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Abstract: Emerging adults (roughly 18-29 years) with substance use disorders can benefit from participation in twelve-step mutual-help organizations (TSMHO), however, their attendance and participation in such groups is relatively low. Twelve-step facilitation therapies, such as the Stimulant Abuser Groups to Engage in 12-Step (STAGE-12), may increase attendance and involvement, and lead to decreased substance use. This study used data from the NIDA Clinical Trials Network STAGE-12 protocol (CTN-0031), a multisite randomized controlled trial, to examine whether age moderated the STAGE-12 effects on substance use and TSMHO meeting attendance and participation, The original STAGE-12 study involved assessments at baseline, mid-treatment (week 4), end-of-treatment (week 8), and 3- and 6-months post-randomization; participants were adults with DSM-IV diagnosed stimulant abuse or dependence (N=450) enrolling in 10 intensive outpatient substance use treatment programs across the U.S. A zero-inflated negative binomial random-effects regression model was utilized to examine age-by-treatment interactions on substance use and meeting attendance and involvement. Analyses found that younger age was associated with larger treatment effects for stimulant use. Specifically, younger age was associated with greater odds of remaining abstinent from stimulants in STAGE-12 versus Treatment-as-Usual; however, among those who were not abstinent during treatment, younger age was related to greater rates of stimulant use at follow-up for those in STAGE-12 compared to TAU. There was no main effect of age on stimulant use. Younger age was also related to somewhat greater active involvement in different types of TSMHO activities among those in STAGE-12 versus TAU. There were no age-by-treatment interactions for other types of substance use or for treatment attendance, however, in contrast to stimulant use; younger age was associated with lower odds of abstinence from non-stimulant drugs at follow-up, regardless of treatment condition. Conclusions: These results suggest that STAGE-12 can be beneficial for some emerging adults with stimulant use disorder, and ongoing assessment of continued use is of particular importance. More targeted research addressing the differences between younger and older adults and their unique responses to treatment is needed, so that developmental variations can be considered in the provision of substance abuse treatment. Age-appropriate treatment could have considerable effects on clinical outcomes and public health. Related protocols: CTN-0031

Abstract:

Engagement in 12-step meetings and activities has been shown to be a powerful aid to recovery from substance use disorders. However, only limited attention has been given to ethnic and racial differences in attitudes toward 12-step and involvement. This study utilized data from CTN-0031, “Stimulant Abuser Groups to Engage in 12-Step (STAGE-12),” a large multisite trial testing the effectiveness of a 12-step facilitation therapy (Twelve-Step Facilitation (TSF)) with stimulant-dependent treatment seekers. It compared baseline differences and treatment outcomes between African American and Caucasian participants. Results of the analysis found select few baseline differences (i.e., African Americans reported higher levels of spirituality than Caucasians; African American participants indicated more perceived benefits of 12-step involvement; Caucasians were more likely to endorse future involvement in 12-step). However, there were no outcome differences (e.g., substance use outcomes, 12-step meeting attendance).

Conclusions: The tested intervention, TSF, produced similar outcomes for both groups, indicating that it may be useful across racial categories. This finding is promising, given that much of the previous research on TSF treatments has focused on alcohol, and stimulant use may present unique problem profiles for African American and Caucasian individuals. That TSF performed equally well among the two study groups is important information for clinicians deciding which evidence-based practice might be best applied to a particular client.

Related protocols: CTN-0031

Abstract:

Few studies have examined the effectiveness of 12-step peer recovery support programs with drug use disorders, especially stimulant use, and it is difficult to know how outcomes related to 12-step attendance and participation generalize to individuals with non-alcohol substance use disorders (SUDs). The NIDA Clinical Trials Network study, STAGE-12, was a clinical trial of 12-step facilitation (N=471) focusing on individuals with cocaine or methamphetamine use disorders. It allowed for examination of four questions:

1. To what extent do treatment-seeking stimulant users use 12-step programs and which ones?
2. Do factors previously found to predict 12-step participation among those with alcohol use disorders also predict participation among stimulant users?
3. What specific baseline “12-step readiness” factors predict subsequent 12-step participation and attendance?
4. Does stimulant drug of choice differentially predict 12-step participation and attendance?

