Increasing ethnic minority participation in substance abuse clinical trials: lessons learned in the National Institute on Drug Abuse's Clinical Trials Network.

Underrepresentation in clinical trials limits the extent to which ethnic minorities benefit from advances in substance abuse treatment. The objective of this article is to share the knowledge gained within the Clinical Trials Network (CTN) of the National Institute on Drug Abuse and other research on recruiting and retaining ethnic minorities into substance abuse clinical trials. The article includes a discussion of two broad areas for improving inclusion-community involvement and cultural adaptation. CTN case studies are included to illustrate three promising strategies for improving ethnic minority inclusion: respondent-driven sampling, community-based participatory research, and the cultural adaptation of the recruitment and retention procedures. The article concludes with two sections describing a number of methodological concerns in the current research base and our proposed research agenda for improving ethnic minority inclusion that builds on the CTN experience.

Do therapist cultural characteristics influence the outcome of substance abuse treatment for Spanish-speaking adults?

This secondary data analysis of the Clinical Trials Network's Motivational Enhancement Therapy effectiveness trial with Spanish-speaking substance users examined whether the degree of birthplace and acculturation similarities between clients and therapists, as well as the therapists' own level of acculturation and birthplace were related to the clients' participation in treatment and level of substance use during outpatient substance use treatment. Sixteen therapists and their 235 clients from the larger effectiveness trial were included in the analyses for this study. Results of the multilevel regression models for client participation in substance use treatment and client days of substance use, taking into account within and between therapist cultural characteristics, revealed that birthplace match and acculturation similarity between each therapist and his or her clients did not predict client outcomes. Instead, therapists' birthplace and level of acculturation independently predicted days of substance use, but not treatment participation for monolingual Spanish-speaking clients. These findings are discussed in the context of the results of the main effectiveness trial and of psychotherapy research with ethnic minority populations, in particular Hispanic minorities.

Some evidence for multidimensional biculturalism: confirmatory factor analysis and measurement invariance analysis on the Bicultural Involvement Questionnaire-Short Version.

In the present study, the authors empirically investigated a multidimensional conceptualization of acculturation using the Bicultural Involvement Questionnaire-Short Version (BIQ-S; J. Szapocznik, W. M. Kurtines, & T. Fernandez, 1980). Baseline data from four prevention trials, representing a total of 893 adolescent and 880 guardian participants of Hispanic descent, were used to examine the factor structure of BIQ-S scores. Results of exploratory and confirmatory factor analyses supported a four-factor solution. The factors were labeled as follows: (a) Comfort With Use of Spanish Language, (b) Comfort With Use of English Language, (c) Enjoyment of Hispanic Cultural Activities, and (d) Enjoyment of American Cultural Activities. The findings support an expansion of the theoretical conceptualization of biculturalism and suggest that within both the heritage and the receiving cultures, comfort with language and enjoyment of other cultural components represent different factors. Measurement invariance analyses revealed stability of the factor structure, as well as some measurement differences, between adolescents and their guardians. (PsycINFO Database Record (c) 2009 APA, all rights reserved).

The impact of acculturative stress and daily hassles on pre-adolescent psychological adjustment: examining anxiety symptoms.

Acculturative stress in relation to anxiety symptoms has not been examined empirically in young Hispanic populations. The present study, conducted with 138 pre-adolescent Hispanic youngsters, investigated this relationship. The findings suggested that acculturative stress was related to physiological, concentration, and worrisome symptoms of anxiety. After decomposing acculturative stress, it became evident that perceived discrimination accounted for a large proportion of the variance in the relationship between acculturative stress and anxiety. Immigration-related stress was mostly associated with worry symptoms. Finally, total daily hassles were an independent predictor of concentration and physiological anxiety symptoms. Implications for prevention interventions and future research are discussed.

Validation of the acculturative stress inventory for children.

