Pregnancy Related Clinical Trial
Official title:
A Randomized Controlled Trial of the Parent-Child Assistance Program in Oklahoma
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | November 15, 2026 |
Est. primary completion date | November 15, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Oklahoma City | Oklahoma City | Oklahoma |
United States | Tulsa | Tulsa | Oklahoma |
Lead Sponsor | Collaborator |
---|---|
University of Oklahoma | Arnall Family Foundation, Casey Family Programs, Oklahoma Human Services, Oklahoma Mental Health and Substance Abuse, OU Dodge Family College of Arts and Sciences, University of Oklahoma Outreach, University of Washington |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in using a reliable method(s) of birth control | The mother is on a reliable method(s) of birth control. | Measured every six months up to 4 years | |
Primary | Change in abstinence | The mother is abstinent from alcohol and drugs for at least six months. | Measured every six months up to 4 years | |
Secondary | Change in criminal justice involvement | The mother has had no new involvement with the criminal justice system. | Measured every six months up to 4 years | |
Secondary | Change in child custody | The mother has physical custody of the index child. | Measured every six months up to 4 years | |
Secondary | Change in stable housing | The mother resides in stable housing. | Measured every six months up to 4 years | |
Secondary | Change in employment | The mother is employed. | Measured every six months up to 4 years | |
Secondary | Change in education | The mother has completed or is enrolled in educational program. | Measured every six months up to 4 years | |
Secondary | Change in use of public benefits | The mother receives public benefits (e.g., housing, food, cash) | Measured every six months up to 4 years |
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