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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
The effects of family therapy for adolescent substance use on parent substance use have not been explored. This study aimed to determine those effects for Brief Strategic Family Therapy (BSFT), as well as the relationship between parent substance abuse and adolescent substance use. Using data from the National Drug Abuse Treatment Clinical Trials Network protocol about the use of BSFT (CTN-0014), which involved 480 adolescents and parents randomized to BSFT or treatment as usual (TAU) across eight outpatient treatment programs, substance use for both parents and adolescents was assessed at baseline and 12 months post-randomization. Family functioning was assessed at baseline, 4, 8, and 12 months post-randomization.
Parents in BSFT significantly decreased their alcohol use as measured by the ASI composite score from baseline to 12 months. Change in family functioning mediated the relationship between Treatment Condition and change in parent alcohol use. Children of parents who reported drug use at baseline had three times as many days of reported substance use at baseline compared with children of parents who did not use or only used alcohol. Adolescents in BSFT had a significantly lower trajectory of substance use than those in TAU if their parents used drugs at baseline.
Conclusions: BSFT is effective in reducing alcohol use in parents, and also in reducing adolescents’ substance use in families where parents were using drugs at baseline. BSFT may also decrease alcohol use among parents by improving family functioning. These results have important clinical implications, providing evidence that BSFT could improve the alcohol use of parents and that BSFT may be particularly beneficial for adolescents of parents who were drug-using at baseline. Though BSFT was developed for adolescent drug abuse, these findings suggest future research is warranted on investigating the cost benefits of delivering BSFT to substance abusing families, as it is suggested that more than one member might obtain improvement in alcohol, drug, and other health outcomes.
Related protocols: CTN-0014
Research shows that interventions for substance use disorders may be helpful in reducing internalizing disorders in adolescents. This paper examines the prevalence and reductions of anxiety and depression symptoms among youth receiving substance use treatment. Four hundred and eighty adolescents ages 12-17 who received treatment for substance abuse as part of the Brief Strategic Family Therapy (BSFT) effectiveness trial in the National Drug Abuse Treatment Clinical Trials Network (protocol CTN-0014) were screened for anxiety and depression using the Diagnostic Interview Schedule for Children-Predictive Scales (DISC-PS). Twelve-month post-randomization assessments were completed by 327 parents and 315 youth. Sixty-five percent of the sample was found to have probability of at least one anxiety disorder or depression diagnosis. Significant reductions of anxiety and depressive symptoms and significant reductions in probable anxiety and depression diagnoses were observed at follow-up. Few differences by treatment type and ethnic group were noticed.
Conclusions: This article makes a novel contribution to the literature by showing that community-based drug abuse treatments may help reduce the prevalence of anxiety and depression symptoms and probability of diagnoses among adolescents. Adolescents with comorbid substance use and mental health problems constitute a unique clinical population at a very high risk for comorbid problems into adulthood to the extent that it has become one of the most pressing issues in developing and testing effective interventions for drug abuse. Results of this study suggest there were significant reductions in symptoms after treatment, even when controlling for other services that these adolescents might have received for these problems, a discovery with important clinical implications.
Related protocols: CTN-0014
Parent substance use has significant effects on adolescent substance use. Dysfunctional family structure and inadequate parenting practices, resulting from parent substance use, are strongly associated with adolescent substance use. This poster reports on an ancillary investigation of CTN-0014 that sought to determine the effects of Brief Strategic Family Therapy (BSFT) on parent substance use; to determine the impact of parent substance use on adolescent substance use; and to examine the mediating effects of family functioning on the relationship between parent substance use and adolescent substance use. Generalized estimated equations revealed that parents in BSFT significantly decreased their alcohol score from baseline to 12 months at a rate of 0.74. Wilcoxon analyses revealed that children of parents who reported substance use at baseline had twice as many days of reported drug use at baseline compared with children of parents who did not use or only used alcohol. Mixed model longitudinal analyses showed that adolescents in BSFT had a significantly lower trajectory of substance use than those in TAU if their parents used substances at baseline. Mediation analyses indicated a statistically significant effect, evidence that change in family functioning significantly predicts parent alcohol use.
Conclusions: BSFT appears to be effective in reducing alcohol use in parents, and in reducing an adolescent’s substance use if their parents were also using at baseline.
Related protocols: CTN-0014
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 participating in the National Drug Abuse Treatment Clinical Trials Network protocol CTN-0014 (“Brief Strategic Family Therapy for Adolescent Drug Abusers”). 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.
Conclusions: This study adds to the existing research on the assessment of anxiety disorder symptoms in both clinically and theoretically important ways. Findings provide data on multi-informant agreement and highlight issues in the use of the DISC-PS to identify anxiety problems in youth.