The psychometric properties of the Acculturative Stress Inventory for Children (ASIC) were examined with a sample of 139 Hispanic children. This self-report instrument was studied using the items of the Societal, Attitudinal, Familial, and Environmental Acculturative Stress Scale for Children (SAFE-C; Chavez, Moran, Reid, & Lopez, 1997), which had face validity for acculturative stress. The psychometric properties of the ASIC were examined by conducting an exploratory principal-axis factor analysis, which yielded a two-factor solution. The first factor includes 8 items assessing perceived discrimination and the 4 items of the second factor measure immigration-related experiences. Evidence of internal consistency and test-retest reliability for the 2 factors and the total scale were found to be adequate. In addition, sufficient estimates of convergent, discriminant, and predictive validity were obtained. Implications for future research of acculturative stress in children involving the ASIC are discussed.

Trauma in Hispanic youth with psychiatric symptoms: Investigating gender and family effects.

OBJECTIVE: Hispanic youth in the general community experience traumatic events and display symptoms of psychological distress more frequently than do Caucasian youth. However, little is known about how traumatic experiences in this ethnic minority population relate to psychopathology in clinical samples and whether these outcomes vary by gender and are impacted by family functioning. We hypothesized that traumatic stress reactions, including posttraumatic stress disorder (PTSD) and internalizing and externalizing symptoms, would vary by gender and by family functioning in a clinical sample of Hispanic youth. METHOD: The current study utilized baseline data from a randomized clinical trial (RCT) involving 200 Hispanic adolescents (122 boys and 78 girls) referred to treatment for experiencing clinical symptoms of 1 or more behavioral disorders and conflictual family relations. The rate of traumatic events, differences in outcomes depending on trauma exposure, and the effects gender, family functioning, and trauma on psychopathology and PTSD symptoms were examined. RESULTS: Analyses revealed that 61% of Hispanic youth in this clinical sample experienced at least 1 traumatic event. Although only 12% of the sample reported PTSD scores in the clinical range, girls reported higher PTSD scores than did boys. Poor family cohesion was particularly detrimental to girls compared with boys and related to internalizing and PTSD symptoms. High family conflict predicted PTSD symptoms in boys but not in girls. CONCLUSIONS: These findings have clinical implications for working with Hispanic populations, suggesting that culturally sensitive interventions should incorporate family-based interventions for individuals who experience trauma to strengthen family bonds and decrease family conflict. (PsycINFO Database Record

Utilizing dissemination findings to help understand and bridge the research and practice gap in the treatment of substance abuse disorders in Hispanic populations.

This article focuses on the gap between research and practice in substance abuse treatment, identifies some of the key findings in the technology transfer literature, and discusses their relevance to the adoption of new technology among Hispanic serving agencies and counselors. In organizing the material we present information within the categories of: (1) evidence, (2) context, and (3) facilitation. When considering the "evidence" for empirically supported substance abuse treatments for Hispanics, there is great concern about the shortage of treatments that have been adequately tested with Hispanics. In this article, we analyze the strengths and weaknesses of strategies recommended to address this problem. In terms of the "context" in which evidence-based practices will be implemented, we consider counselor characteristics and organizational structures that may facilitate or hinder the adoption of these practices and discuss how these may impact Hispanic-serving agencies. Finally, the mechanisms necessary for "facilitation" of evidence-based practices in Hispanic-serving agencies are described. Given the dearth of dissemination research with Hispanics, as well as other minorities, each area described in this article presents unique challenges that can benefit from a field-wide discussion.

Informal discussions in substance abuse treatment sessions with Spanish-speaking clients.

