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Adolescents with cannabis use disorders: Adaptive treatment for poor responders
Accepted Manuscript Adolescents with cannabis use disorders: Adaptive treatment for poor responders
Yifrah Kaminer, Christine McCauley Ohannessian, Rebecca H. Burke PII: DOI: Reference:
S0306-4603(17)30077-1 doi: 10.1016/j.addbeh.2017.02.013 AB 5088
To appear in:
Addictive Behaviors
Received date: Revised date: Accepted date:
9 December 2016 2 February 2017 8 February 2017
Please cite this article as: Yifrah Kaminer, Christine McCauley Ohannessian, Rebecca H. Burke , Adolescents with cannabis use disorders: Adaptive treatment for poor responders. The address for the corresponding author was captured as affiliation for all authors. Please check if appropriate. Ab(2017), doi: 10.1016/j.addbeh.2017.02.013
This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
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Adolescents with Cannabis Use Disorders: Adaptive Treatment for Poor Responders Yifrah Kaminer, M.D, M.B.A, Christine McCauley Ohannessian, Ph.D., Rebecca H. Burke, M.S.
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All authors are with the Alcohol Research Center and Department of Psychiatry, University of
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Connecticut School of Medicine, 263 Farmington Avenue, Farmington, CT 06030. Dr. Ohannessian is also affiliated with the Children’s Center for Community Research,
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Connecticut Children’s Medical Center, Hartford, CT.
Corresponding Author: Yifrah Kaminer, M.D., M.B.A., Alcohol Research Center at the
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University Of Connecticut School Of Medicine, Farmington, CT 06030-2103;
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e-mail:[email protected]
The authors acknowledge James McKay, Ph.D. and Mark Godley Ph.D. for serving as
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consultants on this study.
Support received from the National Institute on Drug Abuse (NIDA) to Dr. Kaminer
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(RO1 DA 3054-02).
Disclosure: All authors have no conflict of interest to report.
ACCEPTED MANUSCRIPT ABSTRACT Objective: Treatment response as measured by both retention and abstinence attainment rates for adolescents with cannabis use disorders (CUD) has been unsatisfactory. This study tested the hypothesis that adaptive treatment (AT) will improve outcomes for poor responders (PR) to
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evidence-based practice interventions. Method: A total of 161 adolescents, 13-18 years of age,
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diagnosed with DSM-IV CUD, enrolled in this outpatient, randomized, AT study. Following a
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7-session weekly motivational enhancement and cognitive behavioral therapy intervention
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(MET/CBT-7) only poor responders (defined as failing to achieve abstinence at week seven for any reason) were randomized into a 10-week AT phase of either an individualized enhanced
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CBT or an Adolescent Community Reinforcement Approach (ACRA) intervention. Good
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responders (GR) enrolled only in follow-up assessments starting at the completion of the AT phase (week 17). Results: Eighty adolescents (50%) met the criterion for poor response to
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treatment. Thirty seven percent of poor responders completed the AT phase and 27% of them
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achieved abstinence. There was no significant difference in retention and abstinence rates between the AT conditions. Although the majority of GR relapsed by week 17, they significantly
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differed from PR both for drug use (71% vs. 91%, respectively; p<0.05) and reporting to
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scheduled assessment on that week (78% vs. 54%, respectively; p<0.01). Conclusion: Continuity of care to achieve abstinence among poor responders remains a therapeutic necessity and a research challenge. Examining innovative AT designed interventions including potential integrative approaches should be further studied in order to improve treatment outcomes. Key Words: adolescents; cannabis use disorders; treatment outcome; poor responders; continued care, adaptive treatment
ACCEPTED MANUSCRIPT Adolescent substance use disorders (SUD) present considerable clinical and public health problems. Yet effective treatment in outpatient programs continues to pose a significant challenge. Most studies have reported similarly unsatisfactory outcomes regardless of modality including the bench mark multi–center and multi-modal Cannabis Youth Treatment (CYT) study
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(Becker & Curry, 2008; Dennis et al. 2004; Kaminer, Winters & Kelly, 2016; Waldron &
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Turner, 2008). These findings should not come as a surprise given that traditional experimental
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designs have emphasized the comparison of fixed, episodic interventions for evaluating outcomes regardless of clinical severity or how the youth has been responding to treatment.
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Indeed, a review of the literature reported the average rate of sustained abstinence among treated
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youth to be 38% (range: 30-55%) at six months and 32% (range: 14-47%) at 12 months (Williams & Chang, 2000). Furthermore, about 60% of adolescents continue to vacillate in and
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out of recovery three months after discharge from outpatient treatment programs (Brown et al.
