Digital Support Intervention for Pregnant People with Opioid Use Disorders

NCT ID: NCT06652880

Last Updated: 2025-02-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-04
• Study Completion Date: 2025-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Customized Digital Application group (Intervention)

Participants are assigned to one of two groups where they will receive one type of parenting support. The intervention group will receive a smartphone app which provides access to comprehensive resources related to parenting and recovery.

The intervention group will be observed to determine how frequently they use the digital app, thoughts about it, and what was found to be helpful. This will occur over a 12-week period.

The intervention group will complete surveys over the study period through the digital app. The times for survey completion are within one week after agreeing to participate in the study, after 6 weeks, and 12 weeks. The surveys include questions about personal history, drug usage and cravings, missed follow-up medical appointments, and parenting outcomes. An interview with the PI at 12 weeks post-delivery.

Group Type: EXPERIMENTAL

Digital technology

Intervention Type: DEVICE

The digital app is a customized comprehensive self-management platform designed to provide recovery and parenting support for individuals with substance use disorders.

Parenting book as support for control group

The bibliotherapy control group will receive a book on what to expect as a parent the first year after delivery.

The control group will complete surveys over the study period and are given the option to complete surveys by phone or videoconference with a Team member. The times for survey completion are within one week after agreeing to participate in the study, after 6 weeks, and 12 weeks. The surveys include questions about personal history, drug usage and cravings, missed follow-up medical appointments, and parenting outcomes. An interview with the PI at 12 weeks post-delivery.

Group Type: ACTIVE_COMPARATOR

Bibliotherapy

Intervention Type: OTHER

Bibliotherapy control group will receive parenting book what to expect the first year.

Interventions

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.

Intervention Type: DEVICE

Bibliotherapy

Bibliotherapy control group will receive parenting book what to expect the first year.

Intervention Type: OTHER

Other Intervention Names

digital app; book

Eligibility Criteria

Inclusion Criteria

Female, pregnant, greater 13 weeks gestational age

• Opioid Dominant Use Disorder and Primary Phenotype
• Residing in natural home environment
• minimum of 18 years of age
• Able to speak and understand English
• Able to understand and provide informed consent

Exclusion Criteria

• Not pregnant, has active illicit opioid use and not currently in treatment
• a violent criminal history
• cannot read and communicate in English

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Phyllis Raynor

Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Phyllis A Raynor, PHD

Role: PRINCIPAL_INVESTIGATOR

University of South Carolina

Locations

MUSC Health Institute of Psychiatry

Charleston, South Carolina, United States

Countries

United States

Other Identifiers

Pro00136341

Identifier Type: -

Identifier Source: org_study_id