Bringing Education Through Technology, Empathic Listening, and Research

NCT05214118 | Completed Results

• 1 other identifier: HM20023314
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• 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

Study Arms (2)

Brochure

NO INTERVENTION

Technology-based program

EXPERIMENTAL

Behavioral: technology-based program

Interventions

technology-based program BEHAVIORAL

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.

Technology-based program

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant females
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Considering/planning adoption
• Present with a serious cognitive/psychiatric impairment
• Existing language barriers making true informed consent impossible

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Results Point of Contact

• Title: Dr. Caitlin E. Martin
• Organization: Virginia Commonwealth University

caitlin.martin@vcuhealth.org

(804) 628-7023

Study Officials

• Caitlin E Martin, MD, MPH

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: January 28, 2022
• Study Start: February 2, 2022
• Primary Completion: January 22, 2024
• Study Completion: January 22, 2024
• Last Updated: July 18, 2025
• Results First Posted: July 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)