search
Back to results

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

Primary Purpose

Marijuana Use, Pregnancy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
eSBIRT
Tailored texting
Sponsored by
Wayne State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Marijuana Use focused on measuring Computerized Brief Intervention

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

  • Wayne State University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

No Intervention

No Intervention

Arm Label

electronic SBIRT (eSBIRT)

Tailored texting

eSBIRT & texting

Assessment only

Screening only

Arm 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.

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.

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
July 14, 2014
Last Updated
June 4, 2018
Sponsor
Wayne State University
Collaborators
National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
search

1. Study Identification

Unique Protocol Identification Number
NCT02191605
Brief Title
Computer-delivered Screening & Brief Intervention for Marijuana Use in Pregnancy
Official Title
Computer-based Screening, Brief Intervention, and Referral to Treatment (SBIRT) for Marijuana Use in Pregnancy: Planning a Stage II Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
September 30, 2015 (Actual)
Primary Completion Date
April 20, 2017 (Actual)
Study Completion Date
October 27, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wayne State University
Collaborators
National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Marijuana Use, Pregnancy
Keywords
Computerized Brief Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
electronic SBIRT (eSBIRT)
Arm Type
Experimental
Arm 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.
Arm Title
Tailored texting
Arm Type
Experimental
Arm 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.
Arm Title
eSBIRT & texting
Arm Type
Experimental
Arm 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.
Arm Title
Assessment only
Arm Type
No Intervention
Arm Description
Participants in the arm will participant in screening and the baseline assessment conducted on the computer only. They will not receive an intervention.
Arm Title
Screening only
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
eSBIRT
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Tailored texting
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants Abstinent From Marijuana for the 7 Days Prior to Delivery
Description
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.
Time Frame
self-reported use during 7 days prior to delivery of their baby
Title
Number of Participants Abstinent From Marijuana for the 90 Days Prior to Delivery
Description
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.
Time Frame
self-reported use during 90 days prior to delivery of their baby

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven J Ondersma, PhD
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

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs