Support for pregnant women with substance use issues
Substance Use Treatment and Access to Resources (STARS) Project
This study is testing whether extra support and home visits for pregnant women with substance use issues can help them and their babies more than standard treatment alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 242 (estimated) |
| Ages | N/A to 55 Years |
| Sex | All |
| Sponsor | University of Oklahoma Academic / other |
| Locations | 1 site (Oklahoma City, Oklahoma) |
| Trial ID | NCT04459000 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a combined intervention for pregnant women struggling with substance use disorders. Participants will be randomized to receive either standard treatment at the STAR prenatal clinic or enhanced support through the STAR program along with the maternal Attachment Biobehavioral Catchup (mABC) home visiting model. The mABC model includes up to 12 home visits from a licensed therapist, focusing on positive parenting and care for substance-exposed infants. A control group will consist of women who opt out of STAR services, allowing for a comparison of outcomes between the groups.
Who should consider this trial
Good fit: Ideal candidates are pregnant women with substance abuse issues who are eligible for services at the STAR prenatal clinic and can communicate in English.
Not a fit: Patients who are unable to read English at an 8th grade comprehension level or those living outside the Oklahoma City metropolitan area may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could improve maternal and infant health outcomes by providing targeted support for substance use issues during pregnancy.
How similar studies have performed: Other studies have shown success with similar integrated approaches to treating substance use disorders in pregnant women, indicating potential for positive outcomes.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Oklahoma City, Oklahoma
- University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States (Recruiting)
Study contacts
- Principal investigator: David Bard, PhD — Ouhsc
- Study coordinator: Mallory Ford, MS
- Email: mallory-ford@ouhsc.edu
- Phone: 405-271-8858
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.