Marijuana Use, Pregnancy
Conditions
Keywords
Computerized Brief Intervention
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.
Interventions
BEHAVIORALeSBIRT
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.
BEHAVIORALTailored texting
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.
Sponsors
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Wayne State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Electronic SBIRT (eSBIRT) 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.
eSBIRT: 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. | 15 |
| Tailored Texting 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.
Tailored texting: 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. | 15 |
| eSBIRT & Texting Participants in this arm will receive both the computerized intervention and tailored text messaging intervention as described in the eSBIRT and Tailored texting arms.
eSBIRT: 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.
Tailored texting: 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. | 15 |
| Assessment Only Participants in the arm will participant in screening and the baseline assessment conducted on the computer only. They will not receive an intervention. | 8 |
| Screening Only 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. | 7 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 9 | 4 | 7 | 3 | 4 |
Baseline characteristics
| Characteristic | Electronic SBIRT (eSBIRT) | Tailored Texting | eSBIRT & Texting | Assessment Only | Screening Only | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 24.3 years STANDARD_DEVIATION 5.9 | 23.5 years STANDARD_DEVIATION 3.7 | 27.2 years STANDARD_DEVIATION 5.4 | 22.6 years STANDARD_DEVIATION 3.2 | NA years | 24.6 years STANDARD_DEVIATION 5 |
| ASSIST marijuana score | 9 scores on a scale | 9 scores on a scale | 6 scores on a scale | 6 scores on a scale | NA scores on a scale | 8 scores on a scale |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 15 Participants | 15 Participants | 8 Participants | 7 Participants | 59 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 12 Participants | 15 Participants | 8 Participants | 5 Participants | 51 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 4 Participants |
| Sex: Female, Male Female | 15 Participants | 15 Participants | 15 Participants | 8 Participants | 7 Participants | 60 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 8 | 0 / 7 |
| other Total, other adverse events | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 8 | 0 / 7 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 8 | 0 / 7 |
Outcome results
Primary
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.
Time frame: self-reported use during 7 days prior to delivery of their baby
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Electronic SBIRT (eSBIRT) | Number of Participants Abstinent From Marijuana for the 7 Days Prior to Delivery | 6 Participants |
| Tailored Texting | Number of Participants Abstinent From Marijuana for the 7 Days Prior to Delivery | 7 Participants |
| eSBIRT & Texting | Number of Participants Abstinent From Marijuana for the 7 Days Prior to Delivery | 6 Participants |
| Assessment Only | Number of Participants Abstinent From Marijuana for the 7 Days Prior to Delivery | 3 Participants |
| Screening Only | Number of Participants Abstinent From Marijuana for the 7 Days Prior to Delivery | 2 Participants |
Primary
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.
Time frame: self-reported use during 90 days prior to delivery of their baby
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Electronic SBIRT (eSBIRT) | Number of Participants Abstinent From Marijuana for the 90 Days Prior to Delivery | 2 Participants |
| Tailored Texting | Number of Participants Abstinent From Marijuana for the 90 Days Prior to Delivery | 5 Participants |
| eSBIRT & Texting | Number of Participants Abstinent From Marijuana for the 90 Days Prior to Delivery | 1 Participants |
| Assessment Only | Number of Participants Abstinent From Marijuana for the 90 Days Prior to Delivery | 2 Participants |
| Screening Only | Number of Participants Abstinent From Marijuana for the 90 Days Prior to Delivery | 2 Participants |