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Abstract: The Clinical Opiate Withdrawal Scale (COWS) is used to assess withdrawal in clinical trials and practice. The aims of this study were to examine the inter-item correlations and factor structure of the COWS in opioid-dependent men and women. This is a secondary data analysis of the National Drug Abuse Treatment Clinical Trials Network study CTN-0003, a randomized clinical trial that compared buprenorphine/naloxone tapering strategies. The trial included 11 sites in 10 US cities. Participants were opioid-dependent individuals (n=516) that had data on the COWS. The COWS at study baseline was analyzed in the study. Inter-item correlations showed weak to moderate relationships between the items. A 1-factor model did not fit the data for men, where resting pulse rate was not related to withdrawal for men, and yawning and gooseflesh skin was not related to withdrawal for women. A reduced model comprised of only the 8 items that were significantly related to the construct of withdrawal in both men and women, and an exploratory 2-factor model, were also assessed but not retained due to inconsistencies across gender. Conclusions: This study failed to find a single model where all items were related to the construct of withdrawal (i.e., statistically significant meaningful factor loadings) for men and women in mild withdrawal. Further research testing the hypothesized factor structure in other opioid-dependent samples, particularly in samples with greater variation in COWS scores and for those in moderate opioid withdrawal, is needed. The COWS was developed to rate severity within each item because that corresponds with clinical severity within the individual on each item; that may not be necessarily the case across items. The composite score simply acknowledges that some individual will show more, or less, withdrawal symptoms within certain physiological systems and may therefore not assess a single construct of withdrawal. Further research testing the hypothesized factor structure in other opioid-dependent samples is needed. Related protocols: CTN-0003

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:

Measurement of pain is important in both clinical and research samples, yet while several tools have been developed to aid in the measurement of pain, no gold standard brief pain assessment is universally utilized. As part of the National Drug Abuse Treatment Clinical Trials Network study CTN-0037, “Stimulant Reduction Intervention Using Dosed Exercise (STRIDE),” a new brief, self-administered measurement of pain frequency, intensity, and burden was developed for potential use in both research and clinical settings. This article describes the development and initial psychometric properties of the instrument, the Pain Frequency, Intensity, and Burden Scale (P-FIBS). The P-FIBS was administered to all participants (N=302) with psychostimulant use disorders enrolled in the multisite STRIDE trial. The four items on the P-FIBS all demonstrated high item-total correlations (range 0.70-0.85) with a high Cronbach’s alpha (0.90). The P-FIBS also demonstrated a strong negative correlation with the bodily pain sub-score of the Short Form Health Survey (r=-0.76, p<0.0001) and did not correlate with a measure of cocaine (r=0.09, p=0.12) or methamphetamine (r=-0.06, p=0.33) craving.

Conclusions: The P-FIBS demonstrates good psychometric properties. This brief measure can be used to assess pain in research settings or as a screen in clinical settings. Further research is needed to assess the measure’s sensitivity to change with treatment.

Related protocols: CTN-0037

Abstract:

Hispanic Americans are substantially underrepresented in clinical and research samples for substance use treatment, with language cited as one of the major barriers to their participation, indicating a need for more validated assessments in Spanish. This study evaluated the psychometric properties of a Spanish version of the Short Inventory of Problems (SIP), used in a multisite, randomized trial conducted for Spanish-speaking substance users, National Drug Abuse Treatment Clinical Trials Network protocol CTN-0021. The sample included 405 Spanish-speaking treatment seekers, mostly male (88%) and legally mandated to treatment (71%). The Spanish version of the revised SIP (SIP-RS), as well as other commonly used assessment measures translated into Spanish, were administered at baseline and at the end of treatment. Internal consistency was excellent and construct validity was supported through correlations with composite scores from the Addiction Severity Index (ASI) and through differential SIP-RS scores according to diagnostic criteria. The SIP-RS also demonstrated an association with substance use and treatment retention, with higher baseline scores associated with significantly less abstinence during treatment and fewer days retained in treatment. However, the latter association was moderate by participants’ legal status.