The four outcome variables, attendance, speaking, duties and 12-step meetings, and other peer recovery support activities, were not related to baseline demographic or substance problem history or severity. Drug of choice was associated with differential days of Alcoholics Anonymous (AA) and Narcotics Anonymous (NA) attendance among those who reported attending, and cocaine users reported more days of attending AA or NA at 1-, 3-, and 6-month follow-ups than did methamphetamine users. Pre-randomization measures of perceived benefit of 12-step groups predicted 12-step attendance at 3- and 6-month follow-ups. Pre-randomization 12-step attendance significantly predicted number of other self-help activities at end-of-treatment, 3- and 6-month follow-ups. Pre-randomization perceived benefit and problem severity both predicted number of self-help activities at end-of-treatment self-help activities at end-of-treatment and 3-month follow-up/ Pre-randomization perceived barriers to 12-step groups were negatively associated with self-help activities at end-of-treatment and 3-month follow-up. Whether or not one participated in any duties was predicted at all times points by pre-randomization in self-help activities.

Conclusions: The primary finding of this study is one of continuity: both readiness to engage in 12-step content and specific prior attendance and active participation (defined as speaking, having duties at, or engaging in related activities) with 12-step programs were the main signs pointing to future involvement in these same areas. Based on these findings, there may be little value in continuing to explore demographic characteristics as predictors of 12-step involvement, and instead future research should focus on measures of perceptions and behaviors that are 12-step specific.

Related protocols: CTN-0031

Abstract:

The field of substance use disorder (SUD) treatment suffers from a “modality mismatch,” in which researchers primarily examine individual therapies even while real-world psychosocial clinicians primarily facilitate groups (especially open groups).

Although understandable reasons exist for this state of affairs, group therapy is not diminishing anytime soon; moreover, clinicians may be ill-equipped at using evidence-based treatments (EBTs) in group format, given limited training along with non-trivial structural differences between modalities.

This one-hour webinar included a review of SUD group therapy research and clinical resources (including two CTN studies), with a focus on facilitators and barriers for using EBTs in group format.

Presenter Dennis C. Wendt, PhD, is a postdoctoral research fellow with the Department of Psychiatry and Behavioral Sciences at the UW School of Medicine.

Additional Resources:

• Download slides (pdf)
• Download handout (pdf)

Abstract:

This study examined associations of therapeutic alliance and treatment delivery fidelity with treatment retention in Stimulant Abusers to Engage in Twelve-Step (STAGE-12), a community-based trial of 12-Step Facilitation (TSF) conducted within the National Drug Abuse Treatment Clinical Trials Network (CTN). The STAGE-12 trial randomized 234 stimulant abusers enrolled in 10 outpatient drug treatment programs to an eight-session, group and individual TSF intervention. During the study, TSF participants rated therapeutic alliance using the Helping Alliance questionnaire-II (HAq-II). After the study, independent raters evaluated treatment delivery fidelity of all TSF sessions on adherence, competence, and therapist empathy. Poisson regression modeling examined relationships of treatment delivery fidelity and therapeutic alliance with treatment retention (measured by number of sessions attended) for 174 participants with complete fidelity and alliance data. Therapeutic alliance (p=.005) and therapist competence (p=.010) were significantly associated with better treatment retention. Therapist adherence was associated with poorer retention in a nonsignificant trend (p=.061).

Conclusions: Stronger therapeutic alliance and higher therapist competence in the delivery of TSF intervention were associated with better treatment retention whereas treatment adherence was not. Training and fidelity monitoring of TSF should focus on general therapist skills and therapeutic alliance development to maximize treatment retention. This is the first study to show a relationship between therapeutic alliance and retention in TSF with substance abusers, and to identify a significant fidelity-retention relationship for manual-guided TSF treatment, a finding that has important implications for treatment delivery.

Related protocols: CTN-0031

Abstract:

This ancillary investigation of data from National Drug Abuse Treatment Clinical Trials Network protocol CTN-0031 (“Stimulant Abuser Groups to Engage in 12-Step (STAGE-12)”), examined whether level of exposure to the STAGE-12 intervention, a 12-step facilitative therapy, is related to treatment outcome. The original study compared STAGE-12 combined with treatment-as-usual (TAU) to TAU alone. These analyses include only those randomized to STAGE-12 (n=234). Assessments occurred at baseline and 30, 60, 90, and 180 days following randomization. High-exposure patients (n=158; attended at least 2 of 3 individual and 3 of 5 group sessions), compared to those with less exposure (n=76), demonstrated: (1) higher odds of self-reported abstinence from, and lower rates of, stimulant and non-stimulant drug use; (2) lower probabilities of stimulant-positive urines; (3) more days of attending and lower odds of not attending 12-Step meetings; (4) greater likelihood of reporting no drug problems; (5) more days of duties at meetings; and (6) more types of 12-Step activities. Many of these differences declined over time, but several were still significant by the last follow-up.

