration of changes in RTC during treatment may help to improve retention among African American substance users, especially men, and will contribute to the reduction of racial/ethnic health disparities found in rates of substance abuse treatment completion.

Related protocols: CTN-0004

Abstract:

It is reasonable to consider family discord after treatment as a potential target for a next-step intervention, since family discord is often comorbid with substance use disorders. This study evaluated family discord after completing an initial course of treatment as a predictor of substance use and retention in the community treatment program during follow-up. Patients were from two multisite randomized clinical trials implemented through the NIDA Clinical Trials Network (CTN-0004 and CTN-0005). There were 315 participants from Study 1 (12-week posttreatment follow-up) and 295 participants from Study 2 (8-week posttreatment follow-up). Negative binomial and logistic regression were used to estimate days of substance use and odds of retention in the community treatment program at follow-up, respectively, from family discord status.

Results found that participants experiencing family discord reported significantly more days of substance use during the posttreatment follow-up period than those who did not experience family discord in both Study 1 (9.12 vs. 2.89 days, p=.0001) and Study 2 (5.58 vs. 2.83 days, p=.0062). Family discord was significantly associated with lower retention in the community treatment program at follow-up in Study 1 (47.6% vs. 60.6%; p=.03), but not in Study 2 (55.3% vs. 64.9%; p=.11).

Conclusions: Family discord after an initial course of treatment might be a clinically relevant predictor of substance use. There is mixed support for a conclusion that family discord is associated with lower retention in the community treatment program at follow-up. Family discord warrants assessment after an initial course of treatment and may be a useful target for adaptive treatment intervention.

Related protocols: CTN-0004, CTN-0005

Abstract:

In order to determine if expectations at pre-treatment are associated with substance use treatment outcomes, this study examined treatment expectations in two National Drug Abuse Treatment Clinical Trials Network (CTN) randomized controlled trials (RCTs) utilizing Motivational Enhancement Therapy (MET) for the treatment of substance use (CTN-0004 and CTN-0021). One RCT was delivered in English (MET-E) and one was delivered in Spanish (MET-S). There were 461 participants MET-E sample and 405 participants MET-S. Participants responded to the following item at pre-treatment: “Do you think you will reduce or stop your use of drugs or alcohol as a result of this treatment?” ANOVAs and chisquare tests were used to examine the relationship between treatment expectations and treatment outcomes in the two samples.

Treatment expectations were not associated with any of the treatment outcomes in MET-E. However, in MET-S, expectations were significantly associated with most of the post-treatment outcomes. Among these, treatment expectations were significantly associated with the percentage of drug positive urines within the treatment period, F (1, 1,163) = 18.83, p = .000, and the percentage of days abstinent from primary drug use while in treatment and through follow-up, F (1, 1,364) = 23.78, p = .000.

Conclusions: There are several possible interpretations to the divergent findings between samples. The first is that the MET-S sample had fewer previous treatments, and that when a treatment is novel, expectations may have more of an influence. The second interpretation is that there may be cultural components that may affect how an individual relates to the treatment process. These findings are preliminary and future research should examine treatment expectations across cultures.

Related protocols: CTN-0004, CTN-0021

Abstract:

Despite previous reports of biased Short Inventory of Problems (SIP) items across racial groups of men who have sex with men, the assumption of measurement invariance has not yet been tested across African-American and non-Latino White outpatient groups for the SIP-R. This study investigated measurement invariance properties of the Short Inventory of Problems-Revised (SIP-R) across racial groups. The sample included 195 African-American and 194 non-Latino White adult participants in a clinical trial investigating the effectiveness of motivational enhancement therapy in the National Institute on Drug Abuse Clinical Trials Network (CTN-0004).

The SIP-R demonstrated configural invariance and weak metric invariance between racial groups, suggesting conceptualizations of adverse consequences of substance use are equivalent across racial groups. However, the SIP-R also indicated partial strong/scalar and strict metric invariance; that is, four of the five constructs suggested differences in the normative levels of the items across racial groups.

