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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Oklahoma
Oklahoma City
RECRUITING
Oklahoma City
Tulsa
RECRUITING
Tulsa
Contact Information
Primary
Julie Gerlinger, Ph.D.
jgerlinger@ou.edu
(405) 325-1751
Backup
Angela Harnden, Ph.D.
aharnden@ou.edu
(405) 919-9708
Time Frame
Start Date: 2022-11-15
Estimated Completion Date: 2026-11-15
Participants
Target number of participants: 200
Treatments
Experimental: Treatment Group
The treatment group consists of women who have used alcohol, opioids, or other drugs during pregnancy and their children. Mothers who are randomly assigned to the treatment group will receive PCAP services through the work of highly trained, closely supervised case managers.
No_intervention: Control Group
The control group consists of women who have used alcohol, opioids, or other drugs during pregnancy and their children. Women in the control group will be provided with a service resource list and receive services as usual, but they will not be enrolled in PCAP.
Related Therapeutic Areas
Sponsors
Leads: University of Oklahoma
Collaborators: University of Washington, University of Oklahoma Outreach, Oklahoma Mental Health and Substance Abuse, Arnall Family Foundation, OU Dodge Family College of Arts and Sciences, Casey Family Programs, Oklahoma Human Services

This content was sourced from clinicaltrials.gov