This study investigated the extent to which bilingual counselors initiated informal discussions about topics that were unrelated to the treatment of their monolingual Spanish-speaking Hispanic clients in a National Institute on Drug Abuse Clinical Trial Network protocol examining the effectiveness of motivational enhancement therapy (MET). Session audiotapes were independently rated to assess counselor treatment fidelity and the incidence of informal discussions. Eighty-three percent of the 23 counselors participating in the trial initiated informal discussions at least once in one or more of their sessions. Counselors delivering MET in the trial initiated informal discussion significantly less often than the counselors delivering standard treatment. Counselors delivering standard treatment were likely to talk informally the most when they were ethnically non-Latin. In addition, informal discussion was found to have significant inverse correlations with client motivation to reduce substance use and client retention in treatment. These results suggest that informal discussion may have adverse consequences on Hispanic clients' motivation for change and substance abuse treatment outcomes and that maintaining a more formal relationship in early treatment sessions may work best with Hispanic clients. Careful counselor training and supervision in MET may suppress the tendency of counselors to talk informally in sessions.

Do treatment improvements in PTSD severity affect substance use outcomes? A secondary analysis from a randomized clinical trial in NIDA's Clinical Trials Network.

OBJECTIVE: The purpose of the analysis was to examine the temporal course of improvement in symptoms of posttraumatic stress disorder (PTSD) and substance use disorder among women in outpatient substance abuse treatment. METHOD: Participants were 353 women randomly assigned to 12 sessions of either trauma-focused or health education group treatment. PTSD and substance use assessments were conducted during treatment and posttreatment at 1 week and after 3, 6, and 12 months. A continuous Markov model was fit on four defined response categories (nonresponse, substance use response, PTSD response, or global response [improvement in both PTSD and substance use]) to investigate the temporal association between improvement in PTSD and substance use symptom severity during the study's treatment phase. A generalized linear model was applied to test this relationship over the follow-up period. RESULTS: Subjects exhibiting nonresponse, substance use response, or global response tended to maintain original classification; subjects exhibiting PTSD response were significantly more likely to transition to global response over time, indicating maintained PTSD improvement was associated with subsequent substance use improvement. Trauma-focused treatment was significantly more effective than health education in achieving substance use improvement, but only among those who were heavy substance users at baseline and had achieved significant PTSD reductions. CONCLUSIONS: PTSD severity reductions were more likely to be associated with substance use improvement, with minimal evidence of substance use symptom reduction improving PTSD symptoms. Results support the self-medication model of coping with PTSD symptoms and an empirical basis for integrated interventions for improved substance use outcomes in patients with severe symptoms.

A multisite randomized effectiveness trial of motivational enhancement therapy for Spanish-speaking substance users.

Hispanic individuals are underrepresented in clinical and research populations and are often excluded from clinical trials in the United States. Hence, there are few data on the effectiveness of most empirically validated therapies for Hispanic substance users. The authors conducted a multisite randomized trial comparing the effectiveness of 3 individual sessions of motivational enhancement therapy with that of 3 individual sessions of counseling as usual on treatment retention and frequency of substance use; all assessment and treatment sessions were conducted in Spanish among 405 individuals seeking treatment for any type of current substance use. Treatment exposure was good, with 66% of participants completing all 3 protocol sessions. Although both interventions resulted in reductions in substance use during the 4-week therapy phase, there were no significant Treatment Condition x Time interactions nor Site x Treatment Condition interactions. Results suggest that the individual treatments delivered in Spanish were both attractive to and effective with this heterogeneous group of Hispanic adults, but the differential effectiveness of motivational enhancement therapy may be limited to those whose primary substance use problem is alcohol and may be fairly modest in magnitude.

Evaluating motivational enhancement therapy adherence and competence among Spanish-speaking therapists.

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. Twenty-three bilingual Hispanic therapists from five community outpatient treatment programs in the United States were randomly assigned to deliver either three sessions of motivational enhancement therapy (MET) or an equivalent number of drug counseling-as-usual (CAU) sessions in Spanish to 405 Spanish-speaking clients randomly assigned to these conditions. 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.

Multisite randomized trial of behavioral interventions for women with co-occurring PTSD and substance use disorders.

