Family and Adolescent Motivational Incentives for Leveraging Youth
Condition: Substance-Related Disorders
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      Research has provided support for the efficacy of cognitive-behavioral and family
      interventions for adolescent substance use disorders (SUD), HIV-risk behaviors, and related
      problems. Despite support for these interventions, substantial heterogeneity in treatment
      outcomes and high relapse rates has been consistently found across studies. Such variability
      highlights the need for innovative strategies to broaden the impact and strengthen the
      durability of effects of adolescent substance abuse treatments. Over the past two decades,
      research has shown the positive effects of contingency management (CM) methods on reductions
      in substance use and other problem behaviors. When combined with evidence-based practices,
      emerging research suggests that CM integration may also be effective for adolescent substance
      abusers. The proposed Stage II efficacy trial examines the integration of CM with two
      empirically-supported interventions: group MET/CBT and FFT. By comparing two intervention
      modalities (group vs. family, the study provides a unique opportunity to examine the
      robustness of the effects of CM across established adolescent treatments, and to compare
      change mechanisms that may account for treatment outcomes. In the proposed research,
      substance abusing adolescents (n = 160) will be randomly assigned either to FFT or group
      MET/CBT. Random assignment will also be used to determine whether or not youth will receive a
      CM condition that provides incentives for abstinence (i.e., clean urine screens) and
      treatment participation. The primary aim of the study is to examine the efficacy of an
      integrated CM intervention for the two evidence-based treatments for adolescents, MET/CBT and
      FFT, compared to these treatments without CM on drug abuse abstinence (a) during treatment
      (i.e., speed of effects) and (b) at post-treatment follow-up assessments (i.e., durability of
      effects). A second aim of the study is to evaluate the effects of CM on hypothesized
      mediators of the intervention effects in the MET/CBT and the FFT conditions. The
      investigators anticipate that the CM conditions, compared to the nonCM conditions, are more
      likely to accelerate the adolescent's motivation (1) to achieve abstinence, to attend and
      participate in treatment, and to complete homework assignments. The investigators will also
      examine the effects of the interventions on HIV-risk behaviors and expect that CM will
      demonstrate the largest reductions in HIV-risk behaviors compared to the nonCM conditions.
    

Detailed description: 
      Research has provided support for the efficacy of cognitive-behavioral and family
      interventions for adolescent substance use disorders (SUD), HIV-risk behaviors, and related
      problems. Despite support for these interventions, substantial heterogeneity in treatment
      outcomes and high relapse rates have been consistently found across studies. Such variability
      highlights the need for innovative strategies to broaden the impact and strengthen the
      durability of effects of adolescent substance abuse treatments. Over the past two decades,
      research has demonstrated the positive effects of contingency management (CM) methods on
      reductions in substance use and other problem behaviors such as HIV-risk, primarily with
      adults. CM has been shown to improve outcomes when combined with evidence-based practices and
      research is emerging to suggest that such integrations may also be effective for adolescent
      substance abusers. The proposed Stage II efficacy trial examines the integration of CM with
      two empirically-supported interventions: group MET/CBT and FFT. By comparing two intervention
      modalities (group vs. family, the study provides a unique opportunity to examine the
      robustness of the effects of CM across established adolescent treatments, and to compare
      change mechanisms that may account for treatment outcomes. In the proposed research,
      substance abusing adolescents (n = 160) will be randomly assigned either to FFT or group
      MET/CBT. Random assignment will also be used to determine whether or not youth will receive a
      CM condition that provides incentives for abstinence (i.e., clean urine screens) and
      treatment participation. Thus, participants will receive one of four intervention conditions,
      two with an integrated CM intervention (MET/CBT-CM, FFT-CM) and two without CM (MET/CBT,
      FFT). The study will employ a 2 (Incentives: CM, nonCM) x 2 (Modality: MET/CBT, FFT) x 5
      (Time: Baseline, 2-, 4-, 8-, and 12-months post-randomization) factorial design. The primary
      aim of the study is to examine the efficacy of an integrated CM intervention for the two
      evidence-based treatments for adolescents, MET/CBT and FFT, compared to these treatments
      without CM on drug abuse abstinence (a) during treatment (i.e., speed of effects) and (b) at
      post-treatment follow-up assessments (i.e., durability of effects). A second aim of the study
      is to evaluate the effects of CM on hypothesized mediators of the intervention effects in the
      MET/CBT and the FFT conditions. The investigators anticipate that the CM conditions, compared
      to the nonCM conditions, are more likely to accelerate the adolescent's motivation (1) to
      achieve abstinence, to attend and participate in treatment, and to complete homework
      assignments. Exploratory analyses will examine differences between modalities (MET/CBT vs
      FFT) on the presumed mediators. The investigators expect that MET/CBT will produce greater
      improvements in adolescents' drug avoidance self-efficacy and FFT will produce greater
      improvements in family relationships. The investigators will also examine the effects of the
      interventions on HIV-risk behaviors and expect that CM will demonstrate the largest
      reductions in HIV-risk behaviors compared to the nonCM conditions.