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2001; Kaminer, Burleson, & Goldberger, 2002; Winters, 2003). According to Waldron and Turner’s (2008) meta-analysis, the present treatment planning approach has overlooked the most
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important challenges facing treatment of youth including: 1) the heterogeneity of youth response
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to treatment; 2) the problem of poor response to treatment; and 3) the difficulty to prevent or delay relapse. There is growing consensus that SUD is a chronic relapsing disorder requiring a
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continuity of care (McLellan, Lewis, O’Brien, & Kleber, 2000; Scott, Foss, & Dennis, 2005). In order to establish effective continuity of care similar to a psycho-pharmacological treatment algorithm, several key questions about the what, when and sequence of therapeutic changes in psychosocial treatment of individuals with SUD should be addressed. For example, what should be done with patients who do not respond to initial treatment? Should their initial treatment be enhanced or switched to something else? If so, to what specific intervention should it be
ACCEPTED MANUSCRIPT switched? Should they receive another treatment to augment what they are already receiving (McKay, 2009)? A total of 15 adaptive treatment (AT) studies were identified and reviewed by McKay (2009). These studies included eight stepped care studies, four extended adaptive monitoring
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studies, and three adaptive continuation studies. All but one of these studies yielded significant
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results in which adaptive procedures led to either better substance use outcomes or to equivalent
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outcomes in treatments with other advantages (e.g., lower cost, lower patients burden, greater safety, etc.), or produced ways to identify which patients would benefit most from the
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continuation treatments. These results are highly encouraging with regard to the potential
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acceptability and effectiveness of adaptive interventions for substance use disorders. Of note, only three studies have now been published employing continuity of care in
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adolescents with SUD. Two of them by Godley and colleagues who examined youth discharged
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from residential treatment only (Godley MD, Godley SH, Dennis, Funk, & Passetti, 2007; Godley MD, & Godley SH, 2014) and one by Kaminer, Burleson and Burke (2008) was
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conducted in an outpatient setting. Kaminer’s study also generated two aftercare manuals, one
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for individual face-to-face continued care psychotherapy and the other for a brief phone intervention (Kaminer & Napolitano, 2004; Kaminer & Napolitano, 2010). The focus in the
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noted studies was on providing continuity of care for treatment completers. However, since a large segment of youth in treatment does not complete treatment and many youth do not achieve abstinence or sobriety, it is of utmost importance to examine continued care interventions to improve outcomes of poor responders to treatment. The adolescent focused literature provides little guidance to the question of what to do with poor responders to treatment. Furthermore, in order to receive continued care services for the maintenance of treatment gains, adolescents need
ACCEPTED MANUSCRIPT to complete the treatment program (Stevens & Morral, 2003). This common approach raises public health concern because poor responders are at higher risk for continued, exacerbated, or renewed substance use, and substance use related consequences (Kaminer & Godley, 2010). Therefore, poor responders have greater and more costly needs than good responders who have
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achieved abstinence. Studies that provide continued care only for treatment completers render
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themselves vulnerable to the methodological risk of a potential selection bias (Godley MD, &
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Godley SH, 2009). Godley and colleagues (2007) posit that because several episodes of treatment and several potential reentries are the rule rather than the exception for youth with
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SUD, a non-completer status does not necessarily indicate that the youth may fail to benefit from
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continued care. Engaging non-completers has been challenging yet feasible when an effective tracking strategy has been used (Scott, 2004; Scott & Dennis, 1998). Finally, the majority of
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adolescents who initiate at least one week of abstinence (94%) do it by the sixth treatment week,
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suggesting that alternative clinical approaches should commence for poor responders immediately thereafter (Brown PC, Budney, Thostenson, & Stanger, 2013).
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The specific aims of this study were: 1) Evaluate and compare the efficacy of two
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different evidence based interventions;(Cognitive Behavioral Therapy (CBT) and Adolescent Community Reinforcement Approach (ACRA) with good outcome records for both retention,
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engagement and outcome at the end of a 10-week AT phase for those who were poor responders to an initial treatment phase; and 2) Compare outcomes (abstinence and treatment completion rates) of the poor responders to good responders (who have not received continuity of care) at the end of the AT phase. The terms continuity of care and Adaptive treatment (which is one specific form of CC) are used interchangeably throughout the article.
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TABLE 1: Demographics
ACCEPTED MANUSCRIPT METHOD Participants Participants were adolescents (aged 13-18 years) in a psychiatric outpatient clinic. A total of 212 referred adolescents were screened. Of those adolescents screened, 202 met
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eligibility criteria; 172 signed consent forms, and 161 engaged in at least one session of the
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males; 32% Hispanic/Latino and 16% African American.
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initial treatment phase (see Table 1). As shown in Table 1, the sample was composed of 82%
Eligibility criteria included: (a) meeting current DSM-IV diagnosis of CUD (APA, 1994);
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(b) willing to accept aftercare and random assignment to aftercare conditions; (c) able to
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comprehend and read English at a fifth-grade level; (d) participant or family member willing to provide locator information; and (e) not planning move out of state for at least 6 months.
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Adolescents were excluded if they: (a) met any substance dependence criteria other than nicotine
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or alcohol; (b) had a lifetime diagnosis of schizophrenia; (c) reported suicidal ideation with a plan, suicidal behavior, or self-injurious behavior in the last 30 days; or (d) had any current
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medical condition compromising their ability to regularly participate in the study.
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Adolescents and their parent/guardian provided signatures on written informed assent and consent forms (approved by the IRB) after the purpose, procedures, risks, benefits and rights of
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the participants were explained and all questions were answered. Procedures
This was a two-phase, prospective, randomized adaptive treatment study with an intentto-treat design and analysis (Lachin, 2000; Stout, Wirtz, Carbonari, & Del Boca, 1994). The first phase consisted of a weekly MET/CBT-7 manualized intervention that is, two Motivational Enhancement Therapy (MET) individual sessions followed by five Cognitive behavioral Therapy
ACCEPTED MANUSCRIPT (CBT) group sessions (Sampl & Kadden, 2001; Webb, Scudder, Kaminer, & Kadden, 2002). Poor response to initial treatment was defined as failing to achieve abstinence at week seven of the initial treatment for any reason (e.g., positive drug urinalysis or drop out). Poor responders were randomized into a 10-week adaptive treatment phase of either an enhanced individualized
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CBT (Garrett & Kaminer, 2009; Waldron, Slesnick, Brody, & Turner, 2001) or an Adolescent
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Community Reinforcement Approach (ACRA) intervention (Godley SH, Meyers, & Smith,
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2001). Therapists were trained and supervised for adherence to manualized treatment of both interventions throughout the study. The good responders, defined as those who achieved
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abstinence during the MET/CBT-7 were NOT assigned to any intervention following the initial
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treatment phase. However, they were included in the periodic follow-up assessments starting at week 17. That is, all subjects enrolled in the initial treatment phase completed follow-up
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assessments at 5 time points over one year from treatment onset.
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Measures
Demographic Measures. Adolescent gender, age and ethnicity/race were used as
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predictors in the analysis (See Table 1).
