NCT05534568 The Oklahoma Parent-Child Assistance Program
| NCT ID | NCT05534568 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Oklahoma |
| Condition | Substance Use Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2022-11-15 |
| Primary Completion | 2025-11-15 |
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 200 participants in total. It began in 2022-11-15 with a primary completion date of 2025-11-15.
⚠ 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
The Parent-Child Assistance Program (PCAP) helps mothers who have used alcohol, opioids, or other drugs during pregnancy and their children through the work of highly trained, closely supervised case managers. Case managers work closely with mothers over the course of three years, meeting the mothers in their own homes when possible, to help them to set goals and take advantage of available resources. The primary aims of PCAP include: (1) assisting mothers in obtaining substance use disorder (SUD) treatment and staying in recovery, (2) linking mothers to community resources that will help them build and maintain healthy, independent family lives for themselves and their children, and (3) preventing future drug and alcohol use during pregnancy. This study brings PCAP to Oklahoma (the state with the highest incarceration rate for women, where most enter the criminal justice system for drug charges) for the first time. This five-year project includes 200 women who will enroll in the study and be randomly assigned to the treatment (100 women) or control group (100 women). The intervention (i.e., PCAP services) will take place over a three-year period at two sites: Oklahoma City, Oklahoma and Tulsa, Oklahoma. This evaluation will measure participants' substance use, substance use disorder (SUD) treatment outcomes, and a host of other well-being outcomes-including but not limited to subsequent substance-exposed births, use of public assistance, education, use of family planning methods, and employment-to evaluate the effects of PCAP services. Among these, the investigators have identified four key outcomes: (1) the mother is on a reliable method of birth control, (2) abstinence for six months, (3) child custody (i.e., placement of children in foster care and/or with kinship providers), and (4) criminal justice involvement.
Eligibility 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
Contact & Investigator
Erin Maher, Ph.D.
PRINCIPAL INVESTIGATOR
University of Oklahoma
Frequently Asked Questions
Who can join the NCT05534568 clinical trial?
This trial is open to female participants only, aged 18 Years or older, 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 NCT05534568 currently recruiting?
Yes, NCT05534568 is actively recruiting participants. Contact the research team at jgerlinger@ou.edu for enrollment information.
Where is the NCT05534568 trial being conducted?
This trial is being conducted at Oklahoma City, United States, Tulsa, United States.
Who is sponsoring the NCT05534568 clinical trial?
NCT05534568 is sponsored by University of Oklahoma. The principal investigator is Erin Maher, Ph.D. at University of Oklahoma. The trial plans to enroll 200 participants.