Recruiting

Observational Study

Sponsor:

University of Oklahoma

Code:

NCT05534568

Conditions

Substance Use Disorders

Pregnancy Related

Alcohol Use Disorder (AUD)

Alcohol Use Complicating Pregnancy, First Trimester

Alcohol Use Complicating Pregnancy, Second Trimester

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Parent-Child Assistance Program

Study Details

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.

Conditions

Substance Use Disorders

Pregnancy Related

Alcohol Use Disorder (AUD)

Alcohol Use Complicating Pregnancy, First Trimester

Alcohol Use Complicating Pregnancy, Second Trimester

Study ID

NCT05534568

Start date

Nov 15, 2022

Status verified date

Jun, 2024

Completion date

Nov 15, 2026

Anticipated

Primary completion date

Nov 15, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Julie Gerlinger, Ph.D.

(405) 325-1751jgerlinger@ou.edu

Angela Harnden, Ph.D.

(405) 919-9708aharnden@ou.edu

Locations

Oklahoma City

Recruiting

Oklahoma City, Oklahoma, United States, 73106

Tulsa

Recruiting

Tulsa, Oklahoma, United States, 74120

More Information

Sponsor

University of Oklahoma

Last update posted

Jun 7, 2024

Last verified

Jun, 2024

Keywords

  • Parent-child assistance
  • Substance use disorder
  • addictions
  • drug dependence
  • drug abuse
  • alcohol dependence
  • alcohol abuse
  • alcoholism
  • recovery services
  • PCAP

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Oklahoma on 2024-06-07.