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Drug use status. Urinalyses were conducted at baseline and randomly during the initial treatment, and AT phases. The substance use panel assessed: cannabis, cocaine, opiates,
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OxyContin, amphetamines and MDMA. At each urinalysis, adolescents were also asked to report any alcohol or other drug use. Self-reports by adolescents have been found to be highly reliable (Buchan, Dennis ML, Tim, & Diamond, 2002), in particular, when a legal contingency is not pending (Burleson & Kaminer, 2006). If an adolescent was found to be positive either at urinalysis or by self-reports, they were coded as positive for drug use.
ACCEPTED MANUSCRIPT Attendance/engagement. Engagement to adaptive treatment conditions was determined by the number of active sessions attended during the AT phase. Data Analysis Plan Given that the independent variable (responder status) and dependent variables (drug use,
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and treatment completion) all were categorical in nature, chi-square analyses were conducted.
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The relationship between treatment outcomes and the demographic variables were examined
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with independent samples t-tests for the continuous demographic variable (age) and with chisquare analyses for the categorical demographic variables (gender and race/ethnicity).
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RESULTS
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Responder Status and Treatment Outcomes
Eighty adolescents (50%) met the criterion for poor response to treatment. Thirty seven
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percent of poor responders completed the AT phase and 27% of them achieved abstinence. Chi-
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square analyses was conducted to examine the relationship between responder status (good versus poor) and drug use (a self-report of use or failed drug test indicted a positive drug use).
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Responder status was significantly associated with drug use (X2(1) = 6.22, p < .05). More
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specifically, drug use was 71% for good responders and 91% for poor responders. A Chi-square test also was conducted to examine the relationship between responder status and treatment
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completion. Treatment completion was assessed at the end of the adaptive treatment phase assessment at week 17. Responder status was significantly related to reporting for planned post treatment assessment on week 17, 78% and 54% for good responders and poor responders, respectively (X2(1) = 10.33, p < .01). Finally, results from independent samples t-tests and chi square analyses indicated that there were no age, gender or race/ethnicity effects on treatment outcomes.
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(See Table 2 for CONSORT and outcomes).
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TABLE 2 CONSORT and Outcomes
ACCEPTED MANUSCRIPT DISCUSSION This is the first report on adaptive treatment for adolescents with cannabis use disorder (CUD) who have been poor responders to an initial evidence based practice (EBP) intervention. In this study, we defined poor responders as those who were not abstinent from all substance use
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at week 7 or those who failed to provide a negative urine specimen for any reason. We expected
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that poor responders would fall into two sub categories: A larger group composed of those who
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failed to achieve negative drug urinalysis during the last session of the MET/CBT-7 treatment and a smaller group estimated at 15-20% composed of “dropouts” and administratively
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discharged adolescents (due to violation of safety rules or need for a higher intensity level of
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treatment) at any time during the initial treatment. A primary goal of the study was to evaluate and compare the efficacy of two different interventions at the end of a 10-week AT phase for
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those who were poor responders to the initial treatment phase. We have found that there was no
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difference in both retention and abstinence rates between the AT conditions. A second aim was to compare outcomes (abstinence and treatment completion rates) of
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the poor responders to good responders (who have not received continuity of care) at the end of
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the AT phase. Although poor responders were significantly less likely to complete treatment and achieve abstinence, the findings provide initial evidence regarding the relative usefulness of
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continued care for some of these poor responders to treatment in an outpatient setting. Importantly, we have replicated findings from our previous study (Kaminer, Burleson, & Burke, 2008) and other literature reviews (Becker & Curry, 2008; Waldron & Turner, 2008) that more than 60% of good responders to initial treatment may relapse if not provided continuity of care. This result emphasizes the necessity for continued care for good responders due to the relapsing remitting nature of substance use disorders in youth.
ACCEPTED MANUSCRIPT To put these findings in a developmentally informed perspective, it is important to understand that alcohol and substance use increases in many adolescents until they reach their early twenties, at which time young adults manifest moderation or cessation of use (Chung & Maisto, 2006; Labouvie, 1996; Winters, Tanner-Smith, Bresani, & Meyer, 2014). The trajectory
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of increased substance use, therefore, may compromise the likelihood of favorable response to
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treatment and increases the odds for continued use and relapse during the post treatment phase.
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Of note, there is a need to further examine the factors responsible for treatment outcomes in youth. The therapeutic process factors that promote the maintenance of behavior change, such
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as response to aftercare, may differ to some extent from those that promote the initiation of
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change, such as the treatment process.
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McKay’s (2009) suggestions of the pivotal issues that need to be addressed in the research of continued care (CC) include defining the goal of continuing care, which can be either
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relapse prevention and/or harm reduction, that is, limiting the severity of episodes of use if they
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have occurred. McKay has also proposed examining modality and method of service delivery, optimal frequency, dosage, and duration of intervention in order to develop an effective CC.
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Based on a review of the adult literature, McKay concluded that CC interventions of one year or
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longer are more likely to show significant positive effects, and that more structured and intensive CC may be more effective (Mckay, 2009). In order to obtain better clinical results for adolescents with SUD, it might be necessary to consider longer periods of CC interventions and to investigate dose-response associations between the frequencies of interventions with outcome. The main limitation of the study is that the majority of participants were male, as such; the limited representation of females compromises the generalizability of the findings. Participants also resided in the Northeast U.S.; therefore, the sample may not reflect adolescents
ACCEPTED MANUSCRIPT living outside of this region. Other limitations include the use of cross sectional analysis and the lack of a control condition within the poor responders group. Nonetheless, the study has a number of strengths that increase confidence in the validity of the results, including assessment instruments with good psychometric properties, randomization, and manualized EBP-CC
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conditions. The sample also was ethnically diverse.
