Indirect Assessment and Intervention for Perinatal Drug Use
Condition: Drug Abuse
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): WIDUS computer-delivered, indirect brief intervention; Nutrition time control/placebo intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Screening
Keywords: pregnancy; screening; motivation