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

Wayne State University

Status: Completed

Conditions: Marijuana Use; Pregnancy

Treatments: Behavioral: Tailored texting; Behavioral: eSBIRT

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02191605

1R34DA036788 (U.S. NIH Grant/Contract)

R34DA036788

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

60 participants in 5 patient groups

electronic SBIRT (eSBIRT)

Experimental group

Description:

Participants in this condition will receive empathic exploration of their thoughts regarding marijuana use, provision of information on possible consequences of marijuana use during pregnancy and potential benefits of changing use (with permission), normed feedback, use of Motivational Interviewing techniques to elicit their own reasons for change, video testimonials modeling successful change, and information on change methods with optional goal setting.

Treatment:

Behavioral: eSBIRT

Tailored texting

Experimental group

Description:

Participants in this condition will chose the frequency and time of text messages that will continue until childbirth or the participant opts out. The text messages will be a mix of marijuana targeted content (without directly referring to marijuana in a way that implies use by the participant) and general content related to healthy pregnancy; using appropriate humor and tips for community resources. Tailoring will focus on gestational age, self-efficacy, and social support.

Treatment:

Behavioral: Tailored texting

eSBIRT & texting

Experimental group

Description:

Participants in this arm will receive both the computerized intervention and tailored text messaging intervention as described in the eSBIRT and Tailored texting arms.

Treatment:

Behavioral: Tailored texting

Behavioral: eSBIRT

Assessment only

No Intervention group

Description:

Participants in the arm will participant in screening and the baseline assessment conducted on the computer only. They will not receive an intervention.

Screening only

No Intervention group

Description:

Participants in this arm of the study will only answer the screening questions and will not be asked the baseline assessment or participate in an intervention.