Trial Outcomes & Findings for Computer-delivered Screening & Brief Intervention for Marijuana Use in Pregnancy (NCT NCT02191605)

NCT ID: NCT02191605

Last Updated: 2018-07-03

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

60 participants

Primary outcome timeframe

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

Results posted on

2018-07-03

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.	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.	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.	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.
Overall Study STARTED	15	15	15	8	7
Overall Study Completed Intervention Portion	15	15	15	8	7
Overall Study COMPLETED	6	11	8	5	3
Overall Study NOT COMPLETED	9	4	7	3	4

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.	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.	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.	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.
Overall Study Lost to Follow-up	9	4	7	3	4

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Electronic SBIRT (eSBIRT) n=15 Participants 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.	Tailored Texting n=15 Participants 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.	eSBIRT & Texting n=15 Participants 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.	Assessment Only n=8 Participants 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 n=7 Participants 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.	Total n=60 Participants Total of all reporting groups
Age, Continuous	24.3 years STANDARD_DEVIATION 5.9 • n=5 Participants	23.5 years STANDARD_DEVIATION 3.7 • n=7 Participants	27.2 years STANDARD_DEVIATION 5.4 • n=5 Participants	22.6 years STANDARD_DEVIATION 3.2 • n=4 Participants	NA years STANDARD_DEVIATION NA • n=21 Participants	24.6 years STANDARD_DEVIATION 5.0 • n=8 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	15 Participants n=7 Participants	15 Participants n=5 Participants	8 Participants n=4 Participants	7 Participants n=21 Participants	60 Participants n=8 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants	15 Participants n=7 Participants	15 Participants n=5 Participants	8 Participants n=4 Participants	7 Participants n=21 Participants	59 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	11 Participants n=5 Participants	12 Participants n=7 Participants	15 Participants n=5 Participants	8 Participants n=4 Participants	5 Participants n=21 Participants	51 Participants n=8 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	4 Participants n=8 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	5 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
ASSIST marijuana score	9 scores on a scale n=5 Participants	9 scores on a scale n=7 Participants	6 scores on a scale n=5 Participants	6 scores on a scale n=4 Participants	NA scores on a scale n=21 Participants	8 scores on a scale n=8 Participants

PRIMARY outcome

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

Outcome measures

Outcome measures
Measure	Electronic SBIRT (eSBIRT) n=6 Participants 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.	Tailored Texting n=7 Participants 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.	eSBIRT & Texting n=7 Participants 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.	Assessment Only n=3 Participants 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 n=3 Participants 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.
Number of Participants Abstinent From Marijuana for the 7 Days Prior to Delivery	6 Participants	7 Participants	6 Participants	3 Participants	2 Participants

PRIMARY outcome

Timeframe: 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.