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

• Sponsor: Wayne State University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02191605
• Collaborator: National Institutes of Health (NIH) (NIH), National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 60
• Location: 1
• Arms: 5
• Actual Duration (Months): 24.9
• Patients Per Site Per Month: 2.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Marijuana Use; Pregnancy	Behavioral: eSBIRT; Behavioral: Tailored texting	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Computer-based Screening, Brief Intervention, and Referral to Treatment (SBIRT) for Marijuana Use in Pregnancy: Planning a Stage II Trial
• Actual Study Start Date: Sep 30, 2015
• Actual Primary Completion Date: Apr 20, 2017
• Actual Study Completion Date: Oct 27, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: 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.
Experimental: 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.	Behavioral: 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.
Experimental: 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.	Behavioral: 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.; Behavioral: 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.
No Intervention: 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.
No 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.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wayne State University	Detroit	Michigan	United States	48202

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Steven J Ondersma, PhD, Wayne State University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 17, 2018

More Information

Publications

None provided.

• Responsible Party: Steven J. Ondersma, Professor, Wayne State University
• ClinicalTrials.gov Identifier: NCT02191605
• Other Study ID Numbers: R34DA036788; 1R34DA036788
• First Posted: Jul 16, 2014
• Last Update Posted: Jul 3, 2018
• Last Verified: Jun 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Steven J. Ondersma, Professor, Wayne State University: Computerized Brief Intervention
• Additional relevant MeSH terms: Marijuana Abuse; Marijuana Use

Study Results

Participant Flow

Arm/Group Title	Electronic SBIRT (eSBIRT)	Tailored Texting	eSBIRT & Texting	Assessment Only	Screening Only
Arm/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. 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.	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.	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.	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.
Period Title: Overall Study
STARTED	15	15	15	8	7
Completed Intervention Portion	15	15	15	8	7
COMPLETED	6	11	8	5	3
NOT COMPLETED	9	4	7	3	4

Baseline Characteristics

Arm/Group Title	Electronic SBIRT (eSBIRT)	Tailored Texting	eSBIRT & Texting	Assessment Only	Screening Only	Total
Arm/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. 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.	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.	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.	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.	Total of all reporting groups
Overall Participants	15	15	15	8	7	60
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	24.3 (5.9)	23.5 (3.7)	27.2 (5.4)	22.6 (3.2)	NA (NA)	24.6 (5.0)
Sex: Female, Male (Count of Participants)
Female	15 100%	15 100%	15 100%	8 100%	7 100%	60 100%
Male	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 6.7%	0 0%	0 0%	0 0%	0 0%	1 1.7%
Not Hispanic or Latino	14 93.3%	15 100%	15 100%	8 100%	7 100%	59 98.3%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	11 73.3%	12 80%	15 100%	8 100%	5 71.4%	51 85%
White	1 6.7%	2 13.3%	0 0%	0 0%	1 14.3%	4 6.7%
More than one race	3 20%	1 6.7%	0 0%	0 0%	1 14.3%	5 8.3%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
ASSIST marijuana score (scores on a scale) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [scores on a scale]	9	9	6	6	NA	8

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Electronic SBIRT (eSBIRT)	Tailored Texting	eSBIRT & Texting	Assessment Only	Screening Only
Arm/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. 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.	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.	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.	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.
Measure Participants	6	7	7	3	3
Count of Participants [Participants]	6 40%	7 46.7%	6 40%	3 37.5%	2 28.6%

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Electronic SBIRT (eSBIRT)	Tailored Texting	eSBIRT & Texting	Assessment Only	Screening Only
Arm/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. 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.	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.	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.	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.
Measure Participants	3	6	2	2	3
Count of Participants [Participants]	2 13.3%	5 33.3%	1 6.7%	2 25%	2 28.6%

Adverse Events

Time Frame	remainder of the pregnancy (24-20 weeks)
Arm/Group Title	Electronic SBIRT (eSBIRT)		Tailored Texting		eSBIRT & Texting		Assessment Only		Screening Only
Arm/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. 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.		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.		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.		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.
All Cause Mortality
	Electronic SBIRT (eSBIRT)		Tailored Texting		eSBIRT & Texting		Assessment Only		Screening Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)		0/15 (0%)		0/8 (0%)		0/7 (0%)
Serious Adverse Events
	Electronic SBIRT (eSBIRT)		Tailored Texting		eSBIRT & Texting		Assessment Only		Screening Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)		0/15 (0%)		0/8 (0%)		0/7 (0%)
Other (Not Including Serious) Adverse Events
	Electronic SBIRT (eSBIRT)		Tailored Texting		eSBIRT & Texting		Assessment Only		Screening Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)		0/15 (0%)		0/8 (0%)		0/7 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.