Project BETTER: Bringing Education Through Technology, Empathic Listening, and Research - A Feasibility Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 29
- Locations
- 2
- Primary Endpoint
- Feasibility of the Intervention
Study Overview
Brief Summary
The purpose of this study is to test a new educational technology-based program and brochure as a supplement to prenatal education from providers. The program provides education about common challenges that pregnant and parenting women receiving medication for Opioid Use Disorder (OUD) often face. Specifically, it addresses the transition from pregnancy to postpartum, possible neonatal abstinence syndrome (NAS) or neonatal withdrawal syndrome (NOWS), and interactions with child welfare.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •≥18 years of age
- •Meet criteria for Opioid Use Disorder
- •Currently receiving MOUD pharmacotherapy (including buprenorphine, buprenorphine/naloxone, or methadone)
- •Pregnant (<34 weeks EGA)
- •Initial in-person visit at OB MOTIVATE clinic for the current pregnancy ≤10 weeks ago
Exclusion Criteria
- •Considering/planning adoption
- •Present with a serious cognitive/psychiatric impairment
- •Existing language barriers making true informed consent impossible
Outcomes
Primary Outcomes
Feasibility of the Intervention
Time Frame: Within 2 weeks of completing the intervention
Participants will complete a survey about the feasibility of the intervention consisting of 4 items rated on a 0 to 6 scale. Scores will be summed to yield a final feasibility score ranging from 0 to 24. Higher scores indicate higher feasibility.
Acceptability of the Intervention
Time Frame: Within 2 weeks of completing the intervention
Participants will complete a survey about the acceptability of the intervention consisting of 10 items rated on a 1 to 5 scale. Higher scores indicated higher acceptability.
Secondary Outcomes
- Change in Perceived Competence(Baseline to within 2 weeks of completing the intervention, up to 5 weeks)
- Change in Parental Competence(Baseline to within 2 weeks of completing the intervention, up to 5 weeks)