Bringing Education Through Technology, Empathic Listening, and Research

Not Applicable

Completed

• Conditions: Pregnancy Related
• Interventions: Behavioral: technology-based program

• Registration Number: NCT05214118
• Lead Sponsor: Virginia Commonwealth University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-10
• Study First Submitted QC: 2022-01-27
• Study First Posted: 2022-01-28
• Study Start: 2022-02-02
• Primary Completion: 2024-01-22
• Study Completion: 2024-01-22
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-10
• Last Update Posted: 2024-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Technology-based program	technology-based program	-

Primary Outcome Measures

Name	Time	Method
Feasibility of the intervention	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	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 Outcome Measures

Name	Time	Method
Change in perceived competence	Baseline to within 2 weeks of completing the intervention, up to 5 weeks	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.
Change in parental competence	Baseline to within 2 weeks of completing the intervention, up to 5 weeks	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.

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States