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

This study has been completed.
Sponsor:
Collaborator:
Johns Hopkins University
Information provided by (Responsible Party):
Hendree E. Jones, National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT01177982
First received: August 6, 2010
Last updated: July 24, 2015
Last verified: July 2015
  Purpose

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.


Condition Intervention Phase
Drug Use Disorders During Pregnancy
Behavioral: Usual RBT (t-RBT)
Behavioral: Reduced RBT (r-RBT)
Behavioral: Abbreviated RBT (a-RBT)
Behavioral: Enhanced RBT (e-RBT)
Behavioral: Early compliant t-RBT
Behavioral: Early non-compliant t-RBT
Behavioral: Early compliant r-RBT
Behavioral: Early non-compliant r-RBT
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Reinforcement-Based Treatment for Pregnant Drug Abusers

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Treatment Completion [ Time Frame: Delivery (data extracted from medical record) ] [ Designated as safety issue: No ]
    Delivering a baby, regardless of delivery hospital, while enrolled in treatment.

  • Substance use [ Time Frame: Once monthly until delivery and at six weeks post-partum ] [ Designated as safety issue: Yes ]
    Drug Use: Urinalysis testing and self reported use (days in past month) for opioids, cocaine and other illicit substance use.


Secondary Outcome Measures:
  • Alcohol [ Time Frame: Once monthly until delivery and at six weeks post-partum ] [ Designated as safety issue: Yes ]
    Alcohol use: Urinalysis testing and self-reported (days in past month) of alcohol use

  • Maternal Obstetrical Course/Outcome [ Time Frame: Delivery (data extracted from medical record) ] [ Designated as safety issue: Yes ]
    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).

  • Birth outcomes [ Time Frame: Delivery (data extracted from medical record) ] [ Designated as safety issue: Yes ]
    Available birth outcome data will be extracted from infant medical records (i.e., birth weight, gestational age, infant complications).

  • Length of Hospital Stay [ Time Frame: Upon release of infant from hospital (data extracted from medical record) ] [ 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 (data extracted from medical record) ] [ Designated as safety issue: Yes ]
    Scores assigned at 1 and 5 minutes and any additional Apgar scoring if applicable will be extracted from the infant medical record


Enrollment: 220
Study Start Date: July 2009
Study Completion Date: May 2015
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 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
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

  Eligibility

Ages Eligible for Study:   18 Years to 46 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01177982

Locations
United States, Maryland
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Margaret Chisolm, MD Johns Hopkins University
  More Information

No publications provided

Responsible Party: Hendree E. Jones, Adjunct Professor, National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT01177982     History of Changes
Other Study ID Numbers: DA14979-06, R01DA014979, DCNBR
Study First Received: August 6, 2010
Last Updated: July 24, 2015
Health Authority: United States: Federal Government
United States:IRB-JHU

Keywords provided by National Institute on Drug Abuse (NIDA):
pregnancy, opioid, cocaine, alcohol, benzodiazepines, neonate

ClinicalTrials.gov processed this record on August 26, 2015