Bringing Education Through Technology, Empathic Listening, and Research

Pregnancy Related Clinical Trial

— BETTER  

Official title:

Project BETTER: Bringing Education Through Technology, Empathic Listening, and Research - A Feasibility Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05214118
• Other study ID #: HM20023314
• Status: Completed
• Phase: N/A
• Start date: February 2, 2022
• Est. completion date: January 22, 2024

Study information

• Verified date: February 2024
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Pregnancy Related

Intervention

Behavioral:
• technology-based program
Participants will be asked to complete three 25-minute modules covering the transition from pregnancy to postpartum, possible neonatal abstinence syndrome (NAS) or neonatal withdrawal syndrome (NOWS), and interactions with child welfare.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

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