Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Indirect Assessment and Intervention for Perinatal Drug Use

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Wayne State University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Steven J. Ondersma, Wayne State University
ClinicalTrials.gov Identifier:
NCT01650675
First received: July 13, 2012
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Drug Abuse
Behavioral: WIDUS computer-delivered, indirect brief intervention
Behavioral: Nutrition time control/placebo intervention
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Screening
Official Title: Indirect Assessment and Intervention for Perinatal Drug Use

Resource links provided by NLM:


Further study details as provided by Wayne State University:

Primary Outcome Measures:
  • Number of drug using days [ Time Frame: since last research visit; up to 90 days prior to current evaluation ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Self-report of risky sexual and/or injection drug use that could place participants at risk of HIV and other STIs


Estimated Enrollment: 500
Study Start Date: June 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control
Participants randomized into the control condition complete assessment and a time-matched interactive session on infant nutrition.
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.
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.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  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: NCT01650675

Contacts
Contact: Casey Thacker, MPH 3139931365 cthacker@med.wayne.edu

Locations
United States, Michigan
Wayne State University Recruiting
Detroit, Michigan, United States, 48202
Contact: Casey Thacker, MPH    313-993-1365    cthacker@med.wayne.edu   
Principal Investigator: Steven J Ondersma, Ph.D.         
Sponsors and Collaborators
Wayne State University
Investigators
Principal Investigator: Steven J Ondersma, Ph.D. Wayne State University
  More Information

No publications provided

Responsible Party: Steven J. Ondersma, Associate Professor, Wayne State University
ClinicalTrials.gov Identifier: NCT01650675     History of Changes
Other Study ID Numbers: R01DA029050, R01DA029050
Study First Received: July 13, 2012
Last Updated: July 7, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Wayne State University:
pregnancy
screening
motivation

ClinicalTrials.gov processed this record on November 27, 2014