Conclusions: This Spanish-translated version of the SIP (SIP-RS) appears to be a reliable and valid assessment of adverse consequences associated with alcohol and drug use, with psychometric properties comparable with the English version. This assessment may prove to be a useful outcome measure for evaluating the efficacy of treatments for substance use disorders, and it may have the potential to identify individuals at risk for early treatment drop-out. Given the growing population of Hispanics in the United States with limited English proficiency, greater effort should be placed toward validating substance abuse assessment instruments for Spanish-speakers, with a particular focus on diverse Hispanic populations.

Related protocols: CTN-0021

Abstract:

This study sought to examine the psychometric properties of a revised version of the SIP (SIP-R) as a measure of adverse consequences for alcohol and drug users in both English and Spanish-speaking populations. The English version was evaluated within a large population of alcohol and drug abuse treatment seekers (N=886) pooled from two national, multisite randomized trials (protocols CTN-0004 and -0005). It was also translated into Spanish and evaluated in a large population of Spanish-speaking substance abuse treatment seekers (N=405) participating in a separate multisite randomized trial (CTN-0021). All trials utilized a common assessment battery that included the ASI, the URICA, and a substance use calendar. Reliability and validity analyses included internal consistency, confirmatory factor analysis, and correlations. Differences in reported consequences were explored using ANOVA. For the English version, results supported the internal consistency and theoretical five-factor structure. Convergent validity was evident through strong correlations with the URICA and the drug composite score from the ASI, whereas weak correlations with other composite scores provided evidence of discriminant validity. Results for the Spanish version were highly similar, with strong internal consistency, factor structure, and a similar pattern of correlations with the ASI and URICA. In both the English and Spanish-speaking samples, baseline SIP-R total scores were higher for those not legally mandated to treatment and were associated with days retained in treatment.

Conclusions: This is the first study to evaluate the SIP-R within such a large, diverse sample of treatment seekers, including evaluation of a Spanish version. Both the English and Spanish versions of the SIP-R demonstrated strong psychometric properties and should be considered a valuable measure of adverse consequences associated with drug and alcohol use.

Related protocols: CTN-0004, CTN-0005, CTN-0021

Abstract:

Assessment of the adverse consequences of substance use serves an important function in both clinical and research settings, yet there is no universally agreed upon measure of consequences relevant to multiple types of substance use disorders. One of the most commonly used measures, the Short Inventory of Problems (SIP), has been adapted and evaluated in several specific populations, but evidence is needed of its reliability and validity across broader samples of persons with substance use disorders. This study evaluated the psychometric properties of a revised version of the SIP (SIP-R) in a large combined sample of alcohol and drug use disorder treatment seekers, with participants pooled from two studies from the National Drug Abuse Treatment Clinical Trials Network (CTN-0004, about motivational enhancement therapy, and CTN-0005, about motivational interviewing).

A total of 886 participants across 10 outpatient treatment facilities completed a common assessment battery that included the SIP-R, Addiction Severity Index (ASI), University of Rhode Island Change Assessment (URICA), HIV Risk Behavior Scale (HRBS), and a substance use calendar. Results supported the SIP-R’s internal reliability (alpha = .95). Confirmatory factor analysis demonstrated that the hypothesized 5-factor model with one higher-order factor produced the best fit. Convergent validity was evident through the SIP-R’s correlation with several composite scores from the ASI and the URICA, and analyses supported its conceptual distinction from quantity indices of drug/alcohol use. The SIP-R also demonstrated an ability to predict treatment retention, with higher scores associated with poorer retention.

Conclusions: These results provide support for the SIP-R’s psychometric properties as a measure of consequences across a broad sample of treatment-seeking drug and alcohol users.

Related protocols: CTN-0004, CTN-0005

Abstract:

This CTN ancillary investigation aimed to address an urgent need for screening of substance use problems in medical settings by examining substance-specific dependence criteria as potential brief screeners for the detection of patients with a substance use disorder (SUD). Researchers examined data from intake assessments of substance use disorders completed by 920 opioid dependent adults from outpatient treatment settings at 11 programs in 10 U.S. cities (part of protocol CTN-0003, which investigated taper schedules for buprenorphine/naloxone dosing). Data were analyzed by factor analysis, item response theory (IRT), sensitivity, and specificity procedures. Across all substances (alcohol, amphetamines, cannabis, cocaine, sedatives), “withdrawal” was among the least prevalent symptoms, while “taking large amounts” and “inability to cut down” were among the more prevalent. Items closely related to the latent trait of a substance use disorder showed good-to-high values of area under the receiver operating characteristic curve in identifying cases of SUD; IRT-defined severe and less discriminative items exhibited low sensitivity in identifying cases of SUD (“withdrawal” for all substances; “time using” for alcohol and sedatives; “giving up activities” for sedatives).

