Viviana E. Horigian

Therapist Adherence in Brief Strategic Family Therapy for Adolescent Drug Abusers.

OBJECTIVE Therapist adherence has been shown to predict clinical outcomes in family therapy. In prior studies, adherence has been represented broadly by core principles and a consistent family (vs. individual) focus. To date, these studies have not captured the range of clinical skills that are represented in complex family-based approaches or examined how variations in these skills predict different clinically relevant outcomes over the course of treatment. In this study, the authors examined the reliability and validity of an observational adherence measure and the relationship between adherence and outcome in a sample of drug-using adolescents who received brief strategic family therapy within a multisite effectiveness study. METHOD Participants were 480 adolescents (age 12-17) and their family members, who were randomized to the Brief Strategic Family Therapist treatment condition (J. Szapocznik, U. Hervis, & S. Schwartz, 2003) or treatment as usual. The adolescents were mostly male (377 vs. 103 female) and Hispanic (213), whereas 148 were White, and 110 were Black. Therapists were also randomly assigned to treatment condition within agencies. RESULTS Results supported the proposed factor structure of the adherence measure, providing evidence that it is possible to capture and discriminate between distinct dimensions of family therapy. Analyses demonstrated that the mean levels of the factors varied over time in theoretically and clinically relevant ways and that therapist adherence was associated with engagement and retention in treatment, improvements in family functioning, and reductions in adolescent drug use. CONCLUSIONS Clinical implications and future research directions are discussed, including the relevance of these findings on training therapists and studies focusing on mechanisms of action in family therapy.

Frontal systems deficits in stimulant-dependent patients: Evidence of pre-illness dysfunction and relationship to treatment response

BACKGROUND Frontal systems dysfunction is present in stimulant-dependent patients. However, it is unclear whether this dysfunction is a pre-morbid risk factor or stimulant-induced, is severe enough to be clinically relevant, and if it is relevant to treatment response. These questions were addressed using the Frontal Systems Behavior Scale (FrSBe), a reliable and valid self-report assessment of three neurobehavioral domains associated with frontal systems functioning (Apathy, Disinhibition, and Executive Dysfunction, summed for a Total), that assesses both pre- and post-morbid functioning, and has a specific cutoff for defining clinically significant abnormalities. METHOD Six sites evaluating 12-step facilitation for stimulant abusers obtained the FrSBe from 180 methamphetamine- and/or cocaine-dependent participants. Dichotomous treatment response measures included self-reported stimulant use, stimulant urine drug screens, and treatment completion. RESULTS A substantial percentage of participants retrospectively reported clinically significant neurobehavioral abnormalities prior to lifetime stimulant abuse initiation (e.g., 67.5% on FrSBe-Total) with a significant increase in the proportion reporting such abnormalities for current functioning (86% on FrSBe-Total; p<0.0001). Treatment response was significantly worse for participants with, relative to those without, clinically significant Disinhibition as measured by treatment non-completion (31.6% vs. 15.6%, OR=2.51) and self-reported stimulant use during treatment (40.5% vs. 16.7%, OR=3.40). CONCLUSION These findings suggest that frontal systems dysfunction is present prior to stimulant-abuse onset and worsens with stimulant use. Disinhibition may be a prime target for intervention in stimulant-dependent individuals.

Brief strategic family therapy™ for adolescent drug abusers: A multi-site effectiveness study

Brief strategic family therapy (BSFT) is a manualized treatment designed to address aspects of family functioning associated with adolescent drug use and behavior problems (J. Szapocznik, U. Hervis, S. Schwartz, (2003). Brief strategic family therapy for adolescent drug abuse. (NIH Publication No. 03-4751). Bethesda, MD: National Institute on Drug Abuse). Within the National Institute on Drug Abuses (NIDAs) Clinical Trials Network, BSFT is being compared to treatment as usual (TAU) in a multisite, prospective randomized clinical trial for drug using adolescents and their families in outpatient settings. The effectiveness of BSFT is being compared to TAU in reducing adolescent drug use, conduct problems, and sexually risky behaviors as well as in improving family functioning and adolescent prosocial behaviors. This paper describes the following aspects of the study: specific aims, research design and study organization, assessment of primary and secondary outcomes, study treatments, data analysis plan, and data monitoring and safety reporting.

Equivalence of family functioning and externalizing behaviors in adolescent substance users of different race/ethnicity

The Brief Strategic Family Therapy for Adolescent Drug Abuse clinical trial of 480 adolescents boys and girls aged 12 to 17 years and their parents was designed to maximize the chance that a sufficient number of Hispanic and Black adolescents would be included to allow valid subgroup comparisons. Examination of measurement invariance is an important step to ensure valid analysis. Two construct areas important to the analysis of trial results, adolescent problem behaviors, and family functioning showed a high degree of measurement invariance, which allowed valid comparisons of mean baseline differences across groups. Results showed that Black families had significantly higher initial levels of family functioning and lower levels of adolescent externalizing behaviors than either Hispanic or White non-Hispanic families. This pattern is consistent with an increased likelihood of referral of Black adolescents with more severe problems to restricted setting rather than to outpatient drug abuse treatment. This possibility highlights the importance of considering differing baseline characteristics of subgroups prior to assessing differential treatment effectiveness to prevent confounding.