Conclusions: This study is the first to report measurement equivalence properties of the SIP-R across racial groups. This study contributes to the growing literature on how substance abuse treatment researchers can ensure unbiased assessment when studying treatment outcomes across racial/ethnic minority groups. Since MI and MET techniques have become standard social work practice in substance abuse treatment settings, the SIP-R is expected to continue to be one of the most prominent outcome measures in practices involving motivational techniques. The current findings encourage the valid use of the SIP-R with samples of African-American and non-Latino White adult outpatients to validly examine treatment outcomes and test potential differential effectiveness of treatments across racial groups.

Related protocols: CTN-0004

Abstract:

In randomized controlled trials (RCTs), the most compelling need is to determine whether the treatment condition was more effective than the control. However, it is generally recognized that not all participants in the treatment group of most clinical trials benefit equally. While subgroup analyses are often used to compare treatment effectiveness across pre-determined subgroups categorized by patient characteristics, methods to empirically identify naturally occurring clusters of persons who benefit most from the treatment group have rarely been implemented. This article provides a modeling framework to accomplish this important task.

Utilizing information about individuals from the treatment group who had poor outcomes, the present study proposes an a priori clustering strategy that classifies the individuals with initially good outcomes in the treatment group into: (a) group GE (good outcome, effective), the latent subgroup of individuals for whom the treatment is likely to be effective and (b) group GI (good outcome, ineffective), the latent subgroup of individuals for whom the treatment is not likely to be effective. The method is illustrated through a reanalysis of a publicly available data set from the National Institute on Drug Abuse’s National Drug Abuse Treatment Clinical Trials Network (protocol CTN-0004). That study examined the effectiveness of motivational enhancement therapy from 461 outpatients with substance use disorder problems. As a diagnostic means utilizing out-of-sample forecasting performance, the present study compared the relapse rates during the long-term follow-up period for the two subgroups. As expected, group GI, composed of individuals for whom the treatment was hypothesized to be ineffective, had a significantly higher relapse rate than group GE (63% vs. 27%).

Conclusions: The proposed method, LGEM, identified latent subgroups GE and GI, and the comparison between the two groups revealed several significantly different and informative characteristics even though both subgroups had good outcomes during the immediate post-therapy period. LGEM has potential as a means of further exploring reasons why individuals respond to treatment conditions, regardless of which treatment arm they are exposed to, and can be implemented after the trial is completed, without need for a pre-specified design and can be used by any type of RCT in a variety of topic areas.

Related protocols: CTN-0004

Abstract:

Although a body of literature supports the effectiveness of Motivational Enhancement Therapy (MET) in reducing substance use for the general population, several studies report inconsistent findings, especially among African Americans (AA). In the National Drug Abuse Treatment Clinical Trials Network’s study on MET, CTN-0004, no overall difference was found between MET and counseling as usual. Among AA overall, MET showed significantly more days of primary substance use than CAU; however, this pattern was reversed among those with high baseline readiness to change (RTC). This ancillary investigation of CTN-0004 hypothesized a mediator relationship in AA patients, such that (1) MET would positively influence RTC over time and (2) increased RTC would be correlated with successful treatment outcomes. Secondary analyses of 194 African Americans in CTN-0004 were performed, assessing at baseline, 4, 8, and 16 weeks by the University of Rhode Island Change Assessment (URICA), based on precontemplation, contemplation, preparation, and action. The primary outcome assessed was the total number of days using the primary substance during the 16 week period.

Over the 16 week period, average total RTC score declined slightly, with no significant difference observed between MET and CAU treatment groups. Overall, the MET group reported 6.6 days of primary substance use vs. 3.1 days in the CAU group (p=0.08). An inconsistent role for RTC as a mediator was observed, with RTC change from baseline to 8 weeks significantly associated with substance use in the MET arm, but RTC change to other timepoints not significant. The MET treatment effect was similar in models with and without controlling for baseline RTC and RTC change over time.

Conclusions: These results provide limited evidence for readiness to change as a mediator of Motivational Enhancement Therapy effect in African American patients. It is possible that RTC plays a larger role in maintenance of abstinence at the beginning of treatment.