Conclusions: Study results suggest that “withdrawal” and “time using” are much less reliable indicators for a substance use disorder than “taking larger amounts than intended” and “inability to cut down,” and that the latter two items should be studied further for consideration in developing a simplified tool for screening patients for SUD in medical settings. These findings have implications for the use of common health indicators in electronic health records systems to improve patient care. This study also demonstrates the unique value of IRT analysis in determining the underlying trait of a set of measures and elucidating item-level psychometric information to help interpret results of sensitivity and specificity; researchers should consider incorporating IRT approaches into their analysis plans to support the psychometric quality of patient-reported items.

Supported by the Duke Clinical Research Institute (CTN DSC 1).

Related protocols: CTN-0003

Abstract:

A better understanding of how to measure motivation to change and how it relates to behavior change in patients with drug and alcohol dependence would broaden our understanding of the role of motivation in addiction treatment. To that aim, an analysis was conducted of two multi-site, randomized clinical trials comparing brief motivational interventions with standard care in the National Drug Abuse Treatment Clinical Trials Network (protocols CTN-0004 and CTN-0005). Patients with primary drug dependence and alcohol dependence entering outpatient treatment participated in a study of either Motivational Enhancement Therapy (n=431) or Motivational Interviewing (n=423). The construct, concurrent, and predictive validity of two composite measures of motivation to change derived from the University of Rhode Island Change Assessment (URICA): Readiness to Change (RTC) and Committee Action (CA) were evaluated. Confirmatory factor analysis confirmed the a priori factor structure of the URICA. RTC was significantly associated with measures of addiction severity at baseline (r=.12-.52, p<.05). Although statistically significant (p<.01), the correlations between treatment outcomes and RTC were low (4=-.15 and -18). Additional analyses did not support a moderating or mediating effect of motivation on treatment retention or substance use.

In conclusion, the construct validity of the URICA was confirmed separately in a large sample of drug- and alcohol-dependent patients. However, evidence for the predictive validity of composite scores was very limited and there were no moderating or mediating effects of either measure on treatment outcome. Thus, increased motivation to change, as measured by the composite scores of motivation derived from the URICA, does not appear to influence treatment outcome.

Related protocols: CTN-0004, CTN-0005

Abstract:

This study assesses the psychometric properties of the Condom Barriers Scale (CBS), an instrument originally designed to measure women’s perceptions and attitudes regarding male condom use, with a sample of men at high risk for human immunodeficiency virus (HIV). Participants include 590 male patients in drug abuse treatment involved in a gender-specific HIV prevention intervention for teaching safer sex skills (protocol CTN-0018). Second-order confirmatory factor analysis generally supported the underlying four-factor subscale structure of the CBS. However, exploratory factor analysis revealed a few specific discrepancies in the factor structure between men and women. Internal consistency and test-retest reliability estimates were moderate to high in value. CBS scores correlated with use of condoms for men with high-risk sexual partners, supporting criterion-related validity.

Overall, the analysis indicates that the CBS is a potentially valid and reliable instrument and has utility for assessing barriers to condom use with men, but may need some item content modifications to allow appropriate assessment of gender differences and comparisons across studies.

