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

• Treatment Completion [ Time Frame: delivery ] [ Designated as safety issue: No ]
  Delivering a baby, regardless of delivery hospital, while enrolled in treatment.
• drug use [ Time Frame: during and post-treatment ] [ Designated as safety issue: Yes ]
  Drug Use: Self-reported drug use of heroin and cocaine will be collected monthly with the ASI. Self-report will be verified by urine drug screening.

• urine testing [ Time Frame: baseline, during and post-treatment ] [ Designated as safety issue: Yes ]
  Urines will be tested immediately using a rapid test for cocaine and opiate metabolites.Urines are tested daily for 2 weeks. From two weeks until study delivery, urine samples will be collected twice a week .
• Alcohol [ Time Frame: baseline, during and post-treatment ] [ Designated as safety issue: Yes ]
  Each time a urine sample is collected, a breathalyzer reading will also be obtained
• Maternal Weight Gain [ Time Frame: baseline, during and post-treatment ] [ Designated as safety issue: Yes ]
  Assessed at every prenatal visit. Change from CAP admission controlled for gestational age at admission will be calculated. Weight is collected as a measure of maternal health.
• Maternal Obstetrical Course/Outcome [ Time Frame: delivery ] [ Designated as safety issue: Yes ]
  These data will be abstracted from the completed delivery record (e.g., Number of OB visits, maternal urine toxicology results at delivery, complications during labor/delivery, placental abruption, and type of delivery, maternal length of hospital stay, length of labor, use of pain medication).
• Physical Birth Parameters [ Time Frame: delivery and postnatal ] [ Designated as safety issue: Yes ]
  Initial birth weight, head circumference, and length provide measures of neonatal well-being and health. Thus, this information will be abstracted from medical records.
• Length of Hospital Stay [ Time Frame: postnatal ] [ Designated as safety issue: Yes ]
  Length of hospital stay is an indicator of health and well-being. The total days in the Newborn Nursery, Pediatrics and Neonatal Intensive Care will be abstracted from the medical records.
• APGAR scores [ Time Frame: delivery ] [ Designated as safety issue: Yes ]
  Scores are assigned to every infant after birth at 1 and 5 minutes, and if compromised, at 10 and 20 minutes.

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 drug-addicted pregnant patients, whether the outcomes achieved with women not receiving methadone will be similar when methadone-maintained patients are included, the individual mediators and moderators that determine which RBT treatment level is best for which patient, and the cost-effectiveness of RBT treatment. Design: The proposed study utilizes a novel approach to conducting a controlled clinical trial, the sequential multiple assignment randomized trial (SMART) design. Participants (N=300) 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 and cocaine use. Secondary outcome measures include maternal measures of HIV risk behavior, other drug use, and psychosocial functioning and neonatal measures of length of hospitalization, physical birth parameters, neurological integrity, and behavioral functioning. Innovation and 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.

• Behavioral: Usual RBT
  Individual therapy Skills modules Functional assessment Behavior contracts Behavior graphing Tangible rewards MI feedback Recreation Outreach Social Club Job Club
• Behavioral: Lite RBT
  Individual therapy Skills modules Functional assessment Behavior contracts Behavior graphing Tangible rewards MI feedback Recreation Outreach
• Behavioral: Less RBT
  Individual therapy Skills modules Functional assessment Behavior contracts Behavior graphing Recreation
• Behavioral: Intense RBT
  Individual therapy Skills modules Functional assessment Behavior contracts Behavior graphing Tangible rewards MI feedback Recreation Outreach Social club Job Club Recovery housing ALU admission Recovery sponsor

• Active Comparator: Lite RBT
  Individual therapy Skills modules Functional assessment Behavior contracts Behavior graphing Tangible rewards MI feedback Recreation Outreach
  Interventions:

  • Behavioral: Lite RBT
  • Behavioral: Less RBT
• Experimental: Usual RBT
  Individual therapy Skills modules Functional assessment Behavior contracts Behavior graphing Tangible rewards MI feedback Recreation Outreach Social Club Job Club
  Interventions:

  • Behavioral: Usual RBT
  • Behavioral: Intense RBT

Inclusion Criteria:

1 Treatment entry at or before 32 weeks EGA with singleton fetus. 3) Evidence of cocaine and/or opiate use.

4) Completion of the residential detoxification stay.

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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