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Although a limited percentage of these adolescents engaged in continued care the
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alternative, that is, lack of continued care might have resulted even in poorer results. The elusive goal remains how to match the needs of poor responders to more effective adaptive
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interventions. In conclusion, in order to achieve abstinence for poor responders, an innovative
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algorithm of continuity of care remains a therapeutic necessity and a clinical research challenge. The addition of reward incentives could be beneficial (Stanger, Lansing, & Budney, 2016). An
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important next step will be to examine potential integrative approaches (Carroll, Easton, Nich,
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2006; Passetti et al. 2016). It would be important to examine the role of mediators of behavior change, moderators such as participant neurobiological characteristics (Hamilton, Sinha, &
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Potenza, 2014) and specific trajectories from early adolescence to adulthood (Derefinko,
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& Chung, 2014).
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Charingo, Peters, Adams, Milch, & Lynam, 2016) to further improve treatment outcomes (Black
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Kaminer Y, & Napolitano C. (2004). Dial for therapy: Aftercare for adolescent substance use disorders. Journal of the American Academy of Child and Adolescent Psychiatry, 43, 171174. Kaminer Y, Burleson J, & Burke R. (2008). Efficacy of outpatient aftercare for Adolescents with Alcohol Use Disorders: A Randomized Controlled Study. Journal of the American Academy of Child and Adolescent Psychiatry, 47, 1405-1412. Kaminer Y, & Godley M. (2010). Adolescent Substance Use Disorders: From Assessment Reactivity to Post Treatment Aftercare: Are we there yet? Child & Adolescent Psychiatric Clinics of North America, 19, 577-590. Kaminer Y, & Napolitano C. (2010). Brief Telephone Aftercare Therapy for Adolescent Substance Abusers. Hazelden, St Paul, MN, USA. Kaminer Y, Winters KC, & Kelly J. In: (Ed.) Kaminer, Y. (2016). Youth Substance Abuse and CoOccurring Disorders. Am Psychiatric Publishing, Inc, Washington, DC. Labouvie E. (1996). Maturing out of substance use: selection and self-correction. Journal of Drug Issues, 26, 455–474. Lachin JM. (2000). Statistical considerations in the intent-to-treat principle. Controlled Clinical Trials. 21, 167-189. McKay JR. (2009). Treating Substance Use Disorders with Adaptive Continuing Care. University of Pennsylvania and Philadelphia Veterans Affairs Medical Center. McLellan AT, Lewis DC, O’Brien CP, & Kleber HD. (2000). Drug dependence, a chronic mental illness. Journal of the American Medical Association, 284, 1689-1695. Passetti LL, Godley MD, & Kaminer Y. (2016). Continuing care for adolescents in treatment for substance use disorders. Child and Adolescent Psychiatric Clinics of North America, 25, 669684. Sampl S, & Kadden R. (2001). Motivational Enhancement Therapy and Cognitive Behavioral Therapy for Adolescent Cannabis Users: 5 sessions. Cannabis Youth Treatment Series Volume 1. Rockville, MD: Center for Substance Abuse Treatment. Scott CK, Foss MA, & Dennis ML. (2005). Utilizing recovery management checkups to shorten the cycle of relapse, treatment reentry, and recovery. Drug and Alcohol Dependence, 78, 325338. Scott CK, & Dennis ML. (1998). Illinois Health Survey Laboratory Adolescent Follow-up manual. Chestnut Health Systems, Chicago, IL. Scott CK. (2004). A replicable model for achieving over 90% follow-up rates in longitudinal studies of substance abusers. Drug and Alcohol Dependence, 74, 21-36. Stanger C, Lansing AH, & Budney AJ. (2016). Advances in research on contingency management for adolescent substance use. Child and Adolescent Psychiatric Clinics of North America, 25, 645-660. Stevens SJ, & Morral AR (Eds.) (2003). Adolescent substance abuse treatment in the United States: Exemplary models from a national evaluation study. Binghampton, NY: Haworth Press. Stout RL, Wirtz PW, Carbonari JP, & Del Boca FK. (1994). Ensuring balanced distribution of prognostic factors in treatment outcome research. In DM Donovan, ME Mattson (Eds). Alcoholism treatment matching research: Methodological and clinical approaches. Journal on Studies of Alcohol Monograph, 12, 70-75. Waldron HB, Slesnick N, Brody JL, & Turner CW. (2001). Four-and seven-month treatment outcomes for adolescent substance-abuse. Journal on Consulting and Clinical Psychology, 62, 802-813.
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Waldron HB, & Turner CW. (2008). Evidence-based psychological treatments for adolescent substance abuse. Journal of Clinical Child and Adolescent Psychology, 37, 238-261. Webb C, Scudder M, Kaminer Y, & Kadden R. (2002). Motivational Enhancement Therapy and Cognitive Behavioral Therapy for adolescent cannabis users: 7 sessions. Cannabis Youth Treatment Series Volume 1. Rockville, MD: Center for Substance Abuse Treatment. Williams RJ, & Chang SY. (2000). A comprehensive and comparative review of adolescent substance abuse treatment outcome. Clinical Psychology and Scientific Practice, 7, 138-166. Winters KC. Young adult outcomes of an adolescent clinical sample at 5-year follow-up. (2003). Alcoholism: Clinical and Experimental Research, 27, 258-259. Winters, K. C., Tanner-Smith, E. E., Bresani, E., & Meyers, K. (2014). Current advances in treatment of adolescent drug use. Dove Medical Press, 5, 199-210.
ACCEPTED MANUSCRIPT Disclosure: All authors have no conflict of interest to report
The authors acknowledge James McKay, Ph.D. and Mark Godley Ph.D. for serving as consultants on this study.
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Support received from the National Institute on Drug Abuse (NIDA) to Dr. Kaminer
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(RO1 DA 3054-02).
ACCEPTED MANUSCRIPT HIGHLIGHTS Poor response to initial evidence-based treatment for adolescents with CUD is approximately 50%; Poor responders to initial treatment manifest both poor retention and abstinence rates for
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continuity of care in the mode of adaptive treatment (AT);
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There was no significant difference in retention and abstinence rates between the AT conditions ACRA and CBT;
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Examining innovative AT designed interventions including potential integrative approaches
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should be further studied in order to improve treatment outcomes.