      The study addresses the question of whether adding a Contingency Management (CM) approach, in
      which adolescents are provided with a monetary incentive for providing clean urine, enhances
      the efficacy of two research-proven interventions for adolescent substance use. Specifically,
      the investigators compare if Functional Family Therapy (FFT) and Motivational
      Enhancement/Cognitive Behavioral Therapy (MET/CBT) combined with CM are better than either
      intervention alone. The investigators also explore the extent to which the addition of CM
      increases the speed with which adolescents achieve abstinence as well as the durability of
      these effects over time. The inclusion of two distinct forms of therapy also permits the
      investigation of how the interventions achieve their effects on adolescent drug use (e.g.,
      improvements in family functioning in FFT vs. improvements in drug avoidance and
      self-efficacy skills in MET/CBT).

      Specific Aim 1: To evaluate the efficacy of CM versus nonCM conditions delivered in the
      context of either group (MET/CBT) or family (FFT) treatments for substance abusing
      adolescents. The investigators will use two substance use dependent variables. The first
      variable assesses the presence or absence of illegal substances in urine samples collected
      weekly beginning at baseline and continuing during the 12-14 weeks of scheduled treatment.
      Urine samples will be collected at all post-randomization assessments. Although most of the
      adolescents are polydrug users, marijuana is the primary drug of abuse. The investigators
      anticipate that once weekly urine screens will be able to detect recent marijuana use. The
      Time Line Follow-back (TLFB) will be used to provide weekly estimates of drug use abstinence
      for a period from 3 months before to 12 months after randomization. Specifically, the
      investigators predict that the CM versus the nonCM conditions will produce a significant main
      effect increase in the number of weeks of drug use abstinence during the treatment phase
      (i.e., months 1-4; Hypothesis 1a) and during the post treatment period (i.e., 4-12 months;
      Hypothesis 1b).

      Specific Aim 2: To evaluate the efficacy of CM versus nonCM on secondary behavioral outcomes.
      Specifically, The investigators predict that CM versus the nonCM conditions will be
      associated with significantly lower levels of sexually risky behaviors (Hypothesis 2a) and
      conduct problems (Hypothesis 2b) over time.

      Specific Aim 3: To evaluate the effects of CM on hypothesized mediators of the MET/CBT and
      the FFT intervention effects. The investigators anticipate that the CM conditions are more
      likely than the nonCM conditions to accelerate the adolescent's motivation (1) to achieve
      abstinence, (2) to attend and participate in treatment, (3) to complete homework assignments.
      The SOCRATES scale will assess their motivation to achieve abstinence. Specifically, the
      investigators predict that youth receiving the CM versus nonCM will show higher rates of
      motivation for change at the 2-month assessment (Hypothesis 3a) and higher rates of treatment
      attendance and homework compliance (as measured by weekly therapist reports) over the course
      of treatment (Hypothesis 3b).

      Exploratory Aims: The investigators will conduct exploratory analyses to examine if the
      number of continuous weeks of abstinence during treatment, adolescent's motivation to achieve
      abstinence, attendance, and homework compliance will mediate abstinence following treatment.
      Additional analyses will examine differences between modalities (MET/CBT vs FFT) on the
      presumed mediators: MET/CBT will produce greater improvements in adolescent's drug avoidance
      self-efficacy and FFT will produce greater improvements in family relationships (as measured
      by the FES). Improvements in drug avoidance self-efficacy and family relationships will
      mediate improvements in MET/CBT and FFT, respectively. The investigators will also explore
      potential differences within modality to determine if adding CM enhances the effects of each
      modalities impact on the presumed mediators of outcome. The results of these analyses will
      help determine if there is sufficient merit to warrant additional research into mechanisms of
      action within each modality. Finally, the investigators will conduct an informal
      cost-effectiveness analysis to derive preliminary estimates of the relative costs of each
      treatment modality, particularly with respect to treatment engagement/attendance and youth
      outplacement to restricted settings.
    

Intervention name(s): Functional Family Therapy; Motivational Enhancement Tx/Cognitive Behavioral Tx; Contingency Management
Intervention type(s): Behavioral; Behavioral; Behavioral
Other intervention name(s): FFT; MET/CBT; CM
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Substance Abuse; Adolescents; Families; Functional Family Therapy; Cognitive Behavioral Therapy; Motivational Therapy; Contingency Management