Reinforcement-Based Treatment for Pregnant Drug Abusers
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 46 |
| Updated: | 1/12/2017 |
| Start Date: | July 2009 |
| End Date: | May 2015 |
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.
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.
Inclusion Criteria:
1. Treatment entry at or before 34 weeks EGA with singleton fetus.
2. Evidence of opioid, cocaine and/or other primary illicit substance use.
Exclusion Criteria:
1. Severe medical or psychiatric concomitant condition interfering with treatment or
needing hospitalization.
2. Age 17 years or younger.
3. Geographical constraints. These women are admitted only for a residential
detoxification and often have plans to obtain aftercare in an outpatient or
residential facility in closer proximity to their home. Thus, this greater distance
from CAP increases the likelihood that these women will not return to CAP and will
not deliver in a hospital that functions under similar protocols that operate in
Baltimore City for treating drug-exposed neonates.
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