Conclusions: Although outpatient substance use disorder treatment is thought to be characterized by high drop-out rates and low rates of treatment completion, exposure to STAGE-12 treatment was relatively high for this 8-session intervention embedded within intensive outpatient treatment as usual. Over two-thirds of patients met criteria for high exposure to the intervention, and there was relatively low early attrition. Those achieving high exposure to STAGE-12 demonstrated more positive outcomes, though the design of this secondary analysis cannot demonstrate a causal relationship between STAGE-12 exposure and positive outcomes. However, the current study demonstrates that it is feasible to interest people entering intensive outpatient treatment in a 12-Step oriented intervention and that individuals who agree to participate can be retained in the intervention at relatively high rates.

Related protocols: CTN-0031

Abstract:

This ancillary investigation of data from National Drug Abuse Treatment Clinical Trials Network protocol CTN-0031 (“Stimulant Abuser Groups to Engage in 12-Step (STAGE 12)”) investigated the correspondence among four groups of raters on adherence to STAGE-12, a manualized 12-step facilitation (TSF) group and individual treatment targeting stimulant abuse. The four rater groups included the study therapists, supervisors, study-related (“TSF expert”) raters, and non-project-related (“external”) raters. Results indicated that external raters rated most critically Mean Adherence — the mean of all the adherence items — and global performance. External raters also demonstrated the highest degree of reliability with the designated expert. Therapists rated their own adherence lower, on average, than did supervisors and TSF expert raters, but therapist ratings also had the poorest reliability.

Conclusions: Findings highlight the challenges in developing practical, but effective methods of fidelity monitoring for evidence-based practice in clinical settings. While funding and licensing agencies increasingly call for use of evidence-based treatments, community-based organizations implementing them will seek the simplest, most reliable and cost-effective ways of monitoring their delivery. These results suggest that there may be a role for on-site therapists or supervisors rating adherence, and that raters unaffiliated with the treatment being tested may provide the most objective ratings. Future research should examine the impact of training therapists on self-rating to determine whether this group and achieve acceptable reliability and objectivity in ratings.

Related protocols: CTN-0031

Abstract:

This study examined the relationships between treatment fidelity and treatment outcomes in a community-based trial of 12-Step Facilitation (TSF) intervention. In a prior multi-site randomized clinical trial, National Drug Abuse Treatment Clinical Trials Network protocol CTN-0031, 234 participants in 10 outpatient drug treatment clinics were assigned to receive the Stimulant Abuser Groups to Engage in 12-Step (STAGE-12) intervention. This secondary analysis reviewed and coded all STAGE-12 sessions for fidelity to the protocol, using the Twelve Step Facilitation Adherence Competence Empathy Scale (TSF-ACES). Linear mixed-effects models tested the relationship between three fidelity measures (adherence, competence, empathy) and six treatment outcomes (number of days of drug use and five Addiction Severity Index (ASI) composite scores) measured at 3 months post-baseline. Adherence, competence, and empathy were robustly associated with improved employment status at follow up. Empathy was inversely associated with drug use, as was competence in a non-significant trend (p=.06). Testing individual ASI drug composite score items suggested that greater competence was associated with fewer days of drug use and, at the same time, with an increased sense of being trouble or bothered by drug use.

Conclusions: Greater competence and empathy in the delivery of a TSF intervention were associated with better drug use and employment outcomes, while adherence was associated with employment outcomes only. Higher therapist competence was associated with lower self-report drug use, and also associated with greater self-report concern about drug use. The nature of TSF intervention may promote high levels of concern about drug use even when actual use is low. This study is suggestive, but not conclusive, that higher fidelity intervention is associated with improved treatment outcome.

Related protocols: CTN-0031, CTN-0031-A-3

Abstract:

Persons addicted to alcohol and drugs are at 5-10 times higher risk for suicide as compared to the general population. To address the need for improved suicide prevention strategies in this population, the Preventing Addiction Related Suicide (PARS) module was developed. Pilot testing of 78 patients from agencies participating the Pacific Northwest Node of the National Drug Abuse Treatment Clinical Trials Network (CTN), all of which offered standard, group-based intensive outpatient program addiction treatment, demonstrated significant post-treatment changes in knowledge and attitudes toward suicide prevention issues. Significant gains were maintained at 1-month follow-up for changes in knowledge, with changes in positive help seeking behaviors in dealing with suicidal issues in friends, family, and self also observed. The PARS was also highly rated by treatment staff as feasible within their standard clinical practice.