Yifrah Kaminer, Christine McCauley Ohannessian, Rebecca H. Burke PII: DOI: Reference:
S0306-4603(17)30077-1 doi: 10.1016/j.addbeh.2017.02.013 AB 5088
To appear in:
Addictive Behaviors
Received date: Revised date: Accepted date:
9 December 2016 2 February 2017 8 February 2017
Please cite this article as: Yifrah Kaminer, Christine McCauley Ohannessian, Rebecca H. Burke , Adolescents with cannabis use disorders: Adaptive treatment for poor responders. The address for the corresponding author was captured as affiliation for all authors. Please check if appropriate. Ab(2017), doi: 10.1016/j.addbeh.2017.02.013
This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT
Adolescents with Cannabis Use Disorders: Adaptive Treatment for Poor Responders Yifrah Kaminer, M.D, M.B.A, Christine McCauley Ohannessian, Ph.D., Rebecca H. Burke, M.S.
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All authors are with the Alcohol Research Center and Department of Psychiatry, University of
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Connecticut School of Medicine, 263 Farmington Avenue, Farmington, CT 06030. Dr. Ohannessian is also affiliated with the Children’s Center for Community Research,
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Connecticut Children’s Medical Center, Hartford, CT.
Corresponding Author: Yifrah Kaminer, M.D., M.B.A., Alcohol Research Center at the
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University Of Connecticut School Of Medicine, Farmington, CT 06030-2103;
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e-mail:[email protected]
The authors acknowledge James McKay, Ph.D. and Mark Godley Ph.D. for serving as
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consultants on this study.
Support received from the National Institute on Drug Abuse (NIDA) to Dr. Kaminer
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(RO1 DA 3054-02).
Disclosure: All authors have no conflict of interest to report.
ACCEPTED MANUSCRIPT ABSTRACT Objective: Treatment response as measured by both retention and abstinence attainment rates for adolescents with cannabis use disorders (CUD) has been unsatisfactory. This study tested the hypothesis that adaptive treatment (AT) will improve outcomes for poor responders (PR) to
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evidence-based practice interventions. Method: A total of 161 adolescents, 13-18 years of age,
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diagnosed with DSM-IV CUD, enrolled in this outpatient, randomized, AT study. Following a
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7-session weekly motivational enhancement and cognitive behavioral therapy intervention
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(MET/CBT-7) only poor responders (defined as failing to achieve abstinence at week seven for any reason) were randomized into a 10-week AT phase of either an individualized enhanced
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CBT or an Adolescent Community Reinforcement Approach (ACRA) intervention. Good
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responders (GR) enrolled only in follow-up assessments starting at the completion of the AT phase (week 17). Results: Eighty adolescents (50%) met the criterion for poor response to
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treatment. Thirty seven percent of poor responders completed the AT phase and 27% of them
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achieved abstinence. There was no significant difference in retention and abstinence rates between the AT conditions. Although the majority of GR relapsed by week 17, they significantly
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differed from PR both for drug use (71% vs. 91%, respectively; p<0.05) and reporting to
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scheduled assessment on that week (78% vs. 54%, respectively; p<0.01). Conclusion: Continuity of care to achieve abstinence among poor responders remains a therapeutic necessity and a research challenge. Examining innovative AT designed interventions including potential integrative approaches should be further studied in order to improve treatment outcomes. Key Words: adolescents; cannabis use disorders; treatment outcome; poor responders; continued care, adaptive treatment
ACCEPTED MANUSCRIPT Adolescent substance use disorders (SUD) present considerable clinical and public health problems. Yet effective treatment in outpatient programs continues to pose a significant challenge. Most studies have reported similarly unsatisfactory outcomes regardless of modality including the bench mark multi–center and multi-modal Cannabis Youth Treatment (CYT) study
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(Becker & Curry, 2008; Dennis et al. 2004; Kaminer, Winters & Kelly, 2016; Waldron &
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Turner, 2008). These findings should not come as a surprise given that traditional experimental
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designs have emphasized the comparison of fixed, episodic interventions for evaluating outcomes regardless of clinical severity or how the youth has been responding to treatment.
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Indeed, a review of the literature reported the average rate of sustained abstinence among treated
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youth to be 38% (range: 30-55%) at six months and 32% (range: 14-47%) at 12 months (Williams & Chang, 2000). Furthermore, about 60% of adolescents continue to vacillate in and
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out of recovery three months after discharge from outpatient treatment programs (Brown et al.
