Helping mothers with substance use issues during pregnancy
A Randomized Controlled Trial of the Parent-Child Assistance Program in Oklahoma
This study is trying out a program to help mothers who have used drugs or alcohol during pregnancy get support and resources to build healthier lives for themselves and their children.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Oklahoma Academic / other |
| Locations | 2 sites (Oklahoma City, Oklahoma and 1 other locations) |
| Trial ID | NCT05534568 on ClinicalTrials.gov |
What this trial studies
The Parent-Child Assistance Program (PCAP) is designed to support mothers who have used alcohol, opioids, or other drugs during pregnancy, along with their children. Over three years, trained case managers work closely with these mothers, often in their homes, to help them set personal goals and access community resources. The program aims to assist mothers in obtaining treatment for substance use disorders, link them to resources for building healthy family lives, and prevent future substance use during pregnancy. This initiative is being implemented in Oklahoma for the first time, targeting a vulnerable population with high rates of incarceration and substance use issues.
Who should consider this trial
Good fit: Ideal candidates for this program are women aged 18 or older who have used alcohol, opioids, or other drugs during pregnancy and reside in Oklahoma City or Tulsa.
Not a fit: Patients who are currently incarcerated or enrolled in similar services may not benefit from this program.
Why it matters
Potential benefit: If successful, this program could significantly improve the health and well-being of mothers and their children affected by substance use disorders.
How similar studies have performed: Previous implementations of the PCAP in Washington state have shown success in improving outcomes for mothers and children affected by substance use disorders.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years or older * Women who have used alcohol, opioids, or other drugs during pregnancy * Women who are (1) pregnant or have a child under 24 months old who was exposed to substances and are not well connected to community services or (2) have a child with fetal Alcohol Spectrum Disorder and are currently with at-risk alcohol use and in childbearing years * Resides in Oklahoma City, Oklahoma or Tulsa, Oklahoma Exclusion Criteria: * Not meeting eligible criteria above * Incarcerated at the time of enrollment * Enrollment in similar services (i.e., ReMerge, Systems of Care (SOC) and/or Family Treatment Courts (FTC) and heading to Termination of Parental Rights (TPR)) * If the participant is receiving services from the Substance use Treatment and Recovery (STAR) Prenatal Clinic and is part of the research, their enrollment in PCAP will be delayed until STAR Prenatal Clinic graduation
Where this trial is running
Oklahoma City, Oklahoma and 1 other locations
- Oklahoma City — Oklahoma City, Oklahoma, United States (Recruiting)
- Tulsa — Tulsa, Oklahoma, United States (Recruiting)
Study contacts
- Principal investigator: Erin Maher, Ph.D. — University of Oklahoma
- Study coordinator: Julie Gerlinger, Ph.D.
- Email: jgerlinger@ou.edu
- Phone: (405) 325-1751
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.