NCT06652880

Digital Support Intervention for Pregnant People with Opioid Use Disorders

Exploring the Preliminary Effects of a Digital Parenting and Recovery Support Intervention for Pregnant People Seeking Recovery from Opioid Use Disorders: a Pilot Randomized Control Trial

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: University of South Carolina · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

The goal of this pilot randomized feasibility study is to explore the benefits of providing parenting and recovery support for pregnant people with Opioid Use Disorders through digital technology (e.g. smartphones). The main question it aims to answer is: • What is the feasibility of providing customized digital parenting and recovery supports to pregnant people with Opioid Use Disorders residing in natural communities? o Feasibility data includes data on study interest, eligibility, time to enroll, participant training on digital app usage, attrition; Secondary outcome exploratory data will include MOUD treatment retention, missed follow up prenatal and early postpartum appointments, drug usage, and parenting outcomes (i.e., scores on the Parental sense of competency scale, Self-rated abilities for health practices scale, and Self-efficacy in infant care scale) through self-report; The intervention group only will also be observed regarding app usage, frequency of use, resources accessed, thoughts about the app, and what was found to be helpful. Researchers will compare the bibliotherapy control group to determine clinical differences in secondary outcomes. Participants will complete the following tasks: * Schedule an online meeting with the research team to receive more information about the study. Once consented to participate, the participant will be randomly assigned to one of the groups. * Complete survey questions within one week after agreeing to participate in the study, after 6 weeks, and 12 weeks. The surveys include questions about drug usage, missed follow-up medical appointments, and parenting outcomes. The total time to complete the survey after consenting to be in the study will take approximately 40 minutes. The total time to complete the surveys after the six week and 12-week study period should take no more than 30 minutes. * Complete a one-hour virtual interview at three months post-delivery (by phone or computer) about the study experience.

Conditions

• Digital Intervention
• Bibliotherapy

Interventions

Type	Name	Description
DEVICE	Digital technology	The digital app is a customized comprehensive self-management platform designed to provide recovery and parenting support for individuals with substance use disorders.
OTHER	Bibliotherapy	Bibliotherapy control group will receive parenting book what to expect the first year.

Timeline

• Start date: 2024-06-04
• Primary completion: 2025-08-28
• Completion: 2025-12-31
• First posted: 2024-10-22
• Last updated: 2025-02-17

Locations

1 site across 1 country: United States