The authors compared the effectiveness of the Seeking Safety group, cognitive-behavioral treatment for substance use disorder and posttraumatic stress disorder (PTSD), to an active comparison health education group (Women's Health Education [WHE]) within the National Institute on Drug Abuse's Clinical Trials Network. The authors randomized 353 women to receive 12 sessions of Seeking Safety (M = 6.2 sessions) or WHE (M = 6.0 sessions) with follow-up assessment 1 week and 3, 6, and 12 months posttreatment. Primary outcomes were the Clinician Administered PTSD Scale (CAPS), the PTSD Symptom Scale-Self Report (PSS-SR), and a substance use inventory (self-reported abstinence and percentage of days of use over 7 days). Intention-to-treat analysis showed large, clinically significant reductions in CAPS and PSS-SR symptoms (d = 1.94 and 1.12, respectively) but no reliable difference between conditions. Substance use outcomes were not significantly different over time between the two treatments and at follow-up showed no significant change from baseline. Study results do not favor Seeking Safety over WHE as an adjunct to substance use disorder treatment for women with PTSD and reflect considerable opportunity to improve clinical outcomes in community-based treatments for these co-occurring conditions.

Adverse events in an integrated trauma-focused intervention for women in community substance abuse treatment.

A substantial number of women who enter substance abuse treatment have a history of trauma and meet criteria for posttraumatic stress disorder (PTSD). Fear regarding the extent to which PTSD treatment can evoke negative consequences remains a research question. This study explored adverse events related to the implementation of an integrated treatment for women with trauma and substance use disorder (Seeking Safety) compared with a nontrauma-focused intervention (Women's Health Education). Three hundred fifty-three women enrolled in community substance abuse treatment were randomized to 1 of the 2 study groups and monitored weekly for adverse events. There were no differences between the two intervention groups in the number of women reporting study-related adverse events (28 [9.6%] for the Seeking Safety group and 21[7.2%] for the Women's Health Education group). Implementing PTSD treatment in substance abuse treatment programs appears to be safe, with minimal impact on intervention-related adverse psychiatric and substance abuse symptoms. More research is needed on the efficacy of such interventions to improve outcomes of PTSD and substance use.

Issues in designing and implementing a Spanish-language multi-site clinical trial.

To address at least in part health disparities in Hispanic populations, the NIDA Clinical Trials Network implemented the first multi-site randomized clinical trial of substance abuse treatment conducted entirely in Spanish. This trial was intended to evaluate the effectiveness of Motivational Enhancement Therapy in a diverse population of Hispanics. In the conduct of this trial, several barriers to the successful implementation of a Spanish-language multi-site trial had to be addressed, including the appropriate translation of assessment instruments, shortage of appropriately trained Spanish-speaking clinical staff, and barriers to recruitment and retention of this population. To encourage similar research, strategies are described that were developed by the study team to meet these challenges.

Relation of childhood worry to information-processing factors in an ethnically diverse community sample.

This study examined information-processing variables in relation to worry in a sample of 292 fifth-grade children from Caucasian, African American, and Hispanic backgrounds. Results revealed that worry was related to threat interpretations for hypothetical situations and, when stress level was not controlled, to higher estimates of future occurrence for perceived threatening situations and ineffective solution choices. In addition, environmental and individual factors such as stress, gender, and socioeconomic status (SES) were found to be important predictors of information-processing variables. Ethnicity did not predict children's information processing when stress level and SES were controlled; however, it interacted with worry to predict problem-solving confidence. The findings support the information-processing model for childhood anxiety in a nonreferred and ethnically diverse sample.

Brief strategic family therapy: lessons learned in efficacy research and challenges to blending research and practice.

In this article, we present key lessons that we have learned from (1) a long program of research on an empirically supported treatment, brief strategic family therapy (BSFT), and (2) our ongoing research and training efforts related to transporting BSFT to the front lines of practice. After briefly presenting the rationale for working with the family when addressing behavior problems and substance abuse in adolescent populations, particularly among Hispanic adolescents, we summarize key findings from our 30-year program of research. The article closes by identifying barriers to the widespread adoption of empirically supported treatments and by presenting current work within the National Institute on Drug Abuse's Clinical Trials Network that attempts to address these barriers and obstacles.