Related protocols: CTN-0014
This set of slides features presentations from a symposium at the 2011 APA convention that focused on substance use treatment with ethnic minorities in the National Drug Abuse Treatment Clinical Trials Network. It begins with an overview of the CTN and its aim to improve substance abuse treatment by bridging the gap between practice and research, and then continues with presentations on a variety of ancillary investigations of CTN protocols: a comparison of gender, race/ethnicity, and age groups in people participating in CTN studies; racial/ethnic differences in the rates and correlates of HIV risk behaviors among drug abusers; the relation of racial/ethnic matching to engagement, retention, and treatment outcomes for adolescent substance users; and the relationship between therapist and patient gender/race-matching and substance use outcomes in two motivational therapy trials (CTN-0004 and CTN-0021). Results from each ancillary investigation are presented, along with discussion of the outcomes and study limitations.
Related protocols: CTN-0001, CTN-0002, CTN-0004, CTN-0005, CTN-0006, CTN-0007, CTN-0014, CTN-0021
This is the primary outcomes article for CTN-0014.
This study was designed to determine the effectiveness of brief strategic family therapy (BSFT, an evidence-based family therapy) compared to treatment as usual (TAU) as provided in community-based adolescent outpatient drug abuse programs. In protocol CTN-0014, BSFT was compared to TAU with a multiethnic sample of adolescents (213 Hispanic, 148 White, and 110 Black) referred for drug abuse treatment at eight community treatment agencies nationwide. Randomization encompassed both adolescents’ families (n=480) and the agency therapists (n=49) who provided either TAU or BSFT services. The primary outcome was adolescent drug use, assessed monthly via adolescent self-report and urinalysis for up to 1 year post-randomization. Secondary outcomes included treatment engagement (2 or more sessions), retention (8 or more sessions), and participants’ reports of family functioning 4, 8, and 12 months following randomization. No overall differences between conditions were observed in the trajectories of self-reports of adolescent drug use. However, the median number of days of self-reported drug use was significantly higher in TAU than in BSFT at the final observation point. BSFT was significantly more effective than TAU in engaging and retaining family members in treatment and in improving parent reports of family functioning.
Conclusions: The current findings provide support for the impact of the BSFT intervention on engagement, retention, and parent-reported family functioning with adolescents from diverse racial/ethnic groups. However, the weak effects on drug use outcomes, combined with the difficulties in establishing optimal implementation of the BSFT model, raise concerns about how to most successfully transport the BSFT model into community settings. These challenges, as well as recommendations for further research, are discussed.
Related protocols: CTN-0014
The National Drug Abuse Treatment Clinical Trials Network (CTN) has faced many challenges over its first eleven years. This review explores some of these challenges and the paths the CTN took to meet these challenges, including: designing clinical trials that reflect the CTN’s mission and changing public health needs, finding the synergies in the varied expertise of clinical treatment providers and academic researchers, promoting evidence-based practices, and expanding the Network into mainstream medical practices to reach a broader patient population. Included in this exploration are specific examples from CTN clinical trials.
CTN studies have shown that quality clinical trials can be successfully implemented into practice settings unfamiliar with research logistics by taking clinicians’ practical needs and research knowledge level into account. The challenges yet to be faced in the CTN’s efforts to expand opportunities to offer existing treatments to the segment of the drug-abusing population that utilizes mainstream health care seem large, but not as large as the potential for improvements in public health.
Related protocols: CTN-0001, CTN-0002, CTN-0003, CTN-0004, CTN-0005, CTN-0006, CTN-0007, CTN-0009, CTN-0010, CTN-0011, CTN-0013, CTN-0014, CTN-0015, CTN-0017, CTN-0018, CTN-0019, CTN-0020, CTN-0021, CTN-0027, CTN-0028, CTN-0029, CTN-0030, CTN-0031, CTN-0032, CTN-0037, CTCN-0044, CTN-0047, CTN-0048, CTN-0049
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 ancillary 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 receiving Brief Strategic Family Therapy as part of protocol CTN-0014, “Brief Strategic Family Therapy (BSFT) for Adolescent Drug Abusers.” 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. 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. Although this measure was developed specifically for the BSFT intervention, it is possible that the domains identified may be present in other empirically based family interventions and, as such, future studies may consider validating the use of this or similar measures with other clinical models and populations. The results of this study provide a necessary first step by validating a measure that can be used to capture the complexity of family therapy, and can be used to understand mechanisms of change in family therapy with drug-using youth.
