N/A
N=29
Bringing Education Through Technology, Empathic Listening, and Research
Pregnancy Related
Bottom Line
View on ClinicalTrials.gov: NCT05214118 ↗Enrolled (actual)
29
Serious AEs
3.5%
Results posted
Jul 2025
Primary outcome: Primary: Feasibility of the Intervention — 21.5; 21.2 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- technology-based program (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Virginia Commonwealth University
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of the Intervention |
21.5; 21.2 | — |
| PRIMARY Acceptability of the Intervention |
47.6; 48.3 | — |
| SECONDARY Change in Perceived Competence |
.75; .3 | — |
| SECONDARY Change in Parental Competence |
3.3; -1.5 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Female
- ≥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
Data sourced from ClinicalTrials.gov (NCT05214118). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.