Computer-delivered Screening & Brief Intervention for Marijuana Use in Pregnancy

Not Applicable

Completed

Conditions: Marijuana Use
Pregnancy

Registration Number: NCT02191605

Lead Sponsor: Wayne State University

Brief Summary: Marijuana is by far the mostly commonly used illicit drug during pregnancy, and prenatal exposure to marijuana can have lasting negative effects. However, current answers to this problem are failing to reach most women who use marijuana while pregnant. This project will develop and begin testing two technology-based, highly practical interventions that could reduce the number of children who are prenatally exposed to marijuana.

Detailed Description: There are at present no evidence-based interventions for marijuana use during pregnancy, despite its being by far the most commonly used illicit drug during pregnancy (particularly among African-American women), and despite growing evidence that it may have a range of long-term cognitive and neurobehavioral consequences. This R34 clinical trial planning grant therefore proposes the development and preliminary validation of two high- reach and mutually compatible technology-based interventions for marijuana use during pregnancy. The first, a theory-based, synchronous, and highly interactive computer-delivered brief intervention, will be based on an emerging knowledge base regarding key elements of efficacious technology-delivered interventions. The second intervention, a series of tailored text messages, will build on the rich literature regarding key tailoring elements. These interventions will be developed and refined with input from pregnant women who report active use of marijuana, as well as from health care providers. They will subsequently be tested-alone and in combination-in a pilot randomized trial involving 80 women actively using marijuana during pregnancy. This Stage I pilot work would set the stage for a confirmatory Stage II trial. It would also produce the first high-reach brief interventions for marijuana use during pregnancy. If effective, these approaches could have a substantial population impact on marijuana use among pregnant women, with potential for lifelong improved outcomes for both mother and child.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 60

Inclusion Criteria

18 to 40 years of age
20 weeks or less gestation
intention to carry pregnancy to term
self-reported marijuana use in month before pregnancy
own a cell phone and willingness to receive text messages
gives consent to access medical records for collection of birth outcome data

Exclusion Criteria

frank cognitive impairment or psychosis
not able to communicate in English
not planning to deliver at a Detroit Medical Center (DMC) hospital
previous or current participant in a study conducted by Dr. Ondersma
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Perinatal Research Branch participant.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Participants Abstinent From Marijuana for the 7 Days Prior to Delivery	self-reported use during 7 days prior to delivery of their baby	Marijuana use will be measured at the time of delivery of their infant by self-report (TimeLine Follow Back interview - TLFB) and urine analysis. This will represent the number of participants who abstinent (reported no marijuana use and had a negative toxicology urine screen) from marijuana for the 7 days prior to delivery.
Number of Participants Abstinent From Marijuana for the 90 Days Prior to Delivery	self-reported use during 90 days prior to delivery of their baby	Marijuana use will be measured at the time of delivery of their infant by self-report (TimeLine Follow Back interview - TLFB) and hair toxicology analysis. This will represent the number of participants who were abstinent (reported no marijuana use and had a negative hair toxicology results) from marijuana for the 90 days prior to delivery.

Secondary Outcome Measures