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

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.

Study Overview

• Status: Completed
• Conditions: Drug Use Disorders During Pregnancy
• Intervention / Treatment: Behavioral: Usual RBT (t-RBT); Behavioral: Reduced RBT (r-RBT); Behavioral: Abbreviated RBT (a-RBT); Behavioral: Early compliant r-RBT; Behavioral: Enhanced RBT (e-RBT); Behavioral: Early non-compliant t-RBT; Behavioral: Early compliant t-RBT; Behavioral: Early non-compliant r-RBT

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins Bayview Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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: 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
Experimental: Reduced RBT (r-RBT); Individual therapy 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
Experimental: Abbreviated RBT (a-RBT); Individual therapy CBT skills modules Functional assessment Behavior contracts Behavior graphing Recreation	Behavioral: Abbreviated RBT (a-RBT); Individual therapy CBT skills modules Functional assessment Behavior contracts Behavior graphing Recreation; 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
Active Comparator: 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 short term housing admission Recovery sponsor	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 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
Active Comparator: 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 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
Active Comparator: 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 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
Experimental: 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: Abbreviated RBT (a-RBT); Individual therapy CBT skills modules Functional assessment Behavior contracts Behavior graphing Recreation; 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
Experimental: 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	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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Completion	Delivering a baby, regardless of delivery hospital, while enrolled in treatment.	Delivery (data extracted from medical record)
Substance use	Drug Use: Urinalysis testing and self reported use (days in past month) for opioids, cocaine and other illicit substance use.	Once monthly until delivery and at six weeks post-partum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alcohol	Alcohol use: Urinalysis testing and self-reported (days in past month) of alcohol use	Once monthly until delivery and at six weeks post-partum
Maternal Obstetrical Course/Outcome	Available maternal data will be abstracted from the completed delivery record (i.e.., maternal urine toxicology results at delivery, complications during labor/delivery, placental abruption, type of delivery, maternal length of hospital stay).	Delivery (data extracted from medical record)
Birth outcomes	Available birth outcome data will be extracted from infant medical records (i.e., birth weight, gestational age, infant complications).	Delivery (data extracted from medical record)
Length of Hospital Stay	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.	Upon release of infant from hospital (data extracted from medical record)
APGAR scores	Scores assigned at 1 and 5 minutes and any additional Apgar scoring if applicable will be extracted from the infant medical record	Delivery (data extracted from medical record)

Collaborators and Investigators

• Sponsor: National Institute on Drug Abuse (NIDA)
• Collaborators: Johns Hopkins University
• Investigators: Principal Investigator: Margaret Chisolm, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: August 6, 2010
• First Submitted That Met QC Criteria: August 6, 2010
• First Posted (Estimate): August 9, 2010

Study Record Updates

• Last Update Posted (Estimate): January 11, 2017
• Last Update Submitted That Met QC Criteria: January 10, 2017
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: pregnancy, opioid, cocaine, alcohol, benzodiazepines, neonate
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: DA14979-06; R01DA014979 (U.S. NIH Grant/Contract); DCNBR (NIDA)