Partnering With Pregnant and Postpartum People to Co-Create a Novel Intervention to Reduce Tobacco and Cannabis Use
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Pittsburgh
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Attendance
Study Overview
Brief Summary
Using both tobacco and cannabis during pregnancy is more common in minoritized groups and can make quitting smoking in pregnancy and remaining smoke free postpartum difficult. Investigators will test an intervention to address prenatal depressive symptoms to encourage people to quit tobacco and cannabis during pregnancy and stay quit postpartum.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Confirmed pregnant
- •Under 26 weeks gestation
- •Plan to remain pregnant
- •English speaking
- •Use of combustible tobacco at least once a week during pregnancy, or at least once a week in the 3 months before pregnancy if stopped
- •Use of cannabis at any frequency during pregnancy or in the 3 months before pregnancy if stopped
Exclusion Criteria
- •Current opioid use or active treatment for Opioid Use Disorder
- •Unable to provide informed consent in English
- •Under 18 years old
Arms & Interventions
Feasibility and Acceptability Trial
Intervention: Perinatal smoking cessation treatment and maintenance sessions (Behavioral)
Outcomes
Primary Outcomes
Attendance
Time Frame: From enrollment to 3 months postpartum
Rate of attendance will be measured by proportion of sessions attended to total available sessions.
Completion of Intervention-Related Procedures
Time Frame: From enrollment to 3 months postpartum
Participant will complete activities designed to help them self-monitor their smoking-related behaviors during and between scheduled treatment sessions. Completion of activities will be measured by the proportion of completed activities to the total number of assigned activities.
Acceptability of the Intervention
Time Frame: From enrollment to 3 months postpartum
Participants' acceptance of the intervention will be measured using the Acceptability of Intervention Measure (AIM) at the 3-month postpartum assessment. This is a 4-item questionnaire with a scale range of 4-20, with a higher score indicating greater acceptance.
Secondary Outcomes
- Abstinence from Tobacco Products(Baseline assessment to 3 months postpartum)
- Abstinence from Cannabis Products(Baseline assessment to 3 months postpartum.)
- Depressive Symptoms from Baseline(Baseline assessment to 3 months postpartum)
- Change in Tobacco Use from Baseline(Baseline assessment to 3 months postpartum)
- Change in Cannabis Use from Baseline(Baseline assessment to 3 months postpartum)
Investigators
Natacha DeGenna
Associate Professor of Psychiatry, Epidemiology, Clinical and Translational Science
University of Pittsburgh