The Oklahoma Parent-Child Assistance Program
NCT05534568 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2024-06-07
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.
Conditions
- Substance Use Disorders
- Pregnancy Related
- Alcohol Use Disorder (AUD)
- Alcohol Use Complicating Pregnancy, First Trimester
- Alcohol Use Complicating Pregnancy, Second Trimester
- Alcohol Use Complicating Pregnancy, Third Trimester
- Alcohol Use Complicating Pregnancy, Unspecified Trimester
- Alcohol Use Complicating Pregnancy, Childbirth, and the Puerperium
- Fetal Alcohol Spectrum Disorders
- Fetal Alcohol Syndrome
- Drug Use Disorders
- Drug Use Complicating Pregnancy, First Trimester
- Drug Use Complicating Pregnancy, Second Trimester
- Drug Use Complicating Pregnancy, Third Trimester
- Drug Use Complicating Pregnancy, Unspecified Trimester
- Drug Use Complicating Pregnancy, Childbirth, and the Puerperium
- Maternal Drugs Affecting Fetus
Interventions
- OTHER
-
Parent-Child Assistance Program
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.
Sponsors & Collaborators
-
University of Oklahoma Outreach
collaborator UNKNOWN -
Oklahoma Mental Health and Substance Abuse
collaborator UNKNOWN -
Arnall Family Foundation
collaborator UNKNOWN -
Oklahoma Human Services
collaborator UNKNOWN -
OU Dodge Family College of Arts and Sciences
collaborator UNKNOWN -
Casey Family Programs
collaborator UNKNOWN - collaborator OTHER
-
University of Oklahoma
lead OTHER
Principal Investigators
-
Erin Maher, Ph.D. · University of Oklahoma
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-11-15
- Primary Completion
- 2025-11-15
- Completion
- 2026-11-15
Countries
- United States
Study Locations
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