Reinforcement-Based Treatment for Pregnant Drug Abusers

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.

Conditions

• Drug Use Disorders During Pregnancy

Interventions

BEHAVIORAL

Usual RBT (t-RBT)

Individual therapy CBT skills modules Functional assessment Behavior contracts Behavior graphing Tangible rewards MI feedback Recreation Outreach Social Club Job Club

BEHAVIORAL

Reduced RBT (r-RBT)

Individual therapy CBT skills modules Functional assessment Behavior contracts Behavior graphing Tangible rewards MI feedback Recreation Outreach

BEHAVIORAL

Abbreviated RBT (a-RBT)

Individual therapy CBT skills modules Functional assessment Behavior contracts Behavior graphing Recreation

BEHAVIORAL

Enhanced RBT (e-RBT)

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

BEHAVIORAL

Early compliant t-RBT

r-RBT Individual therapy Skills modules Functional assessment Behavior contracts Behavior graphing Tangible rewards MI feedback Recreation Outreach t-RBT: Social club Job club

BEHAVIORAL

Early non-compliant t-RBT

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

BEHAVIORAL

Early compliant r-RBT

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

BEHAVIORAL

Early non-compliant r-RBT

r-RBT Individual therapy Skills modules Functional assessment Behavior contracts Behavior graphing Tangible rewards MI feedback Recreation Outreach t-RBT: Social Club Job Club

Sponsors & Collaborators

• Johns Hopkins University

  collaborator OTHER

• National Institute on Drug Abuse (NIDA)

  lead NIH

Principal Investigators

• Margaret Chisolm, MD · Johns Hopkins University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

46 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2009-07-31

Primary Completion

2014-01-31

Completion

2015-05-31

Countries

• United States

Study Locations