Reinforcement-Based Treatment for Pregnant Drug Abusers (HOME II)

National Institutes of Health (NIH)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Drug Use Disorders During Pregnancy

Treatments: Behavioral: Early non-compliant r-RBT; Behavioral: Reduced RBT (r-RBT); Behavioral: Early non-compliant t-RBT; Behavioral: Enhanced RBT (e-RBT); Behavioral: Early compliant r-RBT; Behavioral: Abbreviated RBT (a-RBT); Behavioral: Usual RBT (t-RBT); Behavioral: Early compliant t-RBT

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01177982

DCNBR

R01DA014979 (U.S. NIH Grant/Contract)

DA14979-06

Details and patient eligibility

About

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.

Enrollment: 220 patients

Sex: Female

Ages: 18 to 46 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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220 participants in 8 patient groups

Usual RBT (t-RBT)

Active Comparator group

Description:

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

Treatment:

Behavioral: Usual RBT (t-RBT)

Reduced RBT (r-RBT)

Experimental group

Description:

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

Treatment:

Behavioral: Reduced RBT (r-RBT)

Abbreviated RBT (a-RBT)

Experimental group

Description:

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

Treatment:

Behavioral: Early compliant r-RBT

Behavioral: Abbreviated RBT (a-RBT)

Enhanced RBT (e-RBT)

Active Comparator group

Description:

Individual therapy CBT skills modules Functional assessment Behavior contracts Behavior graphing Tangible rewards MI feedback Recreation Outreach Social club Job club Recovery housing CAP short term housing admission Recovery sponsor

Treatment:

Behavioral: Early non-compliant t-RBT

Behavioral: Enhanced RBT (e-RBT)

Early compliant t-RBT

Active Comparator group

Description:

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

Treatment:

Behavioral: Early compliant t-RBT

Early non-compliant t-RBT

Active Comparator group

Description:

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

Treatment:

Behavioral: Early non-compliant t-RBT

Behavioral: Early compliant r-RBT

Early compliant r-RBT

Experimental group

Description:

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

Treatment:

Behavioral: Early compliant r-RBT

Behavioral: Abbreviated RBT (a-RBT)

Early non-compliant r-RBT

Experimental group

Description:

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

Treatment:

Behavioral: Early non-compliant r-RBT

Behavioral: Early non-compliant t-RBT