Indirect Assessment and Intervention for Perinatal Drug Use

NCT01650675 | Completed Phase 2

• 1 other identifier: R01DA029050
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug Abuse

Keywords

pregnancy; screening; motivation

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Control

PLACEBO COMPARATOR

Participants randomized into the control condition complete assessment and a time-matched interactive session on infant nutrition.

Behavioral: Nutrition time control/placebo intervention

Indirect intervention

EXPERIMENTAL

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

Interventions

WIDUS computer-delivered, indirect brief intervention BEHAVIORAL

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.

Indirect intervention

Nutrition time control/placebo intervention BEHAVIORAL

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.

Control

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wayne State University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Wayne State University

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Steven J Ondersma, Ph.D.

  Wayne State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 13, 2012
• First Posted: July 26, 2012
• Study Start: June 1, 2012
• Primary Completion: November 1, 2014
• Study Completion: May 1, 2015
• Last Updated: December 8, 2015

Record last verified: 2015-12

Locations

US (1)