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2001; Kaminer, Burleson, & Goldberger, 2002; Winters, 2003). According to Waldron and Turner’s (2008) meta-analysis, the present treatment planning approach has overlooked the most
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important challenges facing treatment of youth including: 1) the heterogeneity of youth response
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to treatment; 2) the problem of poor response to treatment; and 3) the difficulty to prevent or delay relapse. There is growing consensus that SUD is a chronic relapsing disorder requiring a
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continuity of care (McLellan, Lewis, O’Brien, & Kleber, 2000; Scott, Foss, & Dennis, 2005). In order to establish effective continuity of care similar to a psycho-pharmacological treatment algorithm, several key questions about the what, when and sequence of therapeutic changes in psychosocial treatment of individuals with SUD should be addressed. For example, what should be done with patients who do not respond to initial treatment? Should their initial treatment be enhanced or switched to something else? If so, to what specific intervention should it be
ACCEPTED MANUSCRIPT switched? Should they receive another treatment to augment what they are already receiving (McKay, 2009)? A total of 15 adaptive treatment (AT) studies were identified and reviewed by McKay (2009). These studies included eight stepped care studies, four extended adaptive monitoring
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studies, and three adaptive continuation studies. All but one of these studies yielded significant
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results in which adaptive procedures led to either better substance use outcomes or to equivalent
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outcomes in treatments with other advantages (e.g., lower cost, lower patients burden, greater safety, etc.), or produced ways to identify which patients would benefit most from the
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continuation treatments. These results are highly encouraging with regard to the potential
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acceptability and effectiveness of adaptive interventions for substance use disorders. Of note, only three studies have now been published employing continuity of care in
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adolescents with SUD. Two of them by Godley and colleagues who examined youth discharged
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from residential treatment only (Godley MD, Godley SH, Dennis, Funk, & Passetti, 2007; Godley MD, & Godley SH, 2014) and one by Kaminer, Burleson and Burke (2008) was
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conducted in an outpatient setting. Kaminer’s study also generated two aftercare manuals, one
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for individual face-to-face continued care psychotherapy and the other for a brief phone intervention (Kaminer & Napolitano, 2004; Kaminer & Napolitano, 2010). The focus in the
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noted studies was on providing continuity of care for treatment completers. However, since a large segment of youth in treatment does not complete treatment and many youth do not achieve abstinence or sobriety, it is of utmost importance to examine continued care interventions to improve outcomes of poor responders to treatment. The adolescent focused literature provides little guidance to the question of what to do with poor responders to treatment. Furthermore, in order to receive continued care services for the maintenance of treatment gains, adolescents need
ACCEPTED MANUSCRIPT to complete the treatment program (Stevens & Morral, 2003). This common approach raises public health concern because poor responders are at higher risk for continued, exacerbated, or renewed substance use, and substance use related consequences (Kaminer & Godley, 2010). Therefore, poor responders have greater and more costly needs than good responders who have
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achieved abstinence. Studies that provide continued care only for treatment completers render
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themselves vulnerable to the methodological risk of a potential selection bias (Godley MD, &
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Godley SH, 2009). Godley and colleagues (2007) posit that because several episodes of treatment and several potential reentries are the rule rather than the exception for youth with
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SUD, a non-completer status does not necessarily indicate that the youth may fail to benefit from
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continued care. Engaging non-completers has been challenging yet feasible when an effective tracking strategy has been used (Scott, 2004; Scott & Dennis, 1998). Finally, the majority of
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adolescents who initiate at least one week of abstinence (94%) do it by the sixth treatment week,
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suggesting that alternative clinical approaches should commence for poor responders immediately thereafter (Brown PC, Budney, Thostenson, & Stanger, 2013).
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The specific aims of this study were: 1) Evaluate and compare the efficacy of two
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different evidence based interventions;(Cognitive Behavioral Therapy (CBT) and Adolescent Community Reinforcement Approach (ACRA) with good outcome records for both retention,
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engagement and outcome at the end of a 10-week AT phase for those who were poor responders to an initial treatment phase; and 2) Compare outcomes (abstinence and treatment completion rates) of the poor responders to good responders (who have not received continuity of care) at the end of the AT phase. The terms continuity of care and Adaptive treatment (which is one specific form of CC) are used interchangeably throughout the article.
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TABLE 1: Demographics
ACCEPTED MANUSCRIPT METHOD Participants Participants were adolescents (aged 13-18 years) in a psychiatric outpatient clinic. A total of 212 referred adolescents were screened. Of those adolescents screened, 202 met
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eligibility criteria; 172 signed consent forms, and 161 engaged in at least one session of the
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males; 32% Hispanic/Latino and 16% African American.
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initial treatment phase (see Table 1). As shown in Table 1, the sample was composed of 82%
Eligibility criteria included: (a) meeting current DSM-IV diagnosis of CUD (APA, 1994);
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(b) willing to accept aftercare and random assignment to aftercare conditions; (c) able to
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comprehend and read English at a fifth-grade level; (d) participant or family member willing to provide locator information; and (e) not planning move out of state for at least 6 months.
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Adolescents were excluded if they: (a) met any substance dependence criteria other than nicotine
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or alcohol; (b) had a lifetime diagnosis of schizophrenia; (c) reported suicidal ideation with a plan, suicidal behavior, or self-injurious behavior in the last 30 days; or (d) had any current
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medical condition compromising their ability to regularly participate in the study.
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Adolescents and their parent/guardian provided signatures on written informed assent and consent forms (approved by the IRB) after the purpose, procedures, risks, benefits and rights of
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the participants were explained and all questions were answered. Procedures
This was a two-phase, prospective, randomized adaptive treatment study with an intentto-treat design and analysis (Lachin, 2000; Stout, Wirtz, Carbonari, & Del Boca, 1994). The first phase consisted of a weekly MET/CBT-7 manualized intervention that is, two Motivational Enhancement Therapy (MET) individual sessions followed by five Cognitive behavioral Therapy
ACCEPTED MANUSCRIPT (CBT) group sessions (Sampl & Kadden, 2001; Webb, Scudder, Kaminer, & Kadden, 2002). Poor response to initial treatment was defined as failing to achieve abstinence at week seven of the initial treatment for any reason (e.g., positive drug urinalysis or drop out). Poor responders were randomized into a 10-week adaptive treatment phase of either an enhanced individualized
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CBT (Garrett & Kaminer, 2009; Waldron, Slesnick, Brody, & Turner, 2001) or an Adolescent
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Community Reinforcement Approach (ACRA) intervention (Godley SH, Meyers, & Smith,
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2001). Therapists were trained and supervised for adherence to manualized treatment of both interventions throughout the study. The good responders, defined as those who achieved
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abstinence during the MET/CBT-7 were NOT assigned to any intervention following the initial
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treatment phase. However, they were included in the periodic follow-up assessments starting at week 17. That is, all subjects enrolled in the initial treatment phase completed follow-up
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assessments at 5 time points over one year from treatment onset.
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Measures
Demographic Measures. Adolescent gender, age and ethnicity/race were used as
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predictors in the analysis (See Table 1).
