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

NCT02191605 | Completed Results DMC

• 2 other identifiers: R34DA0367881R34DA036788
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Marijuana Use; Pregnancy

Keywords

Computerized Brief Intervention

Outcome Measures

Primary Outcomes (2)

• Number of Participants Abstinent From Marijuana for the 7 Days Prior to Delivery

  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.

  self-reported use during 7 days prior to delivery of their baby

• Number of Participants Abstinent From Marijuana for the 90 Days Prior to Delivery

  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.

  self-reported use during 90 days prior to delivery of their baby

Study Arms (5)

electronic SBIRT (eSBIRT)

EXPERIMENTAL

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.

Behavioral: eSBIRT

Tailored texting

EXPERIMENTAL

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.

Behavioral: Tailored texting

eSBIRT & texting

EXPERIMENTAL

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

Behavioral: eSBIRT; Behavioral: Tailored texting

Assessment only

NO INTERVENTION

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

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.

Interventions

eSBIRT BEHAVIORAL

A single 20 minute interactive computer-delivered intervention designed to promote motivation to change prenatal marijuana use, without presuming the participant to be currently using marijuana while pregnant.

eSBIRT & texting; electronic SBIRT (eSBIRT)

Tailored texting BEHAVIORAL

Group text messaging software from Trumpia, Inc. will be used to create the tailored text messages that will be sent to participants assigned to this intervention. Text messages will sent after the initial study participation visit until childbirth or participant opts out of receiving them.

Tailored texting; eSBIRT & texting

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• to 40 years of age
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wayne State University: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Wayne State University

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Marijuana Use

Condition Hierarchy (Ancestors)

Behavior; Substance-Related Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Jessica Beatty
• Organization: Wayne State University, Merrill Palmer Skillman Institute

jbeatty@wayne.edu

3136642518

Study Officials

• Steven J Ondersma, PhD

  Wayne State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 14, 2014
• First Posted: July 16, 2014
• Study Start: September 30, 2015
• Primary Completion: April 20, 2017
• Study Completion: October 27, 2017
• Last Updated: July 3, 2018
• Results First Posted: July 3, 2018

Record last verified: 2018-06

Locations

US (1)