Bringing Education Through Technology, Empathic Listening, and Research

Study Overview
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Brief Summary
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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.

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

Conditions
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Pregnancy Related

Intervention / Treatment
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* Behavioral: technology-based program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Considering/planning adoption Present with a serious cognitive/psychiatric impairment Existing language barriers making true informed consent impossible

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Brochure<br> | |
| Experimental: Technology-based program<br> | Behavioral: technology-based program<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |