NCT01177982

Reinforcement-Based Treatment for Pregnant Drug Abusers

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: National Institute on Drug Abuse (NIDA) · NIH
• Sex: Female
• Age: 18 Years – 46 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2009-07-01
• Primary completion: 2014-01-01
• Completion: 2015-05-01
• First posted: 2010-08-09
• Last updated: 2017-01-11

Locations

1 site across 1 country: United States