Related protocols: CTN-0004

Abstract:

Few studies examine the helpfulness and effectiveness of substance abuse treatment from the clients’ perspective. This secondary analysis of data from National Drug Abuse Treatment Clinical Trials Network protocol CTN-0004, a multisite, randomized clinical trial of Motivational Enhancement Therapy, examined the perceived helpfulness of substance abuse treatment components and its relationship to treatment outcomes among 387 black and white adult participants. Throughout the 16-week trial, participants self-reported substance use. Upon completion of treatment, they completed a self-report measure assessing the perceived helpfulness of treatment components. Black participants rated 9 out of 12 treatment components (e.g., “learning skills that will help me cope with my problems”) as being more helpful than their white counterparts, even after controlling for age, gender, employment status, primary drug type, and treatment assignment. However, perceived helpfulness ratings were not associated with substance use outcomes among black or white participants.

Conclusions: Overall, findings suggest that black adults perceive treatments that focus on teaching new coping skills and information about the intersection between drug use and interpersonal relationship to be more helpful than their white counterparts. Despite the fact this study did not find an association between ratings of helpfulness and decreased primary or other drug use during treatment for black or white participants, race does appear to be an important demographic characteristic to consider in substance abuse treatment preferences.

Related protocols: CTN-0004

Abstract:

Use of psychosocial measures with different conceptual meanings across cultural groups may render treatment outcome analyses invalid in social work research. Determining measurement invariance allows researchers to assess whether the construct of a measure is similarly comprehended and measured across participant groups (e.g., based on race, ethnicity, gender, age, etc.). Nonequivalence is introduced when groups of participants experience or conceptualize a construct differently, or use distinctive criteria to describe the concept. Measurement nonequivalence across cultural groups is posited to occur due to (a) cultural differences in norms and relevance of the constructs being assessed; (b) language of assessment; or (c) potential differences in participants’ environments and opportunity structures to engage in certain behaviors or develop beliefs due to contextual differences, racism, or other forms of discrimination.

To illustrate this statistical procedure, this poster presents measurement invariance properties across racial groups for two commonly used instruments in social work and substance abuse treatment research (the Revised Helping Alliance Questionnaire (HAq-II) and the Short Inventory of Problems (SIP-R)), using data from the National Drug Abuse Treatment Clinical Trials Network protocol CTN-0004 (“Motivational Enhancement Treatment to Improve Treatment Engagement and Outcome in Subjects Seeking Treatment for Substance Abuse”). Analysis shows that use of measures with different conceptual meaning across racial and ethnic groups may render invalid analyses comparing such groups. Conclusions drawn from invalid findings can lead to ineffective treatments and policy initiatives.

Conclusions: Findings support the comparable understanding of therapeutic alliance and consequences of substance as measured by the HAq-II and SIP-R in African American and non-Latino white participants. Difference in reliability caused by the identified items needs verification in future studies to ensure use of reliable HAq-II and SIP-R latent factors.

Related protocols: CTN-0004

Abstract:

Analyses of the effectiveness of substance abuse treatments across racial/ethnic groups should ensure that outcome measures have the same conceptual meaning (i.e., measurement equivalence) across groups. Because racial groups differ in perceptions and experiences of the therapeutic alliance, this study investigated measurement equivalence properties of the Revised Helping Alliance Questionnaire (HAq-II) across racial groups. The sample included 138 African Americans and 133 non-Latino White participants, age 18-64 years, who participated in a randomized clinical trial investigating the effectiveness of Motivational Enhancement Therapy in the National Drug Abuse Treatment Clinical Trials Network (CTN-0004). Results demonstrated configural invariance and two forms of metric invariance (weak and strong/scalar), suggesting that conceptualizations of therapeutic alliance and overall levels of endorsement of therapeutic alliance were comparable across racial groups. The groups indicated partial, strict metric nonequivalence. No studies to date reported measurement equivalence properties of the HAq-II.

Conclusions: Findings support valid measurement and interpretation of HAq-II outcomes. This secondary analysis study contributes to the growing literature on how substance abuse treatment researchers can ensure unbiased assessment when studying treatment outcomes across racial/ethnic minority groups.

