Indirect Assessment and Intervention for Perinatal Drug Use

Drug Abuse Clinical Trial

Official title:

Indirect Assessment and Intervention for Perinatal Drug Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01650675
• Other study ID #: R01DA029050
• Secondary ID: R01DA029050
• Status: Completed
• Phase: Phase 2
• First received: July 13, 2012
• Last updated: December 7, 2015
• Start date: June 2012
• Est. completion date: May 2015

Study information

• Verified date: December 2015
• Source: Wayne State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: May 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Screening

Related Conditions & MeSH terms

• 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.
• 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.

Locations

Country	Name	City	State
United States	Wayne State University	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Wayne State University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of drug using days	Drug use over past 90 days will be measured at a 3 and 6-month follow-up by self-report, hair, and urine analysis.	since last research visit; up to 90 days prior to current evaluation	No
Primary	Change from Baseline HIV and other STI risk at 3 months	Self-report of risky sexual and/or injection drug use that could place participants at risk of HIV and other STIs	since last research visit; up to 90 days from baseline visit	No
Primary	Change from Baseline in HIV and Other STI Risk at 6 months	Self-report of risky sexual and/or injection drug use that could place participants at risk of HIV and other STIs	since last research visit; up to 180 days since baseline visit	No