NCT04459000 Substance Use Treatment and Access to Resources (STARS) Project
| NCT ID | NCT04459000 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Oklahoma |
| Condition | Substance Use Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 242 participants |
| Start Date | 2020-12-16 |
| Primary Completion | 2025-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 242 participants in total. It began in 2020-12-16 with a primary completion date of 2025-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Pregnant woman with substance abuse issue occurring during pregnancy * Eligible for services at the STAR prenatal clinic * Speaks/comprehends English Exclusion Criteria: * Unable to read English at 8th grade comprehension level * Those outside of Oklahoma City metropolitan area.
Contact & Investigator
David Bard, PhD
PRINCIPAL INVESTIGATOR
OUHSC
Frequently Asked Questions
Who can join the NCT04459000 clinical trial?
This trial is open to participants of all sexes, up to 55 Years, studying Substance Use Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04459000 currently recruiting?
Yes, NCT04459000 is actively recruiting participants. Contact the research team at mallory-ford@ouhsc.edu for enrollment information.
Where is the NCT04459000 trial being conducted?
This trial is being conducted at Oklahoma City, United States.
Who is sponsoring the NCT04459000 clinical trial?
NCT04459000 is sponsored by University of Oklahoma. The principal investigator is David Bard, PhD at OUHSC. The trial plans to enroll 242 participants.