Feasibility and Acceptability Trial to Reduce Tobacco and Cannabis Use During Pregnancy and Postpartum
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Pittsburgh
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Confirmed pregnant
Under 26 weeks gestation
Plan to remain pregnant
English speaking
Disqualifiers
Current opioid use or active treatment for Opioid Use Disorder
Unable to provide informed consent in English
Under 18 years old
Trial design
Design model
Single group
Treatments tested in this trial
Perinatal smoking cessation treatment and maintenance sessions
BehavioralParticipants will meet one-on-one with a study interventionist over the course of 6 prenatal treatment sessions and 3 postpartum maintenance sessions. Sessions will include education and discussion on self-monitoring of targets/ problem identification, psychoeducation, behavioral activation, cognitive restructuring, and mindfulness skills.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: Feasibility and Acceptability TrialExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Attendance
Rate of attendance will be measured by proportion of sessions attended to total available sessions.
Time frame
From enrollment to 3 months postpartum2
Completion of Intervention-Related Procedures
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.
Time frame
From enrollment to 3 months postpartum3
Acceptability of the Intervention
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.
Time frame
From enrollment to 3 months postpartumSecondary outcomes
1
Abstinence from Tobacco Products
Abstinence from tobacco products will be measured by proportion of the participants who self-report no use of tobacco and by calculating the proportion of participants with negative urine screens for cotinine at the 3-month postpartum assessment.
Time frame
Baseline assessment to 3 months postpartum2
Abstinence from Cannabis Products
Abstinence from cannabis products will be measured by proportion of the participants who self-report no use of cannabis and by calculating the proportion of participants with negative urine screens for THC at the 3-month postpartum assessment.
Time frame
Baseline assessment to 3 months postpartum.3
Depressive Symptoms from Baseline
Change in depressive symptoms will be measured through self-report Edinburgh Postnatal Depression Scale (EPDS) at baseline assessment, pre-delivery treatment session, and 1 and 3 months postpartum assessments. The scale range is 0-30, with a higher score indicating higher depression.
Time frame
Baseline assessment to 3 months postpartum4
Change in Tobacco Use from Baseline
Change in tobacco use from baseline will be measured through a self-reported smoking questionnaire given at baseline assessment, pre-delivery treatment session, and 1 and 3 months postpartum assessments.
Time frame
Baseline assessment to 3 months postpartumSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Pittsburgh
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov