The Oklahoma Parent-Child Assistance Program

Part of paid clinical trials in Oklahoma City, Oklahoma.

Sponsor
University of Oklahoma
Study ID
NCT05534568
Status
Recruiting
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Conditions

  • Alcohol Use Complicating Pregnancy, Childbirth, and the Puerperium
  • 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 Disorder (AUD)
  • Drug Use Complicating Pregnancy, Childbirth, and the Puerperium
  • 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 Disorders
  • Fetal Alcohol Spectrum Disorders
  • Fetal Alcohol Syndrome
  • Maternal Drugs Affecting Fetus
  • Pregnancy Related
  • Substance Use Disorders

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Parent-Child Assistance Program — OTHER
    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.

Study Details

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.

Key Dates

Start date
Nov 15, 2022
Status verified
Jun 2024
Primary completion
Nov 15, 2025
Completion
Nov 15, 2026

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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.

Primary Outcome Measure

Change in using a reliable method(s) of birth control [ Time Frame: Measured every six months up to 4 years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Oklahoma CityOklahoma CityOklahoma73106
Angela Harnden
TulsaTulsaOklahoma74120
Angela Harnden

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