Related protocols: CTN-0018

Abstract:

This study aimed to examine psychometric properties of the diagnostics criteria for alcohol and marijuana dependences in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), among 462 alcohol users and 311 marijuana users enrolled in two multisite trials of the National Drug Abuse Treatment Clinical Trials Network (CTN-0006 and -0007, Motivational Incentives for Enhanced Drug Abuse Recovery, Drug Free/Methadone Clinics). Diagnostic questions were assessed by the DSM-IV Checklist, and data were analyzed by the item response theory and the multiple indicators-multiple causes method procedures. Criterion symptoms of alcohol and marijuana dependencies exhibited a high level of internal consistency. All individual symptoms showed good discrimination in distinguishing alcohol or marijuana users between high and low severity levels of the continuum. In both groups, “withdrawal” appeared to measure the most severe symptoms of the dependence continuum. There was little evidence of measurement nonequivalence in assessing symptoms of dependence by gender, age, race/ethnicity, and educational level. These findings highlight the clinical utility of the DSM-IV checklist in assessing alcohol- and marijuana dependence syndromes among treatment-seeking substance users. Additionally, the consistent association between severity of dependence and withdrawal supports the DSM-IV subtyping of “with or without physiological features” and this item should continue to have a significant role in treatment planning and patient placement criteria.

Supported by the Duke Clinical Research Institute (CTN DSC 1).

Related protocols: CTN-0006, CTN-0007

Abstract:

Despite the fact that the number of Hispanic individuals in need of treatment for substance use problems is increasing internationally, no studies have investigated the extent to which therapists can provide empirically supported treatments to Spanish-speaking clients with adequate fidelity. In this report, the authors provide data on the psychometric properties of a therapist adherence/competence rating system adapted from a previous English language multisite randomized clinical trial of motivational enhancement therapy (CTN-0004) and used in an independent Spanish version of the trial (CTN-0021). Both studies were conducted within the National Drug Abuse Treatment Clinical Trials Network. Identical in most ways (other than language and relevant cultural adaptations) to the protocol conducted in English, the Spanish MET protocol examined the effectiveness of a three-session adaptation of MET used in Project MATCH compared to counseling-as-usual (CAU) in five US-based community treatment programs. Independent ratings of 325 sessions indicated the adherence/competence rating system had good to excellent interrater reliability and indicated strong support for an a priori defined fundamental MET skill factor. Support for an advanced MET skill factor was relatively weaker. The rating scale indicated significant differences in therapists’ MET adherence and competence across conditions.

These findings indicate that the rating system has promise for assessing the performance of therapists who deliver MET in Spanish and suggest that bilingual Spanish-speaking therapists from the community can be trained to implement MET with adequate fidelity and skill using an intensive multisite training and supervision model.

Related protocols: CTN-0004, CTN-0021

Abstract:

Motivation to change is considered an important component of treatment readiness and response among patients with addictive disorders. A better understanding of how to best measure motivation to change and how motivation relates to successful behavior change among both drug and alcohol abusers would broaden our understanding of the role of motivation in treatment of addictions. In this study, two multi-site, randomized clinical trials comparing brief motivational interventions with standard care were conducted in the National Drug Abuse Treatment Clinical Trials Network (protocols CTN-0004 and -0005). The construct and predictive validity of two composite measures of motivation to change derived from the University of Rhode Island Change Assessment (URICA): Readiness to Change (RTC) and Committed Action (CA) were evaluated. The a priori factor structure of the URICA was confirmed among patients with primary drug and primary alcohol use. Additionally, the RTC was significantly associated with fewer days of drug use among patients with primary drug use and lower treatment retention among patients with primary alcohol use. CA was not significantly associated with treatment outcomes.

Neither RTC nor CA were found to moderate or mediate treatment outcomes at baseline or 4 weeks. In conclusion, increased motivation to change, as measured by the composite scores of motivation derived from the URICA, does not appear to influence treatment outcome.

Related protocols: CTN-0004, CTN-0005

Abstract:

As part of the baseline assessment for protocol CTN-0018 (Reducing HIV/STD Risk Behaviors: A Research Study for Men in Drug Abuse Treatment), participants were administered the Condom Barriers Scale, an instrument originally developed to measure barriers women perceive as impeding condom use. This poster describes the protocol team’s assessment of the psychometrics of the CBS when used with a sample of men at high risk for HIV. Second-order confirmatory factor analysis of the CBS generally supported the underlying 4-factor subscale structure previously identified with women. However, exploratory factor analysis revealed several specific discrepancies in the factor structure between men and women. Some minor modifications of item assignment to scales are indicated when using the CBS with men. Internal consistency and test-retest reliability estimates were moderate to high in value. Overall, the analysis indicates the CBS is a potentially valid and reliable instrument for assessing barriers to condom use with men.

Related protocols: CTN-0018