Parent and Child Agreement on Anxiety Disorder Symptoms Using the DISC Predictive Scales

Growing recognition of the negative impact of anxiety disorders in the lives of youth has made their identification an important clinical task. Multiple perspective assessment (e.g., parents, children) is generally considered a preferred method in the assessment of anxiety disorder symptoms, although it has been generally thought that disagreement between parent and youth ratings of the child’s emotions is common. This study examined parent and child reports of the child’s anxiety disorder symptoms using the Diagnostic Interview Schedule for Children—Predictive Scales (DISC-PS) in a clinic-referred sample of substance using adolescents. Parents and adolescents (N = 480) who were referred for substance abuse treatment were screened for anxiety disorder symptoms using the DISC-PS at pretreatment. Results suggest similar (low) levels of agreement between the parent report and child report versions as found with other anxiety symptom and anxiety disorder measures. Findings provide data on multi-informant agreement and highlight issues in the use of the DISC-PS to identify anxiety problems in youth.

Principles for defining adverse events in behavioral intervention research: lessons from a family-focused adolescent drug abuse trial:

Background Behavioral intervention research has lagged behind biomedical research in developing principles for defining, categorizing, identifying, reporting, and monitoring adverse events and unanticipated problems. Purpose In this article we present a set of principles for defining adverse events and how they were applied in a large national multi-site family therapy study for substance-using adolescents, The Brief Strategic Family Therapy (BSFTTM) Effectiveness Study. Methods The BSFTTM Effectiveness study tested how BSFTTM compares to Treatment as Usual (TAU) for the treatment of drug-abusing adolescents. During protocol development, experts in the BSFTTM intervention, medical safety officers, ethicists and senior investigators defined the procedures for identifying, tracking and reporting adverse events for drug using adolescents as well as their family members. During this process the team identified five key guiding principles. Results The five guiding principles that were used for defining adverse events in this behavioral trial were that that the adverse events should be validated and plausible, and that monitoring systems should assess relatedness, be systematic, and are a shared responsibility. The following non-serious adverse events were identified: arrest, school suspension and drop out, runaway, kicked out of home and violence. The serious adverse events in this study for the identified adolescent participant and all other consented family members were physical or sexual abuse, suicidal behavior, homicidal behavior, hospitalization (drug related or psychiatric related only) and death. The methods used in categorizing, identifying and reporting adverse events in the BSFTTM trial are outlined. More than 50% of the adolescent population (277/481 = 57.5 %) experienced an adverse event during the trial. Family members experienced less adverse events, (61/1338 = 4.5%). The most common event for the adolescent group was arrest (164/277= 59.2%), followed by school suspension/dropout (143/277 = 51.6%), and runaway (79/277= 28.5 %). For the family member group, the most common event was violence (25/ 61 = 40.9%) followed by arrest (13/61 = 21.3%). There was a significant difference in the presence of adverse events in family members that were randomized to BSFTTM 44/721 (6.1%) when compared to Treatment as Usual 17/617 (2.8%) (p = 0.004). A probable explanation for this is that there were more opportunities to identify adverse events for family members assigned to BSFTTM because family members attended therapy sessions. This difference may also represent the risk for family members that participate in an evidence-based family intervention like BSFTTM. Limitations The utility of the principles outside of the BSFTTM trial is unknown. Conclusions Based on the events reported in this trial, the efforts for monitoring and categorizing adverse events appeared justified and appropriate. The strategies and principles described in this paper may be useful for those developing safety plans for behavioral intervention research, and to family therapy researchers for assessing the safety of behavioral family interventions. Clinical Trials 2010; 7: 58—68. http://ctj.sagepub.com

Prospective study of alcohol consumption and the incidence of the metabolic syndrome in US men.

Few studies have evaluated the effects of alcohol consumption on the incidence of the metabolic syndrome (MetS). Therefore, the objective of the present study was to examine the association between alcohol consumption and incident MetS in a population of US men. This is a prospective study of 7483 Caucasian men, who were free of the MetS and CVD at baseline. Information was collected on alcohol consumption, health status and fitness level at an initial clinical examination. Additional health information and determination of incident cases of the MetS were obtained at follow-up clinical examinations between 1979 and 2005. Compared with non-drinkers, the multivariate hazard ratios of the MetS for light (1-3 drinks/week), moderate (4-7 drinks/week), moderate-heavy (8-13 drinks/week) and heavy ( ≥ 14 drinks/week) drinkers were 0.81 (95 % CI 0.68, 0.95), 0.68 (95 % CI 0.57, 0.80), 0.70 (95 % CI 0.59, 0.83) and 0.78 (95 % CI 0.66, 0.91), respectively. This association was seen across age groups, in men with one or more pre-existing MetS risk factors, and those with BMI ≥ 25 kg/m2, and in all alcohol beverage types at most levels of alcohol consumption. An inverse dose-response association between alcohol consumption and low HDL concentrations was observed, while significant associations were observed between high fasting glucose concentrations and moderate, moderate-heavy and heavy levels of alcohol consumption. Alcohol consumption was not significantly associated with central obesity, hypertriacylglycerolaemia or hypertension. All levels of alcohol consumption provided significant inverse associations with incidence of the MetS. In particular, this effect was observed in overweight and/or obese individuals, in those who had pre-existing risk factors for the MetS, and extended across all types of alcoholic beverages consumed.

