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Active, not recruiting Early Phase 1 Interventional

Digital Support Intervention for Pregnant People with Opioid Use Disorders

ClinicalTrials.gov ID: NCT06652880

Public ClinicalTrials.gov record NCT06652880. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 6, 2026, 9:16 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT06652880
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Early Phase 1
Enrollment
32 participants

Conditions and interventions

Interventions

Device · Other

Eligibility (public fields only)

Age range
18 Years to 45 Years
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 3, 2024
Primary completion
Aug 27, 2025
Completion
Dec 30, 2025
Last update posted
Feb 16, 2025

2024 – 2025

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
MUSC Health Institute of Psychiatry Charleston South Carolina 29425

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06652880, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 16, 2025 · Synced Sep 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06652880 live on ClinicalTrials.gov.

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