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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05214118
Other study ID # HM20023314
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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