Bringing Education Through Technology, Empathic Listening, and Research

Virginia Commonwealth University29 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Pregnancy Related

Interventions

technology-based programBEHAVIORAL

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Virginia Commonwealth University

Richmond, Virginia, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Within 2 weeks of completing the intervention

Secondary Outcomes

Change in Perceived Competence

Participants will complete a 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. An increase in perceived competence suggests a greater sense of confidence, mastery, and belief in one's ability to achieve goals within that area. This can be linked to positive outcomes like improved performance, motivation, and goal attainment. A decrease in perceived competence indicates a diminished sense of self-efficacy and belief in one's abilities, potentially leading to reduced motivation, avoidance of challenges, and lower engagement.

Time frame: Baseline to within 2 weeks of completing the intervention, up to 5 weeks

Change in Parental Competence

Participants will complete a survey assessing their feelings of competence related to the parenting. The items will be rated on a 1 to 6 scale. An increase in perceived competence suggests a greater sense of confidence, mastery, and belief in one's ability to achieve goals within that area. This can be linked to positive outcomes like improved performance, motivation, and goal attainment. A decrease in perceived competence indicates a diminished sense of self-efficacy and belief in one's abilities, potentially leading to reduced motivation, avoidance of challenges, and lower engagement.

Data from ClinicalTrials.gov

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