Indirect Assessment and Intervention for Perinatal Drug Use

• ClinicalTrials.gov Identifier: NCT01650675
• Recruitment Status: Completed
• First Posted: July 26, 2012
• Last Update Posted: December 8, 2015
• Sponsor: Wayne State University
• Collaborator: National Institute on Drug Abuse (NIDA)
• Information provided by (Responsible Party): Steven J. Ondersma, Wayne State University

Tracking Information

• First Submitted Date: July 13, 2012
• First Posted Date: July 26, 2012
• Last Update Posted Date: December 8, 2015
• Study Start Date: June 2012
• Actual Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 23, 2012)

• Number of drug using days [ Time Frame: since last research visit; up to 90 days prior to current evaluation ]
  Drug use over past 90 days will be measured at a 3 and 6-month follow-up by self-report, hair, and urine analysis.
• Change from Baseline HIV and other STI risk at 3 months [ Time Frame: since last research visit; up to 90 days from baseline visit ]
  Self-report of risky sexual and/or injection drug use that could place participants at risk of HIV and other STIs
• Change from Baseline in HIV and Other STI Risk at 6 months [ Time Frame: since last research visit; up to 180 days since baseline visit ]
  Self-report of risky sexual and/or injection drug use that could place participants at risk of HIV and other STIs

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Indirect Assessment and Intervention for Perinatal Drug Use
• Official Title: Indirect Assessment and Intervention for Perinatal Drug Use
• Brief Summary: The purpose of this study is to assess the validity of an indirect computer-delivered screener for drug use and assess the efficacy of a computer-delivered brief intervention with urban post-partum women at-risk for substance abuse and HIV during the post-partum period.
• Detailed Description: Two factors limit the potential of brief interventions for the reduction of substance abuse and HIV risk. First, the ability to conduct such interventions is dependent upon willingness to disclose drug use and risky sexual behaviors. This is a significant obstacle given evidence that as few as half of drug-positive individuals-particularly women in the perinatal period-report that use. Second, there are logistic and financial obstacles to implementing even brief intervention programs, particularly with regard to time, training and provider willingness. In response to these limitations, and with NIDA support (DA018975), the Parent Health Lab at the Wayne State University School of Medicine developed and validated a sensitive indirect screener that evaluates correlates of illicit drug use rather than drug use itself. The Lab also developed a brief computer-delivered intervention designed to build change motivation without presuming the presence of risks to accompany the screener. This intervention demonstrated excellent feasibility and acceptability in Phase I testing. Following NIDA's Stage Model of Behavioral Therapy Development, the proposed study will take the next step of validating the computer-delivered indirect screening and intervention process in a Phase II/Stage IIb trial with women determined to be at risk by the indirect drug use screener. In addition, given that 47.8% of the prior sample's participants had an STI at some point in their lives, the proposed study will also further expand the existing focus on HIV risk. Specifically, we plan to: (a) continue development and validation of the WIDUS screener via concomitant collection of WIDUS protocols and hair/urine samples, as well as by building its ability to indirectly predict HIV risk; (b) revise and upgrade the draft indirect intervention based on expert and participant informant feedback; (c) recruit 500 at-risk women from an urban obstetric hospital; and (d) randomly assign participants into intervention and control conditions, with blinded follow-up assessments at 3- and 6-months. If proven efficacious, this logistically feasible, replicable, and low-cost approach could allow a dramatic increase in the reach--and therefore the population impact--of brief interventions for drug use among at-risk post-partum women. Further, any impact on maternal drug use would be further multiplied by indirect effects on the at-risk child.
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Screening
• Condition: Drug Abuse

Intervention

• Behavioral: WIDUS computer-delivered, indirect brief intervention
  A single 20-minute interactive computer-delivered intervention designed to promote motivation to change drug use and risky sexual behavior, if any, without presuming those risks to be specifically present.
• Behavioral: Nutrition time control/placebo intervention
  This time-control intervention, designed in part to help promote RA blinding as to participant condition, focuses on proper infant nutrition using a computer-delivered, interactive format and videos.

Study Arms

• Placebo Comparator: Control
  Participants randomized into the control condition complete assessment and a time-matched interactive session on infant nutrition.
  Intervention: Behavioral: Nutrition time control/placebo intervention
• Experimental: Indirect intervention
  Participants in this condition review a short series of parenting strengths that benefit infants, and are invited to consider their current status in each area. This list includes factors associated with drug use (e.g., safety, emotional health) as well as substance use itself.
  Intervention: Behavioral: WIDUS computer-delivered, indirect brief intervention

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 23, 2012): 500
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: May 2015
• Actual Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 18 years of age or older
• able to communicate in English
• recently gave birth to healthy infant

Exclusion Criteria:

• received narcotic pain medication in past 3 hours
• no sleep since giving birth
• infant deceased or in intensive care
• psychosis or other clear cognitive impairment

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01650675
• Other Study ID Numbers: R01DA029050( U.S. NIH Grant/Contract ); R01DA029050 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Steven J. Ondersma, Wayne State University
• Study Sponsor: Wayne State University
• Collaborators: National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Steven J Ondersma, Ph.D.; Wayne State University

• PRS Account: Wayne State University
• Verification Date: December 2015