Recruitment

Recruitment Status
Completed
Estimated Enrollment
80

Inclusion Criteria

intention to carry pregnancy to term
self-reported marijuana use in month before pregnancy
20 weeks or less gestation
...
intention to carry pregnancy to term
self-reported marijuana use in month before pregnancy
20 weeks or less gestation
own a cell phone and willingness to receive text messages
18 to 40 years of age
gives consent to access medical records for collection of birth outcome data

Exclusion Criteria

not planning to deliver at a Detroit Medical Center (DMC) hospital
not able to communicate in English
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Perinatal Research Branch participant.
...
not planning to deliver at a Detroit Medical Center (DMC) hospital
not able to communicate in English
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Perinatal Research Branch participant.
frank cognitive impairment or psychosis
previous or current participant in a study conducted by Dr. Ondersma

Summary

Conditions
  • Marijuana Use
  • Pregnancy
Type
Interventional
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Participant, Outcomes Assessor)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 40 years
Gender
Only females

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 neurobe...

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.

Inclusion Criteria

intention to carry pregnancy to term
self-reported marijuana use in month before pregnancy
20 weeks or less gestation
...
intention to carry pregnancy to term
self-reported marijuana use in month before pregnancy
20 weeks or less gestation
own a cell phone and willingness to receive text messages
18 to 40 years of age
gives consent to access medical records for collection of birth outcome data

Exclusion Criteria

not planning to deliver at a Detroit Medical Center (DMC) hospital
not able to communicate in English
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Perinatal Research Branch participant.
...
not planning to deliver at a Detroit Medical Center (DMC) hospital
not able to communicate in English
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Perinatal Research Branch participant.
frank cognitive impairment or psychosis
previous or current participant in a study conducted by Dr. Ondersma

Locations

Detroit, Michigan, 48202
Detroit, Michigan, 48202

Tracking Information

NCT #
NCT02191605
Collaborators
  • National Institutes of Health (NIH)
  • National Institute on Drug Abuse (NIDA)
Investigators
  • Principal Investigator: Steven J Ondersma, PhD Wayne State University
  • Steven J Ondersma, PhD Wayne State University