Related protocols: CTN-0004

Abstract:

The development of effective treatments for African Americans and other ethnic minorities is essential for reducing health disparities in substance use. Despite research suggesting that Motivational Enhancement Therapy (MET) may reduce substance use among African Americans, the findings have been inconsistent. This research examined the extent to which readiness-to-change (RTC) affects response to MET among African American substance users. The study was a secondary analysis of the 194 African American substance users participating in National Drug Abuse Treatment Clinical Trials Network (CTN) protocol CTN-0004, a multisite randomized clinical trial evaluating MET. The participants were randomly assigned to receive either three sessions of MET or Counseling-As-Usual (CAU) followed by the ordinary treatment and other services offered at the five participating outpatient programs. Participants were categorized as either high or lower on RTC based on their scores on the University of Rhode Island Change Assessment (URICA). The participants reported their substance use at baseline and throughout the 16 weeks after randomization. Among the high RTC participants, those in MET tended to report fewer days of substance use per week over time than participants in CAU. However, among the lower RTC participants, the CAU group tended to report fewer days of substance use over time than MET participants.

Conclusions: In contrast to previous thinking, the findings suggest that MET may be more effective for high than lower RTC African American participants. This study contributes to the public health need for more empirical evidence on effective substance abuse treatments for African Americans.

Related protocols: CTN-0004

Abstract:

HIV infection disproportionately impacts minorities, yet research on racial/ethnic differences in the prevalence and correlates of HIV risk behaviors is limited. This study examined racial/ethnic differences in the rates of HIV risk behaviors and whether the relationship between HIV risk factors and HIV risk behaviors varies by race/ethnicity in clients participating in National Drug Abuse Treatment Clinical Trial Network (CTN) trials. The sample was 41% non-Hispanic White, 32% non-Hispanic Black, and 27% Hispanic (N = 2,063). HIV risk behaviors and measures of substance and psychosocial HIV risk factors in the past month were obtained. Non-Hispanic Blacks engaged in less HIV sexual risk behaviors overall than non-Hispanic Whites. While non-Hispanic Whites were the most likely to report any injection drug use, Hispanics engaged in the most HIV drug risk behaviors. Specific risk factors were differentially predictive of HIV risk behavior by race/ethnicity. Alcohol use severity was related to engaging in higher sex risk behaviors for non-Hispanic Blacks and Whites. Greater psychiatric severity was related to engaging in higher sex risk behaviors for non-Hispanic Whites. Drug use severity was associated with engaging in higher risk drug behaviors for non-Hispanic Whites and Hispanics, with the magnitude of the relationship stronger for Hispanics.

Conclusions: The findings from the present study suggest that there is a context in which HIV high risk behaviors occur within racial/ethnic groups as well as differences in the presence of risk factors associated with engaging in those behaviors. These findings are consistent with calls to culturally adapt evidence-based interventions and the need to maintain core elements of the intervention when adapting the intervention for increased relevance to the new targets. Further research testing HIV risk prevention interventions within racial/ethnic groups is needed to identify target behaviors or risk factors that are salient to inform HIV interventions.

Related protocols: CTN-0001, CTN-0002, CTN-0004, CTN-0005, CTN-0006, CTN-0007, CTN-0021

Abstract:

This poster provides an overview of four CTN secondary studies that examined treatment outcomes for clients of racial/ethnic minorities. Three of the studies focused on Motivational Enhancement Therapy (CTN-0004) and African Americans, finding that African American males receiving MET reported using more drugs than those receiving usual care, while African American females in MET had higher retention in MET. The studies also found that treatment readiness had an impact on whether or not MET was effective for African Americans, with those with higher readiness responding well to MET, and those with lower readiness responding better to treatment as usual. Another study profiled examined Hispanic national group differences in substance use and treatment outcomes, analyzing data from the CTN MET trial again, but this time looking specifically at different Hispanic ethnic groups: Mexican Americans, Puerto Ricans, Cuban Americans, and other Hispanic Americans. This study found all groups had similar substance use outcomes, but Puerto Ricans and particularly Cuban Americans had lower treatment retention. The final study profile looked at racial/ethnic match and treatment outcomes for women with PTSD and substance use disorders (as part of CTN-0015). That paper found that women who were light substance users and who were racially/ethnically matched with their group therapist were less likely to use substances heavily at follow-up than those who were mismatched racially/ethnically with their therapists.

Related protocols: CTN-0004, CTN-0015