Conclusions: In conclusion, the pilot study of the PARS strongly suggests that broad based suicide prevention in intensive outpatient addiction treatment groups is not only possible but feasible, acceptable, and possibly effective. The pilot data presented here are promising and suggest that futher development and testing of the PARS program or other suicide prevention strategies in addiction treatment settings are indicated.

Abstract:

This is the primary outcomes paper for CTN-0031.

This study, National Drug Abuse Treatment Clinical Trials Network protocol CTN-0031, evaluated the effectiveness of an 8-week combined group plus individual 12-step facilitative intervention on stimulant drug use and 12-step meeting attendance and service. Using a multisite randomized controlled trial, with assessments at baseline, mid-treatment, end of treatment, and 3- and 6-month post-randomization follow-ups (FUs), individuals with stimulant use disorders (n=471) were randomly assigned to treatment as usual (TAU) or TAU into which the Stimulant Abuser Groups to Engage in 12-Step (STAGE-12) intervention was integrated. The STAGE-12 intervention used group sessions focused on increasing acceptance of 12-step principles, as well as individual sessions incorporating an intensive referral procedure connecting participants to 12-step volunteers. Compared with TAU, STAGE-12 participants had significantly greater odds of self-reported stimulant abstinence during the active 8-week treatment phase; however, among those who had not achieved abstinence during this period, STAGE-12 participants had more days of use. STAGE-12 participants had lower Addiction Severity Index Drug Composite scores at and a significant reduction from baseline to the 3-month FU, attended 12-step meetings on a greater number of days during the early phase of active treatment, engaged in more other types of 12-step activities throughout the active treatment phase and the entire FU period, and had more days of self-reported service at meetings from mid-treatment through the 6-month FU.

Conclusions: The present findings are mixed with respect to the impact of integrating the STAGE-12 intervention into intensive outpatient drug treatment compared with treatment as usual on stimulant drug use. However, the results more clearly indicate that individuals in STAGE-12 had higher rates of 12-step meeting attendance and were engaged in more related activities throughout both the active treatment phase and the entire 6-month follow-up period than did those in treatment as usual.

Related protocols: CTN-0031

Abstract:

Stimulant use and abuse is a growing problem for which effective treatments are rare. This presentation describes the impact of a combined group/individual Twelve-Facilitation intervention, Stimulant Abuser Groups to Engage in 12-Step (STAGE-12), on the drug use of individuals with stimulant use disorders.

The clinical trial revealed mixed, albeit promising, results. Specifically, STAGE-12 increases the probability of abstinence from stimulants during active treatment. However, if abstinence is not achieved during treatment, then STAGE-12 participants appear to use stimulants at higher rates. STAGE-12 participation is also associated with significantly lower ASI Drug Composite scores at 3-month follow-up and greater changes in this measure from baseline to 3-month follow-up. Furthermore, at different periods during and following the active treatment phase, STAGE-12 is associated with greater number of days of 12-step self-help meeting attendance, greater number of other 12-step activities engaged in, and higher maximum number of days of duties performed at meetings. In addition, when comparing those who completed a threshold amount of the STAGE-12 intervention to those who did not, the completers have: higher odds of abstinence from, and lower rates of, stimulant and non-stimulant drug use; lower probabilities of stimulant positive urines; and greater odds of attending and higher rates (days) of attending 12-step self-help groups, number of types of other activities engaged in during 30 day assessment windows, and maximum number of days of self-reported duties at meetings.

Throughout the trial, the STAGE-12 intervention proved very popular with both staff and clients at the 10 participating sites. In fact, many sites were eager to implement it program-wide even before the follow-up period had been completed. This presentation concludes by discussing the manner in which the STAGE-12 intervention has begun to be implemented and adopted across the study programs and its impact on practice.

Related protocols: CTN-0031

Abstract:

Twelve-step groups represent a readily available, no-cost recovery source, are applicable to a broad range of clients in different settings, and are consistent with many community-based treatment program and counselor treatment philosophies. Though there is a crushing weight of data supporting the potential positive benefits of 12-step involvement, drop out and non-attendance rates continue to be high, despite clinical recommendations to attend. In the National Drug Abuse Treatment Clinical Trials Network study “Stimulant Abuser Groups to Engage in 12-Step (STAGE-12),” a manual was developed based on Twelve-Step Facilitation Therapy and was then used to address two basic study questions: 1) Does STAGE-12 improve stimulant drug use outcomes in stimulant users compared to treatment-as-usual (TAU)? and 2) Does STAGE-12 improve attendance and involvement in 12-step groups compared to TAU? Data from the project, as well as information about the analysis of that data, is presented, along with a discussion of secondary outcome measures on which differences were found between STAGE-12 and TAU. STAGE-12 was found to increase the probability of abstinence from stimulants during and in the last 30 days of the active treatment phase, but if abstinence was NOT achieved during this period, rates of use appeared to be greater among STAGE-12 participants. STAGE-12 was also associated with greater number of days of 12-step meeting attendance, types of other 12-step activities engaged in, and number of days of self-reported service activities at 12-step meetings.

