Clinical trial Recruiting at 2 sites Interventional Ages 18 and up Women only

Helping mothers with substance use issues during pregnancy

Official title: A Randomized Controlled Trial of the Parent-Child Assistance Program in Oklahoma

Run by University of Oklahoma · NCT05534568 · Data updated 2026-11-12

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

Study typeInterventional
Ages18 Years and up
SexWomen only
Enrollment200 (estimated)
SponsorUniversity of Oklahoma
Academic / other
Locations2 sites (Oklahoma City, Oklahoma and 1 other locations)
StatusRecruiting
StartedNovember 15, 2022
Main results expectedNovember 15, 2025
Study endsNovember 15, 2026
Registry record updatedJune 7, 2024
Trial IDNCT05534568 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably not a fit

Patients who are currently incarcerated or enrolled in similar services may not benefit from this program.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: Previous implementations of the PCAP in Washington state have shown success in improving outcomes for mothers and children affected by substance use disorders.

Who can join: the full rules

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 it's running

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.