Statistical issues in multisite effectiveness trials: the case of brief strategic family therapy for adolescent drug abuse treatment.

The statistical development of the multisite Brief Strategic Family Therapy (BSFT) Trial of the National Institute on Drug Abuses Clinical Trials Network provides a useful, real example of how an effectiveness trial can differ from an efficacy trial. In particular, two design elements distinguish this effectiveness trial from an efficacy trial. First, because the goal of the trial is to show that the use of BSFT would be an improvement on current practice, it was decided to compare BSFT to treatment as usual at each location. This decision ensures that the trial has the most ecological validity to the participating community treatment providers. Second, the desire to generalize the results to general clinical practice dictates that variability (in effect) across community treatment providers be estimated using a random effects model. These two decisions jointly influence the sample size calculations. Allowing variation in treatment as usual, will increase the variability in effect sizes across sites and estimation of this variability as a random effect necessitates a larger sample size (both number of community treatment providers and participants per community treatment provider), than is the case for a fixed site effect estimate. Details of these effects and their implications for the statistical design are presented.

Co-Occurring Disorders: A Challenge for Mexican Community-Based Residential Care Facilities for Substance Use

ABSTRACT Objective: In Mexico, specialized treatment services for people with co-occurring disorders are limited within public health services, while private options are deemed too costly. More than 2,000 community-based residential care facilities have risen as an alternative and are the main source of treatment for individuals with substance use disorders; however, suboptimal practices within such facilities are common. Information on the clinical characteristics of patients receiving care in these facilities is scarce and capacity to provide high-quality care for co-occurring disorders is unknown. The aims of this study were to examine the prevalence of co-occurring disorders in patients receiving treatment for substance use in these community-based residential centers and to assess whether the presence of co-occurring disorders is associated with higher severity of substance use, psychiatric symptomatology, and other health risks. Methods: This study was conducted with 601 patients receiving treatment for substance use disorders at 30 facilities located in five Mexican states, recruited in 2013 and 2014. Patients were assessed with self-report measures on substance use, service utilization, suicidality, HIV risk behaviors, psychiatric symptomatology, and psychiatric disorder diagnostic criteria. Results: The prevalence of any co-occurring disorder in this sample was 62.6%. Antisocial personality disorder was the most prevalent (43.8%), followed by major depressive disorder (30.9%). The presence of a co-occurring disorder was associated with higher severity of psychiatric symptoms (aB = .496, SE = .050, p < .05); more days of substance use (aB = .219, SE = .019, p < .05); current suicidal ideation (aOR = 5.07, 95% CI [2.58, 11.17]; p < .05), plans (aOR = 5.17 95% CI [2.44, 12.73]; p < .05), and attempts (aOR = 6.43 95% CI [1.83, 40.78]; p < .05); more sexual risk behaviors; and more contact with professional services (aOR = 1.77, 95% CI [1.26, 2.49], p < .05). Conclusions: Co-occurring disorders are highly prevalent in community-based residential centers in Mexico and are associated with significantly increased probability of other health risks. This highlights the need to develop care standards for this population and the importance of clinical research in these settings.

Rationale and methods for site selection for a trial using a novel intervention to treat stimulant abuse

Although the selection of appropriate clinical sites has a significant impact on the successful conduct of clinical trials, no generally accepted model is available for site selection. Use of an appropriate site selection process is even more pertinent when conducting large scale, practical clinical trials in practice settings. This report provides a rationale for selecting sites by identifying both a set of basic site selection criteria important to most trials as well as criteria specific to the features of a particular studys design. In this two-tier system, although all these criteria must be met, some criteria are firm and viewed as essential for a site to conduct the trial. Other criteria, such as those that support study recruitment or participant retention, are flexible. These flexible criteria may be addressed through several alternative solutions that meet the original intent of the criterion. We illustrate how the study specific features and requirements of Stimulant Reduction Intervention using Dosed Exercise (STRIDE), a multisite clinical trial evaluating the efficacy of exercise or health education, added to treatment as usual for stimulant abuse are linked to firm and flexible site selection criteria. We also present an iterative, multi-step approach to site selection including building awareness about the study and screening and evaluating sites using these criteria. This simple model could maximize the chance that selected sites will implement a study successfully and achieve trial aims. It may be helpful to researchers who are developing criteria and methods for site selection for specific clinical trials.