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NCT06652880 · ClinicalTrials.gov registry record · Early Phase 1
Digital Support Intervention for Pregnant People with Opioid Use Disorders
A Early Phase 1 study of Digital Intervention and Bibliotherapy, sponsored by University of South Carolina.
- Active
- Registry status
- Early Phase 1
- Development phase
- 32
- Enrollment target
- 1
- Study location
NCT06652880: Active Early Phase 1 study of Digital Intervention and Bibliotherapy, sponsored by University of South Carolina.
NCT06652880 is a Early Phase 1 study of Digital Intervention and Bibliotherapy that is active but no longer recruiting, run by University of South Carolina. The registered enrollment target is 32 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (40% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06652880, a Early Phase 1 study of Digital Intervention and Bibliotherapy, is active but no longer recruiting, sponsored by University of South Carolina.
- ACTIVE NOT RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 32 participants
- Enrollment target
- 1
- Study location
Study 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
Primary Outcome
Recruitment - recruitment measures (e.g., total time, direct calls regarding interest, number eligible/ineligible, refusals) (Qualitative) Qualitative data via interviews at the end of the study period with each participant in the Intervention group regarding type of smart phone used/model; overall experience using the app, times and situations when participants were more likely to use app as a resource, app features most helpful in supporting recovery from OUD, app features most helpful in supp
Conditions Studied
Interventions
- DEVICE Digital technology
- OTHER Bibliotherapy
Study Locations (1)
South Carolina
- MUSC Health Institute of Psychiatry - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2024-06-04 |
| Est. Completion | 2025-12-31 |
| Phase | Early Phase 1 |
What the registry record for NCT06652880 still lists
NCT06652880 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (40% lower).
The record links to 2 conditions, with Digital Intervention appearing as the primary indexed condition, and to 2 interventions - of which Digital technology is the first listed.
NCT06652880 reports a single indexed study location in South Carolina.
Frequently Asked Questions
What is clinical trial NCT06652880 about?
NCT06652880 is a clinical study titled "Digital Support Intervention for Pregnant People with Opioid Use Disorders". 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 cust...
What is the current status of trial NCT06652880?
This trial is currently active not recruiting. It is a Early Phase 1 study. The enrollment target is 32 participants. The study started on 2024-06-04. Estimated completion is 2025-12-31.
What conditions does trial NCT06652880 study?
This clinical trial studies the following conditions: Digital Intervention, Bibliotherapy.
What interventions are being tested in trial NCT06652880?
The interventions under investigation include: Digital technology (DEVICE), Bibliotherapy (OTHER).
Who is sponsoring clinical trial NCT06652880?
This trial is sponsored by University of South Carolina, which has 157 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06652880 being conducted?
This trial has 1 study location across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT06652880's enrollment target sits among peer trials
32 775th of 2000 higher than 1,208 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
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Source ClinicalTrials.gov registry export · 2026-08-08
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