Reinforcement-Based Treatment for Pregnant Drug Abusers
Condition: Drug Use Disorders During Pregnancy
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Objectives: This project is a Stage II behavioral development study designed to answer
      remaining critical questions necessary before disseminating Reinforcement Based Treatment
      (RBT) to the larger treatment community. These questions focus on the levels of intensity of
      RBT most efficacious for substance-using pregnant patients. Design: The proposed study
      utilizes a novel approach to conducting a controlled clinical trial, the sequential multiple
      assignment randomized trial (SMART) design. Participants (N=220) will first be randomized at
      treatment outset into either treatment-as-usual RBT or a reduced intensity RBT. All
      participants will receive a subsequent randomization based upon an assessment of their
      initial two weeks of treatment compliance. Early-non-compliant participants will be
      randomized to receive either the same or an increased level of RBT treatment intensity while
      early-compliant participants will be randomized to receive either the same or decreased level
      of treatment intensity and scope. Primary outcome measures include treatment completion, and
      maternal heroin, cocaine, and other illicit substance use. Secondary outcome measures include
      maternal measures of HIV risk behavior, and psychosocial functioning and neonatal measures of
      length of hospitalization, and birth outcomes. Significance: The proposed project's
      innovation includes: the novelty RBT, use of a cutting-edge SMART model, application of
      advanced statistical techniques and inclusion of a cost-effectiveness approach. The proposed
      project's significance is exceedingly high, as it will lay the foundation for later Stage III
      studies focused on dissemination of stepped care treatment programs for drug-addicted
      pregnant women that can be implemented not only in comprehensive care clinics but in diverse
      community settings that provide services to such women.
    


Intervention name(s): Usual RBT (t-RBT); Reduced RBT (r-RBT); Abbreviated RBT (a-RBT); Enhanced RBT (e-RBT); Early compliant t-RBT; Early non-compliant t-RBT; Early compliant r-RBT; Early non-compliant r-RBT
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral; Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Individual therapy CBT skills modules Functional assessment Behavior contracts Behavior graphing Tangible rewards MI feedback Recreation Outreach Social Club Job Club; Individual therapy CBT skills modules Functional assessment Behavior contracts Behavior graphing Tangible rewards MI feedback Recreation Outreach; Individual therapy CBT skills modules Functional assessment Behavior contracts Behavior graphing Recreation; Individual therapy CBT skills modules Functional assessment Behavior contracts Behavior graphing Tangible rewards MI feedback Recreation Outreach Social club Job Club Recovery housing CAP housing admission Recovery sponsor; r-RBT Individual therapy Skills modules Functional assessment Behavior contracts Behavior graphing Tangible rewards MI feedback Recreation Outreach t-RBT: Social club Job club; t-RBT Individual therapy CBT skills modules Functional assessment Behavior contracts Behavior graphing Tangible rewards MI feedback Recreation Outreach Social club Job club e-RBT: Recovery housing CAP short term housing admission Recovery sponsor; a-RBT Individual therapy CBT skills modules Functional assessment Behavior contracts Behavior graphing Recreation r-RBT: Individual therapy Skills modules Functional assessment Behavior contracts Behavior graphing Tangible rewards MI feedback Recreation Outreach; r-RBT Individual therapy Skills modules Functional assessment Behavior contracts Behavior graphing Tangible rewards MI feedback Recreation Outreach t-RBT: Social Club Job Club
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: pregnancy, opioid, cocaine, alcohol, benzodiazepines, neonate