Last reviewed · How we verify
NCT06652880: PARENTSS
Digital Support Intervention for Pregnant People with Opioid Use Disorders
EARLY_PHASE1 trial testing Digital technology in Digital Intervention in 32 participants. Participants enrolled and being followed up; not accepting new ones.
28 August 2025
Quick facts
| Lead sponsor | University of South Carolina |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | supportive care |
| Enrollment | 32 |
| Start date | 4 June 2024 |
| Primary completion | 28 August 2025 |
| Estimated completion | 31 December 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Digital technology
- Bibliotherapy
Conditions studied
- Digital Intervention — all drugs for Digital Intervention →
- Bibliotherapy — all drugs for Bibliotherapy →
Sponsor
University of South Carolina
Who can join
Adults 18 to 45, female only, with Digital Intervention or Bibliotherapy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06652880
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Digital technology
Trials testing the same drug.
- NCT03871907 — Effect of Digital Technologies on Risk Factor Modification · NA · completed
Other recruiting trials for Digital Intervention
Currently open trials in the same condition.
- NCT07272824 — Usability Study of Gestational and Postpartum Weight Management Program · recruiting
- NCT07400549 — Prospective Exploratory Study on the Comprehensive Application Effectiveness of Exercise Prescription Decision Support T · NA · recruiting
- NCT05645835 — Dynamic Neural Systems Underlying Social-emotional Functions in Older Adults · NA · active not recruiting
Other University of South Carolina trials
Trials by the same sponsor.
- NCT06469749 — Theory-based Social Media Intervention for Non-medical Use of Prescription Opioids in Young Adults · NA · not yet recruiting
- NCT07340580 — Implementation Facilitation of Exercise is Medicine Greenville · NA · not yet recruiting
- NCT07518407 — Dietary Insights and Nutritional Education in Adults on GLP-1 Therapy · NA · not yet recruiting
- NCT07340099 — Church Implementation of a Social Support Intervention to Increase Physical Activity in Older African American Adults · NA · not yet recruiting
- NCT06024317 — Leveraging Community Health Workers and a Digital Health System to Improve the Timeliness of Child Well Visits · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06652880 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of South Carolina
- Last refreshed: 17 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06652880.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing