Pregnancy Related Clinical Trial
— BETTEROfficial title:
Project BETTER: Bringing Education Through Technology, Empathic Listening, and Research - A Feasibility Randomized Controlled Trial
Verified date | February 2024 |
Source | Virginia Commonwealth University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 31 |
Est. completion date | January 22, 2024 |
Est. primary completion date | October 10, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Female 2. =18 years of age 3. Meet criteria for Opioid Use Disorder 4. Currently receiving MOUD pharmacotherapy (including buprenorphine, buprenorphine/naloxone, or methadone) 5. Pregnant (<34 weeks EGA) 6. Initial in-person visit at OB MOTIVATE clinic for the current pregnancy =10 weeks ago Exclusion Criteria: 1. Considering/planning adoption 2. Present with a serious cognitive/psychiatric impairment 3. Existing language barriers making true informed consent impossible |
Country | Name | City | State |
---|---|---|---|
United States | Virginia Commonwealth University | Richmond | Virginia |
Lead Sponsor | Collaborator |
---|---|
Virginia Commonwealth University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility of 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. | Within 2 weeks of completing the intervention | |
Primary | Acceptability of 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. | Within 2 weeks of completing the intervention | |
Secondary | Change in perceived competence | Participants will complete a 12 survey assessing their feelings of competence related to the information covered by the intervention. The items will be rated on a 1 to 7 scale. Higher scores indicated higher perceived competence. | Baseline to within 2 weeks of completing the intervention, up to 5 weeks | |
Secondary | Change in parental competence | Participants will complete a 16 survey assessing their feelings of competence related to the parenting. The items will be rated on a 1 to 6 scale. Higher scores indicated higher perceived parental competence. | Baseline to within 2 weeks of completing the intervention, up to 5 weeks |
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