Abstract:

Greater impulsivity as assessed by the Barratt Impulsiveness Scale-11 (BIS-11) and the Stroop has been associated with treatment outcomes in patients with stimulant use disorders. The present study evaluated the relationships among impulsivity, baseline stimulant use status, and treatment outcomes in methamphetamine- and/or cocaine-dependent participants. Six sites participating in protocol CTN-0031 (Stimulant Abuser Groups to Engage in 12-Step (STAGE-12)), a multi-site clinical trial evaluating 12-step facilitation for stimulant abusers, obtained the Stroop and BIS-11 from 183 methamphetamine- and/or cocaine-dependent participants. The relationships of the BIS-11 and Stroop to baseline stimulant use and treatment outcomes through 6-month follow-up were evaluated. Methamphetamine-dependent, relative to cocaine-dependent, participants evidenced greater impulsivity as measured by BIS-11 total score. There was a trend for poorer response inhibition, as measured by the Stroop, in cocaine-dependent, relative to methamphetamine-dependent participants. When accounting for other factors related to treatment completion, the BIS-11 Motor Impulsiveness Score, which assess the tendency to act without thinking, was predictive of treatment completion status. No relationship greater than r=0.2 was observed between impulsivity and stimulant use during either baseline or treatment/follow-up.

Conclusions: BIS-11 Motor Impulsiveness was a significant predictor of treatment retention. Treatment-seeking methamphetamine and cocaine-dependent patients may have different impulsivity profiles.

Abstract:

Important differences may exist between African American and Caucasian substance abusers regarding involvement in and acceptance of 12-step programs. This ancillary investigation of data from protocol CTN-0031 (STAGE-12), examined baseline differences between 171 African American and 224 Caucasian stimulant abusers enrolled in the study, in terms of experiences in and expectations of 12-step groups, understanding of addiction, and spiritual involvement and beliefs. The analysis found that Caucasian participants indicated a greater likelihood to get involved in self-help groups than African American participants, while African Americans scored higher on a scale measuring the perceived benefits of 12-step groups. Caucasian participants reported higher scores on the eclectic subscale reflecting participants’ beliefs about the treatment and etiology of addiction. African American participants had higher scores than Caucasian participants on the Core Spirituality subscale, the Personal Application/Humility subscale and Total SIBS-R measure of spirituality.

Conclusions: Although Caucasian participants reported a higher likelihood of attending 12-step groups, African Americans report more perceived benefit from meeting attendance than Caucasians. Such results indicate encouragement to attend 12-step groups may be appropriate for substance abuse clients of both races. Results also indicate that African Americans may be more open to the spiritual aspects of the 12-step philosophy than Caucasians.

Related protocols: CTN-0031

Abstract:

Twelve step facilitation (TSF) is an emerging, empirically supported treatment, the study of which will be strengthened by rigorous fidelity assessment. This report describes the development, reliability, and concurrent validity of the Twelve Step Facilitation Adherence Competence Empathy Scale (TSF ACES), a comprehensive fidelity rating scale for group and individual TSF treatment developed for the National Drug Abuse Treatment Clinical Trials Network study, “Stimulant Abuser Groups to Engage in 12-Step” (STAGE-12, CTN-0031). Independent raters used TSF ACES to rate treatment delivery fidelity of 966 (97% of total) TSF group and individual sessions. TSF ACES summary measures assessed therapist treatment adherence, competence, proscribed behaviors, empathy, and overall session performance. TSF ACES showed fair to good overall reliability; weighted kappa coefficients for 59 co-rated sessions ranged from .31 to 1.00, with a mean of .69. Reliability ratings for session summary measures were good to excellent (.69–.91). Internal consistency for the instrument was variable (.47–.71). Relationships of the TSF ACES summary measures with each other, as well as relationships of the summary measures with a measure of therapeutic alliance, provided support for concurrent and convergent validity. Fidelity instruments such as the TSF ACES can be used in clinical implementation to train and supervise counselor adherence and skill. Implications and future directions for the use of the measure in clinical trials and community treatment implementation are discussed.

Related protocols: CTN-0031, CTN-0031-A-3