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NCT04459000 · ClinicalTrials.gov registry record · NA
Substance Use Treatment and Access to Resources (STARS) Project
A NA study of Pregnancy Related and Substance Use Disorders, sponsored by University of Oklahoma.
- Recruiting
- Registry status
- NA
- Development phase
- 242
- Enrollment target
- 1
- Study location
NCT04459000: Recruiting NA study of Pregnancy Related and Substance Use Disorders, sponsored by University of Oklahoma.
NCT04459000 is a NA study of Pregnancy Related and Substance Use Disorders that is actively recruiting participants, run by University of Oklahoma. The registered enrollment target is 242 participants, below the 1,961-participant average among 99 other Pregnancy Related trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04459000, a NA study of Pregnancy Related and Substance Use Disorders, is actively recruiting participants, sponsored by University of Oklahoma.
- RECRUITING
- Registry status
- NA
- Development phase
- 242 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is evaluating a randomized clinical trial and a quasi-experimental observational study combined. Pregnant women with substance abuse issues are referred to the Substance Use Treatment and Recovery (STAR) prenatal clinic, and those who consent to participate in the study will be randomized to the STAR + maternal Attachment Biobehavioral Catchup (mABC) home visiting model or to the STAR only treatment group. Those who opt out of receiving prenatal care at STAR will be recruited as a control group for the QED portion. Those randomized to STAR + mABC will receive additional supports from a licensed therapist, including up to 12 home visits focused on substance exposed babies and positive parenting.
Primary Outcome
Are there group differences in the rate of mother's substance use? Substance use measured using Addiction Severity Index (ASI) assessment self-report. Frequencies of use of different drugs will be monitored.
Conditions Studied
Interventions
- BEHAVIORAL STARS + maternal Attachment Biobehavioral Catchup home visiting model
- BEHAVIORAL STARs Only
Study Locations (1)
Oklahoma
- University of Oklahoma Health Sciences Center - Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 242 participants |
| Start Date | 2020-12-16 |
| Est. Completion | 2025-09 |
| Phase | NA |
What NCT04459000 shows while recruiting
NCT04459000 is an interventional study that assigns participants to a tested intervention. The registered 242 participants enrollment target is mid-sized for trials with a published cap, below the 1,961-participant average among 99 other Pregnancy Related trials with a reported enrollment target (88% lower).
The record links to 3 conditions, with Pregnancy Related appearing as the primary indexed condition, and to 2 interventions - of which STARS + maternal Attachment Biobehavioral Catchup home visiting model is the first listed.
NCT04459000 reports a single indexed study location in Oklahoma.
Frequently Asked Questions
What is clinical trial NCT04459000 about?
NCT04459000 is a clinical study titled "Substance Use Treatment and Access to Resources (STARS) Project". This study is evaluating a randomized clinical trial and a quasi-experimental observational study combined. Pregnant women with substance abuse issues are referred to the Substance Use Treatment and Recovery (STAR) prenatal clinic, and those who consent to participate in the study will be randomized...
What is the current status of trial NCT04459000?
This trial is currently recruiting. It is a NA study. The enrollment target is 242 participants. The study started on 2020-12-16. Estimated completion is 2025-09.
What conditions does trial NCT04459000 study?
This clinical trial studies the following conditions: Pregnancy Related, Substance Use Disorders, Child Neglect.
What interventions are being tested in trial NCT04459000?
The interventions under investigation include: STARS + maternal Attachment Biobehavioral Catchup home visiting model (BEHAVIORAL), STARs Only (BEHAVIORAL).
Who is sponsoring clinical trial NCT04459000?
This trial is sponsored by University of Oklahoma, which has 358 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04459000 being conducted?
This trial has 1 study location across Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pregnancy Related
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04459000's enrollment target sits among peer trials
242 39th of 99 higher than 61 of 99 other Pregnancy Related trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pregnancy Related trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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