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Drug use status. Urinalyses were conducted at baseline and randomly during the initial treatment, and AT phases. The substance use panel assessed: cannabis, cocaine, opiates,
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OxyContin, amphetamines and MDMA. At each urinalysis, adolescents were also asked to report any alcohol or other drug use. Self-reports by adolescents have been found to be highly reliable (Buchan, Dennis ML, Tim, & Diamond, 2002), in particular, when a legal contingency is not pending (Burleson & Kaminer, 2006). If an adolescent was found to be positive either at urinalysis or by self-reports, they were coded as positive for drug use.
ACCEPTED MANUSCRIPT Attendance/engagement. Engagement to adaptive treatment conditions was determined by the number of active sessions attended during the AT phase. Data Analysis Plan Given that the independent variable (responder status) and dependent variables (drug use,
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and treatment completion) all were categorical in nature, chi-square analyses were conducted.
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The relationship between treatment outcomes and the demographic variables were examined
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with independent samples t-tests for the continuous demographic variable (age) and with chisquare analyses for the categorical demographic variables (gender and race/ethnicity).
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RESULTS
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Responder Status and Treatment Outcomes
Eighty adolescents (50%) met the criterion for poor response to treatment. Thirty seven
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percent of poor responders completed the AT phase and 27% of them achieved abstinence. Chi-
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square analyses was conducted to examine the relationship between responder status (good versus poor) and drug use (a self-report of use or failed drug test indicted a positive drug use).
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Responder status was significantly associated with drug use (X2(1) = 6.22, p < .05). More
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specifically, drug use was 71% for good responders and 91% for poor responders. A Chi-square test also was conducted to examine the relationship between responder status and treatment
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completion. Treatment completion was assessed at the end of the adaptive treatment phase assessment at week 17. Responder status was significantly related to reporting for planned post treatment assessment on week 17, 78% and 54% for good responders and poor responders, respectively (X2(1) = 10.33, p < .01). Finally, results from independent samples t-tests and chi square analyses indicated that there were no age, gender or race/ethnicity effects on treatment outcomes.
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(See Table 2 for CONSORT and outcomes).
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TABLE 2 CONSORT and Outcomes
ACCEPTED MANUSCRIPT DISCUSSION This is the first report on adaptive treatment for adolescents with cannabis use disorder (CUD) who have been poor responders to an initial evidence based practice (EBP) intervention. In this study, we defined poor responders as those who were not abstinent from all substance use
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at week 7 or those who failed to provide a negative urine specimen for any reason. We expected
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that poor responders would fall into two sub categories: A larger group composed of those who
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failed to achieve negative drug urinalysis during the last session of the MET/CBT-7 treatment and a smaller group estimated at 15-20% composed of “dropouts” and administratively
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discharged adolescents (due to violation of safety rules or need for a higher intensity level of
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treatment) at any time during the initial treatment. A primary goal of the study was to evaluate and compare the efficacy of two different interventions at the end of a 10-week AT phase for
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those who were poor responders to the initial treatment phase. We have found that there was no
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difference in both retention and abstinence rates between the AT conditions. A second aim was to compare outcomes (abstinence and treatment completion rates) of
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the poor responders to good responders (who have not received continuity of care) at the end of
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the AT phase. Although poor responders were significantly less likely to complete treatment and achieve abstinence, the findings provide initial evidence regarding the relative usefulness of
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continued care for some of these poor responders to treatment in an outpatient setting. Importantly, we have replicated findings from our previous study (Kaminer, Burleson, & Burke, 2008) and other literature reviews (Becker & Curry, 2008; Waldron & Turner, 2008) that more than 60% of good responders to initial treatment may relapse if not provided continuity of care. This result emphasizes the necessity for continued care for good responders due to the relapsing remitting nature of substance use disorders in youth.
ACCEPTED MANUSCRIPT To put these findings in a developmentally informed perspective, it is important to understand that alcohol and substance use increases in many adolescents until they reach their early twenties, at which time young adults manifest moderation or cessation of use (Chung & Maisto, 2006; Labouvie, 1996; Winters, Tanner-Smith, Bresani, & Meyer, 2014). The trajectory
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of increased substance use, therefore, may compromise the likelihood of favorable response to
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treatment and increases the odds for continued use and relapse during the post treatment phase.
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Of note, there is a need to further examine the factors responsible for treatment outcomes in youth. The therapeutic process factors that promote the maintenance of behavior change, such
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as response to aftercare, may differ to some extent from those that promote the initiation of
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change, such as the treatment process.
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McKay’s (2009) suggestions of the pivotal issues that need to be addressed in the research of continued care (CC) include defining the goal of continuing care, which can be either
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relapse prevention and/or harm reduction, that is, limiting the severity of episodes of use if they
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have occurred. McKay has also proposed examining modality and method of service delivery, optimal frequency, dosage, and duration of intervention in order to develop an effective CC.
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Based on a review of the adult literature, McKay concluded that CC interventions of one year or
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longer are more likely to show significant positive effects, and that more structured and intensive CC may be more effective (Mckay, 2009). In order to obtain better clinical results for adolescents with SUD, it might be necessary to consider longer periods of CC interventions and to investigate dose-response associations between the frequencies of interventions with outcome. The main limitation of the study is that the majority of participants were male, as such; the limited representation of females compromises the generalizability of the findings. Participants also resided in the Northeast U.S.; therefore, the sample may not reflect adolescents
ACCEPTED MANUSCRIPT living outside of this region. Other limitations include the use of cross sectional analysis and the lack of a control condition within the poor responders group. Nonetheless, the study has a number of strengths that increase confidence in the validity of the results, including assessment instruments with good psychometric properties, randomization, and manualized EBP-CC
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conditions. The sample also was ethnically diverse.
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Although a limited percentage of these adolescents engaged in continued care the
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alternative, that is, lack of continued care might have resulted even in poorer results. The elusive goal remains how to match the needs of poor responders to more effective adaptive
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interventions. In conclusion, in order to achieve abstinence for poor responders, an innovative
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algorithm of continuity of care remains a therapeutic necessity and a clinical research challenge. The addition of reward incentives could be beneficial (Stanger, Lansing, & Budney, 2016). An
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important next step will be to examine potential integrative approaches (Carroll, Easton, Nich,
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2006; Passetti et al. 2016). It would be important to examine the role of mediators of behavior change, moderators such as participant neurobiological characteristics (Hamilton, Sinha, &
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Potenza, 2014) and specific trajectories from early adolescence to adulthood (Derefinko,
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& Chung, 2014).
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Charingo, Peters, Adams, Milch, & Lynam, 2016) to further improve treatment outcomes (Black
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Kaminer Y, & Napolitano C. (2004). Dial for therapy: Aftercare for adolescent substance use disorders. Journal of the American Academy of Child and Adolescent Psychiatry, 43, 171174. Kaminer Y, Burleson J, & Burke R. (2008). Efficacy of outpatient aftercare for Adolescents with Alcohol Use Disorders: A Randomized Controlled Study. Journal of the American Academy of Child and Adolescent Psychiatry, 47, 1405-1412. Kaminer Y, & Godley M. (2010). Adolescent Substance Use Disorders: From Assessment Reactivity to Post Treatment Aftercare: Are we there yet? Child & Adolescent Psychiatric Clinics of North America, 19, 577-590. Kaminer Y, & Napolitano C. (2010). Brief Telephone Aftercare Therapy for Adolescent Substance Abusers. Hazelden, St Paul, MN, USA. Kaminer Y, Winters KC, & Kelly J. In: (Ed.) Kaminer, Y. (2016). Youth Substance Abuse and CoOccurring Disorders. Am Psychiatric Publishing, Inc, Washington, DC. Labouvie E. (1996). Maturing out of substance use: selection and self-correction. Journal of Drug Issues, 26, 455–474. Lachin JM. (2000). Statistical considerations in the intent-to-treat principle. Controlled Clinical Trials. 21, 167-189. McKay JR. (2009). Treating Substance Use Disorders with Adaptive Continuing Care. University of Pennsylvania and Philadelphia Veterans Affairs Medical Center. McLellan AT, Lewis DC, O’Brien CP, & Kleber HD. (2000). Drug dependence, a chronic mental illness. Journal of the American Medical Association, 284, 1689-1695. Passetti LL, Godley MD, & Kaminer Y. (2016). Continuing care for adolescents in treatment for substance use disorders. Child and Adolescent Psychiatric Clinics of North America, 25, 669684. Sampl S, & Kadden R. (2001). Motivational Enhancement Therapy and Cognitive Behavioral Therapy for Adolescent Cannabis Users: 5 sessions. Cannabis Youth Treatment Series Volume 1. Rockville, MD: Center for Substance Abuse Treatment. Scott CK, Foss MA, & Dennis ML. (2005). Utilizing recovery management checkups to shorten the cycle of relapse, treatment reentry, and recovery. Drug and Alcohol Dependence, 78, 325338. Scott CK, & Dennis ML. (1998). Illinois Health Survey Laboratory Adolescent Follow-up manual. Chestnut Health Systems, Chicago, IL. Scott CK. (2004). A replicable model for achieving over 90% follow-up rates in longitudinal studies of substance abusers. Drug and Alcohol Dependence, 74, 21-36. Stanger C, Lansing AH, & Budney AJ. (2016). Advances in research on contingency management for adolescent substance use. Child and Adolescent Psychiatric Clinics of North America, 25, 645-660. Stevens SJ, & Morral AR (Eds.) (2003). Adolescent substance abuse treatment in the United States: Exemplary models from a national evaluation study. Binghampton, NY: Haworth Press. Stout RL, Wirtz PW, Carbonari JP, & Del Boca FK. (1994). Ensuring balanced distribution of prognostic factors in treatment outcome research. In DM Donovan, ME Mattson (Eds). Alcoholism treatment matching research: Methodological and clinical approaches. Journal on Studies of Alcohol Monograph, 12, 70-75. Waldron HB, Slesnick N, Brody JL, & Turner CW. (2001). Four-and seven-month treatment outcomes for adolescent substance-abuse. Journal on Consulting and Clinical Psychology, 62, 802-813.
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Waldron HB, & Turner CW. (2008). Evidence-based psychological treatments for adolescent substance abuse. Journal of Clinical Child and Adolescent Psychology, 37, 238-261. Webb C, Scudder M, Kaminer Y, & Kadden R. (2002). Motivational Enhancement Therapy and Cognitive Behavioral Therapy for adolescent cannabis users: 7 sessions. Cannabis Youth Treatment Series Volume 1. Rockville, MD: Center for Substance Abuse Treatment. Williams RJ, & Chang SY. (2000). A comprehensive and comparative review of adolescent substance abuse treatment outcome. Clinical Psychology and Scientific Practice, 7, 138-166. Winters KC. Young adult outcomes of an adolescent clinical sample at 5-year follow-up. (2003). Alcoholism: Clinical and Experimental Research, 27, 258-259. Winters, K. C., Tanner-Smith, E. E., Bresani, E., & Meyers, K. (2014). Current advances in treatment of adolescent drug use. Dove Medical Press, 5, 199-210.
ACCEPTED MANUSCRIPT Disclosure: All authors have no conflict of interest to report
The authors acknowledge James McKay, Ph.D. and Mark Godley Ph.D. for serving as consultants on this study.
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Support received from the National Institute on Drug Abuse (NIDA) to Dr. Kaminer
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(RO1 DA 3054-02).
ACCEPTED MANUSCRIPT HIGHLIGHTS Poor response to initial evidence-based treatment for adolescents with CUD is approximately 50%; Poor responders to initial treatment manifest both poor retention and abstinence rates for
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continuity of care in the mode of adaptive treatment (AT);
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There was no significant difference in retention and abstinence rates between the AT conditions ACRA and CBT;
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Examining innovative AT designed interventions including potential integrative approaches
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should be further studied in order to improve treatment outcomes.