Related protocols: CTN-0014
Behavioral intervention research has lagged behind biomedical research in developing principles for defining, categorizing, identifying, reporting, and monitoring adverse events and unanticipated problems. In this article, a set of principles for defining adverse events are presented, along with how they were applied in the National Drug Abuse Treatment Clinical Trials Network multi-site family therapy study for substance-using adolescents, protocol CTN-0014, the Brief Strategic Family Therapy (BSFT) for Adolescent Drug Abusers study. This study tested how BSFT compares to treatment as usual (TAU) for the treatment of drug-abusing adolescents. During protocol development, experts in the BSFT 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: that the adverse events should be validated and plausible and that monitoring systems should assess relatedness, be systematic, and be a shared responsibility. Non-serious adverse events included arrest, school suspension and drop-out, runaway, kicked out of home, and violence. Serious adverse events included physical or sexual abuse, suicidal behavior, homicidal behavior, hospitalization (drug-related or psychiatric only), and death. More than 50% of the adolescent population experienced an adverse event during the trial. Family members experienced fewer (4.5%). The most common event for the adolescent group was arrest, followed by school suspension/drop-out. For the family member group, the most common event was violence, followed by arrest. There was a significant difference in the presence of adverse events in family members that were randomized to BSFT (6.1%) when compared to TAU (2.8%). One probable explanation for this is that there were more opportunities to identify adverse events for family members assigned to BSFT because family members attended therapy sessions.
The safety plan of the BSFT study has important implications for future studies with drug using adolescents and family-based interventions, though as these principles were developed specific to the issues and challenges faced in this single protocol, the application of the principles in designing procedures for defining and tracking adverse events in research on other behavioral interventions or clinical populations may be limited. Safety data in the BSFT trial support the principles that founded the BSFT safety plan, and illustrate the importance of safety monitoring in behavioral intervention research.
Related protocols: CTN-0014
This article describes the development and implementation of a trial of Brief Strategic Family Therapy (BSFT) in eight community substance abuse treatment programs in the National Drug Abuse Treatment Clinical Trials Network (CTN). BSFT is an evidence-based drug intervention for adolescents that addresses family relationships associated with adolescent drug use. It has been shown to be efficacious in reducing adolescent drug use and conduct problems and in improving family functioning overall.
The CTN protocol, protocol CTN-0014, compared BSFT to adolescent outpatient treatment as usual. Researchers and treatment programs collaborated closely to identify and overcome challenges, many of them related to achieving results that were both scientifically rigorous and applicable to the widest possible variety of adolescent substance abuse treatment programs. To meet these challenges, the collaborative team drew on lessons and practices from efficacy, effectiveness, and implementation research. The strategies described in this paper are particularly relevant for furthering implementation research focused on family-based treatments of adolescents.
Related protocols: CTN-0014
This presentation begins with an update on the CTN-0014 platform study, “Mediators and Moderators of BSFT for Adolescent Drug Use.” Previous research on BSFT, a family therapy based on structural family systems theory, has focused mainly on outcomes, with little attention to how the treatment actually works or for whom it might be the most beneficial. Using protocol CTN-0014 as a platform, the authors tested hypotheses about mediators and moderators of BSFT. The study found within-treatment associations between BSFT fidelity and outcome, with minority participants accounting for most of these associations. Associations between BSFT fidelity and observed family change also varied by ethnicity, with significant correlations appearing for minority families, but not whites. Unfortunately, the study also found that the modal quality of BSFT was considerably less than ideal — most of the cases reviewed by the investigators featured BSFT that was considered less than adequate. As fidelity is at the heart of good psychosocial intervention trials, good treatment effectiveness research, and replicable dissemination, the fact that establishing and maintaining high fidelity was very difficult in this trial warrants further examination.
The presentation ends with reflections on future directions for the CTN, including ways to elevate the study of mechanisms, focus on moderators at both the case and organizational level, study therapist development to maximize fidelity, and have centrally organized but independently conducted trials across sites.
Related protocols: CTN-0014, CTN-0014-A-1
The Brief Strategic Family Therapy for Adolescent Drug Abusers clinical trial (protocol CTN-0014) of 480 adolescent 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.
Related protocols: CTN-0014
Effectiveness trials are an important step in the scientific process of developing and evaluating behavioral treatments. The focus on effectiveness research presents a different set of requirements on the research design when compared with efficacy studies. The choice of a control condition has many implications for a clinical trial’s internal and external validity. The purpose of this article was to provide a discussion of the issues involved in choosing a control group for effectiveness trials of behavioral interventions in substance abuse treatment. It uses examples from the CTN to present four possible design options for randomized clinical trials conducted in community treatment programs involving treatment-seeking individuals.
Protocols cited include CTN-0014 (Brief Strategic Family Therapy), CTN-0020 (Job Seekers), CTN-0015 (Women and Trauma), and the unpublished protocol CTN-0025, which would have investigated the use of Community Reinforcement and Family Training (CRAFT) and Al-Anon Nar-Anon Facilitation Therapy (ANFT) for partners of substance abusers.
Related protocols: CTN-0014, CTN-0015, CTN-0020
Brief strategic family therapy TM (BSFT) is a manualized treatment designed to address aspects of family functioning associated with adolescent drug use and behavior problems. Within the National Institute on Drug Abuse’s Clinical Trials Network (CTN), 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 (protocol CTN-0014). 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.
Related protocols: CTN-0014