Indirect Assessment and Intervention for Perinatal Drug Use
Primary Purpose
Drug Abuse
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
WIDUS computer-delivered, indirect brief intervention
Nutrition time control/placebo intervention
Sponsored by
About this trial
This is an interventional screening trial for Drug Abuse focused on measuring pregnancy, screening, motivation
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
Sites / Locations
- Wayne State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Control
Indirect intervention
Arm Description
Participants randomized into the control condition complete assessment and a time-matched interactive session on infant nutrition.
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.
Outcomes
Primary Outcome Measures
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.
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
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01650675
First Posted
July 13, 2012
Last Updated
December 7, 2015
Sponsor
Wayne State University
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT01650675
Brief Title
Indirect Assessment and Intervention for Perinatal Drug Use
Official Title
Indirect Assessment and Intervention for Perinatal Drug Use
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wayne State University
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Abuse
Keywords
pregnancy, screening, motivation
7. Study Design
Primary Purpose
Screening
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
500 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Participants randomized into the control condition complete assessment and a time-matched interactive session on infant nutrition.
Arm Title
Indirect intervention
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
WIDUS computer-delivered, indirect brief intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Nutrition time control/placebo intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of drug using days
Description
Drug use over past 90 days will be measured at a 3 and 6-month follow-up by self-report, hair, and urine analysis.
Time Frame
since last research visit; up to 90 days prior to current evaluation
Title
Change from Baseline HIV and other STI risk at 3 months
Description
Self-report of risky sexual and/or injection drug use that could place participants at risk of HIV and other STIs
Time Frame
since last research visit; up to 90 days from baseline visit
Title
Change from Baseline in HIV and Other STI Risk at 6 months
Description
Self-report of risky sexual and/or injection drug use that could place participants at risk of HIV and other STIs
Time Frame
since last research visit; up to 180 days since baseline visit
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven J Ondersma, Ph.D.
Organizational Affiliation
Wayne State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
12. IPD Sharing Statement
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Indirect Assessment and Intervention for Perinatal Drug Use
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